How effective is chemotherapy in treating neuroendocrine tumors (NETs)? Unfortunately, there is a lack of strong evidence from randomized trials, according to researchers from Gosford Hospital, University of Sydney; Royal North Shore Hospital, Northern Cancer Institute, and Macquarie University Hospitals, all in Australia; and Memorial Sloan Kettering Cancer Center in New York.

Related: Complex Malignancies: A Diagnostic and Therapeutic Trilemma

Few systematic reviews about chemotherapy for patients with NET have been published, and no meta-analyses have been done, the researchers say. They decided to rectify that deficiency and winnowed several hundred “potentially relevant” studies to 8 after examination.

Six studies compared one chemotherapy regimen against another (usually the standard streptozotocin [STZ] plus 5-fluorouracil [5FU]). Two studies compared chemotherapy with interferon (IFN). The researchers found no studies comparing chemotherapy with targeted therapy or somatostatin analogues and none comparing chemotherapy with best-supportive care.

Related: Harnessing Vaccines to Treat Cancers

Their analysis revealed no difference between STZ/5FU and other chemotherapies in response rate, progression-free survival (PFS), 1-year overall survival (OS), and OS. Response rates seemed to be higher for IFN, but no PFS or OS were demonstrated.

Any recommendations for chemotherapy as an option are “largely based on weak evidence,” the researchers charge. The problem, they say, is that the overall quality of the studies was poor. Only one met all features of a randomized trial with low risk of biases. The researchers cite inadequate randomization, lack of blinding, missing data, and selective reporting, among other flaws. In spite of the drawbacks of the studies they examined, their review remains the largest and most comprehensive review and appraisal of the existing evidence of chemotherapy in NET, the researchers say.

Related: Finding Synchronous Cancers

The past few years have seen the “evolution of an impressive array of systemic options,” they conclude, and “it remains to be seen whether chemotherapy shows enough efficacy compared to these options to warrant its side effect profile.” They point out that their review highlights not only the paucity of strong evidence, but also an urgent need of good randomized data—especially on the new, promising chemotherapeutic agents.

Source:

Wong MH, Chan DL, Lee A, et al. PLoS One. 2016;11(6):e0158140.
doi: 10.1371/journal.pone.0158140

How effective is chemotherapy in treating neuroendocrine tumors (NETs)? Unfortunately, there is a lack of strong evidence from randomized trials, according to researchers from Gosford Hospital, University of Sydney; Royal North Shore Hospital, Northern Cancer Institute, and Macquarie University Hospitals, all in Australia; and Memorial Sloan Kettering Cancer Center in New York.

Related: Complex Malignancies: A Diagnostic and Therapeutic Trilemma

Few systematic reviews about chemotherapy for patients with NET have been published, and no meta-analyses have been done, the researchers say. They decided to rectify that deficiency and winnowed several hundred “potentially relevant” studies to 8 after examination.

Six studies compared one chemotherapy regimen against another (usually the standard streptozotocin [STZ] plus 5-fluorouracil [5FU]). Two studies compared chemotherapy with interferon (IFN). The researchers found no studies comparing chemotherapy with targeted therapy or somatostatin analogues and none comparing chemotherapy with best-supportive care.

Related: Harnessing Vaccines to Treat Cancers

Their analysis revealed no difference between STZ/5FU and other chemotherapies in response rate, progression-free survival (PFS), 1-year overall survival (OS), and OS. Response rates seemed to be higher for IFN, but no PFS or OS were demonstrated.

Any recommendations for chemotherapy as an option are “largely based on weak evidence,” the researchers charge. The problem, they say, is that the overall quality of the studies was poor. Only one met all features of a randomized trial with low risk of biases. The researchers cite inadequate randomization, lack of blinding, missing data, and selective reporting, among other flaws. In spite of the drawbacks of the studies they examined, their review remains the largest and most comprehensive review and appraisal of the existing evidence of chemotherapy in NET, the researchers say.

Related: Finding Synchronous Cancers

The past few years have seen the “evolution of an impressive array of systemic options,” they conclude, and “it remains to be seen whether chemotherapy shows enough efficacy compared to these options to warrant its side effect profile.” They point out that their review highlights not only the paucity of strong evidence, but also an urgent need of good randomized data—especially on the new, promising chemotherapeutic agents.

Source:

Wong MH, Chan DL, Lee A, et al. PLoS One. 2016;11(6):e0158140.
doi: 10.1371/journal.pone.0158140

How effective is chemotherapy in treating neuroendocrine tumors (NETs)? Unfortunately, there is a lack of strong evidence from randomized trials, according to researchers from Gosford Hospital, University of Sydney; Royal North Shore Hospital, Northern Cancer Institute, and Macquarie University Hospitals, all in Australia; and Memorial Sloan Kettering Cancer Center in New York.

Related: Complex Malignancies: A Diagnostic and Therapeutic Trilemma

Few systematic reviews about chemotherapy for patients with NET have been published, and no meta-analyses have been done, the researchers say. They decided to rectify that deficiency and winnowed several hundred “potentially relevant” studies to 8 after examination.

Six studies compared one chemotherapy regimen against another (usually the standard streptozotocin [STZ] plus 5-fluorouracil [5FU]). Two studies compared chemotherapy with interferon (IFN). The researchers found no studies comparing chemotherapy with targeted therapy or somatostatin analogues and none comparing chemotherapy with best-supportive care.

Related: Harnessing Vaccines to Treat Cancers

Their analysis revealed no difference between STZ/5FU and other chemotherapies in response rate, progression-free survival (PFS), 1-year overall survival (OS), and OS. Response rates seemed to be higher for IFN, but no PFS or OS were demonstrated.

Any recommendations for chemotherapy as an option are “largely based on weak evidence,” the researchers charge. The problem, they say, is that the overall quality of the studies was poor. Only one met all features of a randomized trial with low risk of biases. The researchers cite inadequate randomization, lack of blinding, missing data, and selective reporting, among other flaws. In spite of the drawbacks of the studies they examined, their review remains the largest and most comprehensive review and appraisal of the existing evidence of chemotherapy in NET, the researchers say.

Related: Finding Synchronous Cancers

The past few years have seen the “evolution of an impressive array of systemic options,” they conclude, and “it remains to be seen whether chemotherapy shows enough efficacy compared to these options to warrant its side effect profile.” They point out that their review highlights not only the paucity of strong evidence, but also an urgent need of good randomized data—especially on the new, promising chemotherapeutic agents.

Source:

Wong MH, Chan DL, Lee A, et al. PLoS One. 2016;11(6):e0158140.
doi: 10.1371/journal.pone.0158140

Limiting hormone receptor testing of diagnostic core biopisies containing ductal carcinoma in situ (DCIS) could save up to $35 million in associated health care costs every year in the United States.

The results of a cost analysis conducted by researchers at Johns Hopkins University were so striking that the hospital has now eliminated reflex testing of core needle biopsies for DCIS, Christopher J. VandenBussche, MD, and his colleagues wrote in the American Journal of Surgical Pathology (2016;40:1090-9).

“We suggest that reflex [hormone receptor] testing of core needle biopsy specimens harboring DCIS should not be performed, as the results do not guide the next step in therapy,” wrote Dr. VandenBussche of Johns Hopkins University, Baltimore. “On the basis of this study, we have convinced our clinicians and no longer reflexively perform estrogen- and progesterone-receptor [ER/PR] testing on core needle biopsy specimens with DCIS at Hopkins and encourage other institutions to follow suit.”

Conducting expensive hormone receptor testing of these biopsy samples before surgery doesn’t make clinical or financial sense, for several reasons, the team said:

• Hormone receptor status at biopsy has no effect on the next treatment step, as DCIS patients always progress first to surgical excision, not neoadjuvant hormone therapy.

• Surgery sometimes reveals extensive breast cancer in patents with pure DCIS, and these cancers will always need ER/PR testing, rendering irrelevant biopsy testing.

• Because ER and PR labeling are often heterogeneous in DCIS, negative results for ER/PR on small core needle biopsy specimens would have to be repeated anyway on surgical excision specimens with larger amounts of DCIS, to be sure that the result is truly negative.

• Hormone therapy for DCIS does decrease recurrence, but it doesn’t impact survival – and it does carry significant adverse effects. Therefore, many women refuse hormone therapy if they do have ER/PR-positive tumors.

• The independent role of PR status in DCIS is unproven, so testing for it is not supported by clinical evidence.

To examine the costs associated with reflexive ER/PR testing, the investigators reviewed 58 core needle biopsies of pure DCIS followed by surgical excision. None of the patients had neoadjuvant hormone therapy. Of the 58 tumors, 76% were pure DCIS, and 16% were DCIS with invasive breast cancer. Most of the DCIS (47) tumors were ER+/PR+; 6 were ER-/PR-; and 5 were ER+/PR-.

The team reviewed the records of 49 patients who underwent surgical excision and ended up with a diagnosis of pure DCIS. These included 46 ER-positive cases, and 3 that were ER-negative in both biopsy and excision.

The findings suggested that ER/PR results from either the biopsy and the surgical excision samples were relevant to therapy in only a portion of these patients.

“We found that the ER/PR results after surgical excision impacted therapy in at most only 16 of 49 cases (33%),” they said. These included the 3 ER-/PR-negative cases, which would, in any case, not have triggered hormone therapy; 10 patients who chose hormone therapy despite a Hopkins oncologist’s neutral recommendation; 1 of 2 who took hormone therapy on a Hopkins oncologist’s recommendation; and 2 of 3 who took it after seeing a non-Hopkins oncologist.

“In contrast,” the authors wrote, “in 33 of the cases (67%), the ER/PR result of the DCIS after surgical excision did not impact therapy.” All of these were ER-positive cases, including 4 patients who opted for bilateral mastectomies (no subsequent role for neoadjuvant therapy), 8 who declined to meet with an oncologist, 1 for whom hormone therapy was contraindicated, 8 (of 8) who declined hormone therapy when their Hopkins oncologist did not recommend it, 10 (of 20) who declined hormone therapy when their Hopkins oncologist was neutral about its risk/benefit ratio, 1 (of 2) who declined hormone therapy when the Hopkins oncologist recommended it, and the 1 patient (of 3) who declined hormone therapy after visiting a non-Hopkins oncologist.

After reviewing the costs associated with these cases, “we found that ER testing … costing $20,685.72 ($357 per patient) had been performed unnecessarily,” the investigators said. In addition, if the PR testing – which has never been proven clinically important in DCIS – had been eliminated, there would have been an additional $86.46 savings per patient, a total savings of $5,014.

“Extrapolating the increased cost of $583 per DCIS diagnosis on core needle biopsy to 60,000 new cases of DCIS in the United States each year, reflex core needle biopsy ER/PR testing unnecessarily increases costs by approximately $35 million,” the authors said. “We recommend that ER/PR not be reflexively ordered on core needle biopsy specimens or surgical excision specimens containing DCIS, but instead that ER alone be performed on surgical excision specimens only when hormone therapy is a serious consideration after medical oncology consultation.”

The group noted that this total reflects the total amount billed, not typical reimbursement. “Regardless,” they said, “the cost of this testing is staggering.”

The authors did not mention the study’s funding source. They had no relevant financial disclosures.

[email protected]

On Twitter @Alz_Gal

Limiting hormone receptor testing of diagnostic core biopisies containing ductal carcinoma in situ (DCIS) could save up to $35 million in associated health care costs every year in the United States.

The results of a cost analysis conducted by researchers at Johns Hopkins University were so striking that the hospital has now eliminated reflex testing of core needle biopsies for DCIS, Christopher J. VandenBussche, MD, and his colleagues wrote in the American Journal of Surgical Pathology (2016;40:1090-9).

“We suggest that reflex [hormone receptor] testing of core needle biopsy specimens harboring DCIS should not be performed, as the results do not guide the next step in therapy,” wrote Dr. VandenBussche of Johns Hopkins University, Baltimore. “On the basis of this study, we have convinced our clinicians and no longer reflexively perform estrogen- and progesterone-receptor [ER/PR] testing on core needle biopsy specimens with DCIS at Hopkins and encourage other institutions to follow suit.”

Conducting expensive hormone receptor testing of these biopsy samples before surgery doesn’t make clinical or financial sense, for several reasons, the team said:

• Hormone receptor status at biopsy has no effect on the next treatment step, as DCIS patients always progress first to surgical excision, not neoadjuvant hormone therapy.

• Surgery sometimes reveals extensive breast cancer in patents with pure DCIS, and these cancers will always need ER/PR testing, rendering irrelevant biopsy testing.

• Because ER and PR labeling are often heterogeneous in DCIS, negative results for ER/PR on small core needle biopsy specimens would have to be repeated anyway on surgical excision specimens with larger amounts of DCIS, to be sure that the result is truly negative.

• Hormone therapy for DCIS does decrease recurrence, but it doesn’t impact survival – and it does carry significant adverse effects. Therefore, many women refuse hormone therapy if they do have ER/PR-positive tumors.

• The independent role of PR status in DCIS is unproven, so testing for it is not supported by clinical evidence.

To examine the costs associated with reflexive ER/PR testing, the investigators reviewed 58 core needle biopsies of pure DCIS followed by surgical excision. None of the patients had neoadjuvant hormone therapy. Of the 58 tumors, 76% were pure DCIS, and 16% were DCIS with invasive breast cancer. Most of the DCIS (47) tumors were ER+/PR+; 6 were ER-/PR-; and 5 were ER+/PR-.

The team reviewed the records of 49 patients who underwent surgical excision and ended up with a diagnosis of pure DCIS. These included 46 ER-positive cases, and 3 that were ER-negative in both biopsy and excision.

The findings suggested that ER/PR results from either the biopsy and the surgical excision samples were relevant to therapy in only a portion of these patients.

“We found that the ER/PR results after surgical excision impacted therapy in at most only 16 of 49 cases (33%),” they said. These included the 3 ER-/PR-negative cases, which would, in any case, not have triggered hormone therapy; 10 patients who chose hormone therapy despite a Hopkins oncologist’s neutral recommendation; 1 of 2 who took hormone therapy on a Hopkins oncologist’s recommendation; and 2 of 3 who took it after seeing a non-Hopkins oncologist.

“In contrast,” the authors wrote, “in 33 of the cases (67%), the ER/PR result of the DCIS after surgical excision did not impact therapy.” All of these were ER-positive cases, including 4 patients who opted for bilateral mastectomies (no subsequent role for neoadjuvant therapy), 8 who declined to meet with an oncologist, 1 for whom hormone therapy was contraindicated, 8 (of 8) who declined hormone therapy when their Hopkins oncologist did not recommend it, 10 (of 20) who declined hormone therapy when their Hopkins oncologist was neutral about its risk/benefit ratio, 1 (of 2) who declined hormone therapy when the Hopkins oncologist recommended it, and the 1 patient (of 3) who declined hormone therapy after visiting a non-Hopkins oncologist.

After reviewing the costs associated with these cases, “we found that ER testing … costing $20,685.72 ($357 per patient) had been performed unnecessarily,” the investigators said. In addition, if the PR testing – which has never been proven clinically important in DCIS – had been eliminated, there would have been an additional $86.46 savings per patient, a total savings of $5,014.

“Extrapolating the increased cost of $583 per DCIS diagnosis on core needle biopsy to 60,000 new cases of DCIS in the United States each year, reflex core needle biopsy ER/PR testing unnecessarily increases costs by approximately $35 million,” the authors said. “We recommend that ER/PR not be reflexively ordered on core needle biopsy specimens or surgical excision specimens containing DCIS, but instead that ER alone be performed on surgical excision specimens only when hormone therapy is a serious consideration after medical oncology consultation.”

The group noted that this total reflects the total amount billed, not typical reimbursement. “Regardless,” they said, “the cost of this testing is staggering.”

The authors did not mention the study’s funding source. They had no relevant financial disclosures.

[email protected]

On Twitter @Alz_Gal

Limiting hormone receptor testing of diagnostic core biopisies containing ductal carcinoma in situ (DCIS) could save up to $35 million in associated health care costs every year in the United States.

The results of a cost analysis conducted by researchers at Johns Hopkins University were so striking that the hospital has now eliminated reflex testing of core needle biopsies for DCIS, Christopher J. VandenBussche, MD, and his colleagues wrote in the American Journal of Surgical Pathology (2016;40:1090-9).

“We suggest that reflex [hormone receptor] testing of core needle biopsy specimens harboring DCIS should not be performed, as the results do not guide the next step in therapy,” wrote Dr. VandenBussche of Johns Hopkins University, Baltimore. “On the basis of this study, we have convinced our clinicians and no longer reflexively perform estrogen- and progesterone-receptor [ER/PR] testing on core needle biopsy specimens with DCIS at Hopkins and encourage other institutions to follow suit.”

Conducting expensive hormone receptor testing of these biopsy samples before surgery doesn’t make clinical or financial sense, for several reasons, the team said:

• Hormone receptor status at biopsy has no effect on the next treatment step, as DCIS patients always progress first to surgical excision, not neoadjuvant hormone therapy.

• Surgery sometimes reveals extensive breast cancer in patents with pure DCIS, and these cancers will always need ER/PR testing, rendering irrelevant biopsy testing.

• Because ER and PR labeling are often heterogeneous in DCIS, negative results for ER/PR on small core needle biopsy specimens would have to be repeated anyway on surgical excision specimens with larger amounts of DCIS, to be sure that the result is truly negative.

• Hormone therapy for DCIS does decrease recurrence, but it doesn’t impact survival – and it does carry significant adverse effects. Therefore, many women refuse hormone therapy if they do have ER/PR-positive tumors.

• The independent role of PR status in DCIS is unproven, so testing for it is not supported by clinical evidence.

To examine the costs associated with reflexive ER/PR testing, the investigators reviewed 58 core needle biopsies of pure DCIS followed by surgical excision. None of the patients had neoadjuvant hormone therapy. Of the 58 tumors, 76% were pure DCIS, and 16% were DCIS with invasive breast cancer. Most of the DCIS (47) tumors were ER+/PR+; 6 were ER-/PR-; and 5 were ER+/PR-.

The team reviewed the records of 49 patients who underwent surgical excision and ended up with a diagnosis of pure DCIS. These included 46 ER-positive cases, and 3 that were ER-negative in both biopsy and excision.

The findings suggested that ER/PR results from either the biopsy and the surgical excision samples were relevant to therapy in only a portion of these patients.

“We found that the ER/PR results after surgical excision impacted therapy in at most only 16 of 49 cases (33%),” they said. These included the 3 ER-/PR-negative cases, which would, in any case, not have triggered hormone therapy; 10 patients who chose hormone therapy despite a Hopkins oncologist’s neutral recommendation; 1 of 2 who took hormone therapy on a Hopkins oncologist’s recommendation; and 2 of 3 who took it after seeing a non-Hopkins oncologist.

“In contrast,” the authors wrote, “in 33 of the cases (67%), the ER/PR result of the DCIS after surgical excision did not impact therapy.” All of these were ER-positive cases, including 4 patients who opted for bilateral mastectomies (no subsequent role for neoadjuvant therapy), 8 who declined to meet with an oncologist, 1 for whom hormone therapy was contraindicated, 8 (of 8) who declined hormone therapy when their Hopkins oncologist did not recommend it, 10 (of 20) who declined hormone therapy when their Hopkins oncologist was neutral about its risk/benefit ratio, 1 (of 2) who declined hormone therapy when the Hopkins oncologist recommended it, and the 1 patient (of 3) who declined hormone therapy after visiting a non-Hopkins oncologist.

After reviewing the costs associated with these cases, “we found that ER testing … costing $20,685.72 ($357 per patient) had been performed unnecessarily,” the investigators said. In addition, if the PR testing – which has never been proven clinically important in DCIS – had been eliminated, there would have been an additional $86.46 savings per patient, a total savings of $5,014.

“Extrapolating the increased cost of $583 per DCIS diagnosis on core needle biopsy to 60,000 new cases of DCIS in the United States each year, reflex core needle biopsy ER/PR testing unnecessarily increases costs by approximately $35 million,” the authors said. “We recommend that ER/PR not be reflexively ordered on core needle biopsy specimens or surgical excision specimens containing DCIS, but instead that ER alone be performed on surgical excision specimens only when hormone therapy is a serious consideration after medical oncology consultation.”

The group noted that this total reflects the total amount billed, not typical reimbursement. “Regardless,” they said, “the cost of this testing is staggering.”

The authors did not mention the study’s funding source. They had no relevant financial disclosures.

[email protected]

On Twitter @Alz_Gal

CHICAGO – Investigational agent PT2385, an inhibitor of hypoxia-inducible factor 2-alpha (HIF-2alpha), appears safe and tolerable and demonstrated early evidence of clinical activity in heavily pretreated patients with advanced clear cell renal cell carcinoma, investigators reported at the annual meeting of the American Society of Clinical Oncology.

In a small, phase I dose-escalation study, 39% of patients in the study achieved complete response, partial response, or stable disease lasting at least 16 weeks.

Dr. Kevin Courtney

PT2385 is a first-in-class, orally administered selective small molecule inhibitor of HIF-2alpha, a transcription factor with a role in clear cell renal cell carcinoma.

“Hypoxia-inducible factor 2-alpha is a key oncogenic driver of clear cell renal cell carcinoma,” Kevin Courtney, MD, PhD, of the University of Texas Southwestern Medical Center, Dallas, said at the meeting.

A total of 51 patients (n = 26 for dose escalation cohort and n = 25 in dose expansion cohort) met the study’s eligibility requirements of having a diagnosis of clear cell renal cell carcinoma, an Eastern Cooperative Oncology Group score ranging from 0 to 1, and at least one prior anticancer therapy. The median age of the cohort was 65 years with the youngest participant being 29 years and the oldest being 80 years old. The majority of patients were male (71%), had received four or more prior systemic therapies (53%), and had undergone vascular endothelial growth factor therapy (98%). Patients were treated with continuous twice-daily oral dosing of PT2385 until progression or toxicity. A total of three patients were treated at the 100-mg dose, three at the 200-mg dose, four at the 400-mg dose, seven at the 800-mg dose, six at a dose of 1,200 mg, and three at a dose of 1,800 mg.

“No dose-limiting toxicity was observed at any dose level,” Dr. Courtney said.

Based on safety, pharmokinetic and pharmodynamic data, 800 mg twice daily was the selected dose for the expansion cohort, he reported.

Of 51 patients treated, 1 patient had a complete response, 3 achieved partial responses, and 16 patients achieved stable disease for at least 16 weeks. The most common grade one or two adverse events were anemia (n = 18), peripheral edema (n = 18), fatigue (n = 18), nausea (n = 15), and back pain (n = 12). Only two grade four adverse events (low lymphocyte count) were reported.

“Notably, hypertension was not seen,” Dr. Courtney said.

At the time the study concluded, the four patients who achieved complete or partial responses remained on the treatment, and five had received treatment for a year or longer.

The study was funded by Peloton Therapeutics. Dr. Courtney reported having stock and ownership interest in, serving in advisory roles for, or receiving research funding from multiple companies. Several coinvestigators reported receiving research funding from or holding patents with multiple companies including Peloton Therapeutics.

[email protected]

On Twitter @jessnicolecraig

CHICAGO – Investigational agent PT2385, an inhibitor of hypoxia-inducible factor 2-alpha (HIF-2alpha), appears safe and tolerable and demonstrated early evidence of clinical activity in heavily pretreated patients with advanced clear cell renal cell carcinoma, investigators reported at the annual meeting of the American Society of Clinical Oncology.

In a small, phase I dose-escalation study, 39% of patients in the study achieved complete response, partial response, or stable disease lasting at least 16 weeks.

Dr. Kevin Courtney

PT2385 is a first-in-class, orally administered selective small molecule inhibitor of HIF-2alpha, a transcription factor with a role in clear cell renal cell carcinoma.

“Hypoxia-inducible factor 2-alpha is a key oncogenic driver of clear cell renal cell carcinoma,” Kevin Courtney, MD, PhD, of the University of Texas Southwestern Medical Center, Dallas, said at the meeting.

A total of 51 patients (n = 26 for dose escalation cohort and n = 25 in dose expansion cohort) met the study’s eligibility requirements of having a diagnosis of clear cell renal cell carcinoma, an Eastern Cooperative Oncology Group score ranging from 0 to 1, and at least one prior anticancer therapy. The median age of the cohort was 65 years with the youngest participant being 29 years and the oldest being 80 years old. The majority of patients were male (71%), had received four or more prior systemic therapies (53%), and had undergone vascular endothelial growth factor therapy (98%). Patients were treated with continuous twice-daily oral dosing of PT2385 until progression or toxicity. A total of three patients were treated at the 100-mg dose, three at the 200-mg dose, four at the 400-mg dose, seven at the 800-mg dose, six at a dose of 1,200 mg, and three at a dose of 1,800 mg.

“No dose-limiting toxicity was observed at any dose level,” Dr. Courtney said.

Based on safety, pharmokinetic and pharmodynamic data, 800 mg twice daily was the selected dose for the expansion cohort, he reported.

Of 51 patients treated, 1 patient had a complete response, 3 achieved partial responses, and 16 patients achieved stable disease for at least 16 weeks. The most common grade one or two adverse events were anemia (n = 18), peripheral edema (n = 18), fatigue (n = 18), nausea (n = 15), and back pain (n = 12). Only two grade four adverse events (low lymphocyte count) were reported.

“Notably, hypertension was not seen,” Dr. Courtney said.

At the time the study concluded, the four patients who achieved complete or partial responses remained on the treatment, and five had received treatment for a year or longer.

The study was funded by Peloton Therapeutics. Dr. Courtney reported having stock and ownership interest in, serving in advisory roles for, or receiving research funding from multiple companies. Several coinvestigators reported receiving research funding from or holding patents with multiple companies including Peloton Therapeutics.

[email protected]

On Twitter @jessnicolecraig

CHICAGO – Investigational agent PT2385, an inhibitor of hypoxia-inducible factor 2-alpha (HIF-2alpha), appears safe and tolerable and demonstrated early evidence of clinical activity in heavily pretreated patients with advanced clear cell renal cell carcinoma, investigators reported at the annual meeting of the American Society of Clinical Oncology.

In a small, phase I dose-escalation study, 39% of patients in the study achieved complete response, partial response, or stable disease lasting at least 16 weeks.

Dr. Kevin Courtney

PT2385 is a first-in-class, orally administered selective small molecule inhibitor of HIF-2alpha, a transcription factor with a role in clear cell renal cell carcinoma.

“Hypoxia-inducible factor 2-alpha is a key oncogenic driver of clear cell renal cell carcinoma,” Kevin Courtney, MD, PhD, of the University of Texas Southwestern Medical Center, Dallas, said at the meeting.

A total of 51 patients (n = 26 for dose escalation cohort and n = 25 in dose expansion cohort) met the study’s eligibility requirements of having a diagnosis of clear cell renal cell carcinoma, an Eastern Cooperative Oncology Group score ranging from 0 to 1, and at least one prior anticancer therapy. The median age of the cohort was 65 years with the youngest participant being 29 years and the oldest being 80 years old. The majority of patients were male (71%), had received four or more prior systemic therapies (53%), and had undergone vascular endothelial growth factor therapy (98%). Patients were treated with continuous twice-daily oral dosing of PT2385 until progression or toxicity. A total of three patients were treated at the 100-mg dose, three at the 200-mg dose, four at the 400-mg dose, seven at the 800-mg dose, six at a dose of 1,200 mg, and three at a dose of 1,800 mg.

“No dose-limiting toxicity was observed at any dose level,” Dr. Courtney said.

Based on safety, pharmokinetic and pharmodynamic data, 800 mg twice daily was the selected dose for the expansion cohort, he reported.

Of 51 patients treated, 1 patient had a complete response, 3 achieved partial responses, and 16 patients achieved stable disease for at least 16 weeks. The most common grade one or two adverse events were anemia (n = 18), peripheral edema (n = 18), fatigue (n = 18), nausea (n = 15), and back pain (n = 12). Only two grade four adverse events (low lymphocyte count) were reported.

“Notably, hypertension was not seen,” Dr. Courtney said.

At the time the study concluded, the four patients who achieved complete or partial responses remained on the treatment, and five had received treatment for a year or longer.

The study was funded by Peloton Therapeutics. Dr. Courtney reported having stock and ownership interest in, serving in advisory roles for, or receiving research funding from multiple companies. Several coinvestigators reported receiving research funding from or holding patents with multiple companies including Peloton Therapeutics.

[email protected]

On Twitter @jessnicolecraig

Gastroesophageal reflux disease (GERD) is fertile soil for medical and psychiatric comorbid conditions, with sleep disorders leading the way, according to Maurice M. Ohayon, MD, who presented the findings of a longitudinal, population-based study on GERD and its "fellow travelers" at the annual meeting of the Associated Professional Sleep Societies. Insomnia, obstructive sleep apnea, and restless legs syndrome were among the most prevalent comorbidities of GERD. However, one sleep disorder symptom was reported to be a problem in up to 46% of those with the digestive disease. To learn more, see Family Practice News at: http://www.familypracticenews.com/specialty-focus/pulmonary-sleep-medicine/single-article-page/gerd-and-sleep-disorders-often-go-hand-in-glove/1dc81a99b64d296e03b86aa28893fbc7.html.

Gastroesophageal reflux disease (GERD) is fertile soil for medical and psychiatric comorbid conditions, with sleep disorders leading the way, according to Maurice M. Ohayon, MD, who presented the findings of a longitudinal, population-based study on GERD and its "fellow travelers" at the annual meeting of the Associated Professional Sleep Societies. Insomnia, obstructive sleep apnea, and restless legs syndrome were among the most prevalent comorbidities of GERD. However, one sleep disorder symptom was reported to be a problem in up to 46% of those with the digestive disease. To learn more, see Family Practice News at: http://www.familypracticenews.com/specialty-focus/pulmonary-sleep-medicine/single-article-page/gerd-and-sleep-disorders-often-go-hand-in-glove/1dc81a99b64d296e03b86aa28893fbc7.html.

Gastroesophageal reflux disease (GERD) is fertile soil for medical and psychiatric comorbid conditions, with sleep disorders leading the way, according to Maurice M. Ohayon, MD, who presented the findings of a longitudinal, population-based study on GERD and its "fellow travelers" at the annual meeting of the Associated Professional Sleep Societies. Insomnia, obstructive sleep apnea, and restless legs syndrome were among the most prevalent comorbidities of GERD. However, one sleep disorder symptom was reported to be a problem in up to 46% of those with the digestive disease. To learn more, see Family Practice News at: http://www.familypracticenews.com/specialty-focus/pulmonary-sleep-medicine/single-article-page/gerd-and-sleep-disorders-often-go-hand-in-glove/1dc81a99b64d296e03b86aa28893fbc7.html.

Patients with hepatitis C virus (HCV) infections may have the best long-term outcomes if they achieve sustained viral response (SVR) before they develop clinically significant portal hypertension, according to a study reported on in the July issue of Gastroenterology. On the other hand, patients in stage 2 cirrhosis were more likely than stage 1 patients to develop liver decompensation and to die of hepatocellular carcinoma, regardless of SVR. “The available evidence, including our own, suggests that it is opportune to treat HCV as early as possible, in order to reduce progression to stages of cirrhosis in which a viral cure may be less likely lead to ultimate achievement of a major benefit,” said Dr. Vito Di Marco and his associates from the University of Palermo, Italy. More on the study, and its limitations, is available at Family Practice News: http://www.familypracticenews.com/specialty-focus/infectious-diseases/single-article-page/early-sustained-viral-response-linked-to-better-outcomes-among-hcv-patients/5089546903e73ad3c6947ff3bd3f8dbc.html.

Patients with hepatitis C virus (HCV) infections may have the best long-term outcomes if they achieve sustained viral response (SVR) before they develop clinically significant portal hypertension, according to a study reported on in the July issue of Gastroenterology. On the other hand, patients in stage 2 cirrhosis were more likely than stage 1 patients to develop liver decompensation and to die of hepatocellular carcinoma, regardless of SVR. “The available evidence, including our own, suggests that it is opportune to treat HCV as early as possible, in order to reduce progression to stages of cirrhosis in which a viral cure may be less likely lead to ultimate achievement of a major benefit,” said Dr. Vito Di Marco and his associates from the University of Palermo, Italy. More on the study, and its limitations, is available at Family Practice News: http://www.familypracticenews.com/specialty-focus/infectious-diseases/single-article-page/early-sustained-viral-response-linked-to-better-outcomes-among-hcv-patients/5089546903e73ad3c6947ff3bd3f8dbc.html.

Patients with hepatitis C virus (HCV) infections may have the best long-term outcomes if they achieve sustained viral response (SVR) before they develop clinically significant portal hypertension, according to a study reported on in the July issue of Gastroenterology. On the other hand, patients in stage 2 cirrhosis were more likely than stage 1 patients to develop liver decompensation and to die of hepatocellular carcinoma, regardless of SVR. “The available evidence, including our own, suggests that it is opportune to treat HCV as early as possible, in order to reduce progression to stages of cirrhosis in which a viral cure may be less likely lead to ultimate achievement of a major benefit,” said Dr. Vito Di Marco and his associates from the University of Palermo, Italy. More on the study, and its limitations, is available at Family Practice News: http://www.familypracticenews.com/specialty-focus/infectious-diseases/single-article-page/early-sustained-viral-response-linked-to-better-outcomes-among-hcv-patients/5089546903e73ad3c6947ff3bd3f8dbc.html.

Many commonly used prescription drugs, over-the-counter agents, and several complimentary or alternative medications can either trigger heart failure or exacerbate the disease in patients with existing heart failure, according to a scientific statement written by a committee of the American Heart Association that was released on July 11. The comprehensive statement lists 88 distinct prescription drugs or drug classes. Read more about the statement at Cardiology News, available here: http://www.ecardiologynews.com/specialty-focus/heart-failure/single-article-page/statement-warns-of-drugs-causing-or-exacerbating-heart-failure/e62f58d7bf5e124f84a09242a258bfb5.html.

Many commonly used prescription drugs, over-the-counter agents, and several complimentary or alternative medications can either trigger heart failure or exacerbate the disease in patients with existing heart failure, according to a scientific statement written by a committee of the American Heart Association that was released on July 11. The comprehensive statement lists 88 distinct prescription drugs or drug classes. Read more about the statement at Cardiology News, available here: http://www.ecardiologynews.com/specialty-focus/heart-failure/single-article-page/statement-warns-of-drugs-causing-or-exacerbating-heart-failure/e62f58d7bf5e124f84a09242a258bfb5.html.

Many commonly used prescription drugs, over-the-counter agents, and several complimentary or alternative medications can either trigger heart failure or exacerbate the disease in patients with existing heart failure, according to a scientific statement written by a committee of the American Heart Association that was released on July 11. The comprehensive statement lists 88 distinct prescription drugs or drug classes. Read more about the statement at Cardiology News, available here: http://www.ecardiologynews.com/specialty-focus/heart-failure/single-article-page/statement-warns-of-drugs-causing-or-exacerbating-heart-failure/e62f58d7bf5e124f84a09242a258bfb5.html.

Alpha-1 antitrypsin deficiency is a common but underrecognized genetic condition that increases the risk of chronic obstructive pulmonary disease (COPD) and liver disease. Because delayed diagnosis is thought to be associated with adverse outcomes, physicians are encouraged to follow available guidelines and test for the disease in all symptomatic adults with fixed airflow obstruction. This article from the Cleveland Clinic Journal of Medicine describes how to detect this genetic condition and the promising new therapies that are being investigated to treat it. The article is available at: http://www.ccjm.org/current-issue/issue-single-view/alpha-1-antitrypsin-deficiency-an-underrecognized-treatable-cause-of-copd/405de7ef6d4fcd6663e0af929c45b845.html.

Alpha-1 antitrypsin deficiency is a common but underrecognized genetic condition that increases the risk of chronic obstructive pulmonary disease (COPD) and liver disease. Because delayed diagnosis is thought to be associated with adverse outcomes, physicians are encouraged to follow available guidelines and test for the disease in all symptomatic adults with fixed airflow obstruction. This article from the Cleveland Clinic Journal of Medicine describes how to detect this genetic condition and the promising new therapies that are being investigated to treat it. The article is available at: http://www.ccjm.org/current-issue/issue-single-view/alpha-1-antitrypsin-deficiency-an-underrecognized-treatable-cause-of-copd/405de7ef6d4fcd6663e0af929c45b845.html.

Alpha-1 antitrypsin deficiency is a common but underrecognized genetic condition that increases the risk of chronic obstructive pulmonary disease (COPD) and liver disease. Because delayed diagnosis is thought to be associated with adverse outcomes, physicians are encouraged to follow available guidelines and test for the disease in all symptomatic adults with fixed airflow obstruction. This article from the Cleveland Clinic Journal of Medicine describes how to detect this genetic condition and the promising new therapies that are being investigated to treat it. The article is available at: http://www.ccjm.org/current-issue/issue-single-view/alpha-1-antitrypsin-deficiency-an-underrecognized-treatable-cause-of-copd/405de7ef6d4fcd6663e0af929c45b845.html.

Historically, the standard of care was for primary care providers to monitor warfarin therapy, but recently, there has been a shift to monitoring patients in anticoagulation clinics. This article from Federal Practitioner provides an overview of the studies done to evaluate the safety and efficacy of face-to-face vs telephone anticoagulation clinics. Find out which method was more effective—if any—at: http://www.fedprac.com/the-publication/issue-single-view/efficacy-and-safety-outcomes-for-patients-taking-warfarin-who-were-switched-from-face-to-face-to-telephone-anticoagulation-clinic/b1833e94751e2fa5c22da1ae82d20f47/ocregister.html.

Historically, the standard of care was for primary care providers to monitor warfarin therapy, but recently, there has been a shift to monitoring patients in anticoagulation clinics. This article from Federal Practitioner provides an overview of the studies done to evaluate the safety and efficacy of face-to-face vs telephone anticoagulation clinics. Find out which method was more effective—if any—at: http://www.fedprac.com/the-publication/issue-single-view/efficacy-and-safety-outcomes-for-patients-taking-warfarin-who-were-switched-from-face-to-face-to-telephone-anticoagulation-clinic/b1833e94751e2fa5c22da1ae82d20f47/ocregister.html.

Historically, the standard of care was for primary care providers to monitor warfarin therapy, but recently, there has been a shift to monitoring patients in anticoagulation clinics. This article from Federal Practitioner provides an overview of the studies done to evaluate the safety and efficacy of face-to-face vs telephone anticoagulation clinics. Find out which method was more effective—if any—at: http://www.fedprac.com/the-publication/issue-single-view/efficacy-and-safety-outcomes-for-patients-taking-warfarin-who-were-switched-from-face-to-face-to-telephone-anticoagulation-clinic/b1833e94751e2fa5c22da1ae82d20f47/ocregister.html.

DENVER – Treatment with a tumor necrosis factor inhibitor strongly linked with protection against progressive hip deterioration in observational data from 576 patients with ankylosing spondylitis enrolled in a prospective U.S. cohort.

But tumor necrosis factor (TNF) inhibitor treatment had less than full success for treating spondyloarthritis (SpA) disease activity in results from a separate registry study of 596 U.S. veterans diagnosed with SpA. About two-thirds were on a TNF inhibitor, and among these recipients, about 40% had suboptimal disease control, Delamo Bekele, MBBS, said at the annual meeting of the Spondyloarthritis (SpA) Research and Treatment Network.

Mitchel L. Zoler/Frontline Medical News

This substantial rate of SpA patients with high disease activity despite TNF inhibitor treatment “suggests a need for more aggressive treatment,” with either a higher TNF inhibitor dosage or by treatment with a different biological drug, said Dr. Bekele, a rheumatologist at Howard University Hospital in Washington.

The analysis that assessed the impact of TNF inhibitor treatment on hip status used data from 576 AS patients enrolled in the Prospective Study of Outcomes in AS (PSOAS) at any of five U.S. centers. PSOAS included patients diagnosed with AS for at least 20 years, and the new study focused on patients who had undergone hip imaging at least twice while in the study and who entered with a Bath AS Radiologic Index (BASRI) hip score of less than 4. The analysis considered patients to have experienced progressive hip deterioration if they had a follow-up BASRI score that was at least two points higher than their baseline score. During a median 3 years of follow-up, 25 patients had this level of hip-disease progression.

Mitchel L. Zoler/Frontline Medical News

A multivariate analysis showed that the rate of hip disease progression was cut by 98% among patients on TNF inhibitor treatment, compared with those not on a TNF inhibitor, a highly significant difference between the two subgroups, reported Daphne Scaramangas-Plumley, MD, a rheumatologist at Cedars-Sinai Medical Center in Los Angeles. The only other variable identified that also correlated with the risk of hip progression was a patient’s hip score at baseline: For every additional point of the BASRI hip score the rate of later worsening rose by 60%.

The second study involved 596 U.S. veterans diagnosed with a type of SpA and enrolled in the Program to Understand the Longterm Outcomes in Spondyloarthritis (PULSAR) registry study at any of seven U.S. Department of Veterans Affairs centers. The analysis showed that about 64% of these SpA patients were receiving a TNF inhibitor. Among these patients on a TNF inhibitor, about 40% continued to have a Bath AS Disease Activity Index (BASDAI) score of 4 or higher, a level high enough to flag an inadequate response to current treatment.

Dr. Scaramangas-Plumley and Dr. Bekele had no disclosures.

[email protected]

On Twitter @mitchelzoler

DENVER – Treatment with a tumor necrosis factor inhibitor strongly linked with protection against progressive hip deterioration in observational data from 576 patients with ankylosing spondylitis enrolled in a prospective U.S. cohort.

But tumor necrosis factor (TNF) inhibitor treatment had less than full success for treating spondyloarthritis (SpA) disease activity in results from a separate registry study of 596 U.S. veterans diagnosed with SpA. About two-thirds were on a TNF inhibitor, and among these recipients, about 40% had suboptimal disease control, Delamo Bekele, MBBS, said at the annual meeting of the Spondyloarthritis (SpA) Research and Treatment Network.

Mitchel L. Zoler/Frontline Medical News

This substantial rate of SpA patients with high disease activity despite TNF inhibitor treatment “suggests a need for more aggressive treatment,” with either a higher TNF inhibitor dosage or by treatment with a different biological drug, said Dr. Bekele, a rheumatologist at Howard University Hospital in Washington.

The analysis that assessed the impact of TNF inhibitor treatment on hip status used data from 576 AS patients enrolled in the Prospective Study of Outcomes in AS (PSOAS) at any of five U.S. centers. PSOAS included patients diagnosed with AS for at least 20 years, and the new study focused on patients who had undergone hip imaging at least twice while in the study and who entered with a Bath AS Radiologic Index (BASRI) hip score of less than 4. The analysis considered patients to have experienced progressive hip deterioration if they had a follow-up BASRI score that was at least two points higher than their baseline score. During a median 3 years of follow-up, 25 patients had this level of hip-disease progression.

Mitchel L. Zoler/Frontline Medical News

A multivariate analysis showed that the rate of hip disease progression was cut by 98% among patients on TNF inhibitor treatment, compared with those not on a TNF inhibitor, a highly significant difference between the two subgroups, reported Daphne Scaramangas-Plumley, MD, a rheumatologist at Cedars-Sinai Medical Center in Los Angeles. The only other variable identified that also correlated with the risk of hip progression was a patient’s hip score at baseline: For every additional point of the BASRI hip score the rate of later worsening rose by 60%.

The second study involved 596 U.S. veterans diagnosed with a type of SpA and enrolled in the Program to Understand the Longterm Outcomes in Spondyloarthritis (PULSAR) registry study at any of seven U.S. Department of Veterans Affairs centers. The analysis showed that about 64% of these SpA patients were receiving a TNF inhibitor. Among these patients on a TNF inhibitor, about 40% continued to have a Bath AS Disease Activity Index (BASDAI) score of 4 or higher, a level high enough to flag an inadequate response to current treatment.

Dr. Scaramangas-Plumley and Dr. Bekele had no disclosures.

[email protected]

On Twitter @mitchelzoler

DENVER – Treatment with a tumor necrosis factor inhibitor strongly linked with protection against progressive hip deterioration in observational data from 576 patients with ankylosing spondylitis enrolled in a prospective U.S. cohort.

But tumor necrosis factor (TNF) inhibitor treatment had less than full success for treating spondyloarthritis (SpA) disease activity in results from a separate registry study of 596 U.S. veterans diagnosed with SpA. About two-thirds were on a TNF inhibitor, and among these recipients, about 40% had suboptimal disease control, Delamo Bekele, MBBS, said at the annual meeting of the Spondyloarthritis (SpA) Research and Treatment Network.

Mitchel L. Zoler/Frontline Medical News

This substantial rate of SpA patients with high disease activity despite TNF inhibitor treatment “suggests a need for more aggressive treatment,” with either a higher TNF inhibitor dosage or by treatment with a different biological drug, said Dr. Bekele, a rheumatologist at Howard University Hospital in Washington.

The analysis that assessed the impact of TNF inhibitor treatment on hip status used data from 576 AS patients enrolled in the Prospective Study of Outcomes in AS (PSOAS) at any of five U.S. centers. PSOAS included patients diagnosed with AS for at least 20 years, and the new study focused on patients who had undergone hip imaging at least twice while in the study and who entered with a Bath AS Radiologic Index (BASRI) hip score of less than 4. The analysis considered patients to have experienced progressive hip deterioration if they had a follow-up BASRI score that was at least two points higher than their baseline score. During a median 3 years of follow-up, 25 patients had this level of hip-disease progression.

Mitchel L. Zoler/Frontline Medical News

A multivariate analysis showed that the rate of hip disease progression was cut by 98% among patients on TNF inhibitor treatment, compared with those not on a TNF inhibitor, a highly significant difference between the two subgroups, reported Daphne Scaramangas-Plumley, MD, a rheumatologist at Cedars-Sinai Medical Center in Los Angeles. The only other variable identified that also correlated with the risk of hip progression was a patient’s hip score at baseline: For every additional point of the BASRI hip score the rate of later worsening rose by 60%.

The second study involved 596 U.S. veterans diagnosed with a type of SpA and enrolled in the Program to Understand the Longterm Outcomes in Spondyloarthritis (PULSAR) registry study at any of seven U.S. Department of Veterans Affairs centers. The analysis showed that about 64% of these SpA patients were receiving a TNF inhibitor. Among these patients on a TNF inhibitor, about 40% continued to have a Bath AS Disease Activity Index (BASDAI) score of 4 or higher, a level high enough to flag an inadequate response to current treatment.

Dr. Scaramangas-Plumley and Dr. Bekele had no disclosures.

[email protected]

On Twitter @mitchelzoler

Like most physicians, Dr. Susan Hardwick-Smith was used to receiving the occasional negative online review about her practice. But a biting post from several years ago was so wrenching that it nearly drove the Houston ob.gyn. out of medicine for good.

The patient blasted Dr. Hardwick-Smith on a popular review site about her care during a delivery and accused the doctor of attempting to force an unnecessary C-section. The account was inaccurate, but privacy laws prevented Dr. Hardwick-Smith from defending herself online or sharing details of the actual encounter, she said.

“She wrote this very detailed account of what a terrible doctor I was, and in my version of reality, I had saved her baby’s life,” said Dr. Hardwick-Smith. “I felt extremely powerless. I lost a lot of sleep over it, and I was considering giving up delivering babies. It was a real turning point for me.”

Rather than hanging up her white coat, Dr. Hardwick-Smith began working with an online reputation company – eMerit – that works to dilute negative reviews by soliciting a greater number of reviews from patients. The offensive post is now buried under hundreds of other reviews that are primarily positive, she said.

Hiring a reputation management company is one strategy for coping with negative online reviews. But cyberlaw experts stress that removing negative posts altogether is no easy feat. The best move to take often depends on the post, the patient, and the circumstance.

By now, it’s no secret that negative online reviews can significantly impact a medical practice, from influencing patient recruitment to affecting practice revenue to ruining a reputation. A 2015 survey of 2,354 consumers by search marketing firm BrightLocal found that 92% of consumers read online reviews – up from 67% in 2010 – and 40% of consumers had formed an opinion by reading just one to three reviews. Of 2,137 patients who viewed online reviews, 35% selected a physician based on positive reviews, while 37% avoided doctors with negative reviews, according to a 2014 study in JAMA (doi:10.1001/jama.2013.283194).

Reviews have become a strong force in the health care industry, said Peter Yelkovac, an online defamation attorney in Northern Indiana.

“Online reviews have really replaced the common ‘word of mouth’ that used to be the primary source for doctors referrals,” Mr. Yelkovac said in an interview. “Now, [patients] go online. Anyone can type anything they want, whether it’s truthful, untruthful, positive, indifferent, or negative.”

Doctor vs. website

In some cases, contacting a website administrator and requesting a review be removed can end the dilemma, said Michael J. Sacopulos, a medical malpractice defense attorney based in Terre Haute, Ind.

Rating sites generally have “terms of use,” and posts that violate the terms usually will be taken down by site administrators with some nudging, Mr. Sacopulos said in an interview. Other sites have “strike policies,” where a reviewee can request that one or two negative reviews be removed.

Still other sites are not as accommodating. Amazon, for instance, has immunity against content posted on the site, Mr. Sacopulos said. Under the Communications Decency Act, interactive computer services, such as a consumer review website, cannot be liable for content independently created or developed by third-party users. Such sites are hardly motivated to remove negative comments when racy posts can drive traffic to the site, he said.

Eric M. Joseph, MD, a facial plastic surgeon in West Orange, N.J., learned this lesson firsthand when he attempted to have a video removed from YouTube. A poster had uploaded copyright-protected before and after photos from Dr. Joseph’s practice onto YouTube and made disparaging comments about the patients in a video that went viral. Dr. Joseph and the patient both flagged the video for removal, but to no avail.

“It was impossible to [talk to] a human being at Google,” Dr, Joseph said. “It almost didn’t come down, and we were in conversations about suing Google. It took months and a cyberattorney who specializes in copyright infringement.”

The video finally was removed, but not before Dr. Joseph spent $6,000 in legal fees and experienced significant distress from the incident. Although most reviews about his practice are positive, he said, it’s difficult not to be affected by negative posts.

“From a psychological standpoint, it stings,” he said. “The burn of a negative review outweighs the sweetness of a positive review 100 times.”

Reputation companies to the rescue?

Like Dr. Hardwick-Smith, Dr. Joseph has utilized the online reputation management company eMerit to improve his online presence. The company gathers reviews from patients at the point of service and posts them to dominate review sites.

The solution to pollution is dilution, which means counterbalancing negative reviews with more representative reviews,” said Jeffrey Segal, MD, a neurosurgeon and attorney, and the founder of eMerit. “The next step is to deescalate conflict if you know who the patient is – to see if the patient problem can be resolved. Typically a patient is pleasantly surprised that you took the effort to call. Because the bar is so low, it’s very easy to exceed it.”

Physicians subscribe to eMerit on a month-to-month basis, paying $100-$600 a month, depending on the practice’s needs, Dr. Segal said. He touted a greater than 90% renewal rate, and said eMerit has captured and uploaded more than 150,000 patient reviews since its inception.

For the online reputation management company Reputation.com, health care providers have become one of the its most frequent clients, said Michael Fertik, company founder. Reputation.com solicits reviews from patients after appointments and ensures their visibility on top review sites. The platform also integrates reviews from general and health care review sites to help providers address patient feedback and receive alerts when negative reviews are posted. Rates start at $50 a month.

Mr. Fertik noted that more reviews not only overtake negative posts, but they make physicians easier to find by patients.

“If you have more than 10-15 reviews, you have a higher chance of getting a new patient because the search engine is going to favor doctors that have more reviews,” he said. “Doctors that have a small number of reviews don’t exist as far as search engines are concerned.”

However, all online reputation management firms are not equal, Mr. Sacopulos warned. Some are unfamiliar with the health care space, while others are unclear on health care privacy regulations. Mr. Sacopulos learned of a company that was sending patients texts to request reviews, which was likely a privacy violation and a violation of the Telecommunications Act, he said.

““Some [companies] are much more credible, and they understand health care law more than others,” he said. “Some have the technological capabilities to do things, but don’t understand the legal environment, so you need to be very careful [about whom] you pick.”

Time to sue?

Litigation is generally the last resort to fighting unfavorable online reviews. If a doctor believes a review is unfair or defamatory, and all other efforts have been exhausted, a lawyer may be able to help, Mr. Yelkovac said.

“When someone says, ‘I want to sue,’ that’s a possibility, but that’s typically far down the road,” he said. “Lawsuits are expensive. Lawsuits have an unknown outcome, and I would say, many times when you do sue for defamation, [the poster] may or may not have a lot of money, so you may end up spending a lot of money and you don’t recover anything from the patient.”

The majority of the lawsuits Mr. Yelkovac handles related to online reviews seek to unmask the poster with the aid of subpoenas and at times computer forensics, he said. From there, doctors can decide which action to take, such as contacting the poster and asking to have the comment removed.

“Sometimes it’s a surprise,” he said. “Sometimes it’s an ex-employee. Sometimes it’s a family member, or it could potentially be a competitor. Many times it’s not even a patient, and sometimes it’s a patient [who] the doctor never thought would post a review.”

Reviews and malpractice risk

Remember that not all unfavorable reviews are necessarily negative for physicians, said Brant Avondet, founder of Searchlight Enterprises, a malpractice risk prediction and online physician ratings research company.

A pattern of reviews that express the same concerns or frustrations by patients can be used to address and change internal policies and problems, such as multiple complaints about long wait times or a crowded parking lot, he said. Perhaps the front desk staff is repeatedly unfriendly to patients. Taking steps to correct these concerns could help in the long run, Mr. Avondet said.

Searchlight Enterprises recently presented study findings about a suggested link between online ratings and legal risk for physicians at a national medical insurance conference. Mr. Avondet and his colleagues evaluated claims data for 4,000 Florida physicians from the Florida Healthcare Practitioner Data Portal from 2000 to 2016 and studied online physician reviews from top rating sites. Doctors were grouped into three categories: surgical, ob.gyn., and “other” specialties. Findings showed the bottom 10% of surgeons studied (those with the worst online reviews) had 150% as many claims as the average for all surgeons. Surgeons in the top 20% (doctors with the best online reviews) had roughly half of the risk of a claim, compared with the average surgeon. Similar results were found for ob.gyns. and other specialties.

“Low and behold, there’s a huge correlation,” Mr. Avondet said. “There’s no shadow of a doubt that there’s something there that predicts your malpractice risk based on how nice or mean you are in the eyes of the patient.”

Mr. Avondet said he encourages physicians to use online reviews to make improvements, thus lowering their liability.

“Look at these reviews as a lens into your practice and things you might need to correct,” he said. “Use it as [insight] for how you can improve your practice and decrease the risk of getting sued.”

[email protected]

On Twitter @legal_med

Like most physicians, Dr. Susan Hardwick-Smith was used to receiving the occasional negative online review about her practice. But a biting post from several years ago was so wrenching that it nearly drove the Houston ob.gyn. out of medicine for good.

The patient blasted Dr. Hardwick-Smith on a popular review site about her care during a delivery and accused the doctor of attempting to force an unnecessary C-section. The account was inaccurate, but privacy laws prevented Dr. Hardwick-Smith from defending herself online or sharing details of the actual encounter, she said.

“She wrote this very detailed account of what a terrible doctor I was, and in my version of reality, I had saved her baby’s life,” said Dr. Hardwick-Smith. “I felt extremely powerless. I lost a lot of sleep over it, and I was considering giving up delivering babies. It was a real turning point for me.”

Rather than hanging up her white coat, Dr. Hardwick-Smith began working with an online reputation company – eMerit – that works to dilute negative reviews by soliciting a greater number of reviews from patients. The offensive post is now buried under hundreds of other reviews that are primarily positive, she said.

Hiring a reputation management company is one strategy for coping with negative online reviews. But cyberlaw experts stress that removing negative posts altogether is no easy feat. The best move to take often depends on the post, the patient, and the circumstance.

By now, it’s no secret that negative online reviews can significantly impact a medical practice, from influencing patient recruitment to affecting practice revenue to ruining a reputation. A 2015 survey of 2,354 consumers by search marketing firm BrightLocal found that 92% of consumers read online reviews – up from 67% in 2010 – and 40% of consumers had formed an opinion by reading just one to three reviews. Of 2,137 patients who viewed online reviews, 35% selected a physician based on positive reviews, while 37% avoided doctors with negative reviews, according to a 2014 study in JAMA (doi:10.1001/jama.2013.283194).

Reviews have become a strong force in the health care industry, said Peter Yelkovac, an online defamation attorney in Northern Indiana.

“Online reviews have really replaced the common ‘word of mouth’ that used to be the primary source for doctors referrals,” Mr. Yelkovac said in an interview. “Now, [patients] go online. Anyone can type anything they want, whether it’s truthful, untruthful, positive, indifferent, or negative.”

Doctor vs. website

In some cases, contacting a website administrator and requesting a review be removed can end the dilemma, said Michael J. Sacopulos, a medical malpractice defense attorney based in Terre Haute, Ind.

Rating sites generally have “terms of use,” and posts that violate the terms usually will be taken down by site administrators with some nudging, Mr. Sacopulos said in an interview. Other sites have “strike policies,” where a reviewee can request that one or two negative reviews be removed.

Still other sites are not as accommodating. Amazon, for instance, has immunity against content posted on the site, Mr. Sacopulos said. Under the Communications Decency Act, interactive computer services, such as a consumer review website, cannot be liable for content independently created or developed by third-party users. Such sites are hardly motivated to remove negative comments when racy posts can drive traffic to the site, he said.

Eric M. Joseph, MD, a facial plastic surgeon in West Orange, N.J., learned this lesson firsthand when he attempted to have a video removed from YouTube. A poster had uploaded copyright-protected before and after photos from Dr. Joseph’s practice onto YouTube and made disparaging comments about the patients in a video that went viral. Dr. Joseph and the patient both flagged the video for removal, but to no avail.

“It was impossible to [talk to] a human being at Google,” Dr, Joseph said. “It almost didn’t come down, and we were in conversations about suing Google. It took months and a cyberattorney who specializes in copyright infringement.”

The video finally was removed, but not before Dr. Joseph spent $6,000 in legal fees and experienced significant distress from the incident. Although most reviews about his practice are positive, he said, it’s difficult not to be affected by negative posts.

“From a psychological standpoint, it stings,” he said. “The burn of a negative review outweighs the sweetness of a positive review 100 times.”

Reputation companies to the rescue?

Like Dr. Hardwick-Smith, Dr. Joseph has utilized the online reputation management company eMerit to improve his online presence. The company gathers reviews from patients at the point of service and posts them to dominate review sites.

The solution to pollution is dilution, which means counterbalancing negative reviews with more representative reviews,” said Jeffrey Segal, MD, a neurosurgeon and attorney, and the founder of eMerit. “The next step is to deescalate conflict if you know who the patient is – to see if the patient problem can be resolved. Typically a patient is pleasantly surprised that you took the effort to call. Because the bar is so low, it’s very easy to exceed it.”

Physicians subscribe to eMerit on a month-to-month basis, paying $100-$600 a month, depending on the practice’s needs, Dr. Segal said. He touted a greater than 90% renewal rate, and said eMerit has captured and uploaded more than 150,000 patient reviews since its inception.

For the online reputation management company Reputation.com, health care providers have become one of the its most frequent clients, said Michael Fertik, company founder. Reputation.com solicits reviews from patients after appointments and ensures their visibility on top review sites. The platform also integrates reviews from general and health care review sites to help providers address patient feedback and receive alerts when negative reviews are posted. Rates start at $50 a month.

Mr. Fertik noted that more reviews not only overtake negative posts, but they make physicians easier to find by patients.

“If you have more than 10-15 reviews, you have a higher chance of getting a new patient because the search engine is going to favor doctors that have more reviews,” he said. “Doctors that have a small number of reviews don’t exist as far as search engines are concerned.”

However, all online reputation management firms are not equal, Mr. Sacopulos warned. Some are unfamiliar with the health care space, while others are unclear on health care privacy regulations. Mr. Sacopulos learned of a company that was sending patients texts to request reviews, which was likely a privacy violation and a violation of the Telecommunications Act, he said.

““Some [companies] are much more credible, and they understand health care law more than others,” he said. “Some have the technological capabilities to do things, but don’t understand the legal environment, so you need to be very careful [about whom] you pick.”

Time to sue?

Litigation is generally the last resort to fighting unfavorable online reviews. If a doctor believes a review is unfair or defamatory, and all other efforts have been exhausted, a lawyer may be able to help, Mr. Yelkovac said.

“When someone says, ‘I want to sue,’ that’s a possibility, but that’s typically far down the road,” he said. “Lawsuits are expensive. Lawsuits have an unknown outcome, and I would say, many times when you do sue for defamation, [the poster] may or may not have a lot of money, so you may end up spending a lot of money and you don’t recover anything from the patient.”

The majority of the lawsuits Mr. Yelkovac handles related to online reviews seek to unmask the poster with the aid of subpoenas and at times computer forensics, he said. From there, doctors can decide which action to take, such as contacting the poster and asking to have the comment removed.

“Sometimes it’s a surprise,” he said. “Sometimes it’s an ex-employee. Sometimes it’s a family member, or it could potentially be a competitor. Many times it’s not even a patient, and sometimes it’s a patient [who] the doctor never thought would post a review.”

Reviews and malpractice risk

Remember that not all unfavorable reviews are necessarily negative for physicians, said Brant Avondet, founder of Searchlight Enterprises, a malpractice risk prediction and online physician ratings research company.

A pattern of reviews that express the same concerns or frustrations by patients can be used to address and change internal policies and problems, such as multiple complaints about long wait times or a crowded parking lot, he said. Perhaps the front desk staff is repeatedly unfriendly to patients. Taking steps to correct these concerns could help in the long run, Mr. Avondet said.

Searchlight Enterprises recently presented study findings about a suggested link between online ratings and legal risk for physicians at a national medical insurance conference. Mr. Avondet and his colleagues evaluated claims data for 4,000 Florida physicians from the Florida Healthcare Practitioner Data Portal from 2000 to 2016 and studied online physician reviews from top rating sites. Doctors were grouped into three categories: surgical, ob.gyn., and “other” specialties. Findings showed the bottom 10% of surgeons studied (those with the worst online reviews) had 150% as many claims as the average for all surgeons. Surgeons in the top 20% (doctors with the best online reviews) had roughly half of the risk of a claim, compared with the average surgeon. Similar results were found for ob.gyns. and other specialties.

“Low and behold, there’s a huge correlation,” Mr. Avondet said. “There’s no shadow of a doubt that there’s something there that predicts your malpractice risk based on how nice or mean you are in the eyes of the patient.”

Mr. Avondet said he encourages physicians to use online reviews to make improvements, thus lowering their liability.

“Look at these reviews as a lens into your practice and things you might need to correct,” he said. “Use it as [insight] for how you can improve your practice and decrease the risk of getting sued.”

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Like most physicians, Dr. Susan Hardwick-Smith was used to receiving the occasional negative online review about her practice. But a biting post from several years ago was so wrenching that it nearly drove the Houston ob.gyn. out of medicine for good.

The patient blasted Dr. Hardwick-Smith on a popular review site about her care during a delivery and accused the doctor of attempting to force an unnecessary C-section. The account was inaccurate, but privacy laws prevented Dr. Hardwick-Smith from defending herself online or sharing details of the actual encounter, she said.

“She wrote this very detailed account of what a terrible doctor I was, and in my version of reality, I had saved her baby’s life,” said Dr. Hardwick-Smith. “I felt extremely powerless. I lost a lot of sleep over it, and I was considering giving up delivering babies. It was a real turning point for me.”

Rather than hanging up her white coat, Dr. Hardwick-Smith began working with an online reputation company – eMerit – that works to dilute negative reviews by soliciting a greater number of reviews from patients. The offensive post is now buried under hundreds of other reviews that are primarily positive, she said.

Hiring a reputation management company is one strategy for coping with negative online reviews. But cyberlaw experts stress that removing negative posts altogether is no easy feat. The best move to take often depends on the post, the patient, and the circumstance.

By now, it’s no secret that negative online reviews can significantly impact a medical practice, from influencing patient recruitment to affecting practice revenue to ruining a reputation. A 2015 survey of 2,354 consumers by search marketing firm BrightLocal found that 92% of consumers read online reviews – up from 67% in 2010 – and 40% of consumers had formed an opinion by reading just one to three reviews. Of 2,137 patients who viewed online reviews, 35% selected a physician based on positive reviews, while 37% avoided doctors with negative reviews, according to a 2014 study in JAMA (doi:10.1001/jama.2013.283194).

Reviews have become a strong force in the health care industry, said Peter Yelkovac, an online defamation attorney in Northern Indiana.

“Online reviews have really replaced the common ‘word of mouth’ that used to be the primary source for doctors referrals,” Mr. Yelkovac said in an interview. “Now, [patients] go online. Anyone can type anything they want, whether it’s truthful, untruthful, positive, indifferent, or negative.”

Doctor vs. website

In some cases, contacting a website administrator and requesting a review be removed can end the dilemma, said Michael J. Sacopulos, a medical malpractice defense attorney based in Terre Haute, Ind.

Rating sites generally have “terms of use,” and posts that violate the terms usually will be taken down by site administrators with some nudging, Mr. Sacopulos said in an interview. Other sites have “strike policies,” where a reviewee can request that one or two negative reviews be removed.

Still other sites are not as accommodating. Amazon, for instance, has immunity against content posted on the site, Mr. Sacopulos said. Under the Communications Decency Act, interactive computer services, such as a consumer review website, cannot be liable for content independently created or developed by third-party users. Such sites are hardly motivated to remove negative comments when racy posts can drive traffic to the site, he said.

Eric M. Joseph, MD, a facial plastic surgeon in West Orange, N.J., learned this lesson firsthand when he attempted to have a video removed from YouTube. A poster had uploaded copyright-protected before and after photos from Dr. Joseph’s practice onto YouTube and made disparaging comments about the patients in a video that went viral. Dr. Joseph and the patient both flagged the video for removal, but to no avail.

“It was impossible to [talk to] a human being at Google,” Dr, Joseph said. “It almost didn’t come down, and we were in conversations about suing Google. It took months and a cyberattorney who specializes in copyright infringement.”

The video finally was removed, but not before Dr. Joseph spent $6,000 in legal fees and experienced significant distress from the incident. Although most reviews about his practice are positive, he said, it’s difficult not to be affected by negative posts.

“From a psychological standpoint, it stings,” he said. “The burn of a negative review outweighs the sweetness of a positive review 100 times.”

Reputation companies to the rescue?

Like Dr. Hardwick-Smith, Dr. Joseph has utilized the online reputation management company eMerit to improve his online presence. The company gathers reviews from patients at the point of service and posts them to dominate review sites.

The solution to pollution is dilution, which means counterbalancing negative reviews with more representative reviews,” said Jeffrey Segal, MD, a neurosurgeon and attorney, and the founder of eMerit. “The next step is to deescalate conflict if you know who the patient is – to see if the patient problem can be resolved. Typically a patient is pleasantly surprised that you took the effort to call. Because the bar is so low, it’s very easy to exceed it.”

Physicians subscribe to eMerit on a month-to-month basis, paying $100-$600 a month, depending on the practice’s needs, Dr. Segal said. He touted a greater than 90% renewal rate, and said eMerit has captured and uploaded more than 150,000 patient reviews since its inception.

For the online reputation management company Reputation.com, health care providers have become one of the its most frequent clients, said Michael Fertik, company founder. Reputation.com solicits reviews from patients after appointments and ensures their visibility on top review sites. The platform also integrates reviews from general and health care review sites to help providers address patient feedback and receive alerts when negative reviews are posted. Rates start at $50 a month.

Mr. Fertik noted that more reviews not only overtake negative posts, but they make physicians easier to find by patients.

“If you have more than 10-15 reviews, you have a higher chance of getting a new patient because the search engine is going to favor doctors that have more reviews,” he said. “Doctors that have a small number of reviews don’t exist as far as search engines are concerned.”

However, all online reputation management firms are not equal, Mr. Sacopulos warned. Some are unfamiliar with the health care space, while others are unclear on health care privacy regulations. Mr. Sacopulos learned of a company that was sending patients texts to request reviews, which was likely a privacy violation and a violation of the Telecommunications Act, he said.

““Some [companies] are much more credible, and they understand health care law more than others,” he said. “Some have the technological capabilities to do things, but don’t understand the legal environment, so you need to be very careful [about whom] you pick.”

Time to sue?

Litigation is generally the last resort to fighting unfavorable online reviews. If a doctor believes a review is unfair or defamatory, and all other efforts have been exhausted, a lawyer may be able to help, Mr. Yelkovac said.

“When someone says, ‘I want to sue,’ that’s a possibility, but that’s typically far down the road,” he said. “Lawsuits are expensive. Lawsuits have an unknown outcome, and I would say, many times when you do sue for defamation, [the poster] may or may not have a lot of money, so you may end up spending a lot of money and you don’t recover anything from the patient.”

The majority of the lawsuits Mr. Yelkovac handles related to online reviews seek to unmask the poster with the aid of subpoenas and at times computer forensics, he said. From there, doctors can decide which action to take, such as contacting the poster and asking to have the comment removed.

“Sometimes it’s a surprise,” he said. “Sometimes it’s an ex-employee. Sometimes it’s a family member, or it could potentially be a competitor. Many times it’s not even a patient, and sometimes it’s a patient [who] the doctor never thought would post a review.”

Reviews and malpractice risk

Remember that not all unfavorable reviews are necessarily negative for physicians, said Brant Avondet, founder of Searchlight Enterprises, a malpractice risk prediction and online physician ratings research company.

A pattern of reviews that express the same concerns or frustrations by patients can be used to address and change internal policies and problems, such as multiple complaints about long wait times or a crowded parking lot, he said. Perhaps the front desk staff is repeatedly unfriendly to patients. Taking steps to correct these concerns could help in the long run, Mr. Avondet said.

Searchlight Enterprises recently presented study findings about a suggested link between online ratings and legal risk for physicians at a national medical insurance conference. Mr. Avondet and his colleagues evaluated claims data for 4,000 Florida physicians from the Florida Healthcare Practitioner Data Portal from 2000 to 2016 and studied online physician reviews from top rating sites. Doctors were grouped into three categories: surgical, ob.gyn., and “other” specialties. Findings showed the bottom 10% of surgeons studied (those with the worst online reviews) had 150% as many claims as the average for all surgeons. Surgeons in the top 20% (doctors with the best online reviews) had roughly half of the risk of a claim, compared with the average surgeon. Similar results were found for ob.gyns. and other specialties.

“Low and behold, there’s a huge correlation,” Mr. Avondet said. “There’s no shadow of a doubt that there’s something there that predicts your malpractice risk based on how nice or mean you are in the eyes of the patient.”

Mr. Avondet said he encourages physicians to use online reviews to make improvements, thus lowering their liability.

“Look at these reviews as a lens into your practice and things you might need to correct,” he said. “Use it as [insight] for how you can improve your practice and decrease the risk of getting sued.”

[email protected]

On Twitter @legal_med