ABSTRACT

The ulnar nerve is most commonly compressed at the elbow in the cubital tunnel. Conservative and operative treatments have been applied for cubital tunnel syndrome. Surgical management options include decompression, medial epicondylectomy, and various anterior transposition techniques. We describe a novel technique of anterior transposition of the ulnar nerve by using Osborne’s ligament as a sling to avoid subluxation. Osborne’s ligament is incised posteriorly and medially on the olecranon to create a sling with 2 to 3 cm width. The sling is tailored to wrap around the ulnar nerve and attached to the flexor-pronator fascia or dermis to create a smooth gliding surface without causing compression. Ten patients with cubital tunnel syndrome, established by physical examination findings and electromyography/nerve conduction studies underwent ulnar nerve transposition using this technique and were able to participate in a phone survey. The average follow-up was 15.6 months (range, 4-28 months). The average time to become subjectively “better” after surgery was 4.2 weeks. The pain intensity was reduced from an average of 7.5 preoperatively to <1, on a 10-point scale, at the time of the survey. All patients had symptomatic relief without any complication. The proposed technique using Osborne’s ligament as a ligamentofascial or ligamentodermal sling offers a unique way of creating a non-compressive sling with the component of the cubital tunnel itself and has an additional benefit of creating a smooth gliding surface for early return of function.

Continue to: Ulnar nerve compression at the elbow...

Ulnar nerve compression at the elbow is a common nerve compression syndrome in the upper extremity. There are multiple sites of compression of the ulnar nerve distal to the axilla. The most common site of ulnar nerve compression is at the cubital tunnel.¹ When ulnar nerve compression is clinically suspected, electromyography (EMG) and nerve conduction velocity studies (NCS) may be performed to help support the diagnosis. However, a false negative rate in excess of 10% is found in patients with clinical signs and symptoms of cubital tunnel syndrome.² Treatment of cubital tunnel syndrome involves nonsurgical treatments, including activity modification, use of nonsteroidal anti-inflammatory drugs, splinting, and physical therapy or surgical treatment.^3-5

Surgical management of cubital tunnel syndrome is indicated after a failed nonsurgical management or a presentation with motor weakness. The most common surgical treatments include in situ decompression, subcutaneous transposition, intramuscular transposition, submuscular transposition, and medial epicondylectomy, or their combination.⁶ However, optimal surgical management of cubital tunnel syndrome remains controversial.^2,7 The overall goal of surgery is to eliminate all sites of compression and obtain a tension-free nerve that glides smoothly.

After the initial concept of subcutaneous anterior ulnar nerve transposition was developed by Curtis⁸ in 1898, many different techniques have been derived including epineurial suture, fasciodermal sling, and subcutaneous to fascia suture.^8-10 Common complications of subcutaneous ulnar nerve transposition include nerve fibrosis, recurrent subluxation, and inadequate division of the intermuscular septum.⁹ Additionally, thin patients often have repeated trauma to their ulnar nerves after subcutaneous transposition.³  

The anatomy of the cubital tunnel is well described, but it has multiple names and descriptions throughout the literature. Osborne¹¹ originally described a transverse fibrous band as the fascial connection between the 2 heads of the flexor carpi ulnaris that forms the roof of the cubital tunnel. O’Driscoll and colleagues⁵ conducted a cadaver study and proposed calling Osborne’s band as the cubital tunnel retinaculum. They described 4 different variations of anatomy and the retinaculum as a 4-mm wide band of tissue located proximally in the cubital tunnel that is distinct from the arcuate ligament and the fascia between the 2 heads of the flexor carpi ulnaris.⁵ Green and Rayan¹² studied cubital tunnel anatomy and referred to the ligament that spans the medial epicondyle and the olecranon as the arcuate ligament, which is also distinct from the flexor carpi ulnaris aponeurosis. These variations in named anatomy make describing procedures around the cubital tunnel challenging. In this study, the fascial band between the 2 heads of the flexor carpi ulnaris, as originally described by Osborne,¹¹ will be referred to as Osborne’s ligament.

We describe a novel technique of anterior subcutaneous ulnar nerve transposition, where Osborne’s ligament is used as a sling to prevent ulnar nerve subluxation over the medial epicondyle. We also describe the results of our initial subset of patients who were treated with this technique.

Continue to: MATERIALS AND METHODS...

MATERIALS AND METHODS

We performed a chart review of all patients operated on between January 2010 and March 2012 by the same surgeon. We recruited 15 consecutive patients who were diagnosed with ulnar nerve transposition for moderate to severe cubital tunnel syndrome through EMG/NCS and physical examination during this time frame. Operative reports were then reviewed. In 14 of these 15 cases, Osborne’s ligament was used as a ligamentofascial or ligamentodermal sling. In the fifteenth patient, preoperative subluxation of the ulnar nerve was identified with movement of elbow, and Osborne’s ligament was found to not be large enough to provide an appropriate sling. Three patients were unreachable, and 1 patient chose to not participate in the study. Of the initial 15 patients, 10 were given a telephone survey (Appendix A), which was prepared based on the recommendation of Novak and colleagues¹³ and incorporated with questions regarding preoperative symptoms, satisfaction, smoking history, and employment status. This study was Institutional Review Board approved at our institution, and appropriate consent was obtained from the participants.

Appendix A. Ulnar Nerve Telephone Survey

SURGICAL TECHNIQUE

A 10 to 12 cm incision centered over the cubital tunnel is made. The medial antebrachial cutaneous nerve is identified and protected. After dissection through superficial fascia, Osborne’s ligament is identified. The ligament is then released posteriorly from the olecranon and is assessed. The ulnar nerve is then freed in a proximal to distal manner to preserve vascular structures that supply the epineurium. The medial intermuscular septum is examined and excised as a site of compression. The ulnar nerve is then mobilized. Once mobilized, the ulnar nerve is transposed anterior to the medial epicondyle and checked to ensure that no sharp curves are made and nothing is impinging on the nerve while passively flexing and extending the elbow. The Osborne’s ligament is then passed over the top of the previously transposed ulnar nerve to create a sling that is ligamentofascial if sutured to the flexor/pronator fascia or ligamentodermal if sutured to dermis. Importantly, the flexor/pronator fascia is not incised. The remaining soft tissue and fascia of the cubital tunnel are then closed with 2-0 vicryl suture. The free end of the Osborne’s ligament is sutured to flexor/pronator fascia or to dermis, anterior to the medial epicondyle with No. 0 vicryl suture. This process is conducted in a tension-free manner to prevent creating a new site of compression. The nerve is then rechecked for appropriate, tension-free gliding followed by closure of the wound in layers after irrigation (additional details are shown in Figures 1-5).

RESULTS

Ten of the 15 patients were available for telephone review. The results of the telephone survey are as follows. The average time to telephone survey was 15.6 months (range, 4-28 months). The average time to become subjectively “better” was 4.2 weeks (range, 2-6 weeks). The average time back to work was 1.6 weeks (range, 1 day to 3 weeks). Three patients were retired and did not go back to work. All patients stated they were subjectively “better” after surgery, and when asked, all patients stated that they would choose surgery again. The average pain prior to surgery was 7.5 (range, 5.5-9.5) on a 10-point scale. The average pain after surgery at final phone interview was 0.1 on a 10-point scale (range, 0-1). All patients stated that their sensation was subjectively better after the surgery. One patient said that his strength worsened, another patient said that his strength was the same, and the remaining patients said that their strength was better. One patient was a smoker, and no patients had acute traumatic injuries that caused their ulnar nerve symptoms.

Continue to: DISCUSSION...

DISCUSSION

Subcutaneous ulnar nerve transposition is an effective way to treat ulnar nerve compression at the cubital tunnel in appropriate patients. Many techniques have been described, including epineurial suture, fasciodermal sling, and using the medial intermuscular septum as a sling for the ulnar nerve.^9,10,14,15 Eaton and colleagues¹⁴ described the creation of a 1 cm × 1 cm flap based on antebrachial fascial connected to the medial epicondyle. This flap is reflected medially and acts as a fasciodermal sling posterior to the transposed nerve at the medial epicondyle. This sling also acts like a septum to prevent posterior subluxation. Only subcutaneous fat is superficial to the nerve, in contrast to previous attempts at subcutaneous transposition. At an average of 18 months of follow-up, 14 patients showed improvement in their symptoms.¹⁴ Pribyl and Robinson,⁹ in 1998, described a procedure where a portion of the intermuscular septum is divided from a distance of 3 to 4 cm proximal to its insertion on the medial epicondyle; the portion is used as a sling and sutured to the fascia of the flexor/pronator mass or alternatively to the subcutaneous tissues. Tan and colleagues¹⁵ modified Pribyl and Robinson’s technique by creating a “V” sling with the intermuscular septum; this technique led to complete resolution of symptoms in 17 of 20 patients and improved the symptoms in the 3 remaining patients. Richmond and Southmayd¹⁰ reported excellent results in 83% of patients who had epineurium sutured to the fascia during subcutaneous transposition. However, each aforementioned technique has its own unique theoretical set of problems. The shortcoming of Eaton and colleagues’¹⁴ fasciodermal sling is the creation of a raw bed while creating the sling over the flexor-pronator fascia, which is prone to scarring. Moreover, given that the flexor-pronator fascia is incised, theoretically, the healing period is prolonged and the grip strength in the initial postoperative period decreases. Utilizing the medial intermuscular septum as a sling can create a narrow band, which creates sharp angles that limit nerve gliding. Suturing the epineurium to the fascia by using the technique of Richmond and Southmayd¹⁰ creates a construct that is resistant to tension-free gliding.

In this study, Osborne’s ligament was successfully used as a ligamentofascial or ligamentodermal sling in our subset of patients. We believe this is partially due to the large smooth gliding surface of Osborne’s ligament that helps to minimize sharp curves and allows for the ulnar nerve to glide tension free. This could be seen with other techniques as described previously. Furthermore, our technique is different because the flexor pronator fascia is not incised, which results in less soft tissue trauma and less pain generation; we suspect that the patients were able to have an early return to work and did not complain of decreased strength because the flexor pronator fascia was not disturbed. Our surveyed patients essentially had complete cessation of pain and were able to return to work in about 10 to 11 days. The patients reported that they felt subjectively “better” in approximately 4 weeks and reported no complications. Sensation was also subjectively “better” in all of the patients surveyed.

This study presents several limitations. The study was retrospective in nature and did not include randomization or a control group. In addition, there is a possibility of significant recall bias in the telephone survey that relies on patient recollection. Finally, the telephone survey is an invalidated outcome measure, and no formal statistical analysis was performed.

CONCLUSION

Subcutaneous ulnar nerve transposition using Osborne’s ligament as a ligamentofascial or ligamentodermal sling is a novel technique that creates a broad based, smooth-gliding sling for tension-free excursion of the ulnar nerve and showed success in our subset of patients.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

The ulnar nerve is most commonly compressed at the elbow in the cubital tunnel. Conservative and operative treatments have been applied for cubital tunnel syndrome. Surgical management options include decompression, medial epicondylectomy, and various anterior transposition techniques. We describe a novel technique of anterior transposition of the ulnar nerve by using Osborne’s ligament as a sling to avoid subluxation. Osborne’s ligament is incised posteriorly and medially on the olecranon to create a sling with 2 to 3 cm width. The sling is tailored to wrap around the ulnar nerve and attached to the flexor-pronator fascia or dermis to create a smooth gliding surface without causing compression. Ten patients with cubital tunnel syndrome, established by physical examination findings and electromyography/nerve conduction studies underwent ulnar nerve transposition using this technique and were able to participate in a phone survey. The average follow-up was 15.6 months (range, 4-28 months). The average time to become subjectively “better” after surgery was 4.2 weeks. The pain intensity was reduced from an average of 7.5 preoperatively to <1, on a 10-point scale, at the time of the survey. All patients had symptomatic relief without any complication. The proposed technique using Osborne’s ligament as a ligamentofascial or ligamentodermal sling offers a unique way of creating a non-compressive sling with the component of the cubital tunnel itself and has an additional benefit of creating a smooth gliding surface for early return of function.

Continue to: Ulnar nerve compression at the elbow...

Ulnar nerve compression at the elbow is a common nerve compression syndrome in the upper extremity. There are multiple sites of compression of the ulnar nerve distal to the axilla. The most common site of ulnar nerve compression is at the cubital tunnel.¹ When ulnar nerve compression is clinically suspected, electromyography (EMG) and nerve conduction velocity studies (NCS) may be performed to help support the diagnosis. However, a false negative rate in excess of 10% is found in patients with clinical signs and symptoms of cubital tunnel syndrome.² Treatment of cubital tunnel syndrome involves nonsurgical treatments, including activity modification, use of nonsteroidal anti-inflammatory drugs, splinting, and physical therapy or surgical treatment.^3-5

Surgical management of cubital tunnel syndrome is indicated after a failed nonsurgical management or a presentation with motor weakness. The most common surgical treatments include in situ decompression, subcutaneous transposition, intramuscular transposition, submuscular transposition, and medial epicondylectomy, or their combination.⁶ However, optimal surgical management of cubital tunnel syndrome remains controversial.^2,7 The overall goal of surgery is to eliminate all sites of compression and obtain a tension-free nerve that glides smoothly.

After the initial concept of subcutaneous anterior ulnar nerve transposition was developed by Curtis⁸ in 1898, many different techniques have been derived including epineurial suture, fasciodermal sling, and subcutaneous to fascia suture.^8-10 Common complications of subcutaneous ulnar nerve transposition include nerve fibrosis, recurrent subluxation, and inadequate division of the intermuscular septum.⁹ Additionally, thin patients often have repeated trauma to their ulnar nerves after subcutaneous transposition.³  

The anatomy of the cubital tunnel is well described, but it has multiple names and descriptions throughout the literature. Osborne¹¹ originally described a transverse fibrous band as the fascial connection between the 2 heads of the flexor carpi ulnaris that forms the roof of the cubital tunnel. O’Driscoll and colleagues⁵ conducted a cadaver study and proposed calling Osborne’s band as the cubital tunnel retinaculum. They described 4 different variations of anatomy and the retinaculum as a 4-mm wide band of tissue located proximally in the cubital tunnel that is distinct from the arcuate ligament and the fascia between the 2 heads of the flexor carpi ulnaris.⁵ Green and Rayan¹² studied cubital tunnel anatomy and referred to the ligament that spans the medial epicondyle and the olecranon as the arcuate ligament, which is also distinct from the flexor carpi ulnaris aponeurosis. These variations in named anatomy make describing procedures around the cubital tunnel challenging. In this study, the fascial band between the 2 heads of the flexor carpi ulnaris, as originally described by Osborne,¹¹ will be referred to as Osborne’s ligament.

We describe a novel technique of anterior subcutaneous ulnar nerve transposition, where Osborne’s ligament is used as a sling to prevent ulnar nerve subluxation over the medial epicondyle. We also describe the results of our initial subset of patients who were treated with this technique.

Continue to: MATERIALS AND METHODS...

MATERIALS AND METHODS

We performed a chart review of all patients operated on between January 2010 and March 2012 by the same surgeon. We recruited 15 consecutive patients who were diagnosed with ulnar nerve transposition for moderate to severe cubital tunnel syndrome through EMG/NCS and physical examination during this time frame. Operative reports were then reviewed. In 14 of these 15 cases, Osborne’s ligament was used as a ligamentofascial or ligamentodermal sling. In the fifteenth patient, preoperative subluxation of the ulnar nerve was identified with movement of elbow, and Osborne’s ligament was found to not be large enough to provide an appropriate sling. Three patients were unreachable, and 1 patient chose to not participate in the study. Of the initial 15 patients, 10 were given a telephone survey (Appendix A), which was prepared based on the recommendation of Novak and colleagues¹³ and incorporated with questions regarding preoperative symptoms, satisfaction, smoking history, and employment status. This study was Institutional Review Board approved at our institution, and appropriate consent was obtained from the participants.

Appendix A. Ulnar Nerve Telephone Survey

SURGICAL TECHNIQUE

A 10 to 12 cm incision centered over the cubital tunnel is made. The medial antebrachial cutaneous nerve is identified and protected. After dissection through superficial fascia, Osborne’s ligament is identified. The ligament is then released posteriorly from the olecranon and is assessed. The ulnar nerve is then freed in a proximal to distal manner to preserve vascular structures that supply the epineurium. The medial intermuscular septum is examined and excised as a site of compression. The ulnar nerve is then mobilized. Once mobilized, the ulnar nerve is transposed anterior to the medial epicondyle and checked to ensure that no sharp curves are made and nothing is impinging on the nerve while passively flexing and extending the elbow. The Osborne’s ligament is then passed over the top of the previously transposed ulnar nerve to create a sling that is ligamentofascial if sutured to the flexor/pronator fascia or ligamentodermal if sutured to dermis. Importantly, the flexor/pronator fascia is not incised. The remaining soft tissue and fascia of the cubital tunnel are then closed with 2-0 vicryl suture. The free end of the Osborne’s ligament is sutured to flexor/pronator fascia or to dermis, anterior to the medial epicondyle with No. 0 vicryl suture. This process is conducted in a tension-free manner to prevent creating a new site of compression. The nerve is then rechecked for appropriate, tension-free gliding followed by closure of the wound in layers after irrigation (additional details are shown in Figures 1-5).

RESULTS

Ten of the 15 patients were available for telephone review. The results of the telephone survey are as follows. The average time to telephone survey was 15.6 months (range, 4-28 months). The average time to become subjectively “better” was 4.2 weeks (range, 2-6 weeks). The average time back to work was 1.6 weeks (range, 1 day to 3 weeks). Three patients were retired and did not go back to work. All patients stated they were subjectively “better” after surgery, and when asked, all patients stated that they would choose surgery again. The average pain prior to surgery was 7.5 (range, 5.5-9.5) on a 10-point scale. The average pain after surgery at final phone interview was 0.1 on a 10-point scale (range, 0-1). All patients stated that their sensation was subjectively better after the surgery. One patient said that his strength worsened, another patient said that his strength was the same, and the remaining patients said that their strength was better. One patient was a smoker, and no patients had acute traumatic injuries that caused their ulnar nerve symptoms.

Continue to: DISCUSSION...

DISCUSSION

Subcutaneous ulnar nerve transposition is an effective way to treat ulnar nerve compression at the cubital tunnel in appropriate patients. Many techniques have been described, including epineurial suture, fasciodermal sling, and using the medial intermuscular septum as a sling for the ulnar nerve.^9,10,14,15 Eaton and colleagues¹⁴ described the creation of a 1 cm × 1 cm flap based on antebrachial fascial connected to the medial epicondyle. This flap is reflected medially and acts as a fasciodermal sling posterior to the transposed nerve at the medial epicondyle. This sling also acts like a septum to prevent posterior subluxation. Only subcutaneous fat is superficial to the nerve, in contrast to previous attempts at subcutaneous transposition. At an average of 18 months of follow-up, 14 patients showed improvement in their symptoms.¹⁴ Pribyl and Robinson,⁹ in 1998, described a procedure where a portion of the intermuscular septum is divided from a distance of 3 to 4 cm proximal to its insertion on the medial epicondyle; the portion is used as a sling and sutured to the fascia of the flexor/pronator mass or alternatively to the subcutaneous tissues. Tan and colleagues¹⁵ modified Pribyl and Robinson’s technique by creating a “V” sling with the intermuscular septum; this technique led to complete resolution of symptoms in 17 of 20 patients and improved the symptoms in the 3 remaining patients. Richmond and Southmayd¹⁰ reported excellent results in 83% of patients who had epineurium sutured to the fascia during subcutaneous transposition. However, each aforementioned technique has its own unique theoretical set of problems. The shortcoming of Eaton and colleagues’¹⁴ fasciodermal sling is the creation of a raw bed while creating the sling over the flexor-pronator fascia, which is prone to scarring. Moreover, given that the flexor-pronator fascia is incised, theoretically, the healing period is prolonged and the grip strength in the initial postoperative period decreases. Utilizing the medial intermuscular septum as a sling can create a narrow band, which creates sharp angles that limit nerve gliding. Suturing the epineurium to the fascia by using the technique of Richmond and Southmayd¹⁰ creates a construct that is resistant to tension-free gliding.

In this study, Osborne’s ligament was successfully used as a ligamentofascial or ligamentodermal sling in our subset of patients. We believe this is partially due to the large smooth gliding surface of Osborne’s ligament that helps to minimize sharp curves and allows for the ulnar nerve to glide tension free. This could be seen with other techniques as described previously. Furthermore, our technique is different because the flexor pronator fascia is not incised, which results in less soft tissue trauma and less pain generation; we suspect that the patients were able to have an early return to work and did not complain of decreased strength because the flexor pronator fascia was not disturbed. Our surveyed patients essentially had complete cessation of pain and were able to return to work in about 10 to 11 days. The patients reported that they felt subjectively “better” in approximately 4 weeks and reported no complications. Sensation was also subjectively “better” in all of the patients surveyed.

This study presents several limitations. The study was retrospective in nature and did not include randomization or a control group. In addition, there is a possibility of significant recall bias in the telephone survey that relies on patient recollection. Finally, the telephone survey is an invalidated outcome measure, and no formal statistical analysis was performed.

CONCLUSION

Subcutaneous ulnar nerve transposition using Osborne’s ligament as a ligamentofascial or ligamentodermal sling is a novel technique that creates a broad based, smooth-gliding sling for tension-free excursion of the ulnar nerve and showed success in our subset of patients.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

The ulnar nerve is most commonly compressed at the elbow in the cubital tunnel. Conservative and operative treatments have been applied for cubital tunnel syndrome. Surgical management options include decompression, medial epicondylectomy, and various anterior transposition techniques. We describe a novel technique of anterior transposition of the ulnar nerve by using Osborne’s ligament as a sling to avoid subluxation. Osborne’s ligament is incised posteriorly and medially on the olecranon to create a sling with 2 to 3 cm width. The sling is tailored to wrap around the ulnar nerve and attached to the flexor-pronator fascia or dermis to create a smooth gliding surface without causing compression. Ten patients with cubital tunnel syndrome, established by physical examination findings and electromyography/nerve conduction studies underwent ulnar nerve transposition using this technique and were able to participate in a phone survey. The average follow-up was 15.6 months (range, 4-28 months). The average time to become subjectively “better” after surgery was 4.2 weeks. The pain intensity was reduced from an average of 7.5 preoperatively to <1, on a 10-point scale, at the time of the survey. All patients had symptomatic relief without any complication. The proposed technique using Osborne’s ligament as a ligamentofascial or ligamentodermal sling offers a unique way of creating a non-compressive sling with the component of the cubital tunnel itself and has an additional benefit of creating a smooth gliding surface for early return of function.

Continue to: Ulnar nerve compression at the elbow...

Ulnar nerve compression at the elbow is a common nerve compression syndrome in the upper extremity. There are multiple sites of compression of the ulnar nerve distal to the axilla. The most common site of ulnar nerve compression is at the cubital tunnel.¹ When ulnar nerve compression is clinically suspected, electromyography (EMG) and nerve conduction velocity studies (NCS) may be performed to help support the diagnosis. However, a false negative rate in excess of 10% is found in patients with clinical signs and symptoms of cubital tunnel syndrome.² Treatment of cubital tunnel syndrome involves nonsurgical treatments, including activity modification, use of nonsteroidal anti-inflammatory drugs, splinting, and physical therapy or surgical treatment.^3-5

Surgical management of cubital tunnel syndrome is indicated after a failed nonsurgical management or a presentation with motor weakness. The most common surgical treatments include in situ decompression, subcutaneous transposition, intramuscular transposition, submuscular transposition, and medial epicondylectomy, or their combination.⁶ However, optimal surgical management of cubital tunnel syndrome remains controversial.^2,7 The overall goal of surgery is to eliminate all sites of compression and obtain a tension-free nerve that glides smoothly.

After the initial concept of subcutaneous anterior ulnar nerve transposition was developed by Curtis⁸ in 1898, many different techniques have been derived including epineurial suture, fasciodermal sling, and subcutaneous to fascia suture.^8-10 Common complications of subcutaneous ulnar nerve transposition include nerve fibrosis, recurrent subluxation, and inadequate division of the intermuscular septum.⁹ Additionally, thin patients often have repeated trauma to their ulnar nerves after subcutaneous transposition.³  

The anatomy of the cubital tunnel is well described, but it has multiple names and descriptions throughout the literature. Osborne¹¹ originally described a transverse fibrous band as the fascial connection between the 2 heads of the flexor carpi ulnaris that forms the roof of the cubital tunnel. O’Driscoll and colleagues⁵ conducted a cadaver study and proposed calling Osborne’s band as the cubital tunnel retinaculum. They described 4 different variations of anatomy and the retinaculum as a 4-mm wide band of tissue located proximally in the cubital tunnel that is distinct from the arcuate ligament and the fascia between the 2 heads of the flexor carpi ulnaris.⁵ Green and Rayan¹² studied cubital tunnel anatomy and referred to the ligament that spans the medial epicondyle and the olecranon as the arcuate ligament, which is also distinct from the flexor carpi ulnaris aponeurosis. These variations in named anatomy make describing procedures around the cubital tunnel challenging. In this study, the fascial band between the 2 heads of the flexor carpi ulnaris, as originally described by Osborne,¹¹ will be referred to as Osborne’s ligament.

We describe a novel technique of anterior subcutaneous ulnar nerve transposition, where Osborne’s ligament is used as a sling to prevent ulnar nerve subluxation over the medial epicondyle. We also describe the results of our initial subset of patients who were treated with this technique.

Continue to: MATERIALS AND METHODS...

MATERIALS AND METHODS

We performed a chart review of all patients operated on between January 2010 and March 2012 by the same surgeon. We recruited 15 consecutive patients who were diagnosed with ulnar nerve transposition for moderate to severe cubital tunnel syndrome through EMG/NCS and physical examination during this time frame. Operative reports were then reviewed. In 14 of these 15 cases, Osborne’s ligament was used as a ligamentofascial or ligamentodermal sling. In the fifteenth patient, preoperative subluxation of the ulnar nerve was identified with movement of elbow, and Osborne’s ligament was found to not be large enough to provide an appropriate sling. Three patients were unreachable, and 1 patient chose to not participate in the study. Of the initial 15 patients, 10 were given a telephone survey (Appendix A), which was prepared based on the recommendation of Novak and colleagues¹³ and incorporated with questions regarding preoperative symptoms, satisfaction, smoking history, and employment status. This study was Institutional Review Board approved at our institution, and appropriate consent was obtained from the participants.

Appendix A. Ulnar Nerve Telephone Survey

SURGICAL TECHNIQUE

A 10 to 12 cm incision centered over the cubital tunnel is made. The medial antebrachial cutaneous nerve is identified and protected. After dissection through superficial fascia, Osborne’s ligament is identified. The ligament is then released posteriorly from the olecranon and is assessed. The ulnar nerve is then freed in a proximal to distal manner to preserve vascular structures that supply the epineurium. The medial intermuscular septum is examined and excised as a site of compression. The ulnar nerve is then mobilized. Once mobilized, the ulnar nerve is transposed anterior to the medial epicondyle and checked to ensure that no sharp curves are made and nothing is impinging on the nerve while passively flexing and extending the elbow. The Osborne’s ligament is then passed over the top of the previously transposed ulnar nerve to create a sling that is ligamentofascial if sutured to the flexor/pronator fascia or ligamentodermal if sutured to dermis. Importantly, the flexor/pronator fascia is not incised. The remaining soft tissue and fascia of the cubital tunnel are then closed with 2-0 vicryl suture. The free end of the Osborne’s ligament is sutured to flexor/pronator fascia or to dermis, anterior to the medial epicondyle with No. 0 vicryl suture. This process is conducted in a tension-free manner to prevent creating a new site of compression. The nerve is then rechecked for appropriate, tension-free gliding followed by closure of the wound in layers after irrigation (additional details are shown in Figures 1-5).

RESULTS

Ten of the 15 patients were available for telephone review. The results of the telephone survey are as follows. The average time to telephone survey was 15.6 months (range, 4-28 months). The average time to become subjectively “better” was 4.2 weeks (range, 2-6 weeks). The average time back to work was 1.6 weeks (range, 1 day to 3 weeks). Three patients were retired and did not go back to work. All patients stated they were subjectively “better” after surgery, and when asked, all patients stated that they would choose surgery again. The average pain prior to surgery was 7.5 (range, 5.5-9.5) on a 10-point scale. The average pain after surgery at final phone interview was 0.1 on a 10-point scale (range, 0-1). All patients stated that their sensation was subjectively better after the surgery. One patient said that his strength worsened, another patient said that his strength was the same, and the remaining patients said that their strength was better. One patient was a smoker, and no patients had acute traumatic injuries that caused their ulnar nerve symptoms.

Continue to: DISCUSSION...

DISCUSSION

Subcutaneous ulnar nerve transposition is an effective way to treat ulnar nerve compression at the cubital tunnel in appropriate patients. Many techniques have been described, including epineurial suture, fasciodermal sling, and using the medial intermuscular septum as a sling for the ulnar nerve.^9,10,14,15 Eaton and colleagues¹⁴ described the creation of a 1 cm × 1 cm flap based on antebrachial fascial connected to the medial epicondyle. This flap is reflected medially and acts as a fasciodermal sling posterior to the transposed nerve at the medial epicondyle. This sling also acts like a septum to prevent posterior subluxation. Only subcutaneous fat is superficial to the nerve, in contrast to previous attempts at subcutaneous transposition. At an average of 18 months of follow-up, 14 patients showed improvement in their symptoms.¹⁴ Pribyl and Robinson,⁹ in 1998, described a procedure where a portion of the intermuscular septum is divided from a distance of 3 to 4 cm proximal to its insertion on the medial epicondyle; the portion is used as a sling and sutured to the fascia of the flexor/pronator mass or alternatively to the subcutaneous tissues. Tan and colleagues¹⁵ modified Pribyl and Robinson’s technique by creating a “V” sling with the intermuscular septum; this technique led to complete resolution of symptoms in 17 of 20 patients and improved the symptoms in the 3 remaining patients. Richmond and Southmayd¹⁰ reported excellent results in 83% of patients who had epineurium sutured to the fascia during subcutaneous transposition. However, each aforementioned technique has its own unique theoretical set of problems. The shortcoming of Eaton and colleagues’¹⁴ fasciodermal sling is the creation of a raw bed while creating the sling over the flexor-pronator fascia, which is prone to scarring. Moreover, given that the flexor-pronator fascia is incised, theoretically, the healing period is prolonged and the grip strength in the initial postoperative period decreases. Utilizing the medial intermuscular septum as a sling can create a narrow band, which creates sharp angles that limit nerve gliding. Suturing the epineurium to the fascia by using the technique of Richmond and Southmayd¹⁰ creates a construct that is resistant to tension-free gliding.

In this study, Osborne’s ligament was successfully used as a ligamentofascial or ligamentodermal sling in our subset of patients. We believe this is partially due to the large smooth gliding surface of Osborne’s ligament that helps to minimize sharp curves and allows for the ulnar nerve to glide tension free. This could be seen with other techniques as described previously. Furthermore, our technique is different because the flexor pronator fascia is not incised, which results in less soft tissue trauma and less pain generation; we suspect that the patients were able to have an early return to work and did not complain of decreased strength because the flexor pronator fascia was not disturbed. Our surveyed patients essentially had complete cessation of pain and were able to return to work in about 10 to 11 days. The patients reported that they felt subjectively “better” in approximately 4 weeks and reported no complications. Sensation was also subjectively “better” in all of the patients surveyed.

This study presents several limitations. The study was retrospective in nature and did not include randomization or a control group. In addition, there is a possibility of significant recall bias in the telephone survey that relies on patient recollection. Finally, the telephone survey is an invalidated outcome measure, and no formal statistical analysis was performed.

CONCLUSION

Subcutaneous ulnar nerve transposition using Osborne’s ligament as a ligamentofascial or ligamentodermal sling is a novel technique that creates a broad based, smooth-gliding sling for tension-free excursion of the ulnar nerve and showed success in our subset of patients.

This paper will be judged for the Resident Writer’s Award.

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Outcomes for women with operable HER2-positive breast cancer were similar whether they received standard combination chemotherapy with either concurrent or sequential paclitaxel/trastuzumab, long-term results of the phase 3, randomized American College of Surgeons Oncology Group Z1041 trial showed.

Among 280 women with HER-2 positive breast cancer followed for a median of 5.1 years, there were no significant differences in either pathological complete response rates (pCR), disease-free survival (DFS), or overall survival with either concurrent or sequential therapy, wrote Aman U. Buzdar, MD, from the University of Texas MD Anderson Cancer Center, Houston, and his colleagues.

“A previous publication of this study’s primary analysis reported that breast pCR in patients treated with paclitaxel and trastuzumab followed by FEC [fluorouracil, epirubicin, cyclophosphamide] and trastuzumab did not differ significantly from that of patients receiving FEC followed by paclitaxel and trastuzumab. We now report the findings concerning the secondary outcomes, that is, with a median follow-up of approximately 5 years, DFS is similar among the two treatment arms,” they wrote in JAMA Oncology.

The purpose of the current analysis was to evaluate long-term outcomes associated with the two treatment approaches.

In the trial, conducted at 36 centers in the continental United States and Puerto Rico, 280 women (median age, 50 years; range, 28-76 years) were treated with 500 mg/m² of fluorouracil, 75 mg/m² epirubicin, and 500 mg/m² cyclophosphamide every 3 weeks for 12 weeks with concurrent weekly paclitaxel at 80 mg/m² and trastuzumab at 2 mg/kg – after an initial dose of 4 mg/kg – or the same paclitaxel/trastuzumab combination delivered weekly for 12 weeks, followed by FEC every 3 weeks with weekly trastuzumab for 12 weeks.

Women who also had hormone receptor–positive disease received endocrine therapy. Radiotherapy was delivered at the discretion of the attending physician.

As noted, there were no differences in either DFS rates (adjusted hazard ratio, 1.02; P = .96) or overall survival rates (adjusted HR, 1.17; P = .73) between the trial arms.

The authors concluded that “concurrent administration of trastuzumab with FEC was not found to offer additional clinical benefit and is not warranted.”

The study was supported by grants to participating institutions from the National Cancer Institute. Dr. Buzdar reported no conflicts of interest. Three coauthors reported research support, consulting fees, travel support, and/or other relationships with multiple companies.

SOURCE: Buzdar AU et al. JAMA Oncol. 2018 Sept 6. doi: 10.1001/jamaoncol.2018.3691.

Outcomes for women with operable HER2-positive breast cancer were similar whether they received standard combination chemotherapy with either concurrent or sequential paclitaxel/trastuzumab, long-term results of the phase 3, randomized American College of Surgeons Oncology Group Z1041 trial showed.

Among 280 women with HER-2 positive breast cancer followed for a median of 5.1 years, there were no significant differences in either pathological complete response rates (pCR), disease-free survival (DFS), or overall survival with either concurrent or sequential therapy, wrote Aman U. Buzdar, MD, from the University of Texas MD Anderson Cancer Center, Houston, and his colleagues.

“A previous publication of this study’s primary analysis reported that breast pCR in patients treated with paclitaxel and trastuzumab followed by FEC [fluorouracil, epirubicin, cyclophosphamide] and trastuzumab did not differ significantly from that of patients receiving FEC followed by paclitaxel and trastuzumab. We now report the findings concerning the secondary outcomes, that is, with a median follow-up of approximately 5 years, DFS is similar among the two treatment arms,” they wrote in JAMA Oncology.

The purpose of the current analysis was to evaluate long-term outcomes associated with the two treatment approaches.

In the trial, conducted at 36 centers in the continental United States and Puerto Rico, 280 women (median age, 50 years; range, 28-76 years) were treated with 500 mg/m² of fluorouracil, 75 mg/m² epirubicin, and 500 mg/m² cyclophosphamide every 3 weeks for 12 weeks with concurrent weekly paclitaxel at 80 mg/m² and trastuzumab at 2 mg/kg – after an initial dose of 4 mg/kg – or the same paclitaxel/trastuzumab combination delivered weekly for 12 weeks, followed by FEC every 3 weeks with weekly trastuzumab for 12 weeks.

Women who also had hormone receptor–positive disease received endocrine therapy. Radiotherapy was delivered at the discretion of the attending physician.

As noted, there were no differences in either DFS rates (adjusted hazard ratio, 1.02; P = .96) or overall survival rates (adjusted HR, 1.17; P = .73) between the trial arms.

The authors concluded that “concurrent administration of trastuzumab with FEC was not found to offer additional clinical benefit and is not warranted.”

The study was supported by grants to participating institutions from the National Cancer Institute. Dr. Buzdar reported no conflicts of interest. Three coauthors reported research support, consulting fees, travel support, and/or other relationships with multiple companies.

SOURCE: Buzdar AU et al. JAMA Oncol. 2018 Sept 6. doi: 10.1001/jamaoncol.2018.3691.

Outcomes for women with operable HER2-positive breast cancer were similar whether they received standard combination chemotherapy with either concurrent or sequential paclitaxel/trastuzumab, long-term results of the phase 3, randomized American College of Surgeons Oncology Group Z1041 trial showed.

Among 280 women with HER-2 positive breast cancer followed for a median of 5.1 years, there were no significant differences in either pathological complete response rates (pCR), disease-free survival (DFS), or overall survival with either concurrent or sequential therapy, wrote Aman U. Buzdar, MD, from the University of Texas MD Anderson Cancer Center, Houston, and his colleagues.

“A previous publication of this study’s primary analysis reported that breast pCR in patients treated with paclitaxel and trastuzumab followed by FEC [fluorouracil, epirubicin, cyclophosphamide] and trastuzumab did not differ significantly from that of patients receiving FEC followed by paclitaxel and trastuzumab. We now report the findings concerning the secondary outcomes, that is, with a median follow-up of approximately 5 years, DFS is similar among the two treatment arms,” they wrote in JAMA Oncology.

The purpose of the current analysis was to evaluate long-term outcomes associated with the two treatment approaches.

In the trial, conducted at 36 centers in the continental United States and Puerto Rico, 280 women (median age, 50 years; range, 28-76 years) were treated with 500 mg/m² of fluorouracil, 75 mg/m² epirubicin, and 500 mg/m² cyclophosphamide every 3 weeks for 12 weeks with concurrent weekly paclitaxel at 80 mg/m² and trastuzumab at 2 mg/kg – after an initial dose of 4 mg/kg – or the same paclitaxel/trastuzumab combination delivered weekly for 12 weeks, followed by FEC every 3 weeks with weekly trastuzumab for 12 weeks.

Women who also had hormone receptor–positive disease received endocrine therapy. Radiotherapy was delivered at the discretion of the attending physician.

As noted, there were no differences in either DFS rates (adjusted hazard ratio, 1.02; P = .96) or overall survival rates (adjusted HR, 1.17; P = .73) between the trial arms.

The authors concluded that “concurrent administration of trastuzumab with FEC was not found to offer additional clinical benefit and is not warranted.”

The study was supported by grants to participating institutions from the National Cancer Institute. Dr. Buzdar reported no conflicts of interest. Three coauthors reported research support, consulting fees, travel support, and/or other relationships with multiple companies.

SOURCE: Buzdar AU et al. JAMA Oncol. 2018 Sept 6. doi: 10.1001/jamaoncol.2018.3691.

The global incidence of rosacea among adults is approximately 5%, based on data from a meta-analysis and systematic review.

Rosacea.org

The National Rosacea Society Expert Committee recently updated its phenotype-based classification system, but the global prevalence and incidence of rosacea remain unknown, wrote Lise Gether, MD, of the University of Copenhagen, Denmark, and her colleagues.

In a review published in the British Journal of Dermatology, the researchers examined the prevalence of rosacea among dermatology patients and in the general population worldwide by analyzing 32 studies including 41 populations and 26,538,319 individuals. The study populations comprised 22 from Europe, 9 from North America, 4 from Asia, 3 from South America, and 3 from Africa. Of the 32 studies, 18 included the general population and 14 included only dermatology patients.

Overall, the pooled proportion of individuals with rosacea was 5.46% in the general population and 2.39% among dermatology patients. Of note, the pooled proportions varied when the studies were grouped by diagnostic method: self-diagnosis (9.7%), physician diagnosis (5.5%), and health care database estimate (1.05%).

Rosacea prevalence by age was highest among individuals aged 45-60 years, but “based on the available data, it was not possible to make useful stratified estimates,” the researchers said.

The researchers estimated rosacea prevalence by gender using data from the 10 studies that reported numbers from both genders. Based on a population of 5,601,642 women and 3,529,559 men, the pooled proportions were similar; 5.4% for women and 3.9% for men.

“The methods used to study the prevalence of rosacea are of great importance as misclassification may be a concern,” the researchers noted. Individuals with mild to moderate rosacea might not seek medical treatment, which might contribute to the low prevalence from health care database estimates. Conversely, the high prevalence with self-reports might suggest a lack of specificity in the questionnaires.

There were no external funding sources. Dr. Gether had no relevant financial disclosures. Coauthors disclosed relationships with companies including Galderma, Pfizer, Eli Lilly, Novartis, and Janssen.
 

SOURCE: Gether L et al. Br J Dermatol. 2018. doi: 10.1111/bjd.16481

The global incidence of rosacea among adults is approximately 5%, based on data from a meta-analysis and systematic review.

Rosacea.org

The National Rosacea Society Expert Committee recently updated its phenotype-based classification system, but the global prevalence and incidence of rosacea remain unknown, wrote Lise Gether, MD, of the University of Copenhagen, Denmark, and her colleagues.

In a review published in the British Journal of Dermatology, the researchers examined the prevalence of rosacea among dermatology patients and in the general population worldwide by analyzing 32 studies including 41 populations and 26,538,319 individuals. The study populations comprised 22 from Europe, 9 from North America, 4 from Asia, 3 from South America, and 3 from Africa. Of the 32 studies, 18 included the general population and 14 included only dermatology patients.

Overall, the pooled proportion of individuals with rosacea was 5.46% in the general population and 2.39% among dermatology patients. Of note, the pooled proportions varied when the studies were grouped by diagnostic method: self-diagnosis (9.7%), physician diagnosis (5.5%), and health care database estimate (1.05%).

Rosacea prevalence by age was highest among individuals aged 45-60 years, but “based on the available data, it was not possible to make useful stratified estimates,” the researchers said.

The researchers estimated rosacea prevalence by gender using data from the 10 studies that reported numbers from both genders. Based on a population of 5,601,642 women and 3,529,559 men, the pooled proportions were similar; 5.4% for women and 3.9% for men.

“The methods used to study the prevalence of rosacea are of great importance as misclassification may be a concern,” the researchers noted. Individuals with mild to moderate rosacea might not seek medical treatment, which might contribute to the low prevalence from health care database estimates. Conversely, the high prevalence with self-reports might suggest a lack of specificity in the questionnaires.

There were no external funding sources. Dr. Gether had no relevant financial disclosures. Coauthors disclosed relationships with companies including Galderma, Pfizer, Eli Lilly, Novartis, and Janssen.
 

SOURCE: Gether L et al. Br J Dermatol. 2018. doi: 10.1111/bjd.16481

The global incidence of rosacea among adults is approximately 5%, based on data from a meta-analysis and systematic review.

Rosacea.org

The National Rosacea Society Expert Committee recently updated its phenotype-based classification system, but the global prevalence and incidence of rosacea remain unknown, wrote Lise Gether, MD, of the University of Copenhagen, Denmark, and her colleagues.

In a review published in the British Journal of Dermatology, the researchers examined the prevalence of rosacea among dermatology patients and in the general population worldwide by analyzing 32 studies including 41 populations and 26,538,319 individuals. The study populations comprised 22 from Europe, 9 from North America, 4 from Asia, 3 from South America, and 3 from Africa. Of the 32 studies, 18 included the general population and 14 included only dermatology patients.

Overall, the pooled proportion of individuals with rosacea was 5.46% in the general population and 2.39% among dermatology patients. Of note, the pooled proportions varied when the studies were grouped by diagnostic method: self-diagnosis (9.7%), physician diagnosis (5.5%), and health care database estimate (1.05%).

Rosacea prevalence by age was highest among individuals aged 45-60 years, but “based on the available data, it was not possible to make useful stratified estimates,” the researchers said.

The researchers estimated rosacea prevalence by gender using data from the 10 studies that reported numbers from both genders. Based on a population of 5,601,642 women and 3,529,559 men, the pooled proportions were similar; 5.4% for women and 3.9% for men.

“The methods used to study the prevalence of rosacea are of great importance as misclassification may be a concern,” the researchers noted. Individuals with mild to moderate rosacea might not seek medical treatment, which might contribute to the low prevalence from health care database estimates. Conversely, the high prevalence with self-reports might suggest a lack of specificity in the questionnaires.

There were no external funding sources. Dr. Gether had no relevant financial disclosures. Coauthors disclosed relationships with companies including Galderma, Pfizer, Eli Lilly, Novartis, and Janssen.
 

SOURCE: Gether L et al. Br J Dermatol. 2018. doi: 10.1111/bjd.16481

This article was produced in partnership with The New York Times.

One of the world’s top breast cancer doctors failed to disclose millions of dollars in payments from drug and health care companies in recent years, omitting his financial ties from dozens of research articles in prestigious publications like the New England Journal of Medicine and the Lancet.

The researcher, José Baselga, MD, a towering figure in the cancer world, is the chief medical officer at Memorial Sloan Kettering Cancer Center in New York. He has held board memberships or advisory roles with Roche and Bristol-Myers Squibb, among other corporations; has had a stake in start-ups testing cancer therapies; and played a key role in the development of breakthrough drugs that have revolutionized treatments for breast cancer.

According to an analysis by ProPublica and the New York Times, Dr. Baselga did not follow financial disclosure rules set by the American Association for Cancer Research when he was president of the group. He also left out payments he received from companies connected to cancer research in his articles published in the group’s journal, Cancer Discovery. At the same time, he has been one of the journal’s two editors in chief.

At a conference this year and before analysts in 2017, he put a positive spin on the results of two Roche-sponsored clinical trials that many others considered disappointments, without disclosing his relationship to the company. Since 2014, he has received more than $3 million from Roche in consulting fees and for his stake in a company it acquired.

Dr. Baselga did not dispute his relationships with at least a dozen companies. In an interview, he said the disclosure lapses were unintentional.

He stressed that much of his industry work was publicly known although he declined to provide payment figures from his involvement with some biotech start-ups. “I acknowledge that there have been inconsistencies, but that’s what it is,” he said. “It’s not that I do not appreciate the importance.”

Dr. Baselga’s extensive corporate relationships – and his frequent failure to disclose them – illustrate how permeable the boundaries remain between academic research and industry, and how weakly reporting requirements are enforced by the medical journals and professional societies charged with policing them.

A decade ago, a series of scandals involving the secret influence of the pharmaceutical industry on drug research prompted the medical community to beef up its conflict-of-interest disclosure requirements. Ethicists worry that outside entanglements can shape the way studies are designed and medications are prescribed to patients, allowing bias to influence medical practice. Disclosing those connections allows the public, other scientists, and doctors to evaluate the research and weigh potential conflicts.

If leaders don’t follow the rules, then we don’t really have rules,” said Walid Gellad, MD, an of the department of medicine at the University of Pittsburgh and director of its Center for Pharmaceutical Policy and Prescribing. “It says that the rules don’t matter.”

The penalties for such ethical lapses are not severe. The cancer research group, the American Association for Cancer Research, warns authors who fill out disclosure forms for its journals that they face a 3-year ban on publishing if they are found to have financial relationships that they did not disclose. But the ban is not included in the conflict-of-interest policy posted on its website, and the group said no author had ever been barred.

Many journals and professional societies do not check conflicts and simply require authors to correct the record.

Officials at the AACR, the American Society of Clinical Oncology and the New England Journal of Medicine said they were looking into Dr. Baselga’s omissions after inquiries from the Times and ProPublica. The Lancet declined to say whether it would look into the matter.

Christine Hickey, a spokeswoman for Memorial Sloan Kettering, said that Dr. Baselga had properly informed the hospital of his outside industry work and that it was Dr. Baselga’s responsibility to disclose such relationships to entities such as medical journals. The cancer center, she said, “has a rigorous and comprehensive compliance program in place to promote honesty and objectivity in scientific research.”

Asked if he planned to correct his disclosures, Dr. Baselga asked reporters what they would recommend. In a statement several days later, he said he would correct his conflict-of-interest reporting for 17 articles, including in the New England Journal of Medicine, the Lancet, and the publication he edits, Cancer Discovery. He said that he did not believe disclosure was required for dozens of other articles detailing early stages of research.

“I have spent my career caring for cancer patients and bringing new therapies to the clinic with the goal of extending and saving lives,” Dr. Baselga said in the statement. “While I have been inconsistent with disclosures and acknowledge that fact, that is a far cry from compromising my responsibilities as a physician, as a scientist and as a clinical leader.”
 

The corporate imprint on cancer research

Dr. Baselga, 59, supervises clinical operations at Memorial Sloan Kettering, one of the nation’s top cancer centers and wields influence over the lives of patients and companies wishing to conduct trials there. He was paid more than $1.5 million in compensation by the cancer center in 2016, according to the hospital’s latest available tax disclosures, but that does not include his consulting or board fees from outside companies.

Many top medical researchers have ties to the for-profit health care industry, and some overlap is seen as a good thing – after all, these are the companies charged with developing the drugs, medical devices and diagnostic tests of the future.

Dr. Baselga’s relationship to industry is extensive. In addition to sitting on the board of Bristol-Myers Squibb, he is a director of Varian Medical Systems, which sells radiation equipment and for whom Memorial Sloan Kettering is a client.

In all, Dr. Baselga has served on the boards of at least six companies since 2013, positions that have required him to assume a fiduciary responsibility to protect the interests of those companies, even as he oversees the cancer center’s medical operations.

The hospital and Dr. Baselga said steps had been taken to prevent him from having a say in any business between the cancer center and the companies on whose boards he sits.

The chief executive of Memorial Sloan Kettering, Craig B. Thompson, MD, settled lawsuits several years ago that were filed by the University of Pennsylvania, Philadelphia, and an affiliated research center. They contended that he hid research conducted while he was at Penn to start a new company, Agios Pharmaceuticals, and did not share the earnings. Dr. Thompson disputed the allegations. He now sits on the board of Merck, which manufactures Keytruda, a blockbuster cancer therapy.

Ms. Hickey said the cancer center cannot fulfill its charitable mission without working with industry. “We encourage collaboration and are proud that our work has led to the approval of novel, lifesaving cancer treatments for patients around the world,” she said.
 

Some disclosures are required; others aren’t

After the scandals a decade ago over lack of disclosure, the federal government began requiring drug and device manufacturers to publicly disclose payments to doctors in 2013.

From August 2013 through 2017, Dr. Baselga received nearly $3.5 million from nine companies, according to the federal Open Payments database, which compiles disclosures filed by drug and device companies.

Dr. Baselga has disclosed in other forums investments and advisory roles in biotech start-ups, but he declined to provide a tally of financial interests in those firms. Companies that have not received approval from the Food and Drug Administration for their products – projects still in the testing phases – do not have to report payments they make to doctors.

Serving on boards can be lucrative. In 2017, Dr. Baselga received $260,000 in cash and stock awards to sit on Varian’s board of directors, according to the company’s corporate filings.

ProPublica and the Times analyzed Dr. Baselga’s publications in medical journals since 2013, the year he joined Memorial Sloan Kettering. He failed to disclose any industry relationships in more than 100, or about 60% of the time, a figure that has increased with each passing year. Last year, he did not list any potential conflicts in 87% of the articles that he wrote or cowrote.

Dr. Baselga compiled a color-coded list of his articles and offered a different interpretation. Sixty-two of the papers for which he did not disclose any potential conflict represented “conceptual, basic laboratory or translational work,” and did not require one, he said. Questions could be raised about others, he said, but he added that most “had no clinical nor financial implications.” That left the 17 papers he plans to correct.

Early-stage research often carries financial weight because it helps companies decide whether to move ahead with a product. In about two-thirds of Dr. Baselga’s articles that lacked details of his industry ties, one or more of his coauthors listed theirs.

In 2015, Dr. Baselga published an article in the New England Journal about a Roche-sponsored trial of one of the company’s drugs, Zelboraf. Despite his financial ties to Roche, he declared that he had “nothing to disclose.” Fourteen of his coauthors reported ties to Roche.

Dr. Baselga defended the articles, saying that “these are high-quality manuscripts reporting on important clinical trials that led to a better understanding of cancer treatments.”

The guidelines enacted by most major medical journals and professional societies ask authors and presenters to list recent financial relationships that could pose a conflict.

But much of this reporting still relies on the honor system. A study in August in the journal JAMA Oncology found that one-third of authors in a sample of cancer trials did not report all payments from the studies’ sponsors.

“We don’t routinely check because we don’t have those kind of resources,” said Rita F. Redberg, MD, the editor of JAMA Internal Medicine, who has been critical of the influence of industry on medical practice. “We rely on trust and integrity. It’s kind of an assumed part of the professional relationship.”

Jennifer Zeis, a spokeswoman for the New England Journal of Medicine, said in an email that it had now asked Dr. Baselga to amend his disclosures. She said the journal planned to overhaul its tracking of industry relationships.

The AACR said it had begun an “extensive review” of the disclosure forms submitted by Dr. Baselga.

It said that it had never barred an author from publishing, and that “such an action would be necessary only in cases of egregious, consistent violations of the rules.”

Among the most prominent relationships that Dr. Baselga has often failed to disclose is with the Swiss pharmaceutical giant Roche and its United States subsidiary Genentech.

In June 2017, at the annual meeting of the ASCO in Chicago, Dr. Baselga spoke at a Roche-sponsored investor event about study results that the company had been counting on to persuade oncologists to move patients from Herceptin – which was facing competition from cheaper alternatives – to a combination treatment involving Herceptin and a newer, more expensive drug, Perjeta.

The results were so underwhelming that Roche’s stock fell 5 % on the news. One analyst described the results as a “lead balloon,” and an editorial in the New England Journal called it a “disappointment.”

Dr. Baselga, however, told analysts that critiques were “weird” and “strange.”

This June, at the same cancer conference, Dr. Baselga struck an upbeat note about the results of a Roche trial of the drug taselisib, saying in a blog post published on the cancer center website that the results were “incredibly exciting” while conceding the side effects from the drug were high.

That same day, Roche announced it was scrapping plans to develop the drug. The news was another disappointment involving the class of drugs called PI3K inhibitors, which is a major focus of Dr. Baselga’s current research.

In neither case did Dr. Baselga reveal that his ties to Roche and Genentech went beyond serving as a trial investigator. In 2014, Roche acquired Seragon, a cancer research company in which Dr. Baselga had an ownership stake, for $725 million. Dr. Baselga received more than $3 million in 2014 and 2015 for his stake in the company, according to the federal Open Payments database.

From 2013 to 2017, Roche also paid Dr. Baselga more than $50,000 in consulting fees, according to the database.

These details were not included in the conflict-of-interest statements that are required of all presenters at the ASCO conference, although he did disclose ownership interests and consulting relationships with several other companies in the prior two years.

ASCO said it would conduct an internal review of Dr. Baselga’s disclosures and would refer the findings to a panel.

Dr. Baselga said that he played no role in the Seragon acquisition and that he had cut ties with Roche since joining the board of a competitor, Bristol-Myers, in March. As for his presentations at the ASCO meetings in the last 2 years, he said he had also noted shortcomings in the studies.

The combination of Perjeta with Herceptin was later approved by the FDA for certain high-risk patients. As for taselisib, Dr. Baselga stands by his belief that the PI3K class of drugs will be an important target for fighting cancer.
 

Katie Thomas covers the pharmaceutical industry for the New York Times.

This article was produced in partnership with The New York Times.

One of the world’s top breast cancer doctors failed to disclose millions of dollars in payments from drug and health care companies in recent years, omitting his financial ties from dozens of research articles in prestigious publications like the New England Journal of Medicine and the Lancet.

The researcher, José Baselga, MD, a towering figure in the cancer world, is the chief medical officer at Memorial Sloan Kettering Cancer Center in New York. He has held board memberships or advisory roles with Roche and Bristol-Myers Squibb, among other corporations; has had a stake in start-ups testing cancer therapies; and played a key role in the development of breakthrough drugs that have revolutionized treatments for breast cancer.

According to an analysis by ProPublica and the New York Times, Dr. Baselga did not follow financial disclosure rules set by the American Association for Cancer Research when he was president of the group. He also left out payments he received from companies connected to cancer research in his articles published in the group’s journal, Cancer Discovery. At the same time, he has been one of the journal’s two editors in chief.

At a conference this year and before analysts in 2017, he put a positive spin on the results of two Roche-sponsored clinical trials that many others considered disappointments, without disclosing his relationship to the company. Since 2014, he has received more than $3 million from Roche in consulting fees and for his stake in a company it acquired.

Dr. Baselga did not dispute his relationships with at least a dozen companies. In an interview, he said the disclosure lapses were unintentional.

He stressed that much of his industry work was publicly known although he declined to provide payment figures from his involvement with some biotech start-ups. “I acknowledge that there have been inconsistencies, but that’s what it is,” he said. “It’s not that I do not appreciate the importance.”

Dr. Baselga’s extensive corporate relationships – and his frequent failure to disclose them – illustrate how permeable the boundaries remain between academic research and industry, and how weakly reporting requirements are enforced by the medical journals and professional societies charged with policing them.

A decade ago, a series of scandals involving the secret influence of the pharmaceutical industry on drug research prompted the medical community to beef up its conflict-of-interest disclosure requirements. Ethicists worry that outside entanglements can shape the way studies are designed and medications are prescribed to patients, allowing bias to influence medical practice. Disclosing those connections allows the public, other scientists, and doctors to evaluate the research and weigh potential conflicts.

If leaders don’t follow the rules, then we don’t really have rules,” said Walid Gellad, MD, an of the department of medicine at the University of Pittsburgh and director of its Center for Pharmaceutical Policy and Prescribing. “It says that the rules don’t matter.”

The penalties for such ethical lapses are not severe. The cancer research group, the American Association for Cancer Research, warns authors who fill out disclosure forms for its journals that they face a 3-year ban on publishing if they are found to have financial relationships that they did not disclose. But the ban is not included in the conflict-of-interest policy posted on its website, and the group said no author had ever been barred.

Many journals and professional societies do not check conflicts and simply require authors to correct the record.

Officials at the AACR, the American Society of Clinical Oncology and the New England Journal of Medicine said they were looking into Dr. Baselga’s omissions after inquiries from the Times and ProPublica. The Lancet declined to say whether it would look into the matter.

Christine Hickey, a spokeswoman for Memorial Sloan Kettering, said that Dr. Baselga had properly informed the hospital of his outside industry work and that it was Dr. Baselga’s responsibility to disclose such relationships to entities such as medical journals. The cancer center, she said, “has a rigorous and comprehensive compliance program in place to promote honesty and objectivity in scientific research.”

Asked if he planned to correct his disclosures, Dr. Baselga asked reporters what they would recommend. In a statement several days later, he said he would correct his conflict-of-interest reporting for 17 articles, including in the New England Journal of Medicine, the Lancet, and the publication he edits, Cancer Discovery. He said that he did not believe disclosure was required for dozens of other articles detailing early stages of research.

“I have spent my career caring for cancer patients and bringing new therapies to the clinic with the goal of extending and saving lives,” Dr. Baselga said in the statement. “While I have been inconsistent with disclosures and acknowledge that fact, that is a far cry from compromising my responsibilities as a physician, as a scientist and as a clinical leader.”
 

The corporate imprint on cancer research

Dr. Baselga, 59, supervises clinical operations at Memorial Sloan Kettering, one of the nation’s top cancer centers and wields influence over the lives of patients and companies wishing to conduct trials there. He was paid more than $1.5 million in compensation by the cancer center in 2016, according to the hospital’s latest available tax disclosures, but that does not include his consulting or board fees from outside companies.

Many top medical researchers have ties to the for-profit health care industry, and some overlap is seen as a good thing – after all, these are the companies charged with developing the drugs, medical devices and diagnostic tests of the future.

Dr. Baselga’s relationship to industry is extensive. In addition to sitting on the board of Bristol-Myers Squibb, he is a director of Varian Medical Systems, which sells radiation equipment and for whom Memorial Sloan Kettering is a client.

In all, Dr. Baselga has served on the boards of at least six companies since 2013, positions that have required him to assume a fiduciary responsibility to protect the interests of those companies, even as he oversees the cancer center’s medical operations.

The hospital and Dr. Baselga said steps had been taken to prevent him from having a say in any business between the cancer center and the companies on whose boards he sits.

The chief executive of Memorial Sloan Kettering, Craig B. Thompson, MD, settled lawsuits several years ago that were filed by the University of Pennsylvania, Philadelphia, and an affiliated research center. They contended that he hid research conducted while he was at Penn to start a new company, Agios Pharmaceuticals, and did not share the earnings. Dr. Thompson disputed the allegations. He now sits on the board of Merck, which manufactures Keytruda, a blockbuster cancer therapy.

Ms. Hickey said the cancer center cannot fulfill its charitable mission without working with industry. “We encourage collaboration and are proud that our work has led to the approval of novel, lifesaving cancer treatments for patients around the world,” she said.
 

Some disclosures are required; others aren’t

After the scandals a decade ago over lack of disclosure, the federal government began requiring drug and device manufacturers to publicly disclose payments to doctors in 2013.

From August 2013 through 2017, Dr. Baselga received nearly $3.5 million from nine companies, according to the federal Open Payments database, which compiles disclosures filed by drug and device companies.

Dr. Baselga has disclosed in other forums investments and advisory roles in biotech start-ups, but he declined to provide a tally of financial interests in those firms. Companies that have not received approval from the Food and Drug Administration for their products – projects still in the testing phases – do not have to report payments they make to doctors.

Serving on boards can be lucrative. In 2017, Dr. Baselga received $260,000 in cash and stock awards to sit on Varian’s board of directors, according to the company’s corporate filings.

ProPublica and the Times analyzed Dr. Baselga’s publications in medical journals since 2013, the year he joined Memorial Sloan Kettering. He failed to disclose any industry relationships in more than 100, or about 60% of the time, a figure that has increased with each passing year. Last year, he did not list any potential conflicts in 87% of the articles that he wrote or cowrote.

Dr. Baselga compiled a color-coded list of his articles and offered a different interpretation. Sixty-two of the papers for which he did not disclose any potential conflict represented “conceptual, basic laboratory or translational work,” and did not require one, he said. Questions could be raised about others, he said, but he added that most “had no clinical nor financial implications.” That left the 17 papers he plans to correct.

Early-stage research often carries financial weight because it helps companies decide whether to move ahead with a product. In about two-thirds of Dr. Baselga’s articles that lacked details of his industry ties, one or more of his coauthors listed theirs.

In 2015, Dr. Baselga published an article in the New England Journal about a Roche-sponsored trial of one of the company’s drugs, Zelboraf. Despite his financial ties to Roche, he declared that he had “nothing to disclose.” Fourteen of his coauthors reported ties to Roche.

Dr. Baselga defended the articles, saying that “these are high-quality manuscripts reporting on important clinical trials that led to a better understanding of cancer treatments.”

The guidelines enacted by most major medical journals and professional societies ask authors and presenters to list recent financial relationships that could pose a conflict.

But much of this reporting still relies on the honor system. A study in August in the journal JAMA Oncology found that one-third of authors in a sample of cancer trials did not report all payments from the studies’ sponsors.

“We don’t routinely check because we don’t have those kind of resources,” said Rita F. Redberg, MD, the editor of JAMA Internal Medicine, who has been critical of the influence of industry on medical practice. “We rely on trust and integrity. It’s kind of an assumed part of the professional relationship.”

Jennifer Zeis, a spokeswoman for the New England Journal of Medicine, said in an email that it had now asked Dr. Baselga to amend his disclosures. She said the journal planned to overhaul its tracking of industry relationships.

The AACR said it had begun an “extensive review” of the disclosure forms submitted by Dr. Baselga.

It said that it had never barred an author from publishing, and that “such an action would be necessary only in cases of egregious, consistent violations of the rules.”

Among the most prominent relationships that Dr. Baselga has often failed to disclose is with the Swiss pharmaceutical giant Roche and its United States subsidiary Genentech.

In June 2017, at the annual meeting of the ASCO in Chicago, Dr. Baselga spoke at a Roche-sponsored investor event about study results that the company had been counting on to persuade oncologists to move patients from Herceptin – which was facing competition from cheaper alternatives – to a combination treatment involving Herceptin and a newer, more expensive drug, Perjeta.

The results were so underwhelming that Roche’s stock fell 5 % on the news. One analyst described the results as a “lead balloon,” and an editorial in the New England Journal called it a “disappointment.”

Dr. Baselga, however, told analysts that critiques were “weird” and “strange.”

This June, at the same cancer conference, Dr. Baselga struck an upbeat note about the results of a Roche trial of the drug taselisib, saying in a blog post published on the cancer center website that the results were “incredibly exciting” while conceding the side effects from the drug were high.

That same day, Roche announced it was scrapping plans to develop the drug. The news was another disappointment involving the class of drugs called PI3K inhibitors, which is a major focus of Dr. Baselga’s current research.

In neither case did Dr. Baselga reveal that his ties to Roche and Genentech went beyond serving as a trial investigator. In 2014, Roche acquired Seragon, a cancer research company in which Dr. Baselga had an ownership stake, for $725 million. Dr. Baselga received more than $3 million in 2014 and 2015 for his stake in the company, according to the federal Open Payments database.

From 2013 to 2017, Roche also paid Dr. Baselga more than $50,000 in consulting fees, according to the database.

These details were not included in the conflict-of-interest statements that are required of all presenters at the ASCO conference, although he did disclose ownership interests and consulting relationships with several other companies in the prior two years.

ASCO said it would conduct an internal review of Dr. Baselga’s disclosures and would refer the findings to a panel.

Dr. Baselga said that he played no role in the Seragon acquisition and that he had cut ties with Roche since joining the board of a competitor, Bristol-Myers, in March. As for his presentations at the ASCO meetings in the last 2 years, he said he had also noted shortcomings in the studies.

The combination of Perjeta with Herceptin was later approved by the FDA for certain high-risk patients. As for taselisib, Dr. Baselga stands by his belief that the PI3K class of drugs will be an important target for fighting cancer.
 

Katie Thomas covers the pharmaceutical industry for the New York Times.

This article was produced in partnership with The New York Times.

One of the world’s top breast cancer doctors failed to disclose millions of dollars in payments from drug and health care companies in recent years, omitting his financial ties from dozens of research articles in prestigious publications like the New England Journal of Medicine and the Lancet.

The researcher, José Baselga, MD, a towering figure in the cancer world, is the chief medical officer at Memorial Sloan Kettering Cancer Center in New York. He has held board memberships or advisory roles with Roche and Bristol-Myers Squibb, among other corporations; has had a stake in start-ups testing cancer therapies; and played a key role in the development of breakthrough drugs that have revolutionized treatments for breast cancer.

According to an analysis by ProPublica and the New York Times, Dr. Baselga did not follow financial disclosure rules set by the American Association for Cancer Research when he was president of the group. He also left out payments he received from companies connected to cancer research in his articles published in the group’s journal, Cancer Discovery. At the same time, he has been one of the journal’s two editors in chief.

At a conference this year and before analysts in 2017, he put a positive spin on the results of two Roche-sponsored clinical trials that many others considered disappointments, without disclosing his relationship to the company. Since 2014, he has received more than $3 million from Roche in consulting fees and for his stake in a company it acquired.

Dr. Baselga did not dispute his relationships with at least a dozen companies. In an interview, he said the disclosure lapses were unintentional.

He stressed that much of his industry work was publicly known although he declined to provide payment figures from his involvement with some biotech start-ups. “I acknowledge that there have been inconsistencies, but that’s what it is,” he said. “It’s not that I do not appreciate the importance.”

Dr. Baselga’s extensive corporate relationships – and his frequent failure to disclose them – illustrate how permeable the boundaries remain between academic research and industry, and how weakly reporting requirements are enforced by the medical journals and professional societies charged with policing them.

A decade ago, a series of scandals involving the secret influence of the pharmaceutical industry on drug research prompted the medical community to beef up its conflict-of-interest disclosure requirements. Ethicists worry that outside entanglements can shape the way studies are designed and medications are prescribed to patients, allowing bias to influence medical practice. Disclosing those connections allows the public, other scientists, and doctors to evaluate the research and weigh potential conflicts.

If leaders don’t follow the rules, then we don’t really have rules,” said Walid Gellad, MD, an of the department of medicine at the University of Pittsburgh and director of its Center for Pharmaceutical Policy and Prescribing. “It says that the rules don’t matter.”

The penalties for such ethical lapses are not severe. The cancer research group, the American Association for Cancer Research, warns authors who fill out disclosure forms for its journals that they face a 3-year ban on publishing if they are found to have financial relationships that they did not disclose. But the ban is not included in the conflict-of-interest policy posted on its website, and the group said no author had ever been barred.

Many journals and professional societies do not check conflicts and simply require authors to correct the record.

Officials at the AACR, the American Society of Clinical Oncology and the New England Journal of Medicine said they were looking into Dr. Baselga’s omissions after inquiries from the Times and ProPublica. The Lancet declined to say whether it would look into the matter.

Christine Hickey, a spokeswoman for Memorial Sloan Kettering, said that Dr. Baselga had properly informed the hospital of his outside industry work and that it was Dr. Baselga’s responsibility to disclose such relationships to entities such as medical journals. The cancer center, she said, “has a rigorous and comprehensive compliance program in place to promote honesty and objectivity in scientific research.”

Asked if he planned to correct his disclosures, Dr. Baselga asked reporters what they would recommend. In a statement several days later, he said he would correct his conflict-of-interest reporting for 17 articles, including in the New England Journal of Medicine, the Lancet, and the publication he edits, Cancer Discovery. He said that he did not believe disclosure was required for dozens of other articles detailing early stages of research.

“I have spent my career caring for cancer patients and bringing new therapies to the clinic with the goal of extending and saving lives,” Dr. Baselga said in the statement. “While I have been inconsistent with disclosures and acknowledge that fact, that is a far cry from compromising my responsibilities as a physician, as a scientist and as a clinical leader.”
 

The corporate imprint on cancer research

Dr. Baselga, 59, supervises clinical operations at Memorial Sloan Kettering, one of the nation’s top cancer centers and wields influence over the lives of patients and companies wishing to conduct trials there. He was paid more than $1.5 million in compensation by the cancer center in 2016, according to the hospital’s latest available tax disclosures, but that does not include his consulting or board fees from outside companies.

Many top medical researchers have ties to the for-profit health care industry, and some overlap is seen as a good thing – after all, these are the companies charged with developing the drugs, medical devices and diagnostic tests of the future.

Dr. Baselga’s relationship to industry is extensive. In addition to sitting on the board of Bristol-Myers Squibb, he is a director of Varian Medical Systems, which sells radiation equipment and for whom Memorial Sloan Kettering is a client.

In all, Dr. Baselga has served on the boards of at least six companies since 2013, positions that have required him to assume a fiduciary responsibility to protect the interests of those companies, even as he oversees the cancer center’s medical operations.

The hospital and Dr. Baselga said steps had been taken to prevent him from having a say in any business between the cancer center and the companies on whose boards he sits.

The chief executive of Memorial Sloan Kettering, Craig B. Thompson, MD, settled lawsuits several years ago that were filed by the University of Pennsylvania, Philadelphia, and an affiliated research center. They contended that he hid research conducted while he was at Penn to start a new company, Agios Pharmaceuticals, and did not share the earnings. Dr. Thompson disputed the allegations. He now sits on the board of Merck, which manufactures Keytruda, a blockbuster cancer therapy.

Ms. Hickey said the cancer center cannot fulfill its charitable mission without working with industry. “We encourage collaboration and are proud that our work has led to the approval of novel, lifesaving cancer treatments for patients around the world,” she said.
 

Some disclosures are required; others aren’t

After the scandals a decade ago over lack of disclosure, the federal government began requiring drug and device manufacturers to publicly disclose payments to doctors in 2013.

From August 2013 through 2017, Dr. Baselga received nearly $3.5 million from nine companies, according to the federal Open Payments database, which compiles disclosures filed by drug and device companies.

Dr. Baselga has disclosed in other forums investments and advisory roles in biotech start-ups, but he declined to provide a tally of financial interests in those firms. Companies that have not received approval from the Food and Drug Administration for their products – projects still in the testing phases – do not have to report payments they make to doctors.

Serving on boards can be lucrative. In 2017, Dr. Baselga received $260,000 in cash and stock awards to sit on Varian’s board of directors, according to the company’s corporate filings.

ProPublica and the Times analyzed Dr. Baselga’s publications in medical journals since 2013, the year he joined Memorial Sloan Kettering. He failed to disclose any industry relationships in more than 100, or about 60% of the time, a figure that has increased with each passing year. Last year, he did not list any potential conflicts in 87% of the articles that he wrote or cowrote.

Dr. Baselga compiled a color-coded list of his articles and offered a different interpretation. Sixty-two of the papers for which he did not disclose any potential conflict represented “conceptual, basic laboratory or translational work,” and did not require one, he said. Questions could be raised about others, he said, but he added that most “had no clinical nor financial implications.” That left the 17 papers he plans to correct.

Early-stage research often carries financial weight because it helps companies decide whether to move ahead with a product. In about two-thirds of Dr. Baselga’s articles that lacked details of his industry ties, one or more of his coauthors listed theirs.

In 2015, Dr. Baselga published an article in the New England Journal about a Roche-sponsored trial of one of the company’s drugs, Zelboraf. Despite his financial ties to Roche, he declared that he had “nothing to disclose.” Fourteen of his coauthors reported ties to Roche.

Dr. Baselga defended the articles, saying that “these are high-quality manuscripts reporting on important clinical trials that led to a better understanding of cancer treatments.”

The guidelines enacted by most major medical journals and professional societies ask authors and presenters to list recent financial relationships that could pose a conflict.

But much of this reporting still relies on the honor system. A study in August in the journal JAMA Oncology found that one-third of authors in a sample of cancer trials did not report all payments from the studies’ sponsors.

“We don’t routinely check because we don’t have those kind of resources,” said Rita F. Redberg, MD, the editor of JAMA Internal Medicine, who has been critical of the influence of industry on medical practice. “We rely on trust and integrity. It’s kind of an assumed part of the professional relationship.”

Jennifer Zeis, a spokeswoman for the New England Journal of Medicine, said in an email that it had now asked Dr. Baselga to amend his disclosures. She said the journal planned to overhaul its tracking of industry relationships.

The AACR said it had begun an “extensive review” of the disclosure forms submitted by Dr. Baselga.

It said that it had never barred an author from publishing, and that “such an action would be necessary only in cases of egregious, consistent violations of the rules.”

Among the most prominent relationships that Dr. Baselga has often failed to disclose is with the Swiss pharmaceutical giant Roche and its United States subsidiary Genentech.

In June 2017, at the annual meeting of the ASCO in Chicago, Dr. Baselga spoke at a Roche-sponsored investor event about study results that the company had been counting on to persuade oncologists to move patients from Herceptin – which was facing competition from cheaper alternatives – to a combination treatment involving Herceptin and a newer, more expensive drug, Perjeta.

The results were so underwhelming that Roche’s stock fell 5 % on the news. One analyst described the results as a “lead balloon,” and an editorial in the New England Journal called it a “disappointment.”

Dr. Baselga, however, told analysts that critiques were “weird” and “strange.”

This June, at the same cancer conference, Dr. Baselga struck an upbeat note about the results of a Roche trial of the drug taselisib, saying in a blog post published on the cancer center website that the results were “incredibly exciting” while conceding the side effects from the drug were high.

That same day, Roche announced it was scrapping plans to develop the drug. The news was another disappointment involving the class of drugs called PI3K inhibitors, which is a major focus of Dr. Baselga’s current research.

In neither case did Dr. Baselga reveal that his ties to Roche and Genentech went beyond serving as a trial investigator. In 2014, Roche acquired Seragon, a cancer research company in which Dr. Baselga had an ownership stake, for $725 million. Dr. Baselga received more than $3 million in 2014 and 2015 for his stake in the company, according to the federal Open Payments database.

From 2013 to 2017, Roche also paid Dr. Baselga more than $50,000 in consulting fees, according to the database.

These details were not included in the conflict-of-interest statements that are required of all presenters at the ASCO conference, although he did disclose ownership interests and consulting relationships with several other companies in the prior two years.

ASCO said it would conduct an internal review of Dr. Baselga’s disclosures and would refer the findings to a panel.

Dr. Baselga said that he played no role in the Seragon acquisition and that he had cut ties with Roche since joining the board of a competitor, Bristol-Myers, in March. As for his presentations at the ASCO meetings in the last 2 years, he said he had also noted shortcomings in the studies.

The combination of Perjeta with Herceptin was later approved by the FDA for certain high-risk patients. As for taselisib, Dr. Baselga stands by his belief that the PI3K class of drugs will be an important target for fighting cancer.
 

Katie Thomas covers the pharmaceutical industry for the New York Times.

The prevalence of pediatric asthma is lowest in Oregon and highest in Alabama, according to estimates from the American Lung Association.

Oregon’s rate comes in at 557 per 10,000 population under the age of 18 years, just ahead of Montana at 574 per 10,000 and Iowa at 577. The prevalence of pediatric asthma in Alabama is 1,315 per 10,000, with North Carolina (1,149), Connecticut (1,107), Hawaii (1,026), and New York (1,005) joining it as members of the over-1,000 club. (MDedge News used the ALA’s estimates for persons under age 18 years with asthma in each state and Census Bureau estimates for population to calculate an unadjusted rate for each state.)

The ALA analysis was based on data from the Behavioral Risk Factor Behavioral System surveys for 2016 (31 states), 2015 (District of Columbia, Louisiana, New Hampshire, Texas), 2014 (Alabama, Maryland, North Carolina, Tennessee, West Virginia), 2012 (North Dakota and Wyoming), and 2011 (Iowa). National data were used for eight states (Alaska, Arkansas, Colorado, Delaware, Idaho, South Carolina, South Dakota, Virginia) that had no data available.

[email protected]

The prevalence of pediatric asthma is lowest in Oregon and highest in Alabama, according to estimates from the American Lung Association.

Oregon’s rate comes in at 557 per 10,000 population under the age of 18 years, just ahead of Montana at 574 per 10,000 and Iowa at 577. The prevalence of pediatric asthma in Alabama is 1,315 per 10,000, with North Carolina (1,149), Connecticut (1,107), Hawaii (1,026), and New York (1,005) joining it as members of the over-1,000 club. (MDedge News used the ALA’s estimates for persons under age 18 years with asthma in each state and Census Bureau estimates for population to calculate an unadjusted rate for each state.)

The ALA analysis was based on data from the Behavioral Risk Factor Behavioral System surveys for 2016 (31 states), 2015 (District of Columbia, Louisiana, New Hampshire, Texas), 2014 (Alabama, Maryland, North Carolina, Tennessee, West Virginia), 2012 (North Dakota and Wyoming), and 2011 (Iowa). National data were used for eight states (Alaska, Arkansas, Colorado, Delaware, Idaho, South Carolina, South Dakota, Virginia) that had no data available.

[email protected]

The prevalence of pediatric asthma is lowest in Oregon and highest in Alabama, according to estimates from the American Lung Association.

Oregon’s rate comes in at 557 per 10,000 population under the age of 18 years, just ahead of Montana at 574 per 10,000 and Iowa at 577. The prevalence of pediatric asthma in Alabama is 1,315 per 10,000, with North Carolina (1,149), Connecticut (1,107), Hawaii (1,026), and New York (1,005) joining it as members of the over-1,000 club. (MDedge News used the ALA’s estimates for persons under age 18 years with asthma in each state and Census Bureau estimates for population to calculate an unadjusted rate for each state.)

The ALA analysis was based on data from the Behavioral Risk Factor Behavioral System surveys for 2016 (31 states), 2015 (District of Columbia, Louisiana, New Hampshire, Texas), 2014 (Alabama, Maryland, North Carolina, Tennessee, West Virginia), 2012 (North Dakota and Wyoming), and 2011 (Iowa). National data were used for eight states (Alaska, Arkansas, Colorado, Delaware, Idaho, South Carolina, South Dakota, Virginia) that had no data available.

[email protected]

Don’t miss the CHEST Annual Meeting 2018 in San Antonio, Oct 6-10. Watch as CHEST 2018 Program Chair David A. Schulman, MD, MPH, FCCP, walks you through the vision of this year’s meeting. View complete details at chestmeeting.chestnet.org.

Don’t miss the CHEST Annual Meeting 2018 in San Antonio, Oct 6-10. Watch as CHEST 2018 Program Chair David A. Schulman, MD, MPH, FCCP, walks you through the vision of this year’s meeting. View complete details at chestmeeting.chestnet.org.

Don’t miss the CHEST Annual Meeting 2018 in San Antonio, Oct 6-10. Watch as CHEST 2018 Program Chair David A. Schulman, MD, MPH, FCCP, walks you through the vision of this year’s meeting. View complete details at chestmeeting.chestnet.org.

MUNICH – Patients with left-sided endocarditis who are clinically stable after a couple weeks of inpatient intravenous antibiotics may at that point become candidates for discharge on oral antibiotics for the remainder of their treatment course, according to the findings of the randomized, multicenter, Danish POET trial.

Bruce Jancin/MDedge News

“Shifting to oral antibiotic treatment in stabilized patients with endocarditis was as effective and safe as continued intravenous antibiotic treatment and was given during half the antibiotic treatment period. These novel findings may have a significant impact on future clinical practice for the management of patients who are stable,” Henning Bundgård, MD, said at the annual congress of the European Society of Cardiology.

Both ESC and American Heart Association/American College of Cardiology guidelines now recommend treatment of infective endocarditis with intravenous antibiotics for up to 6 weeks. Safely cutting the duration of in-hospital intravenous antibiotics in half is likely to generate major cost savings while improving patient quality of life and avoiding prolonged exposure to the iatrogenic risks inherent to the hospital environment, noted Dr. Bundgård, a cardiologist at Copenhagen University Hospital.

The rationale for the POET (Partial Oral Treatment of Endocarditis) trial was the investigators’ recognition that, even though infectious endocarditis is a feared disease with an in-hospital mortality of 15% or more, the great majority of serious complications occur in the early critical phase of therapy; that is, during the first 10 days or so of inpatient intravenous antibiotic therapy.

“After stabilization, the main reason for staying in the hospital is just to receive IV antibiotics,” Dr. Bundgård noted.

POET included 400 patients with left-sided endocarditis hospitalized at multiple cardiac centers across Denmark, 35% of whom had at least one major comorbid condition. When this reporter observed that this was the smallest study he’d ever seen reported from Denmark, where researchers famously like to utilize interconnected national databases to conduct nationwide observational studies incorporating the country’s entire population, the cardiologist replied, “Denmark is a small country, but we like to make big trials. And this is actually the largest-ever clinical trial in endocarditis, so we are still going big.”

Important to the generalizability of the POET results was the requirement that all 400 participants had to be infected with streptococcus, Staphylococcus aureus, Enterococcus faecalis, or coagulase-negative staphylococci – the major pathogens responsible for three-quarters of all cases of infectious endocarditis.

Once participants were clinically stable after a median of 17 days of intravenous antibiotics, they were randomized to continued in-hospital intravenous antibiotic therapy for a median of another 19 days or to discharge on two oral antibiotics from different classes with different mechanisms of action administered for a median of 17 days, with selection of the oral agents being guided by the results of bacterial susceptibility testing.

The primary outcome was a composite of all-cause mortality, embolic events, unplanned cardiac surgery, and relapse of bacteremia from randomization through 6 months after completion of antibiotic therapy. This occurred in 9.0% of the orally treated group and 12.1% of patients on full-course intravenous therapy for a 28% relative risk reduction, which statistically established the noninferioritiy of the partial oral regimen. The results were similar in patients with native as compared with prosthetic valves, with or without major comorbidities, and in surgically as opposed to conservatively treated patients.

Rates of three of the four components of the composite endpoint were similar in both groups. However, all-cause mortality occurred in 3.5% of the oral therapy group, compared with 6.5% of those on intravenous therapy. Dr. Bundgård said he and his coinvestigators think the disparity in mortality was probably caused by play of chance, although he added that they were struck that four sudden deaths occurred in the intravenous group and none in patients who got oral antibiotics.

Side effects were similarly mild and low frequency in both study arms.

Audience members were eager for details on how the Danish investigators decided patients were clinically stable on intravenous antibiotics and thus ready for randomization, as well as the outpatient follow-up procedures employed in those discharged on oral therapy.

Dr. Bundgård explained that clinical stability required that a patient be afebrile, have C-reactive protein and leukocyte levels less than 35% of their peaks, and needed to have been on intravenous antibiotics for a minimum of 10 days. Moreover, patients who underwent valve surgery during their hospitalization, as did 38% of POET participants, had to wait a minimum of 7 days afterwards before they could be declared clinically stable. Lastly, just prior to randomization all participants underwent transesophageal echocardiography to rule out abscess formation or other valve abnormalities requiring surgery.

Outpatient follow-up required that patients drop in two or three times per week to be checked by a familiar physician or nurse at the hospital ward where they had stayed. Compliance was very good, although it should be noted that only five patients in the POET study were intravenous drug abusers.

Asked why investigators discharged patients on oral therapy rather than on home intravenous antibiotics, Dr. Bundgård explained that home intravenous antibiotic therapy isn’t utilized in Denmark because of the expense and logistic complexity.

Bruce Jancin/MDedge News

Discussant Chris P. Gale, MD, urged care in generalizing the study findings.

“The ‘O’ in POET does not stand for ‘outpatient.’ Outpatients were only selected for oral therapy if they had no heart failure, no emboli, no arrhythmia, no complicating comorbidities, and they were strictly monitored – and frequently. Should we elect to adopt POET into practice, I would recommend strict adherence to the study’s patient selection and monitoring criteria,” said Dr. Gale, a cardiologist at the University of Leeds (England).

The POET results clearly swayed the full-house audience attending the late-breaking Hot Line session in the conference main arena. Immediately before Dr. Bundgård’s presentation, 66% of the audience indicated electronically that they would continue intravenous antibiotics for another 2-4 weeks in a patient with infectious endocarditis who had responded well to 2 weeks of such therapy. After seeing the study results, however, only 19% would still follow that course of action, while 59% of the audience would switch to oral antibiotics and discharge the patient.

Dr. Bundgård reported having no financial conflicts regarding the POET study, which was funded by the Danish Heart Foundation and other research foundations.

Simultaneous with Dr. Bundgård’s presentation in Munich, the POET results were published online by the New England Journal of Medicine (2018 Aug 28. doi: 10.1056/NEJMoa1808312).

[email protected]

MUNICH – Patients with left-sided endocarditis who are clinically stable after a couple weeks of inpatient intravenous antibiotics may at that point become candidates for discharge on oral antibiotics for the remainder of their treatment course, according to the findings of the randomized, multicenter, Danish POET trial.

Bruce Jancin/MDedge News

“Shifting to oral antibiotic treatment in stabilized patients with endocarditis was as effective and safe as continued intravenous antibiotic treatment and was given during half the antibiotic treatment period. These novel findings may have a significant impact on future clinical practice for the management of patients who are stable,” Henning Bundgård, MD, said at the annual congress of the European Society of Cardiology.

Both ESC and American Heart Association/American College of Cardiology guidelines now recommend treatment of infective endocarditis with intravenous antibiotics for up to 6 weeks. Safely cutting the duration of in-hospital intravenous antibiotics in half is likely to generate major cost savings while improving patient quality of life and avoiding prolonged exposure to the iatrogenic risks inherent to the hospital environment, noted Dr. Bundgård, a cardiologist at Copenhagen University Hospital.

The rationale for the POET (Partial Oral Treatment of Endocarditis) trial was the investigators’ recognition that, even though infectious endocarditis is a feared disease with an in-hospital mortality of 15% or more, the great majority of serious complications occur in the early critical phase of therapy; that is, during the first 10 days or so of inpatient intravenous antibiotic therapy.

“After stabilization, the main reason for staying in the hospital is just to receive IV antibiotics,” Dr. Bundgård noted.

POET included 400 patients with left-sided endocarditis hospitalized at multiple cardiac centers across Denmark, 35% of whom had at least one major comorbid condition. When this reporter observed that this was the smallest study he’d ever seen reported from Denmark, where researchers famously like to utilize interconnected national databases to conduct nationwide observational studies incorporating the country’s entire population, the cardiologist replied, “Denmark is a small country, but we like to make big trials. And this is actually the largest-ever clinical trial in endocarditis, so we are still going big.”

Important to the generalizability of the POET results was the requirement that all 400 participants had to be infected with streptococcus, Staphylococcus aureus, Enterococcus faecalis, or coagulase-negative staphylococci – the major pathogens responsible for three-quarters of all cases of infectious endocarditis.

Once participants were clinically stable after a median of 17 days of intravenous antibiotics, they were randomized to continued in-hospital intravenous antibiotic therapy for a median of another 19 days or to discharge on two oral antibiotics from different classes with different mechanisms of action administered for a median of 17 days, with selection of the oral agents being guided by the results of bacterial susceptibility testing.

The primary outcome was a composite of all-cause mortality, embolic events, unplanned cardiac surgery, and relapse of bacteremia from randomization through 6 months after completion of antibiotic therapy. This occurred in 9.0% of the orally treated group and 12.1% of patients on full-course intravenous therapy for a 28% relative risk reduction, which statistically established the noninferioritiy of the partial oral regimen. The results were similar in patients with native as compared with prosthetic valves, with or without major comorbidities, and in surgically as opposed to conservatively treated patients.

Rates of three of the four components of the composite endpoint were similar in both groups. However, all-cause mortality occurred in 3.5% of the oral therapy group, compared with 6.5% of those on intravenous therapy. Dr. Bundgård said he and his coinvestigators think the disparity in mortality was probably caused by play of chance, although he added that they were struck that four sudden deaths occurred in the intravenous group and none in patients who got oral antibiotics.

Side effects were similarly mild and low frequency in both study arms.

Audience members were eager for details on how the Danish investigators decided patients were clinically stable on intravenous antibiotics and thus ready for randomization, as well as the outpatient follow-up procedures employed in those discharged on oral therapy.

Dr. Bundgård explained that clinical stability required that a patient be afebrile, have C-reactive protein and leukocyte levels less than 35% of their peaks, and needed to have been on intravenous antibiotics for a minimum of 10 days. Moreover, patients who underwent valve surgery during their hospitalization, as did 38% of POET participants, had to wait a minimum of 7 days afterwards before they could be declared clinically stable. Lastly, just prior to randomization all participants underwent transesophageal echocardiography to rule out abscess formation or other valve abnormalities requiring surgery.

Outpatient follow-up required that patients drop in two or three times per week to be checked by a familiar physician or nurse at the hospital ward where they had stayed. Compliance was very good, although it should be noted that only five patients in the POET study were intravenous drug abusers.

Asked why investigators discharged patients on oral therapy rather than on home intravenous antibiotics, Dr. Bundgård explained that home intravenous antibiotic therapy isn’t utilized in Denmark because of the expense and logistic complexity.

Bruce Jancin/MDedge News

Discussant Chris P. Gale, MD, urged care in generalizing the study findings.

“The ‘O’ in POET does not stand for ‘outpatient.’ Outpatients were only selected for oral therapy if they had no heart failure, no emboli, no arrhythmia, no complicating comorbidities, and they were strictly monitored – and frequently. Should we elect to adopt POET into practice, I would recommend strict adherence to the study’s patient selection and monitoring criteria,” said Dr. Gale, a cardiologist at the University of Leeds (England).

The POET results clearly swayed the full-house audience attending the late-breaking Hot Line session in the conference main arena. Immediately before Dr. Bundgård’s presentation, 66% of the audience indicated electronically that they would continue intravenous antibiotics for another 2-4 weeks in a patient with infectious endocarditis who had responded well to 2 weeks of such therapy. After seeing the study results, however, only 19% would still follow that course of action, while 59% of the audience would switch to oral antibiotics and discharge the patient.

Dr. Bundgård reported having no financial conflicts regarding the POET study, which was funded by the Danish Heart Foundation and other research foundations.

Simultaneous with Dr. Bundgård’s presentation in Munich, the POET results were published online by the New England Journal of Medicine (2018 Aug 28. doi: 10.1056/NEJMoa1808312).

[email protected]

MUNICH – Patients with left-sided endocarditis who are clinically stable after a couple weeks of inpatient intravenous antibiotics may at that point become candidates for discharge on oral antibiotics for the remainder of their treatment course, according to the findings of the randomized, multicenter, Danish POET trial.

Bruce Jancin/MDedge News

“Shifting to oral antibiotic treatment in stabilized patients with endocarditis was as effective and safe as continued intravenous antibiotic treatment and was given during half the antibiotic treatment period. These novel findings may have a significant impact on future clinical practice for the management of patients who are stable,” Henning Bundgård, MD, said at the annual congress of the European Society of Cardiology.

Both ESC and American Heart Association/American College of Cardiology guidelines now recommend treatment of infective endocarditis with intravenous antibiotics for up to 6 weeks. Safely cutting the duration of in-hospital intravenous antibiotics in half is likely to generate major cost savings while improving patient quality of life and avoiding prolonged exposure to the iatrogenic risks inherent to the hospital environment, noted Dr. Bundgård, a cardiologist at Copenhagen University Hospital.

The rationale for the POET (Partial Oral Treatment of Endocarditis) trial was the investigators’ recognition that, even though infectious endocarditis is a feared disease with an in-hospital mortality of 15% or more, the great majority of serious complications occur in the early critical phase of therapy; that is, during the first 10 days or so of inpatient intravenous antibiotic therapy.

“After stabilization, the main reason for staying in the hospital is just to receive IV antibiotics,” Dr. Bundgård noted.

POET included 400 patients with left-sided endocarditis hospitalized at multiple cardiac centers across Denmark, 35% of whom had at least one major comorbid condition. When this reporter observed that this was the smallest study he’d ever seen reported from Denmark, where researchers famously like to utilize interconnected national databases to conduct nationwide observational studies incorporating the country’s entire population, the cardiologist replied, “Denmark is a small country, but we like to make big trials. And this is actually the largest-ever clinical trial in endocarditis, so we are still going big.”

Important to the generalizability of the POET results was the requirement that all 400 participants had to be infected with streptococcus, Staphylococcus aureus, Enterococcus faecalis, or coagulase-negative staphylococci – the major pathogens responsible for three-quarters of all cases of infectious endocarditis.

Once participants were clinically stable after a median of 17 days of intravenous antibiotics, they were randomized to continued in-hospital intravenous antibiotic therapy for a median of another 19 days or to discharge on two oral antibiotics from different classes with different mechanisms of action administered for a median of 17 days, with selection of the oral agents being guided by the results of bacterial susceptibility testing.

The primary outcome was a composite of all-cause mortality, embolic events, unplanned cardiac surgery, and relapse of bacteremia from randomization through 6 months after completion of antibiotic therapy. This occurred in 9.0% of the orally treated group and 12.1% of patients on full-course intravenous therapy for a 28% relative risk reduction, which statistically established the noninferioritiy of the partial oral regimen. The results were similar in patients with native as compared with prosthetic valves, with or without major comorbidities, and in surgically as opposed to conservatively treated patients.

Rates of three of the four components of the composite endpoint were similar in both groups. However, all-cause mortality occurred in 3.5% of the oral therapy group, compared with 6.5% of those on intravenous therapy. Dr. Bundgård said he and his coinvestigators think the disparity in mortality was probably caused by play of chance, although he added that they were struck that four sudden deaths occurred in the intravenous group and none in patients who got oral antibiotics.

Side effects were similarly mild and low frequency in both study arms.

Audience members were eager for details on how the Danish investigators decided patients were clinically stable on intravenous antibiotics and thus ready for randomization, as well as the outpatient follow-up procedures employed in those discharged on oral therapy.

Dr. Bundgård explained that clinical stability required that a patient be afebrile, have C-reactive protein and leukocyte levels less than 35% of their peaks, and needed to have been on intravenous antibiotics for a minimum of 10 days. Moreover, patients who underwent valve surgery during their hospitalization, as did 38% of POET participants, had to wait a minimum of 7 days afterwards before they could be declared clinically stable. Lastly, just prior to randomization all participants underwent transesophageal echocardiography to rule out abscess formation or other valve abnormalities requiring surgery.

Outpatient follow-up required that patients drop in two or three times per week to be checked by a familiar physician or nurse at the hospital ward where they had stayed. Compliance was very good, although it should be noted that only five patients in the POET study were intravenous drug abusers.

Asked why investigators discharged patients on oral therapy rather than on home intravenous antibiotics, Dr. Bundgård explained that home intravenous antibiotic therapy isn’t utilized in Denmark because of the expense and logistic complexity.

Bruce Jancin/MDedge News

Discussant Chris P. Gale, MD, urged care in generalizing the study findings.

“The ‘O’ in POET does not stand for ‘outpatient.’ Outpatients were only selected for oral therapy if they had no heart failure, no emboli, no arrhythmia, no complicating comorbidities, and they were strictly monitored – and frequently. Should we elect to adopt POET into practice, I would recommend strict adherence to the study’s patient selection and monitoring criteria,” said Dr. Gale, a cardiologist at the University of Leeds (England).

The POET results clearly swayed the full-house audience attending the late-breaking Hot Line session in the conference main arena. Immediately before Dr. Bundgård’s presentation, 66% of the audience indicated electronically that they would continue intravenous antibiotics for another 2-4 weeks in a patient with infectious endocarditis who had responded well to 2 weeks of such therapy. After seeing the study results, however, only 19% would still follow that course of action, while 59% of the audience would switch to oral antibiotics and discharge the patient.

Dr. Bundgård reported having no financial conflicts regarding the POET study, which was funded by the Danish Heart Foundation and other research foundations.

Simultaneous with Dr. Bundgård’s presentation in Munich, the POET results were published online by the New England Journal of Medicine (2018 Aug 28. doi: 10.1056/NEJMoa1808312).

[email protected]