Carolyn Sachs

KOLOA, HAWAII – Two studies show encouraging results for the effectiveness of including family-focused therapy in the treatment of adolescents with bipolar disorder.

Although patients must be “stabilized and treated with the appropriate medication, clearly with bipolar adolescents I think that there's a huge need for the family to be there and be involved in the therapy,” said W. Edward Craighead, Ph.D., the J. Rex Fuqua chair in child psychiatry at Emory University, Atlanta.

Speaking at a premeeting session of the annual meeting of the American College of Psychiatrists, Dr. Craighead referred first to a preliminary open study of 20 bipolar adolescent patients that he and his colleagues conducted over the course of 12 months (J. Affect. Disord. 2004;82:S113-28).

In the study, combined treatment with family-focused therapy (FFT) and medication was associated with much improved ratings by parents on the Child Behavior Checklist and reductions in the Schedule for Affective Disorders and Schizophrenia for School-Age Children depression and mania scores.

In bipolar patients, “medications are much better at reducing and managing the mania, but are not as good with the depression side,” Dr. Craighead observed, adding that “what's encouraging about [FFT] is that the effect is primarily on the depressive side.”

The second study of bipolar adolescents, in which Dr. Craighead is also an investigator, is currently under review by a journal. This two-site study compared the effectiveness of FFT plus medication versus crisis-management intervention plus medication. “There was a significantly larger effect for FFT,” he said, “and the primary effect was on fewer depressive symptoms over 2 years.”

The results of this new study in adolescents support the findings of earlier trials that examined the effectiveness of FFT in bipolar adults. He described one such study–a randomized trial of 101 adults in which FFT with pharmacotherapy showed significant benefits over crisis management with pharmacotherapy in reducing symptoms of mood disorder (Arch. Gen. Psychiatry 2003;60:904-12).

Family-focused therapy, Dr. Craighead noted, involves 21 outpatient sessions in which patients and their families receive psychoeducation about bipolar disorder, communication enhancement training, and problem-solving skills training.

The treatment, developed by David Miklowitz, Ph.D., and the late Michael Goldstein, Ph.D., is described in their book “Bipolar Disorder: A Family-Focused Treatment Approach” (New York: The Guilford Press, 1997). Dr. Miklowitz's new edition of the book was published in April.

Dr. Craighead holds stock in, consults with, or has contractual arrangements with Forest Laboratories, NovaDel Pharma, and John Wiley & Sons. He also disclosed that he had received an honorarium from Forest Laboratories.

KOLOA, HAWAII – Two studies show encouraging results for the effectiveness of including family-focused therapy in the treatment of adolescents with bipolar disorder.

Although patients must be “stabilized and treated with the appropriate medication, clearly with bipolar adolescents I think that there's a huge need for the family to be there and be involved in the therapy,” said W. Edward Craighead, Ph.D., the J. Rex Fuqua chair in child psychiatry at Emory University, Atlanta.

Speaking at a premeeting session of the annual meeting of the American College of Psychiatrists, Dr. Craighead referred first to a preliminary open study of 20 bipolar adolescent patients that he and his colleagues conducted over the course of 12 months (J. Affect. Disord. 2004;82:S113-28).

In the study, combined treatment with family-focused therapy (FFT) and medication was associated with much improved ratings by parents on the Child Behavior Checklist and reductions in the Schedule for Affective Disorders and Schizophrenia for School-Age Children depression and mania scores.

In bipolar patients, “medications are much better at reducing and managing the mania, but are not as good with the depression side,” Dr. Craighead observed, adding that “what's encouraging about [FFT] is that the effect is primarily on the depressive side.”

The second study of bipolar adolescents, in which Dr. Craighead is also an investigator, is currently under review by a journal. This two-site study compared the effectiveness of FFT plus medication versus crisis-management intervention plus medication. “There was a significantly larger effect for FFT,” he said, “and the primary effect was on fewer depressive symptoms over 2 years.”

The results of this new study in adolescents support the findings of earlier trials that examined the effectiveness of FFT in bipolar adults. He described one such study–a randomized trial of 101 adults in which FFT with pharmacotherapy showed significant benefits over crisis management with pharmacotherapy in reducing symptoms of mood disorder (Arch. Gen. Psychiatry 2003;60:904-12).

Family-focused therapy, Dr. Craighead noted, involves 21 outpatient sessions in which patients and their families receive psychoeducation about bipolar disorder, communication enhancement training, and problem-solving skills training.

The treatment, developed by David Miklowitz, Ph.D., and the late Michael Goldstein, Ph.D., is described in their book “Bipolar Disorder: A Family-Focused Treatment Approach” (New York: The Guilford Press, 1997). Dr. Miklowitz's new edition of the book was published in April.

Dr. Craighead holds stock in, consults with, or has contractual arrangements with Forest Laboratories, NovaDel Pharma, and John Wiley & Sons. He also disclosed that he had received an honorarium from Forest Laboratories.

KOLOA, HAWAII – Two studies show encouraging results for the effectiveness of including family-focused therapy in the treatment of adolescents with bipolar disorder.

Although patients must be “stabilized and treated with the appropriate medication, clearly with bipolar adolescents I think that there's a huge need for the family to be there and be involved in the therapy,” said W. Edward Craighead, Ph.D., the J. Rex Fuqua chair in child psychiatry at Emory University, Atlanta.

Speaking at a premeeting session of the annual meeting of the American College of Psychiatrists, Dr. Craighead referred first to a preliminary open study of 20 bipolar adolescent patients that he and his colleagues conducted over the course of 12 months (J. Affect. Disord. 2004;82:S113-28).

In the study, combined treatment with family-focused therapy (FFT) and medication was associated with much improved ratings by parents on the Child Behavior Checklist and reductions in the Schedule for Affective Disorders and Schizophrenia for School-Age Children depression and mania scores.

In bipolar patients, “medications are much better at reducing and managing the mania, but are not as good with the depression side,” Dr. Craighead observed, adding that “what's encouraging about [FFT] is that the effect is primarily on the depressive side.”

The second study of bipolar adolescents, in which Dr. Craighead is also an investigator, is currently under review by a journal. This two-site study compared the effectiveness of FFT plus medication versus crisis-management intervention plus medication. “There was a significantly larger effect for FFT,” he said, “and the primary effect was on fewer depressive symptoms over 2 years.”

The results of this new study in adolescents support the findings of earlier trials that examined the effectiveness of FFT in bipolar adults. He described one such study–a randomized trial of 101 adults in which FFT with pharmacotherapy showed significant benefits over crisis management with pharmacotherapy in reducing symptoms of mood disorder (Arch. Gen. Psychiatry 2003;60:904-12).

Family-focused therapy, Dr. Craighead noted, involves 21 outpatient sessions in which patients and their families receive psychoeducation about bipolar disorder, communication enhancement training, and problem-solving skills training.

The treatment, developed by David Miklowitz, Ph.D., and the late Michael Goldstein, Ph.D., is described in their book “Bipolar Disorder: A Family-Focused Treatment Approach” (New York: The Guilford Press, 1997). Dr. Miklowitz's new edition of the book was published in April.

Dr. Craighead holds stock in, consults with, or has contractual arrangements with Forest Laboratories, NovaDel Pharma, and John Wiley & Sons. He also disclosed that he had received an honorarium from Forest Laboratories.

WAIKOLOA, HAWAII — Early administration of fresh-frozen plasma to address coagulopathy can potentially reduce mortality, according to a study of 97 patients who received massive transfusions.

Although hemorrhage is still a major cause of early mortality in trauma patients, it is commonly believed that patients are not coagulopathic when they arrive in the emergency department, and that coagulopathy develops over time, said Dr. Swaminatha Mahadevan, who is associate chief of emergency medicine at Stanford (Calif.) University.

However, recent studies suggest that patients are coagulopathic when they “hit the ED door,” Dr. Mahadevan said at a symposium on emergency medicine sponsored by Stanford University.

“Most massive-transfusion protocols don't address this,” he added.

In Stanford's massive-transfusion protocol, and in many such guidelines throughout the United States, fresh-frozen plasma (FFP) is not given until the patient has received 4–6 U of blood, Dr. Mahadevan said.

In his presentation, Dr. Mahadevan referred to findings from a published study done at the University of Texas, Houston, which pointed to the need for earlier administration of FFP (J. Trauma 2007;62:112–9).

The University of Texas investigators reviewed data on 97 severely injured patients who required a massive transfusion of at least 10 U of packed red blood cells during their first 24 hours in the university hospital. “These patients were sick enough that they eventually had to go to the operating room, or to interventional radiology, to stop the bleeding,” Dr. Mahadevan said.

All of the patients studied were found to have had severe coagulopathy on arrival at the ED, with international normalized ratios (INRs) of 1.8, plus or minus 0.2.

Nevertheless, Dr. Mahadevan noted, because of the way the massive-transfusion guidelines have been set up, none of the patients received FFP until after they received 6 U of packed red cells.

Upon arrival in the ICU following initial resuscitation in the ED, the patients' INRs were still high (1.6, plus or minus 0.1).

Finally, they would start receiving packed red cells and FFP in a 1:1 ratio, Dr. Mahadevan said.

The patients were still moderately coagulopathic 8 hours later, he noted, with a mean INR of 1.4, plus or minus 0.03.

The University of Texas study found that the severity of coagulopathy on ICU admission correlated with an increase in mortality, Dr. Mahadevan observed.

“If your INR was greater than 2, you had a 50% mortality, which, obviously, is significant,” he commented.

Learning from this study, Dr. Mahadevan stressed that “we should be assuming that these patients are coagulopathic, and [we should be] giving FFP right out of the gates,” with an initial transfusion in a 1:1 ratio with packed red blood cells.

Based on the study's findings, the University of Texas investigators influenced the hospital to revise its massive-transfusion protocol for severe bleeding, Dr. Mahadevan noted.

WAIKOLOA, HAWAII — Early administration of fresh-frozen plasma to address coagulopathy can potentially reduce mortality, according to a study of 97 patients who received massive transfusions.

Although hemorrhage is still a major cause of early mortality in trauma patients, it is commonly believed that patients are not coagulopathic when they arrive in the emergency department, and that coagulopathy develops over time, said Dr. Swaminatha Mahadevan, who is associate chief of emergency medicine at Stanford (Calif.) University.

However, recent studies suggest that patients are coagulopathic when they “hit the ED door,” Dr. Mahadevan said at a symposium on emergency medicine sponsored by Stanford University.

“Most massive-transfusion protocols don't address this,” he added.

In Stanford's massive-transfusion protocol, and in many such guidelines throughout the United States, fresh-frozen plasma (FFP) is not given until the patient has received 4–6 U of blood, Dr. Mahadevan said.

In his presentation, Dr. Mahadevan referred to findings from a published study done at the University of Texas, Houston, which pointed to the need for earlier administration of FFP (J. Trauma 2007;62:112–9).

The University of Texas investigators reviewed data on 97 severely injured patients who required a massive transfusion of at least 10 U of packed red blood cells during their first 24 hours in the university hospital. “These patients were sick enough that they eventually had to go to the operating room, or to interventional radiology, to stop the bleeding,” Dr. Mahadevan said.

All of the patients studied were found to have had severe coagulopathy on arrival at the ED, with international normalized ratios (INRs) of 1.8, plus or minus 0.2.

Nevertheless, Dr. Mahadevan noted, because of the way the massive-transfusion guidelines have been set up, none of the patients received FFP until after they received 6 U of packed red cells.

Upon arrival in the ICU following initial resuscitation in the ED, the patients' INRs were still high (1.6, plus or minus 0.1).

Finally, they would start receiving packed red cells and FFP in a 1:1 ratio, Dr. Mahadevan said.

The patients were still moderately coagulopathic 8 hours later, he noted, with a mean INR of 1.4, plus or minus 0.03.

The University of Texas study found that the severity of coagulopathy on ICU admission correlated with an increase in mortality, Dr. Mahadevan observed.

“If your INR was greater than 2, you had a 50% mortality, which, obviously, is significant,” he commented.

Learning from this study, Dr. Mahadevan stressed that “we should be assuming that these patients are coagulopathic, and [we should be] giving FFP right out of the gates,” with an initial transfusion in a 1:1 ratio with packed red blood cells.

Based on the study's findings, the University of Texas investigators influenced the hospital to revise its massive-transfusion protocol for severe bleeding, Dr. Mahadevan noted.

WAIKOLOA, HAWAII — Early administration of fresh-frozen plasma to address coagulopathy can potentially reduce mortality, according to a study of 97 patients who received massive transfusions.

Although hemorrhage is still a major cause of early mortality in trauma patients, it is commonly believed that patients are not coagulopathic when they arrive in the emergency department, and that coagulopathy develops over time, said Dr. Swaminatha Mahadevan, who is associate chief of emergency medicine at Stanford (Calif.) University.

However, recent studies suggest that patients are coagulopathic when they “hit the ED door,” Dr. Mahadevan said at a symposium on emergency medicine sponsored by Stanford University.

“Most massive-transfusion protocols don't address this,” he added.

In Stanford's massive-transfusion protocol, and in many such guidelines throughout the United States, fresh-frozen plasma (FFP) is not given until the patient has received 4–6 U of blood, Dr. Mahadevan said.

In his presentation, Dr. Mahadevan referred to findings from a published study done at the University of Texas, Houston, which pointed to the need for earlier administration of FFP (J. Trauma 2007;62:112–9).

The University of Texas investigators reviewed data on 97 severely injured patients who required a massive transfusion of at least 10 U of packed red blood cells during their first 24 hours in the university hospital. “These patients were sick enough that they eventually had to go to the operating room, or to interventional radiology, to stop the bleeding,” Dr. Mahadevan said.

All of the patients studied were found to have had severe coagulopathy on arrival at the ED, with international normalized ratios (INRs) of 1.8, plus or minus 0.2.

Nevertheless, Dr. Mahadevan noted, because of the way the massive-transfusion guidelines have been set up, none of the patients received FFP until after they received 6 U of packed red cells.

Upon arrival in the ICU following initial resuscitation in the ED, the patients' INRs were still high (1.6, plus or minus 0.1).

Finally, they would start receiving packed red cells and FFP in a 1:1 ratio, Dr. Mahadevan said.

The patients were still moderately coagulopathic 8 hours later, he noted, with a mean INR of 1.4, plus or minus 0.03.

The University of Texas study found that the severity of coagulopathy on ICU admission correlated with an increase in mortality, Dr. Mahadevan observed.

“If your INR was greater than 2, you had a 50% mortality, which, obviously, is significant,” he commented.

Learning from this study, Dr. Mahadevan stressed that “we should be assuming that these patients are coagulopathic, and [we should be] giving FFP right out of the gates,” with an initial transfusion in a 1:1 ratio with packed red blood cells.

Based on the study's findings, the University of Texas investigators influenced the hospital to revise its massive-transfusion protocol for severe bleeding, Dr. Mahadevan noted.

KAUI, HAWAII – Preschoolers at genetic risk for antisocial behavior may benefit from family-based preventive intervention, Dr. Glen O. Gabbard said at the annual meeting of the American College of Psychiatrists.

“I worked in the prison system for 6 years. One of the things you see again and again is that antisocial patients are not very responsive to individual therapy,” he said.

If they don't receive any treatment until they are adults, “you're not going to get anywhere with them,” said Dr. Gabbard, Brown Foundation Professor of Psychoanalysis and professor of psychiatry at Baylor College of Medicine, Houston. “We need to start thinking about early preventive approaches based on family therapy models.”

In a recent study that he discussed, investigators enrolled 92 preschoolers who were considered to be at substantial genetic risk for antisocial behavior because they had siblings with a history of juvenile delinquency (Arch. Gen. Psychiatry 2007;64:1172-9).

The children were randomized to one of two groups. In the family-intervention group, the preschoolers and their parents had 22 weekly group sessions and 10 biweekly home visits over a 6- to 8-month period. The control group received assessments and monthly telephone calls. Salivary cortisol levels were measured as an indicator of response to stress.

Since salivary cortisol levels are lower in people who exhibit antisocial behavior and have conduct problems, “the thought here is that maybe the early-life experience can alter cortisol release,” he noted.

Compared with the control group, children who had undergone family-based intervention had increased salivary cortisol levels when faced with entry into an unfamiliar group of peers. “Something changed in their reading of social groups so that they had more anxiety,” Dr. Gabbard said.

“The antisocial patient doesn't engage the amygdala in the way that a borderline patient does,” he observed. The antisocial patient has “less of a fear response.” Family-based preventive intervention may play a role in boosting activation of the amygdala and modifying the hypothalamic-pituitary-adrenal axis when someone is faced with a threatening situation, he said.

“Preventive family therapy may give us some hope in what has been a rather dismal history of treating the psychopathic or antisocial patient,” said Dr. Gabbard, who disclosed no relevant conflicts.

Preventive family therapy might play a role in boosting activation of the amygdala. DR. GABBARD

KAUI, HAWAII – Preschoolers at genetic risk for antisocial behavior may benefit from family-based preventive intervention, Dr. Glen O. Gabbard said at the annual meeting of the American College of Psychiatrists.

“I worked in the prison system for 6 years. One of the things you see again and again is that antisocial patients are not very responsive to individual therapy,” he said.

If they don't receive any treatment until they are adults, “you're not going to get anywhere with them,” said Dr. Gabbard, Brown Foundation Professor of Psychoanalysis and professor of psychiatry at Baylor College of Medicine, Houston. “We need to start thinking about early preventive approaches based on family therapy models.”

In a recent study that he discussed, investigators enrolled 92 preschoolers who were considered to be at substantial genetic risk for antisocial behavior because they had siblings with a history of juvenile delinquency (Arch. Gen. Psychiatry 2007;64:1172-9).

The children were randomized to one of two groups. In the family-intervention group, the preschoolers and their parents had 22 weekly group sessions and 10 biweekly home visits over a 6- to 8-month period. The control group received assessments and monthly telephone calls. Salivary cortisol levels were measured as an indicator of response to stress.

Since salivary cortisol levels are lower in people who exhibit antisocial behavior and have conduct problems, “the thought here is that maybe the early-life experience can alter cortisol release,” he noted.

Compared with the control group, children who had undergone family-based intervention had increased salivary cortisol levels when faced with entry into an unfamiliar group of peers. “Something changed in their reading of social groups so that they had more anxiety,” Dr. Gabbard said.

“The antisocial patient doesn't engage the amygdala in the way that a borderline patient does,” he observed. The antisocial patient has “less of a fear response.” Family-based preventive intervention may play a role in boosting activation of the amygdala and modifying the hypothalamic-pituitary-adrenal axis when someone is faced with a threatening situation, he said.

“Preventive family therapy may give us some hope in what has been a rather dismal history of treating the psychopathic or antisocial patient,” said Dr. Gabbard, who disclosed no relevant conflicts.

Preventive family therapy might play a role in boosting activation of the amygdala. DR. GABBARD

KAUI, HAWAII – Preschoolers at genetic risk for antisocial behavior may benefit from family-based preventive intervention, Dr. Glen O. Gabbard said at the annual meeting of the American College of Psychiatrists.

“I worked in the prison system for 6 years. One of the things you see again and again is that antisocial patients are not very responsive to individual therapy,” he said.

If they don't receive any treatment until they are adults, “you're not going to get anywhere with them,” said Dr. Gabbard, Brown Foundation Professor of Psychoanalysis and professor of psychiatry at Baylor College of Medicine, Houston. “We need to start thinking about early preventive approaches based on family therapy models.”

In a recent study that he discussed, investigators enrolled 92 preschoolers who were considered to be at substantial genetic risk for antisocial behavior because they had siblings with a history of juvenile delinquency (Arch. Gen. Psychiatry 2007;64:1172-9).

The children were randomized to one of two groups. In the family-intervention group, the preschoolers and their parents had 22 weekly group sessions and 10 biweekly home visits over a 6- to 8-month period. The control group received assessments and monthly telephone calls. Salivary cortisol levels were measured as an indicator of response to stress.

Since salivary cortisol levels are lower in people who exhibit antisocial behavior and have conduct problems, “the thought here is that maybe the early-life experience can alter cortisol release,” he noted.

Compared with the control group, children who had undergone family-based intervention had increased salivary cortisol levels when faced with entry into an unfamiliar group of peers. “Something changed in their reading of social groups so that they had more anxiety,” Dr. Gabbard said.

“The antisocial patient doesn't engage the amygdala in the way that a borderline patient does,” he observed. The antisocial patient has “less of a fear response.” Family-based preventive intervention may play a role in boosting activation of the amygdala and modifying the hypothalamic-pituitary-adrenal axis when someone is faced with a threatening situation, he said.

“Preventive family therapy may give us some hope in what has been a rather dismal history of treating the psychopathic or antisocial patient,” said Dr. Gabbard, who disclosed no relevant conflicts.

Preventive family therapy might play a role in boosting activation of the amygdala. DR. GABBARD

MAUI, HAWAII — Clinical trial participation can be a moneymaker for an office practice with some realistic planning and savvy negotiations, according to Dr. Roy Fleischmann and Dr. Alvin Wells.

“If you're looking to make a profit, you've got to get a profit,” Dr. Fleischmann said. “If I'm getting paid double what I'd get paid for seeing the patient, I have a feeling I'm OK.” That extra in reimbursement provides a cushion to cover the unexpected, said Dr. Fleischmann of the University of Texas Southwestern Medical Center at Dallas.

Dr. Fleischmann explained, “You've got to figure out what your real charges are,” and that includes allocating a reasonable portion of overhead to cover the share of phone and utility costs incurred because of the project. He said he calculates the average amount of overhead attributable to a patient visit and incorporates that in his cost estimate.

“You do have to think about your time,” as well, in determining the costs of doing a trial, Dr. Fleischmann added. “You have to go to the investigative meeting—it costs you a day. You have to do the site opening—that costs you an hour. You have to fill out the case report form. You have to sign all those lab reports when they come in.”

Once you know your real costs, he recommends negotiating a minimum of 30% profit, which can act as a cushion to protect against unforeseen expenses. Amendments to the protocol and deadline extensions can increase associated expenses.

The key is to have someone other than the physician negotiate the contract with the company running the research. Dr. Fleischmann, who is in a large group, has an accountant do the negotiating. It's important to find someone you trust “to have the wherewithal to say, 'This is what we really need.'” It has to be fair, he added. “You're not getting rich on this, but it's a fair value,” he said, “and they need to understand that.”

Dr. Wells noted that costs and the bottom line cannot be ignored in the decision of whether to participate in a clinical trial. In estimating what he needs to be paid for a study, Dr. Wells, director of the Rheumatology and Immunotherapy Center in Oak Creek, Wisc., explained that he works with his billing staff to see what he is being paid for various patient visits, and then adjusts those numbers upward by 20%.

Dr. Wells, who is not part of a large practice, uses his coordinator to negotiate for him. “She does the dirty work,” he said. “We play good cop, bad cop.”

Both Dr. Wells and Dr. Fleischmann made their remarks during a symposium sponsored by Excellence in Rheumatology Education.

Beyond planning for a profit, physicians should pick their research projects carefully. Dr. Fleischmann noted that it's important to pick studies for which you have the patients. And be realistic about how many patients you can deliver, he added. His own large group practice is participating in two studies involving patients who have not responded to anti-tumor necrosis factor (TNF) agents. Because only a few of his patients have not responded to TNF blockers, he has committed to providing “1 or 2 patients; we're not going to do 12 of them,” Dr. Fleischmann said.

Although physicians always have the option of advertising for patients to meet recruitment goals, Dr. Fleischman advised against this. Work with patients from your own practice, he urged. “Patient recruitment is a killer,” he observed. “Nobody does it well.” If you don't have the patients in your practice who are willing to participate in a trial, he said, “you're not going to be able to do it.”

Dr. Wells noted convincing your patients to be in a trial can be tough. He reported finding it difficult to enroll patients in the current trial of celecoxib (Celebrex). Bad publicity about increased risk for heart attacks and strokes with cyclo-oxygenase-2 inhibitors gave his patients pause.

In considering whether to participate in a trial, “many times the patient will do it because of [their loyalty to] you,” Dr. Wells noted.

Dr. Fleischmann urged audience members to “be your own center” when doing a study. Or join up with a group of physicians with whom you are an equal partner. Avoid going through contract research organizations when doing trials, he said.

Contracts should include clauses to provide for renegotiation if the company makes a change during the course of a trial. “Sometimes companies will listen to it, and sometimes companies won't,” he said. “But if you've got the study,” he pointed out, and “you have patients in the study, you actually have a hook.” For instance, your patients can be withdrawn from the study.

Dr. Wells observed that there are bound to be differences in perspective between someone who has done “tons of clinical trials in a huge research group and somebody who is just essentially starting.”

Noting that he has done fewer trials than Dr. Fleischmann, Dr. Wells said he “might be willing to break even to get my foot in the door on a trial.” And, he said, “You get to answer some interesting questions.”

Dr. Fleischmann agreed that sometimes there are reasons to do a trial other than for money. “There are trials where we don't make money,” he said, “because there's an answer that we want to get.”

There is no correct answer on how long to keep records after a trial. “A lot of companies will say 15 years. That's the usual,” Dr. Fleischmann said. However, the Food and Drug Administration has the ability to go back and look at the data from a study at any point in time, he said.

“We keep them forever,” he said. He stores his records from clinical trials at Iron Mountain, and “the storage fee is actually part of the budget.”

He referred to a case from his own practice, in which the FDA performed an audit on a study 18 years after its completion. Dr. Fleischmann asked what would have happened if he had not had the data. “We could send you to jail,” he was told.

Dr. Fleischmann disclosed the following relationships with Abbott Laboratories, Amgen Inc., Centocor Inc., Genentech Inc., and Wyeth: speakers bureau, consultant/adviser, and research grants. He also is on the speakers bureau for Hoffmann-La Roche Inc.

Dr. Wells disclosed that he is a consultant/adviser for Abbott, Amgen, Bristol-Myers Squibb Co., Centocor, Genentech, and TAP Pharmaceutical Products Inc.

MAUI, HAWAII — Clinical trial participation can be a moneymaker for an office practice with some realistic planning and savvy negotiations, according to Dr. Roy Fleischmann and Dr. Alvin Wells.

“If you're looking to make a profit, you've got to get a profit,” Dr. Fleischmann said. “If I'm getting paid double what I'd get paid for seeing the patient, I have a feeling I'm OK.” That extra in reimbursement provides a cushion to cover the unexpected, said Dr. Fleischmann of the University of Texas Southwestern Medical Center at Dallas.

Dr. Fleischmann explained, “You've got to figure out what your real charges are,” and that includes allocating a reasonable portion of overhead to cover the share of phone and utility costs incurred because of the project. He said he calculates the average amount of overhead attributable to a patient visit and incorporates that in his cost estimate.

“You do have to think about your time,” as well, in determining the costs of doing a trial, Dr. Fleischmann added. “You have to go to the investigative meeting—it costs you a day. You have to do the site opening—that costs you an hour. You have to fill out the case report form. You have to sign all those lab reports when they come in.”

Once you know your real costs, he recommends negotiating a minimum of 30% profit, which can act as a cushion to protect against unforeseen expenses. Amendments to the protocol and deadline extensions can increase associated expenses.

The key is to have someone other than the physician negotiate the contract with the company running the research. Dr. Fleischmann, who is in a large group, has an accountant do the negotiating. It's important to find someone you trust “to have the wherewithal to say, 'This is what we really need.'” It has to be fair, he added. “You're not getting rich on this, but it's a fair value,” he said, “and they need to understand that.”

Dr. Wells noted that costs and the bottom line cannot be ignored in the decision of whether to participate in a clinical trial. In estimating what he needs to be paid for a study, Dr. Wells, director of the Rheumatology and Immunotherapy Center in Oak Creek, Wisc., explained that he works with his billing staff to see what he is being paid for various patient visits, and then adjusts those numbers upward by 20%.

Dr. Wells, who is not part of a large practice, uses his coordinator to negotiate for him. “She does the dirty work,” he said. “We play good cop, bad cop.”

Both Dr. Wells and Dr. Fleischmann made their remarks during a symposium sponsored by Excellence in Rheumatology Education.

Beyond planning for a profit, physicians should pick their research projects carefully. Dr. Fleischmann noted that it's important to pick studies for which you have the patients. And be realistic about how many patients you can deliver, he added. His own large group practice is participating in two studies involving patients who have not responded to anti-tumor necrosis factor (TNF) agents. Because only a few of his patients have not responded to TNF blockers, he has committed to providing “1 or 2 patients; we're not going to do 12 of them,” Dr. Fleischmann said.

Although physicians always have the option of advertising for patients to meet recruitment goals, Dr. Fleischman advised against this. Work with patients from your own practice, he urged. “Patient recruitment is a killer,” he observed. “Nobody does it well.” If you don't have the patients in your practice who are willing to participate in a trial, he said, “you're not going to be able to do it.”

Dr. Wells noted convincing your patients to be in a trial can be tough. He reported finding it difficult to enroll patients in the current trial of celecoxib (Celebrex). Bad publicity about increased risk for heart attacks and strokes with cyclo-oxygenase-2 inhibitors gave his patients pause.

In considering whether to participate in a trial, “many times the patient will do it because of [their loyalty to] you,” Dr. Wells noted.

Dr. Fleischmann urged audience members to “be your own center” when doing a study. Or join up with a group of physicians with whom you are an equal partner. Avoid going through contract research organizations when doing trials, he said.

Contracts should include clauses to provide for renegotiation if the company makes a change during the course of a trial. “Sometimes companies will listen to it, and sometimes companies won't,” he said. “But if you've got the study,” he pointed out, and “you have patients in the study, you actually have a hook.” For instance, your patients can be withdrawn from the study.

Dr. Wells observed that there are bound to be differences in perspective between someone who has done “tons of clinical trials in a huge research group and somebody who is just essentially starting.”

Noting that he has done fewer trials than Dr. Fleischmann, Dr. Wells said he “might be willing to break even to get my foot in the door on a trial.” And, he said, “You get to answer some interesting questions.”

Dr. Fleischmann agreed that sometimes there are reasons to do a trial other than for money. “There are trials where we don't make money,” he said, “because there's an answer that we want to get.”

There is no correct answer on how long to keep records after a trial. “A lot of companies will say 15 years. That's the usual,” Dr. Fleischmann said. However, the Food and Drug Administration has the ability to go back and look at the data from a study at any point in time, he said.

“We keep them forever,” he said. He stores his records from clinical trials at Iron Mountain, and “the storage fee is actually part of the budget.”

He referred to a case from his own practice, in which the FDA performed an audit on a study 18 years after its completion. Dr. Fleischmann asked what would have happened if he had not had the data. “We could send you to jail,” he was told.

Dr. Fleischmann disclosed the following relationships with Abbott Laboratories, Amgen Inc., Centocor Inc., Genentech Inc., and Wyeth: speakers bureau, consultant/adviser, and research grants. He also is on the speakers bureau for Hoffmann-La Roche Inc.

Dr. Wells disclosed that he is a consultant/adviser for Abbott, Amgen, Bristol-Myers Squibb Co., Centocor, Genentech, and TAP Pharmaceutical Products Inc.

MAUI, HAWAII — Clinical trial participation can be a moneymaker for an office practice with some realistic planning and savvy negotiations, according to Dr. Roy Fleischmann and Dr. Alvin Wells.

“If you're looking to make a profit, you've got to get a profit,” Dr. Fleischmann said. “If I'm getting paid double what I'd get paid for seeing the patient, I have a feeling I'm OK.” That extra in reimbursement provides a cushion to cover the unexpected, said Dr. Fleischmann of the University of Texas Southwestern Medical Center at Dallas.

Dr. Fleischmann explained, “You've got to figure out what your real charges are,” and that includes allocating a reasonable portion of overhead to cover the share of phone and utility costs incurred because of the project. He said he calculates the average amount of overhead attributable to a patient visit and incorporates that in his cost estimate.

“You do have to think about your time,” as well, in determining the costs of doing a trial, Dr. Fleischmann added. “You have to go to the investigative meeting—it costs you a day. You have to do the site opening—that costs you an hour. You have to fill out the case report form. You have to sign all those lab reports when they come in.”

Once you know your real costs, he recommends negotiating a minimum of 30% profit, which can act as a cushion to protect against unforeseen expenses. Amendments to the protocol and deadline extensions can increase associated expenses.

The key is to have someone other than the physician negotiate the contract with the company running the research. Dr. Fleischmann, who is in a large group, has an accountant do the negotiating. It's important to find someone you trust “to have the wherewithal to say, 'This is what we really need.'” It has to be fair, he added. “You're not getting rich on this, but it's a fair value,” he said, “and they need to understand that.”

Dr. Wells noted that costs and the bottom line cannot be ignored in the decision of whether to participate in a clinical trial. In estimating what he needs to be paid for a study, Dr. Wells, director of the Rheumatology and Immunotherapy Center in Oak Creek, Wisc., explained that he works with his billing staff to see what he is being paid for various patient visits, and then adjusts those numbers upward by 20%.

Dr. Wells, who is not part of a large practice, uses his coordinator to negotiate for him. “She does the dirty work,” he said. “We play good cop, bad cop.”

Both Dr. Wells and Dr. Fleischmann made their remarks during a symposium sponsored by Excellence in Rheumatology Education.

Beyond planning for a profit, physicians should pick their research projects carefully. Dr. Fleischmann noted that it's important to pick studies for which you have the patients. And be realistic about how many patients you can deliver, he added. His own large group practice is participating in two studies involving patients who have not responded to anti-tumor necrosis factor (TNF) agents. Because only a few of his patients have not responded to TNF blockers, he has committed to providing “1 or 2 patients; we're not going to do 12 of them,” Dr. Fleischmann said.

Although physicians always have the option of advertising for patients to meet recruitment goals, Dr. Fleischman advised against this. Work with patients from your own practice, he urged. “Patient recruitment is a killer,” he observed. “Nobody does it well.” If you don't have the patients in your practice who are willing to participate in a trial, he said, “you're not going to be able to do it.”

Dr. Wells noted convincing your patients to be in a trial can be tough. He reported finding it difficult to enroll patients in the current trial of celecoxib (Celebrex). Bad publicity about increased risk for heart attacks and strokes with cyclo-oxygenase-2 inhibitors gave his patients pause.

In considering whether to participate in a trial, “many times the patient will do it because of [their loyalty to] you,” Dr. Wells noted.

Dr. Fleischmann urged audience members to “be your own center” when doing a study. Or join up with a group of physicians with whom you are an equal partner. Avoid going through contract research organizations when doing trials, he said.

Contracts should include clauses to provide for renegotiation if the company makes a change during the course of a trial. “Sometimes companies will listen to it, and sometimes companies won't,” he said. “But if you've got the study,” he pointed out, and “you have patients in the study, you actually have a hook.” For instance, your patients can be withdrawn from the study.

Dr. Wells observed that there are bound to be differences in perspective between someone who has done “tons of clinical trials in a huge research group and somebody who is just essentially starting.”

Noting that he has done fewer trials than Dr. Fleischmann, Dr. Wells said he “might be willing to break even to get my foot in the door on a trial.” And, he said, “You get to answer some interesting questions.”

Dr. Fleischmann agreed that sometimes there are reasons to do a trial other than for money. “There are trials where we don't make money,” he said, “because there's an answer that we want to get.”

There is no correct answer on how long to keep records after a trial. “A lot of companies will say 15 years. That's the usual,” Dr. Fleischmann said. However, the Food and Drug Administration has the ability to go back and look at the data from a study at any point in time, he said.

“We keep them forever,” he said. He stores his records from clinical trials at Iron Mountain, and “the storage fee is actually part of the budget.”

He referred to a case from his own practice, in which the FDA performed an audit on a study 18 years after its completion. Dr. Fleischmann asked what would have happened if he had not had the data. “We could send you to jail,” he was told.

Dr. Fleischmann disclosed the following relationships with Abbott Laboratories, Amgen Inc., Centocor Inc., Genentech Inc., and Wyeth: speakers bureau, consultant/adviser, and research grants. He also is on the speakers bureau for Hoffmann-La Roche Inc.

Dr. Wells disclosed that he is a consultant/adviser for Abbott, Amgen, Bristol-Myers Squibb Co., Centocor, Genentech, and TAP Pharmaceutical Products Inc.

WAIKOLOA, HAWAII — Dr. Roy G. Geronemus warned against the cavalier approach of not using eye shields during laser surgery.

"The eyelid is very thin," he observed at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation. When using a device that works at 1.5 mm, "you damned well better" protect the patient's eyelids.

"With the CO₂ lasers, I think you should put a shield underneath the eyelids if you're treating the lids." Because it is possible that plastic shields will melt, said Dr. Geronemus of the New York University Medical Center, he prefers to use metal eye shields.

In a subsequent presentation, Dr. R. Rox Anderson, professor of dermatology at Harvard Medical School, Boston, and director of the Wellman Center for Photomedicine at Massachusetts General Hospital, also advocated for routine use of an eye shield, "especially if you're going to be treating inside the bony orbit."

Both lasers and intense pulsed lights used for hair removal in this area can be extremely damaging to the patient's eyes, he noted. "These devices are made to kill melanin-containing structures at great depth in the tissue, and the greatest amount of melanin in the body is in the uveal tract and the retina," Dr. Anderson said. "They're retinal killers."

Eye shields can also protect against possible injury from cryogen spray, he said. "There are cases of cryogen spray freezing the cornea and hurting it."

Dr. Anderson cautioned not to let anesthetics get under the eye shields when inserting them. "Most of our anesthetics, particularly EMLA [combination lidocaine and prilocaine cream], are really quite irritating," Dr. Anderson said, and can cause corneal burns.

Dr. Anderson disclosed that he had no relevant conflicts.

Dr. Geronemus disclosed that he is a shareholder in Thermage Inc., Reliant Technologies Inc., and Light BioScience LLC.

He is on the medical advisory boards of PhotoMedex Inc., Lumenis Ltd., Rhytec Inc., Candela Corp., Zeltiq Aesthetics, and Skin Cancer Company, and is an investigator for Reliant Technologies, Medicis Pharmaceutical Corp., Rhytec, DUSA Pharmaceuticals Inc., L'Oreal, Cutera Inc., Allergan Inc., and DermTech International. SDEF and SKIN & ALLERGY NEWS are wholly owned subsidiaries of Elsevier.

WAIKOLOA, HAWAII — Dr. Roy G. Geronemus warned against the cavalier approach of not using eye shields during laser surgery.

"The eyelid is very thin," he observed at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation. When using a device that works at 1.5 mm, "you damned well better" protect the patient's eyelids.

"With the CO₂ lasers, I think you should put a shield underneath the eyelids if you're treating the lids." Because it is possible that plastic shields will melt, said Dr. Geronemus of the New York University Medical Center, he prefers to use metal eye shields.

In a subsequent presentation, Dr. R. Rox Anderson, professor of dermatology at Harvard Medical School, Boston, and director of the Wellman Center for Photomedicine at Massachusetts General Hospital, also advocated for routine use of an eye shield, "especially if you're going to be treating inside the bony orbit."

Both lasers and intense pulsed lights used for hair removal in this area can be extremely damaging to the patient's eyes, he noted. "These devices are made to kill melanin-containing structures at great depth in the tissue, and the greatest amount of melanin in the body is in the uveal tract and the retina," Dr. Anderson said. "They're retinal killers."

Eye shields can also protect against possible injury from cryogen spray, he said. "There are cases of cryogen spray freezing the cornea and hurting it."

Dr. Anderson cautioned not to let anesthetics get under the eye shields when inserting them. "Most of our anesthetics, particularly EMLA [combination lidocaine and prilocaine cream], are really quite irritating," Dr. Anderson said, and can cause corneal burns.

Dr. Anderson disclosed that he had no relevant conflicts.

Dr. Geronemus disclosed that he is a shareholder in Thermage Inc., Reliant Technologies Inc., and Light BioScience LLC.

He is on the medical advisory boards of PhotoMedex Inc., Lumenis Ltd., Rhytec Inc., Candela Corp., Zeltiq Aesthetics, and Skin Cancer Company, and is an investigator for Reliant Technologies, Medicis Pharmaceutical Corp., Rhytec, DUSA Pharmaceuticals Inc., L'Oreal, Cutera Inc., Allergan Inc., and DermTech International. SDEF and SKIN & ALLERGY NEWS are wholly owned subsidiaries of Elsevier.

WAIKOLOA, HAWAII — Dr. Roy G. Geronemus warned against the cavalier approach of not using eye shields during laser surgery.

"The eyelid is very thin," he observed at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation. When using a device that works at 1.5 mm, "you damned well better" protect the patient's eyelids.

"With the CO₂ lasers, I think you should put a shield underneath the eyelids if you're treating the lids." Because it is possible that plastic shields will melt, said Dr. Geronemus of the New York University Medical Center, he prefers to use metal eye shields.

In a subsequent presentation, Dr. R. Rox Anderson, professor of dermatology at Harvard Medical School, Boston, and director of the Wellman Center for Photomedicine at Massachusetts General Hospital, also advocated for routine use of an eye shield, "especially if you're going to be treating inside the bony orbit."

Both lasers and intense pulsed lights used for hair removal in this area can be extremely damaging to the patient's eyes, he noted. "These devices are made to kill melanin-containing structures at great depth in the tissue, and the greatest amount of melanin in the body is in the uveal tract and the retina," Dr. Anderson said. "They're retinal killers."

Eye shields can also protect against possible injury from cryogen spray, he said. "There are cases of cryogen spray freezing the cornea and hurting it."

Dr. Anderson cautioned not to let anesthetics get under the eye shields when inserting them. "Most of our anesthetics, particularly EMLA [combination lidocaine and prilocaine cream], are really quite irritating," Dr. Anderson said, and can cause corneal burns.

Dr. Anderson disclosed that he had no relevant conflicts.

Dr. Geronemus disclosed that he is a shareholder in Thermage Inc., Reliant Technologies Inc., and Light BioScience LLC.

He is on the medical advisory boards of PhotoMedex Inc., Lumenis Ltd., Rhytec Inc., Candela Corp., Zeltiq Aesthetics, and Skin Cancer Company, and is an investigator for Reliant Technologies, Medicis Pharmaceutical Corp., Rhytec, DUSA Pharmaceuticals Inc., L'Oreal, Cutera Inc., Allergan Inc., and DermTech International. SDEF and SKIN & ALLERGY NEWS are wholly owned subsidiaries of Elsevier.

WAIKOLOA, HAWAII — Deep filler injections can address volume loss that occurs in facial bone structure during the aging process, according to Dr. Howard K. Steinman.

"The shape and volume of the maxilla and mandible change with aging," Dr. Steinman said at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.

"This significantly contributes to facial age-related cosmetic deformities," he added.

Injecting fillers deep, near the periosteum, can address these issues, he said. Although this has been well documented in plastic surgery literature, it is probably a new concept for most dermatologists.

Dr. Steinman, who is in private practice in Chula Vista, Calif., said that he first became aware of the clinical importance of facial skeletal movement last year at SDEF in Hawaii during a workshop that was led by Dr. William Philip Werschler of the University of Washington, Seattle, and Dr. Danny Vleggaar of the Nouvelle Clinique Vert Pré, Geneva.

"Ever since I discovered this and researched it, it has altered the way that I see my cosmetic patients and how I use fillers," he said. "Understanding these changes often permits more effective correction with less filler volume."

Dr. Steinman described the maxilla as a "ledge of the midface tissues." As the maxilla moves inferiorly and posteriorly, the muscles and other soft tissues attached to it descend. This aging process is in addition to laxity and the loss of fat volume over time. Lateral tear troughs, for example, begin to form as a result of the descent of the maxilla causing enlargement of the orbital rim, in addition to the soft tissue changes.

Putting filler immediately above the periosteum replaces orbital rim that has moved. "You're going to lift up the tissues, and you're going to help redrape and eliminate the lateral tear trough," he said, noting that he routinely does this using Radiesse (BioForm Medical).

When working on nasal labial folds, Dr. Steinman angles the needle down all the way to the periosteum and injects as he pulls back slightly—a technique he learned from Dr. Vleggaar.

He imagines a triangle in the corner of the nose and the nasal labial fold.

"I do three injections from the inferior apex of the triangle, injecting superiorly and filling this triangle," he said. "This is a great technique for doing rejuvenation of this fold with very little filler."

The mandible also changes as patients get older, he said. The height of the mandibular shortens, which the muscles and soft tissue attached to the mandible rim have to accommodate for, resulting in "jowling" and the formation of prejowl sulcus.

To correct this problem, he injects deeply along the mandibular rim "bulking it up" as best he can before injecting into the subdermal plane. Again, a small quantity of filler can be used in this procedure, he noted.

With the advent of botulinum toxin type A, said Dr. Steinman "all of us that were 'pre-Botox' in our training suddenly learned to see facial muscles and their cosmetic effects," he said. "They're part of [the] assessment armamentarium."

He predicted dermatologists will start to perceive facial skeletal changes the same way they now perceive facial muscles and will adapt treatments accordingly.

Dr. Steinman disclosed that he had no relevant conflicts of interest.

SDEF and SKIN & ALLERGY NEWS are wholly owned subsidiaries of Elsevier.

Dr.Steinman suggests imagining a triangle in the corner of the nose and nasal labial fold (before, left image). Perform "three injections from the inferior apex of the triangle, injecting superiorly and filling" it (after, right). Photos courtesy Dr. Howard K. Steinman

Facial skeletal changes will be perceived by dermatologists in the same way that facial muscles are now perceived. DR. STEINMAN

WAIKOLOA, HAWAII — Deep filler injections can address volume loss that occurs in facial bone structure during the aging process, according to Dr. Howard K. Steinman.

"The shape and volume of the maxilla and mandible change with aging," Dr. Steinman said at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.

"This significantly contributes to facial age-related cosmetic deformities," he added.

Injecting fillers deep, near the periosteum, can address these issues, he said. Although this has been well documented in plastic surgery literature, it is probably a new concept for most dermatologists.

Dr. Steinman, who is in private practice in Chula Vista, Calif., said that he first became aware of the clinical importance of facial skeletal movement last year at SDEF in Hawaii during a workshop that was led by Dr. William Philip Werschler of the University of Washington, Seattle, and Dr. Danny Vleggaar of the Nouvelle Clinique Vert Pré, Geneva.

"Ever since I discovered this and researched it, it has altered the way that I see my cosmetic patients and how I use fillers," he said. "Understanding these changes often permits more effective correction with less filler volume."

Dr. Steinman described the maxilla as a "ledge of the midface tissues." As the maxilla moves inferiorly and posteriorly, the muscles and other soft tissues attached to it descend. This aging process is in addition to laxity and the loss of fat volume over time. Lateral tear troughs, for example, begin to form as a result of the descent of the maxilla causing enlargement of the orbital rim, in addition to the soft tissue changes.

Putting filler immediately above the periosteum replaces orbital rim that has moved. "You're going to lift up the tissues, and you're going to help redrape and eliminate the lateral tear trough," he said, noting that he routinely does this using Radiesse (BioForm Medical).

When working on nasal labial folds, Dr. Steinman angles the needle down all the way to the periosteum and injects as he pulls back slightly—a technique he learned from Dr. Vleggaar.

He imagines a triangle in the corner of the nose and the nasal labial fold.

"I do three injections from the inferior apex of the triangle, injecting superiorly and filling this triangle," he said. "This is a great technique for doing rejuvenation of this fold with very little filler."

The mandible also changes as patients get older, he said. The height of the mandibular shortens, which the muscles and soft tissue attached to the mandible rim have to accommodate for, resulting in "jowling" and the formation of prejowl sulcus.

To correct this problem, he injects deeply along the mandibular rim "bulking it up" as best he can before injecting into the subdermal plane. Again, a small quantity of filler can be used in this procedure, he noted.

With the advent of botulinum toxin type A, said Dr. Steinman "all of us that were 'pre-Botox' in our training suddenly learned to see facial muscles and their cosmetic effects," he said. "They're part of [the] assessment armamentarium."

He predicted dermatologists will start to perceive facial skeletal changes the same way they now perceive facial muscles and will adapt treatments accordingly.

Dr. Steinman disclosed that he had no relevant conflicts of interest.

SDEF and SKIN & ALLERGY NEWS are wholly owned subsidiaries of Elsevier.

Dr.Steinman suggests imagining a triangle in the corner of the nose and nasal labial fold (before, left image). Perform "three injections from the inferior apex of the triangle, injecting superiorly and filling" it (after, right). Photos courtesy Dr. Howard K. Steinman

Facial skeletal changes will be perceived by dermatologists in the same way that facial muscles are now perceived. DR. STEINMAN

WAIKOLOA, HAWAII — Deep filler injections can address volume loss that occurs in facial bone structure during the aging process, according to Dr. Howard K. Steinman.

"The shape and volume of the maxilla and mandible change with aging," Dr. Steinman said at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.

"This significantly contributes to facial age-related cosmetic deformities," he added.

Injecting fillers deep, near the periosteum, can address these issues, he said. Although this has been well documented in plastic surgery literature, it is probably a new concept for most dermatologists.

Dr. Steinman, who is in private practice in Chula Vista, Calif., said that he first became aware of the clinical importance of facial skeletal movement last year at SDEF in Hawaii during a workshop that was led by Dr. William Philip Werschler of the University of Washington, Seattle, and Dr. Danny Vleggaar of the Nouvelle Clinique Vert Pré, Geneva.

"Ever since I discovered this and researched it, it has altered the way that I see my cosmetic patients and how I use fillers," he said. "Understanding these changes often permits more effective correction with less filler volume."

Dr. Steinman described the maxilla as a "ledge of the midface tissues." As the maxilla moves inferiorly and posteriorly, the muscles and other soft tissues attached to it descend. This aging process is in addition to laxity and the loss of fat volume over time. Lateral tear troughs, for example, begin to form as a result of the descent of the maxilla causing enlargement of the orbital rim, in addition to the soft tissue changes.

Putting filler immediately above the periosteum replaces orbital rim that has moved. "You're going to lift up the tissues, and you're going to help redrape and eliminate the lateral tear trough," he said, noting that he routinely does this using Radiesse (BioForm Medical).

When working on nasal labial folds, Dr. Steinman angles the needle down all the way to the periosteum and injects as he pulls back slightly—a technique he learned from Dr. Vleggaar.

He imagines a triangle in the corner of the nose and the nasal labial fold.

"I do three injections from the inferior apex of the triangle, injecting superiorly and filling this triangle," he said. "This is a great technique for doing rejuvenation of this fold with very little filler."

The mandible also changes as patients get older, he said. The height of the mandibular shortens, which the muscles and soft tissue attached to the mandible rim have to accommodate for, resulting in "jowling" and the formation of prejowl sulcus.

To correct this problem, he injects deeply along the mandibular rim "bulking it up" as best he can before injecting into the subdermal plane. Again, a small quantity of filler can be used in this procedure, he noted.

With the advent of botulinum toxin type A, said Dr. Steinman "all of us that were 'pre-Botox' in our training suddenly learned to see facial muscles and their cosmetic effects," he said. "They're part of [the] assessment armamentarium."

He predicted dermatologists will start to perceive facial skeletal changes the same way they now perceive facial muscles and will adapt treatments accordingly.

Dr. Steinman disclosed that he had no relevant conflicts of interest.

SDEF and SKIN & ALLERGY NEWS are wholly owned subsidiaries of Elsevier.

Dr.Steinman suggests imagining a triangle in the corner of the nose and nasal labial fold (before, left image). Perform "three injections from the inferior apex of the triangle, injecting superiorly and filling" it (after, right). Photos courtesy Dr. Howard K. Steinman

Facial skeletal changes will be perceived by dermatologists in the same way that facial muscles are now perceived. DR. STEINMAN

MAUI, HAWAII — Clinical trial participation can be a moneymaker for a practice with some realistic planning and savvy negotiations, according to Dr. Roy Fleischmann and Dr. Alvin Well.

"If you're looking to make a profit, you've got to get a profit," said Dr. Fleischmann.

"If I'm getting paid double what I'd get paid for seeing the patient, I have a feeling I'm OK." That extra in reimbursement provides a cushion to cover the unexpected, said Dr. Fleischmann of the University of Texas Southwestern Medical Center at Dallas.

Dr. Fleischmann explained, "You've got to figure out what your real charges are," and that includes allocating a reasonable portion of overhead to cover the share of phone and utility costs incurred because of the project. He said he calculates the average amount of overhead attributable to a patient visit and incorporates that in his cost estimate.

"You do have to think about your time," as well in determining the costs of doing a trial, Dr. Fleischmann added. "You have to go to the investigative meeting—it costs you a day. You have to do the site opening—that costs you an hour. You have to fill out the case report form. You have to sign all those lab reports when they come in."

Once you know your real costs, he recommends negotiating a minimum of 30% profit, which can help protect against unforeseen expenses. "I can guess, in looking at the protocol, what's going to happen if it goes perfectly well," Dr. Fleischmann said. But things do not usually go perfectly well with resulting amendments to the protocol and deadline extensions.

The key is to have someone other than the physician negotiate the contract with the company running the research. Dr. Fleischmann, who is in a large group, has an accountant do this job. Find someone you trust "to have the wherewithal to say, 'This is what we really need.'" It has to be fair, Dr. Fleischmann added.

Dr. Wells noted that costs and the bottom line cannot be ignored in the decision of whether to participate in a clinical trial. In estimating what he needs to be paid for a study, Dr. Wells, director of the Rheumatology and Immunotherapy Center in Oak Creek, Wisc., explained that he works with his billing staff to see what he is being paid for various patient visits, and then adjusts those numbers upward by 20%.

Dr. Wells, who is not part of a large practice, uses his coordinator to negotiate for him. "We play good cop, bad cop."

Dr. Wells and Dr. Fleischmann made their remarks at a symposium sponsored by Excellence in Rheumatology Education.

Beyond planning for a profit, physicians should select their research projects carefully. Dr. Fleischmann noted that it's important to pick studies for which you have the patients. And be realistic about how many patients you can deliver, he added. His own large group practice is participating in two studies involving patients who have not responded to anti-tumor necrosis factor (TNF) agents. Because only a few of his patients have not responded to TNF blockers, he has committed to providing "1 or 2 patients; we're not going to do 12 of them,'" Dr. Fleischmann said.

Although physicians always have the option of advertising for patients to meet recruitment goals, Dr. Fleischman advised against it. Work with patients from your own practice, he urged.

Don't count on outside sources, such as advertising, to bring patients on board. "Patient recruitment is a killer," he observed. "Nobody does it well."

If you don't have the patients in your practice willing to participate in a trial, he said, "you're not going to be able to do it."

Dr. Wells noted that convincing your patients to be in a trial can be tough. He reported finding it difficult to enroll patients in the current trial of celecoxib (Celebrex). Bad publicity about use of COX-2 inhibitors with the possibility of increased risk for heart attacks and strokes has given his patients pause. Many times, the patient will decide to participate because of [their loyalty to] you, Dr. Wells noted.

Dr. Fleischmann urged the audience to "be your own center" when doing a study, or join with a group of physicians with whom you are an equal partner. Avoid going through contract research organizations, he said.

Contracts should include clauses to provide for renegotiation if the company makes a change during the course of a trial. "Sometimes, companies will listen to it, and sometimes companies won't," he said. "But if you've got the study," he pointed out, and "you have patients in the study, you actually have a hook." For instance, your patients can be withdrawn from the study.

Dr. Wells observed that there are bound to be differences in perspective between physicians working in large group practices and those working in solo practices; between someone who has done "tons of clinical trials in a huge research group and somebody who is just essentially starting."

Noting that he might be in a somewhat different position from Dr. Fleischmann, who has done many trials, Dr. Wells said that he "might be willing to break even to get my foot in the door on a trial, or even make maybe just a little less of a profit." And, he said, "If you take the Celebrex trial as an example, you get to answer some interesting questions."

Dr. Fleischmann agreed sometimes there are reasons to do a trial other than for money. "There are trials where we don't make money," he said, "because there's an answer that we want to get."

There is no correct answer on how long to keep records after a trial. "A lot of companies will say 15 years. That's the usual," Dr. Fleischmann said. However, the Food and Drug Administration has the ability to go back and look at the data from a study at any point in time, he said.

"We keep them forever," he said, adding that he stores his records at Iron Mountain and the storage fee is part of the budget.

Dr. Fleischmann disclosed the following relationships with Abbott Laboratories, Amgen, Centocor, Genentech, and Wyeth: speakers bureau, consultant/adviser, and research grants. He also is on the speakers bureau for Hoffmann-La Roche. Dr. Wells is a consultant/adviser for Abbott, Amgen, Bristol-Myers Squibb, Centocor, Genentech, and TAP Pharmaceutical Products.

MAUI, HAWAII — Clinical trial participation can be a moneymaker for a practice with some realistic planning and savvy negotiations, according to Dr. Roy Fleischmann and Dr. Alvin Well.

"If you're looking to make a profit, you've got to get a profit," said Dr. Fleischmann.

"If I'm getting paid double what I'd get paid for seeing the patient, I have a feeling I'm OK." That extra in reimbursement provides a cushion to cover the unexpected, said Dr. Fleischmann of the University of Texas Southwestern Medical Center at Dallas.

Dr. Fleischmann explained, "You've got to figure out what your real charges are," and that includes allocating a reasonable portion of overhead to cover the share of phone and utility costs incurred because of the project. He said he calculates the average amount of overhead attributable to a patient visit and incorporates that in his cost estimate.

"You do have to think about your time," as well in determining the costs of doing a trial, Dr. Fleischmann added. "You have to go to the investigative meeting—it costs you a day. You have to do the site opening—that costs you an hour. You have to fill out the case report form. You have to sign all those lab reports when they come in."

Once you know your real costs, he recommends negotiating a minimum of 30% profit, which can help protect against unforeseen expenses. "I can guess, in looking at the protocol, what's going to happen if it goes perfectly well," Dr. Fleischmann said. But things do not usually go perfectly well with resulting amendments to the protocol and deadline extensions.

The key is to have someone other than the physician negotiate the contract with the company running the research. Dr. Fleischmann, who is in a large group, has an accountant do this job. Find someone you trust "to have the wherewithal to say, 'This is what we really need.'" It has to be fair, Dr. Fleischmann added.

Dr. Wells noted that costs and the bottom line cannot be ignored in the decision of whether to participate in a clinical trial. In estimating what he needs to be paid for a study, Dr. Wells, director of the Rheumatology and Immunotherapy Center in Oak Creek, Wisc., explained that he works with his billing staff to see what he is being paid for various patient visits, and then adjusts those numbers upward by 20%.

Dr. Wells, who is not part of a large practice, uses his coordinator to negotiate for him. "We play good cop, bad cop."

Dr. Wells and Dr. Fleischmann made their remarks at a symposium sponsored by Excellence in Rheumatology Education.

Beyond planning for a profit, physicians should select their research projects carefully. Dr. Fleischmann noted that it's important to pick studies for which you have the patients. And be realistic about how many patients you can deliver, he added. His own large group practice is participating in two studies involving patients who have not responded to anti-tumor necrosis factor (TNF) agents. Because only a few of his patients have not responded to TNF blockers, he has committed to providing "1 or 2 patients; we're not going to do 12 of them,'" Dr. Fleischmann said.

Although physicians always have the option of advertising for patients to meet recruitment goals, Dr. Fleischman advised against it. Work with patients from your own practice, he urged.

Don't count on outside sources, such as advertising, to bring patients on board. "Patient recruitment is a killer," he observed. "Nobody does it well."

If you don't have the patients in your practice willing to participate in a trial, he said, "you're not going to be able to do it."

Dr. Wells noted that convincing your patients to be in a trial can be tough. He reported finding it difficult to enroll patients in the current trial of celecoxib (Celebrex). Bad publicity about use of COX-2 inhibitors with the possibility of increased risk for heart attacks and strokes has given his patients pause. Many times, the patient will decide to participate because of [their loyalty to] you, Dr. Wells noted.

Dr. Fleischmann urged the audience to "be your own center" when doing a study, or join with a group of physicians with whom you are an equal partner. Avoid going through contract research organizations, he said.

Contracts should include clauses to provide for renegotiation if the company makes a change during the course of a trial. "Sometimes, companies will listen to it, and sometimes companies won't," he said. "But if you've got the study," he pointed out, and "you have patients in the study, you actually have a hook." For instance, your patients can be withdrawn from the study.

Dr. Wells observed that there are bound to be differences in perspective between physicians working in large group practices and those working in solo practices; between someone who has done "tons of clinical trials in a huge research group and somebody who is just essentially starting."

Noting that he might be in a somewhat different position from Dr. Fleischmann, who has done many trials, Dr. Wells said that he "might be willing to break even to get my foot in the door on a trial, or even make maybe just a little less of a profit." And, he said, "If you take the Celebrex trial as an example, you get to answer some interesting questions."

Dr. Fleischmann agreed sometimes there are reasons to do a trial other than for money. "There are trials where we don't make money," he said, "because there's an answer that we want to get."

There is no correct answer on how long to keep records after a trial. "A lot of companies will say 15 years. That's the usual," Dr. Fleischmann said. However, the Food and Drug Administration has the ability to go back and look at the data from a study at any point in time, he said.

"We keep them forever," he said, adding that he stores his records at Iron Mountain and the storage fee is part of the budget.

Dr. Fleischmann disclosed the following relationships with Abbott Laboratories, Amgen, Centocor, Genentech, and Wyeth: speakers bureau, consultant/adviser, and research grants. He also is on the speakers bureau for Hoffmann-La Roche. Dr. Wells is a consultant/adviser for Abbott, Amgen, Bristol-Myers Squibb, Centocor, Genentech, and TAP Pharmaceutical Products.

MAUI, HAWAII — Clinical trial participation can be a moneymaker for a practice with some realistic planning and savvy negotiations, according to Dr. Roy Fleischmann and Dr. Alvin Well.

"If you're looking to make a profit, you've got to get a profit," said Dr. Fleischmann.

"If I'm getting paid double what I'd get paid for seeing the patient, I have a feeling I'm OK." That extra in reimbursement provides a cushion to cover the unexpected, said Dr. Fleischmann of the University of Texas Southwestern Medical Center at Dallas.

Dr. Fleischmann explained, "You've got to figure out what your real charges are," and that includes allocating a reasonable portion of overhead to cover the share of phone and utility costs incurred because of the project. He said he calculates the average amount of overhead attributable to a patient visit and incorporates that in his cost estimate.

"You do have to think about your time," as well in determining the costs of doing a trial, Dr. Fleischmann added. "You have to go to the investigative meeting—it costs you a day. You have to do the site opening—that costs you an hour. You have to fill out the case report form. You have to sign all those lab reports when they come in."

Once you know your real costs, he recommends negotiating a minimum of 30% profit, which can help protect against unforeseen expenses. "I can guess, in looking at the protocol, what's going to happen if it goes perfectly well," Dr. Fleischmann said. But things do not usually go perfectly well with resulting amendments to the protocol and deadline extensions.

The key is to have someone other than the physician negotiate the contract with the company running the research. Dr. Fleischmann, who is in a large group, has an accountant do this job. Find someone you trust "to have the wherewithal to say, 'This is what we really need.'" It has to be fair, Dr. Fleischmann added.

Dr. Wells noted that costs and the bottom line cannot be ignored in the decision of whether to participate in a clinical trial. In estimating what he needs to be paid for a study, Dr. Wells, director of the Rheumatology and Immunotherapy Center in Oak Creek, Wisc., explained that he works with his billing staff to see what he is being paid for various patient visits, and then adjusts those numbers upward by 20%.

Dr. Wells, who is not part of a large practice, uses his coordinator to negotiate for him. "We play good cop, bad cop."

Dr. Wells and Dr. Fleischmann made their remarks at a symposium sponsored by Excellence in Rheumatology Education.

Beyond planning for a profit, physicians should select their research projects carefully. Dr. Fleischmann noted that it's important to pick studies for which you have the patients. And be realistic about how many patients you can deliver, he added. His own large group practice is participating in two studies involving patients who have not responded to anti-tumor necrosis factor (TNF) agents. Because only a few of his patients have not responded to TNF blockers, he has committed to providing "1 or 2 patients; we're not going to do 12 of them,'" Dr. Fleischmann said.

Although physicians always have the option of advertising for patients to meet recruitment goals, Dr. Fleischman advised against it. Work with patients from your own practice, he urged.

Don't count on outside sources, such as advertising, to bring patients on board. "Patient recruitment is a killer," he observed. "Nobody does it well."

If you don't have the patients in your practice willing to participate in a trial, he said, "you're not going to be able to do it."

Dr. Wells noted that convincing your patients to be in a trial can be tough. He reported finding it difficult to enroll patients in the current trial of celecoxib (Celebrex). Bad publicity about use of COX-2 inhibitors with the possibility of increased risk for heart attacks and strokes has given his patients pause. Many times, the patient will decide to participate because of [their loyalty to] you, Dr. Wells noted.

Dr. Fleischmann urged the audience to "be your own center" when doing a study, or join with a group of physicians with whom you are an equal partner. Avoid going through contract research organizations, he said.

Contracts should include clauses to provide for renegotiation if the company makes a change during the course of a trial. "Sometimes, companies will listen to it, and sometimes companies won't," he said. "But if you've got the study," he pointed out, and "you have patients in the study, you actually have a hook." For instance, your patients can be withdrawn from the study.

Dr. Wells observed that there are bound to be differences in perspective between physicians working in large group practices and those working in solo practices; between someone who has done "tons of clinical trials in a huge research group and somebody who is just essentially starting."

Noting that he might be in a somewhat different position from Dr. Fleischmann, who has done many trials, Dr. Wells said that he "might be willing to break even to get my foot in the door on a trial, or even make maybe just a little less of a profit." And, he said, "If you take the Celebrex trial as an example, you get to answer some interesting questions."

Dr. Fleischmann agreed sometimes there are reasons to do a trial other than for money. "There are trials where we don't make money," he said, "because there's an answer that we want to get."

There is no correct answer on how long to keep records after a trial. "A lot of companies will say 15 years. That's the usual," Dr. Fleischmann said. However, the Food and Drug Administration has the ability to go back and look at the data from a study at any point in time, he said.

"We keep them forever," he said, adding that he stores his records at Iron Mountain and the storage fee is part of the budget.

Dr. Fleischmann disclosed the following relationships with Abbott Laboratories, Amgen, Centocor, Genentech, and Wyeth: speakers bureau, consultant/adviser, and research grants. He also is on the speakers bureau for Hoffmann-La Roche. Dr. Wells is a consultant/adviser for Abbott, Amgen, Bristol-Myers Squibb, Centocor, Genentech, and TAP Pharmaceutical Products.

MAUI, HAWAII – Clinical trial participation can be a moneymaker for a rheumatology practice with some realistic planning and savvy negotiations, according to Dr. Roy Fleischmann and Dr. Alvin Well.

“If you're looking to make a profit, you've got to get a profit,” said Dr. Fleisch-mann. “If I'm getting paid double what I'd get paid for seeing the patient, I have a feeling I'm OK.” That provides a cushion to cover the unexpected, said Dr. Fleischmann of the University of Texas Southwestern Medical Center at Dallas.

Dr. Fleischmann explained, “You've got to figure out what your real charges are,” and that includes allocating a portion of overhead to cover the phone and utility costs incurred because of the project. He said he calculates the average amount of overhead attributable to a patient visit and incorporates that in his cost estimate.

“You do have to think about your time,” as well, in determining the costs of doing a trial, Dr. Fleischmann added. “You have to go to the investigative meeting–it costs you a day. You have to do the site opening–that costs you an hour. You have to fill out the case report form. You have to sign all those lab reports when they come in.”

Once you know your real costs, he recommends negotiating a minimum of 30% profit, which can act as a cushion to protect against unforeseen expenses. “I can guess, in looking at the protocol, what's going to happen if it goes perfectly well,” Dr. Fleischmann said. But things do not usually go perfectly well with resulting amendments to the protocol and deadline extensions, which associated increased expenses.

The key is to have someone other than the rheumatologist negotiate the contract with the company running the research. Dr. Fleischmann has an accountant do it. He or she must be someone you trust “to have the wherewithal to say 'This is what we really need.'” He added, “You're not getting rich on this, but it's a fair value, and they need to understand that.”

Dr. Wells noted that costs and the bottom line cannot be ignored in the decision of whether to participate in a clinical trial. In estimating what he needs to be paid for a study, Dr. Wells, director of the Rheumatology and Immunotherapy Center in Oak Creek, Wisc., explained that he works with his billing staff to see what he is being paid for various patient visits, and then adjusts those numbers upward by 20%.

Dr. Wells, who is not part of a large practice, uses his coordinator to negotiate.

Dr. Wells and Dr. Fleischmann made their remarks at a symposium sponsored by Excellence in Rheumatology Education.

Beyond planning for a profit, physicians should pick their research projects carefully. Dr. Fleischmann noted that it's important to pick studies for which you have the patients. Be realistic about how many patients you can deliver, he added. His own large group practice is participating in two studies involving patients who have not responded to anti-tumor necrosis factor agents. He has committed to providing “1 or 2 patients; we're not going to do 12 of them,” Dr. Fleischmann said.

Although physicians always have the option of advertising for patients to meet recruitment goals, Dr. Fleischman advised against this. Work with patients from your own practice, he urged.

Dr. Wells noted that convincing your patients to be in a trial can be tough. He found it difficult to enroll patients in the current trial of celecoxib (Celebrex). Bad publicity about COX-2 inhibitors and an increased risk for heart attacks and strokes gave patients pause. “Many times the patient will do it because of [their loyalty to] you,” Dr. Wells noted.

Dr. Fleischmann urged audience members to “be your own center” when doing a study. Or join up with a group of physicians with whom you are an equal partner. Avoid going through contract research organizations when doing trials, he urged.

Contracts should include clauses to provide for renegotiation if the company makes a change during a trial. “Sometimes, companies will listen to it, and sometimes companies won't,” he said. “But if you've got the study,” and “you have patients in the study, you actually have a hook.” For instance, your patients can be withdrawn.

Dr. Wells observed that there are bound to be differences in perspective between physicians working in large group practices and those working in solo practices; between someone who has done “tons of clinical trials in a huge research group and somebody who is just essentially starting.”

Dr. Wells said he “might be willing to break even to get my foot in the door on a trial, or even make maybe just a little less of a profit.” And, he said, “If you take the Celebrex trial as an example, you get to answer some interesting questions.”

Dr. Fleischmann agreed that sometimes there are reasons to do a trial other than for money. “There are trials where we don't make money,” he said, “because there's an answer that we want to get.”

There's no right answer on how long to keep records after a trial. “A lot of companies will say 15 years,” Dr. Fleischmann said. But the Food and Drug Administration can ask to see the data at any point. He stores his records from clinical trials at Iron Mountain, and “the storage fee is actually part of the budget.”

He referred to a case from his own practice, in which the FDA performed an audit on a study 18 years after its completion. Since he still had the data, Dr. Fleisch-mann felt secure in asking what would have happened if he had not had the data. “We could send you to jail,” he was told.

Dr. Fleischmann disclosed the following relationships with Abbott Laboratories, Amgen Inc., Centocor Inc., Genentech Inc., and Wyeth: speakers bureau, consultant/adviser, and research grants. He also is on the speakers bureau for Hoffmann-La Roche Inc.

Dr. Wells disclosed that he is a consultant/adviser for Abbott, Amgen, Bristol-Myers Squibb Co., Centocor, Genentech, and TAP Pharmaceutical Products Inc.

MAUI, HAWAII – Clinical trial participation can be a moneymaker for a rheumatology practice with some realistic planning and savvy negotiations, according to Dr. Roy Fleischmann and Dr. Alvin Well.

“If you're looking to make a profit, you've got to get a profit,” said Dr. Fleisch-mann. “If I'm getting paid double what I'd get paid for seeing the patient, I have a feeling I'm OK.” That provides a cushion to cover the unexpected, said Dr. Fleischmann of the University of Texas Southwestern Medical Center at Dallas.

Dr. Fleischmann explained, “You've got to figure out what your real charges are,” and that includes allocating a portion of overhead to cover the phone and utility costs incurred because of the project. He said he calculates the average amount of overhead attributable to a patient visit and incorporates that in his cost estimate.

“You do have to think about your time,” as well, in determining the costs of doing a trial, Dr. Fleischmann added. “You have to go to the investigative meeting–it costs you a day. You have to do the site opening–that costs you an hour. You have to fill out the case report form. You have to sign all those lab reports when they come in.”

Once you know your real costs, he recommends negotiating a minimum of 30% profit, which can act as a cushion to protect against unforeseen expenses. “I can guess, in looking at the protocol, what's going to happen if it goes perfectly well,” Dr. Fleischmann said. But things do not usually go perfectly well with resulting amendments to the protocol and deadline extensions, which associated increased expenses.

The key is to have someone other than the rheumatologist negotiate the contract with the company running the research. Dr. Fleischmann has an accountant do it. He or she must be someone you trust “to have the wherewithal to say 'This is what we really need.'” He added, “You're not getting rich on this, but it's a fair value, and they need to understand that.”

Dr. Wells noted that costs and the bottom line cannot be ignored in the decision of whether to participate in a clinical trial. In estimating what he needs to be paid for a study, Dr. Wells, director of the Rheumatology and Immunotherapy Center in Oak Creek, Wisc., explained that he works with his billing staff to see what he is being paid for various patient visits, and then adjusts those numbers upward by 20%.

Dr. Wells, who is not part of a large practice, uses his coordinator to negotiate.

Dr. Wells and Dr. Fleischmann made their remarks at a symposium sponsored by Excellence in Rheumatology Education.

Beyond planning for a profit, physicians should pick their research projects carefully. Dr. Fleischmann noted that it's important to pick studies for which you have the patients. Be realistic about how many patients you can deliver, he added. His own large group practice is participating in two studies involving patients who have not responded to anti-tumor necrosis factor agents. He has committed to providing “1 or 2 patients; we're not going to do 12 of them,” Dr. Fleischmann said.

Although physicians always have the option of advertising for patients to meet recruitment goals, Dr. Fleischman advised against this. Work with patients from your own practice, he urged.

Dr. Wells noted that convincing your patients to be in a trial can be tough. He found it difficult to enroll patients in the current trial of celecoxib (Celebrex). Bad publicity about COX-2 inhibitors and an increased risk for heart attacks and strokes gave patients pause. “Many times the patient will do it because of [their loyalty to] you,” Dr. Wells noted.

Dr. Fleischmann urged audience members to “be your own center” when doing a study. Or join up with a group of physicians with whom you are an equal partner. Avoid going through contract research organizations when doing trials, he urged.

Contracts should include clauses to provide for renegotiation if the company makes a change during a trial. “Sometimes, companies will listen to it, and sometimes companies won't,” he said. “But if you've got the study,” and “you have patients in the study, you actually have a hook.” For instance, your patients can be withdrawn.

Dr. Wells observed that there are bound to be differences in perspective between physicians working in large group practices and those working in solo practices; between someone who has done “tons of clinical trials in a huge research group and somebody who is just essentially starting.”

Dr. Wells said he “might be willing to break even to get my foot in the door on a trial, or even make maybe just a little less of a profit.” And, he said, “If you take the Celebrex trial as an example, you get to answer some interesting questions.”

Dr. Fleischmann agreed that sometimes there are reasons to do a trial other than for money. “There are trials where we don't make money,” he said, “because there's an answer that we want to get.”

There's no right answer on how long to keep records after a trial. “A lot of companies will say 15 years,” Dr. Fleischmann said. But the Food and Drug Administration can ask to see the data at any point. He stores his records from clinical trials at Iron Mountain, and “the storage fee is actually part of the budget.”

He referred to a case from his own practice, in which the FDA performed an audit on a study 18 years after its completion. Since he still had the data, Dr. Fleisch-mann felt secure in asking what would have happened if he had not had the data. “We could send you to jail,” he was told.

Dr. Fleischmann disclosed the following relationships with Abbott Laboratories, Amgen Inc., Centocor Inc., Genentech Inc., and Wyeth: speakers bureau, consultant/adviser, and research grants. He also is on the speakers bureau for Hoffmann-La Roche Inc.

Dr. Wells disclosed that he is a consultant/adviser for Abbott, Amgen, Bristol-Myers Squibb Co., Centocor, Genentech, and TAP Pharmaceutical Products Inc.

MAUI, HAWAII – Clinical trial participation can be a moneymaker for a rheumatology practice with some realistic planning and savvy negotiations, according to Dr. Roy Fleischmann and Dr. Alvin Well.

“If you're looking to make a profit, you've got to get a profit,” said Dr. Fleisch-mann. “If I'm getting paid double what I'd get paid for seeing the patient, I have a feeling I'm OK.” That provides a cushion to cover the unexpected, said Dr. Fleischmann of the University of Texas Southwestern Medical Center at Dallas.

Dr. Fleischmann explained, “You've got to figure out what your real charges are,” and that includes allocating a portion of overhead to cover the phone and utility costs incurred because of the project. He said he calculates the average amount of overhead attributable to a patient visit and incorporates that in his cost estimate.

“You do have to think about your time,” as well, in determining the costs of doing a trial, Dr. Fleischmann added. “You have to go to the investigative meeting–it costs you a day. You have to do the site opening–that costs you an hour. You have to fill out the case report form. You have to sign all those lab reports when they come in.”

Once you know your real costs, he recommends negotiating a minimum of 30% profit, which can act as a cushion to protect against unforeseen expenses. “I can guess, in looking at the protocol, what's going to happen if it goes perfectly well,” Dr. Fleischmann said. But things do not usually go perfectly well with resulting amendments to the protocol and deadline extensions, which associated increased expenses.

The key is to have someone other than the rheumatologist negotiate the contract with the company running the research. Dr. Fleischmann has an accountant do it. He or she must be someone you trust “to have the wherewithal to say 'This is what we really need.'” He added, “You're not getting rich on this, but it's a fair value, and they need to understand that.”

Dr. Wells noted that costs and the bottom line cannot be ignored in the decision of whether to participate in a clinical trial. In estimating what he needs to be paid for a study, Dr. Wells, director of the Rheumatology and Immunotherapy Center in Oak Creek, Wisc., explained that he works with his billing staff to see what he is being paid for various patient visits, and then adjusts those numbers upward by 20%.

Dr. Wells, who is not part of a large practice, uses his coordinator to negotiate.

Dr. Wells and Dr. Fleischmann made their remarks at a symposium sponsored by Excellence in Rheumatology Education.

Beyond planning for a profit, physicians should pick their research projects carefully. Dr. Fleischmann noted that it's important to pick studies for which you have the patients. Be realistic about how many patients you can deliver, he added. His own large group practice is participating in two studies involving patients who have not responded to anti-tumor necrosis factor agents. He has committed to providing “1 or 2 patients; we're not going to do 12 of them,” Dr. Fleischmann said.

Although physicians always have the option of advertising for patients to meet recruitment goals, Dr. Fleischman advised against this. Work with patients from your own practice, he urged.

Dr. Wells noted that convincing your patients to be in a trial can be tough. He found it difficult to enroll patients in the current trial of celecoxib (Celebrex). Bad publicity about COX-2 inhibitors and an increased risk for heart attacks and strokes gave patients pause. “Many times the patient will do it because of [their loyalty to] you,” Dr. Wells noted.

Dr. Fleischmann urged audience members to “be your own center” when doing a study. Or join up with a group of physicians with whom you are an equal partner. Avoid going through contract research organizations when doing trials, he urged.

Contracts should include clauses to provide for renegotiation if the company makes a change during a trial. “Sometimes, companies will listen to it, and sometimes companies won't,” he said. “But if you've got the study,” and “you have patients in the study, you actually have a hook.” For instance, your patients can be withdrawn.

Dr. Wells observed that there are bound to be differences in perspective between physicians working in large group practices and those working in solo practices; between someone who has done “tons of clinical trials in a huge research group and somebody who is just essentially starting.”

Dr. Wells said he “might be willing to break even to get my foot in the door on a trial, or even make maybe just a little less of a profit.” And, he said, “If you take the Celebrex trial as an example, you get to answer some interesting questions.”

Dr. Fleischmann agreed that sometimes there are reasons to do a trial other than for money. “There are trials where we don't make money,” he said, “because there's an answer that we want to get.”

There's no right answer on how long to keep records after a trial. “A lot of companies will say 15 years,” Dr. Fleischmann said. But the Food and Drug Administration can ask to see the data at any point. He stores his records from clinical trials at Iron Mountain, and “the storage fee is actually part of the budget.”

He referred to a case from his own practice, in which the FDA performed an audit on a study 18 years after its completion. Since he still had the data, Dr. Fleisch-mann felt secure in asking what would have happened if he had not had the data. “We could send you to jail,” he was told.

Dr. Fleischmann disclosed the following relationships with Abbott Laboratories, Amgen Inc., Centocor Inc., Genentech Inc., and Wyeth: speakers bureau, consultant/adviser, and research grants. He also is on the speakers bureau for Hoffmann-La Roche Inc.

Dr. Wells disclosed that he is a consultant/adviser for Abbott, Amgen, Bristol-Myers Squibb Co., Centocor, Genentech, and TAP Pharmaceutical Products Inc.

HONOLULU — Men diagnosed with osteopenia through dual-energy x-ray absorptiometry are unlikely to have a change in diagnosis at a 3-year follow-up DXA test, according to a study presented in a poster at the annual meeting of the American Society for Bone and Mineral Research.

“The interval for a follow-up bone density should be lengthened, or perhaps the repeat DXA should not be done unless there is an additional risk factor noted,” wrote Dr. Robert A. Adler of the endocrinology section of McGuire Veterans Affairs Medical Center and Virginia Commonwealth University, Richmond, and his colleagues. Increased risk for developing osteoporosis could, for example, be a concern for prostate cancer patients on androgen deprivation therapy.

The researchers followed 78 men with osteopenia (T score of lumbar spine, femoral neck, total hip, total forearm or distal 1/3 forearm between −1 and −2.4) from a baseline DXA test through follow-up DXA testing an average of 998 days later. Mean age and weight at baseline were 70.7 years and 76.4 kg, respectively.

The men, patients from primary care practices at a Veterans Affairs medical center, had been referred for an initial DXA test after a screening program using the Osteoporosis Self-Assessment Tool had found them to be at greater risk for osteoporosis.

Mean percent changes in bone mineral density (BMD) from baseline to follow-up were 1.8% for lumbar spine, −0.4% for femoral neck, −0.7% for total hip, −1.1% for 1/3 radius, and −1.6% for total forearm.

“The BMD changes were minimal, approximately plus or minus 2%,” the researchers noted, and affected diagnosis very rarely: Only one patient started therapy for osteoporosis after the follow-up DXA test because of a significant change in BMD.

Although the patients were advised at diagnosis with osteopenia to begin taking calcium and vitamin D supplements, only about one-fourth to one-third of the 78 actually received the supplementation after the baseline DXA test. But after the second DXA, “an additional 17 men were prescribed supplements,” the authors wrote.

Although these results suggest a second DXA test may encourage clinicians to prescribe such preventive measures for their patients, “there should be cheaper ways to improve clinician behavior,” wrote the authors. Dr. Adler said he had no conflicts of interest to disclose.

HONOLULU — Men diagnosed with osteopenia through dual-energy x-ray absorptiometry are unlikely to have a change in diagnosis at a 3-year follow-up DXA test, according to a study presented in a poster at the annual meeting of the American Society for Bone and Mineral Research.

“The interval for a follow-up bone density should be lengthened, or perhaps the repeat DXA should not be done unless there is an additional risk factor noted,” wrote Dr. Robert A. Adler of the endocrinology section of McGuire Veterans Affairs Medical Center and Virginia Commonwealth University, Richmond, and his colleagues. Increased risk for developing osteoporosis could, for example, be a concern for prostate cancer patients on androgen deprivation therapy.

The researchers followed 78 men with osteopenia (T score of lumbar spine, femoral neck, total hip, total forearm or distal 1/3 forearm between −1 and −2.4) from a baseline DXA test through follow-up DXA testing an average of 998 days later. Mean age and weight at baseline were 70.7 years and 76.4 kg, respectively.

The men, patients from primary care practices at a Veterans Affairs medical center, had been referred for an initial DXA test after a screening program using the Osteoporosis Self-Assessment Tool had found them to be at greater risk for osteoporosis.

Mean percent changes in bone mineral density (BMD) from baseline to follow-up were 1.8% for lumbar spine, −0.4% for femoral neck, −0.7% for total hip, −1.1% for 1/3 radius, and −1.6% for total forearm.

“The BMD changes were minimal, approximately plus or minus 2%,” the researchers noted, and affected diagnosis very rarely: Only one patient started therapy for osteoporosis after the follow-up DXA test because of a significant change in BMD.

Although the patients were advised at diagnosis with osteopenia to begin taking calcium and vitamin D supplements, only about one-fourth to one-third of the 78 actually received the supplementation after the baseline DXA test. But after the second DXA, “an additional 17 men were prescribed supplements,” the authors wrote.

Although these results suggest a second DXA test may encourage clinicians to prescribe such preventive measures for their patients, “there should be cheaper ways to improve clinician behavior,” wrote the authors. Dr. Adler said he had no conflicts of interest to disclose.

HONOLULU — Men diagnosed with osteopenia through dual-energy x-ray absorptiometry are unlikely to have a change in diagnosis at a 3-year follow-up DXA test, according to a study presented in a poster at the annual meeting of the American Society for Bone and Mineral Research.

“The interval for a follow-up bone density should be lengthened, or perhaps the repeat DXA should not be done unless there is an additional risk factor noted,” wrote Dr. Robert A. Adler of the endocrinology section of McGuire Veterans Affairs Medical Center and Virginia Commonwealth University, Richmond, and his colleagues. Increased risk for developing osteoporosis could, for example, be a concern for prostate cancer patients on androgen deprivation therapy.

The researchers followed 78 men with osteopenia (T score of lumbar spine, femoral neck, total hip, total forearm or distal 1/3 forearm between −1 and −2.4) from a baseline DXA test through follow-up DXA testing an average of 998 days later. Mean age and weight at baseline were 70.7 years and 76.4 kg, respectively.

The men, patients from primary care practices at a Veterans Affairs medical center, had been referred for an initial DXA test after a screening program using the Osteoporosis Self-Assessment Tool had found them to be at greater risk for osteoporosis.

Mean percent changes in bone mineral density (BMD) from baseline to follow-up were 1.8% for lumbar spine, −0.4% for femoral neck, −0.7% for total hip, −1.1% for 1/3 radius, and −1.6% for total forearm.

“The BMD changes were minimal, approximately plus or minus 2%,” the researchers noted, and affected diagnosis very rarely: Only one patient started therapy for osteoporosis after the follow-up DXA test because of a significant change in BMD.

Although the patients were advised at diagnosis with osteopenia to begin taking calcium and vitamin D supplements, only about one-fourth to one-third of the 78 actually received the supplementation after the baseline DXA test. But after the second DXA, “an additional 17 men were prescribed supplements,” the authors wrote.

Although these results suggest a second DXA test may encourage clinicians to prescribe such preventive measures for their patients, “there should be cheaper ways to improve clinician behavior,” wrote the authors. Dr. Adler said he had no conflicts of interest to disclose.

HONOLULU — Men diagnosed with osteopenia through dual-energy x-ray absorptiometry are unlikely to have a change in diagnosis at a 3-year follow-up DXA, according to a study presented at the annual meeting of the American Society for Bone and Mineral Research.

“The interval for a follow-up bone density should be lengthened, or perhaps the repeat DXA should not be done unless there is an additional risk factor noted,” wrote Dr. Robert A. Adler of the endocrinology section of McGuire Veterans Affairs Medical Center and Virginia Commonwealth University, Richmond, and colleagues.

The researchers followed 78 men with osteopenia (T score of lumbar spine, femoral neck, total hip, total forearm or distal 1/3 forearm between -1 and -2.4) from a baseline DXA test through follow-up DXA testing an average of 998 days later.

The mean age and weight of the patients at baseline were 70.7 years and 76.4 kg, respectively.

All of the men had been referred for an initial DXA test after a screening program using the Osteoporosis Self-Assessment Tool had found them to be at increased risk for osteoporosis.

Mean percent changes in bone mineral density (BMD) from baseline to follow-up were 1.8% for lumbar spine, -0.4% for femoral neck, -0.7 for total hip, -1.1 for 1/3 radius, and -1.6 for total forearm.

“The BMD changes were minimal, approximately plus or minus 2%,” the researchers noted, and affected diagnosis very rarely: Only one patient started therapy for osteoporosis after the follow-up DXA test because of a significant change in BMD.

Although it was recommended upon diagnosis with osteopenia that the patients take calcium and vitamin D supplements, only about one-fourth to one-third actually received the supplementation after the baseline DXA.

“After the second DXA, an additional 17 men were prescribed supplements,” the researchers pointed out.

Although these results suggest that a second DXA test may encourage clinicians to prescribe such preventive measures as calcium and vitamin D supplements for their patients, “there should be cheaper ways to improve clinician behavior,” the researchers suggested.

Dr. Adler stated that he had no conflicts of interest.

HONOLULU — Men diagnosed with osteopenia through dual-energy x-ray absorptiometry are unlikely to have a change in diagnosis at a 3-year follow-up DXA, according to a study presented at the annual meeting of the American Society for Bone and Mineral Research.

“The interval for a follow-up bone density should be lengthened, or perhaps the repeat DXA should not be done unless there is an additional risk factor noted,” wrote Dr. Robert A. Adler of the endocrinology section of McGuire Veterans Affairs Medical Center and Virginia Commonwealth University, Richmond, and colleagues.

The researchers followed 78 men with osteopenia (T score of lumbar spine, femoral neck, total hip, total forearm or distal 1/3 forearm between -1 and -2.4) from a baseline DXA test through follow-up DXA testing an average of 998 days later.

The mean age and weight of the patients at baseline were 70.7 years and 76.4 kg, respectively.

All of the men had been referred for an initial DXA test after a screening program using the Osteoporosis Self-Assessment Tool had found them to be at increased risk for osteoporosis.

Mean percent changes in bone mineral density (BMD) from baseline to follow-up were 1.8% for lumbar spine, -0.4% for femoral neck, -0.7 for total hip, -1.1 for 1/3 radius, and -1.6 for total forearm.

“The BMD changes were minimal, approximately plus or minus 2%,” the researchers noted, and affected diagnosis very rarely: Only one patient started therapy for osteoporosis after the follow-up DXA test because of a significant change in BMD.

Although it was recommended upon diagnosis with osteopenia that the patients take calcium and vitamin D supplements, only about one-fourth to one-third actually received the supplementation after the baseline DXA.

“After the second DXA, an additional 17 men were prescribed supplements,” the researchers pointed out.

Although these results suggest that a second DXA test may encourage clinicians to prescribe such preventive measures as calcium and vitamin D supplements for their patients, “there should be cheaper ways to improve clinician behavior,” the researchers suggested.

Dr. Adler stated that he had no conflicts of interest.

HONOLULU — Men diagnosed with osteopenia through dual-energy x-ray absorptiometry are unlikely to have a change in diagnosis at a 3-year follow-up DXA, according to a study presented at the annual meeting of the American Society for Bone and Mineral Research.

“The interval for a follow-up bone density should be lengthened, or perhaps the repeat DXA should not be done unless there is an additional risk factor noted,” wrote Dr. Robert A. Adler of the endocrinology section of McGuire Veterans Affairs Medical Center and Virginia Commonwealth University, Richmond, and colleagues.

The researchers followed 78 men with osteopenia (T score of lumbar spine, femoral neck, total hip, total forearm or distal 1/3 forearm between -1 and -2.4) from a baseline DXA test through follow-up DXA testing an average of 998 days later.

The mean age and weight of the patients at baseline were 70.7 years and 76.4 kg, respectively.

All of the men had been referred for an initial DXA test after a screening program using the Osteoporosis Self-Assessment Tool had found them to be at increased risk for osteoporosis.

Mean percent changes in bone mineral density (BMD) from baseline to follow-up were 1.8% for lumbar spine, -0.4% for femoral neck, -0.7 for total hip, -1.1 for 1/3 radius, and -1.6 for total forearm.

“The BMD changes were minimal, approximately plus or minus 2%,” the researchers noted, and affected diagnosis very rarely: Only one patient started therapy for osteoporosis after the follow-up DXA test because of a significant change in BMD.

Although it was recommended upon diagnosis with osteopenia that the patients take calcium and vitamin D supplements, only about one-fourth to one-third actually received the supplementation after the baseline DXA.

“After the second DXA, an additional 17 men were prescribed supplements,” the researchers pointed out.

Although these results suggest that a second DXA test may encourage clinicians to prescribe such preventive measures as calcium and vitamin D supplements for their patients, “there should be cheaper ways to improve clinician behavior,” the researchers suggested.

Dr. Adler stated that he had no conflicts of interest.