Red blood cells

The European Commission (EC) has granted marketing authorization for ferric maltol (Feraccru) to treat iron-deficiency anemia in adults with inflammatory bowel disease (IBD).

The product can now be marketed for this indication in the 28 member countries of the European Union, as well as Iceland, Liechtenstein, and Norway.

The company developing the drug, Shield Therapeutics, said it will begin a roll-out of commercialization in the coming months.

Feraccru contains iron in a stable ferric state as a complex with a trimaltol ligand—ferric maltol. It is formulated as 30 mg of ferric iron in a hard gelatin capsule.

The complex is designed to provide iron for uptake across the intestinal wall and transfer to the iron transport and storage proteins—transferrin and ferritin, respectively. Feraccru dissociates on uptake from the gastrointestinal tract, and ferric maltol itself does not appear to enter the systemic circulation.

Phase 3 trials

The EC’s approval of ferric maltol is based on results of 2 phase 3 studies—AEGIS 1 and AEGIS 2. The results of these studies were published in Inflammatory Bowel Diseases in March 2015.

Together, the trials included 128 adult patients with IBD (ulcerative colitis and Crohn’s disease), iron-deficiency anemia, and recorded intolerance of ferrous sulphate. They were randomized to receive either 30 mg of ferric maltol twice a day or a matched placebo capsule for 12 weeks.

The primary efficacy endpoint was the change in hemoglobin (Hb) levels from baseline to week 12. The mean improvement in Hb in the ferric maltol group compared to the placebo group was 2.25 g/dL (P<0.0001).

The absolute mean Hb concentration improved from 11.00 g/dL at baseline to 13.20 g/dL at week 12 in the ferric maltol group. In the placebo group, the mean Hb values were similar at baseline and week 12—11.10 g/dL and 11.20 g/dL, respectively.

The incidence of treatment-emergent adverse events (AEs) was 58% in the ferric maltol group and 72% in the placebo group. However, not all of these events were considered treatment-related.

AEs that were considered treatment-related occurred in 25% of ferric maltol-treated patients and 11.7% of placebo-treated patients. The most common treatment-related AEs in the ferric maltol group were abdominal pain, constipation, and flatulence—each occurring in 6.7% of patients.

“The phase 3 clinical studies clearly demonstrated Feraccru’s effectiveness,” said Andreas Stallmach, MD, of University Clinic Jena in Germany.

“[T]his pan-European marketing authorization gives treating physicians like myself the opportunity to fulfill an important and currently unmet need for patients who are unable to tolerate other oral products, as Feraccru could provide an oral alternative to intravenous iron infusion.’’

Red blood cells

The European Commission (EC) has granted marketing authorization for ferric maltol (Feraccru) to treat iron-deficiency anemia in adults with inflammatory bowel disease (IBD).

The product can now be marketed for this indication in the 28 member countries of the European Union, as well as Iceland, Liechtenstein, and Norway.

The company developing the drug, Shield Therapeutics, said it will begin a roll-out of commercialization in the coming months.

Feraccru contains iron in a stable ferric state as a complex with a trimaltol ligand—ferric maltol. It is formulated as 30 mg of ferric iron in a hard gelatin capsule.

The complex is designed to provide iron for uptake across the intestinal wall and transfer to the iron transport and storage proteins—transferrin and ferritin, respectively. Feraccru dissociates on uptake from the gastrointestinal tract, and ferric maltol itself does not appear to enter the systemic circulation.

Phase 3 trials

The EC’s approval of ferric maltol is based on results of 2 phase 3 studies—AEGIS 1 and AEGIS 2. The results of these studies were published in Inflammatory Bowel Diseases in March 2015.

Together, the trials included 128 adult patients with IBD (ulcerative colitis and Crohn’s disease), iron-deficiency anemia, and recorded intolerance of ferrous sulphate. They were randomized to receive either 30 mg of ferric maltol twice a day or a matched placebo capsule for 12 weeks.

The primary efficacy endpoint was the change in hemoglobin (Hb) levels from baseline to week 12. The mean improvement in Hb in the ferric maltol group compared to the placebo group was 2.25 g/dL (P<0.0001).

The absolute mean Hb concentration improved from 11.00 g/dL at baseline to 13.20 g/dL at week 12 in the ferric maltol group. In the placebo group, the mean Hb values were similar at baseline and week 12—11.10 g/dL and 11.20 g/dL, respectively.

The incidence of treatment-emergent adverse events (AEs) was 58% in the ferric maltol group and 72% in the placebo group. However, not all of these events were considered treatment-related.

AEs that were considered treatment-related occurred in 25% of ferric maltol-treated patients and 11.7% of placebo-treated patients. The most common treatment-related AEs in the ferric maltol group were abdominal pain, constipation, and flatulence—each occurring in 6.7% of patients.

“The phase 3 clinical studies clearly demonstrated Feraccru’s effectiveness,” said Andreas Stallmach, MD, of University Clinic Jena in Germany.

“[T]his pan-European marketing authorization gives treating physicians like myself the opportunity to fulfill an important and currently unmet need for patients who are unable to tolerate other oral products, as Feraccru could provide an oral alternative to intravenous iron infusion.’’

Red blood cells

The European Commission (EC) has granted marketing authorization for ferric maltol (Feraccru) to treat iron-deficiency anemia in adults with inflammatory bowel disease (IBD).

The product can now be marketed for this indication in the 28 member countries of the European Union, as well as Iceland, Liechtenstein, and Norway.

The company developing the drug, Shield Therapeutics, said it will begin a roll-out of commercialization in the coming months.

Feraccru contains iron in a stable ferric state as a complex with a trimaltol ligand—ferric maltol. It is formulated as 30 mg of ferric iron in a hard gelatin capsule.

The complex is designed to provide iron for uptake across the intestinal wall and transfer to the iron transport and storage proteins—transferrin and ferritin, respectively. Feraccru dissociates on uptake from the gastrointestinal tract, and ferric maltol itself does not appear to enter the systemic circulation.

Phase 3 trials

The EC’s approval of ferric maltol is based on results of 2 phase 3 studies—AEGIS 1 and AEGIS 2. The results of these studies were published in Inflammatory Bowel Diseases in March 2015.

Together, the trials included 128 adult patients with IBD (ulcerative colitis and Crohn’s disease), iron-deficiency anemia, and recorded intolerance of ferrous sulphate. They were randomized to receive either 30 mg of ferric maltol twice a day or a matched placebo capsule for 12 weeks.

The primary efficacy endpoint was the change in hemoglobin (Hb) levels from baseline to week 12. The mean improvement in Hb in the ferric maltol group compared to the placebo group was 2.25 g/dL (P<0.0001).

The absolute mean Hb concentration improved from 11.00 g/dL at baseline to 13.20 g/dL at week 12 in the ferric maltol group. In the placebo group, the mean Hb values were similar at baseline and week 12—11.10 g/dL and 11.20 g/dL, respectively.

The incidence of treatment-emergent adverse events (AEs) was 58% in the ferric maltol group and 72% in the placebo group. However, not all of these events were considered treatment-related.

AEs that were considered treatment-related occurred in 25% of ferric maltol-treated patients and 11.7% of placebo-treated patients. The most common treatment-related AEs in the ferric maltol group were abdominal pain, constipation, and flatulence—each occurring in 6.7% of patients.

“The phase 3 clinical studies clearly demonstrated Feraccru’s effectiveness,” said Andreas Stallmach, MD, of University Clinic Jena in Germany.

“[T]his pan-European marketing authorization gives treating physicians like myself the opportunity to fulfill an important and currently unmet need for patients who are unable to tolerate other oral products, as Feraccru could provide an oral alternative to intravenous iron infusion.’’

Cells infected with

Plasmodium vivax

Image by Mae Melvin

Results of a phase 1 trial suggest a vaccine candidate does not prevent Plasmodium vivax malaria.

The vaccine, VMP001/AS01_B, did not prevent malaria in any of the 30 subjects tested, although it did significantly delay parasitemia in 59% of subjects.

Lieutenant Colonel Jason W. Bennett, of the Walter Reed Army Institute

of Research (WRAIR) in Silver Spring, Maryland, and his colleagues reported these results in PLOS Neglected Tropical Diseases.

The vaccine antigen VMP001 is an Escherichia coli-produced, synthetic, chimeric, recombinant protein that incorporates the 3 major domains of circumsporozoite protein but is distinct from the native molecule. The VMP001 antigen was adjuvanted with AS01_B, a proprietary liposome-based adjuvant system from GlaxoSmithKline.

For this phase 1 study, the investigators tested VMP001/AS01_B in 30 healthy volunteers. The subjects received 3 intramuscular injections of VMP001 at 15 μg (n=10), 30 μg (n=10), or 60 μg (n=10), respectively, all formulated in 500 μL of AS01_B at each immunization.

Fourteen days after the third immunization, the subjects were exposed to mosquitoes carrying P vivax. Six non-vaccinated control subjects were exposed to the mosquitoes as well.

The investigators said VMP001/AS01_B was well tolerated and generated robust immune responses. However, it did not protect the subjects from malaria infection.

Still, the vaccine induced a “small but significant” delay in time to parasitemia in 59% of vaccinated subjects, when compared to controls.

Colonel Robert Paris, director of the US Military Malaria Research Program at WRAIR, believes the investigators can use the results of this study to design a better vaccine for P vivax malaria.

“Findings from the analysis of the immune response of vaccinated subjects have given us clues to improve vaccine candidates,” he said. “[S]tudies are now underway at WRAIR to develop next-generation vivax vaccines.”

Cells infected with

Plasmodium vivax

Image by Mae Melvin

Results of a phase 1 trial suggest a vaccine candidate does not prevent Plasmodium vivax malaria.

The vaccine, VMP001/AS01_B, did not prevent malaria in any of the 30 subjects tested, although it did significantly delay parasitemia in 59% of subjects.

Lieutenant Colonel Jason W. Bennett, of the Walter Reed Army Institute

of Research (WRAIR) in Silver Spring, Maryland, and his colleagues reported these results in PLOS Neglected Tropical Diseases.

The vaccine antigen VMP001 is an Escherichia coli-produced, synthetic, chimeric, recombinant protein that incorporates the 3 major domains of circumsporozoite protein but is distinct from the native molecule. The VMP001 antigen was adjuvanted with AS01_B, a proprietary liposome-based adjuvant system from GlaxoSmithKline.

For this phase 1 study, the investigators tested VMP001/AS01_B in 30 healthy volunteers. The subjects received 3 intramuscular injections of VMP001 at 15 μg (n=10), 30 μg (n=10), or 60 μg (n=10), respectively, all formulated in 500 μL of AS01_B at each immunization.

Fourteen days after the third immunization, the subjects were exposed to mosquitoes carrying P vivax. Six non-vaccinated control subjects were exposed to the mosquitoes as well.

The investigators said VMP001/AS01_B was well tolerated and generated robust immune responses. However, it did not protect the subjects from malaria infection.

Still, the vaccine induced a “small but significant” delay in time to parasitemia in 59% of vaccinated subjects, when compared to controls.

Colonel Robert Paris, director of the US Military Malaria Research Program at WRAIR, believes the investigators can use the results of this study to design a better vaccine for P vivax malaria.

“Findings from the analysis of the immune response of vaccinated subjects have given us clues to improve vaccine candidates,” he said. “[S]tudies are now underway at WRAIR to develop next-generation vivax vaccines.”

Cells infected with

Plasmodium vivax

Image by Mae Melvin

Results of a phase 1 trial suggest a vaccine candidate does not prevent Plasmodium vivax malaria.

The vaccine, VMP001/AS01_B, did not prevent malaria in any of the 30 subjects tested, although it did significantly delay parasitemia in 59% of subjects.

Lieutenant Colonel Jason W. Bennett, of the Walter Reed Army Institute

of Research (WRAIR) in Silver Spring, Maryland, and his colleagues reported these results in PLOS Neglected Tropical Diseases.

The vaccine antigen VMP001 is an Escherichia coli-produced, synthetic, chimeric, recombinant protein that incorporates the 3 major domains of circumsporozoite protein but is distinct from the native molecule. The VMP001 antigen was adjuvanted with AS01_B, a proprietary liposome-based adjuvant system from GlaxoSmithKline.

For this phase 1 study, the investigators tested VMP001/AS01_B in 30 healthy volunteers. The subjects received 3 intramuscular injections of VMP001 at 15 μg (n=10), 30 μg (n=10), or 60 μg (n=10), respectively, all formulated in 500 μL of AS01_B at each immunization.

Fourteen days after the third immunization, the subjects were exposed to mosquitoes carrying P vivax. Six non-vaccinated control subjects were exposed to the mosquitoes as well.

The investigators said VMP001/AS01_B was well tolerated and generated robust immune responses. However, it did not protect the subjects from malaria infection.

Still, the vaccine induced a “small but significant” delay in time to parasitemia in 59% of vaccinated subjects, when compared to controls.

Colonel Robert Paris, director of the US Military Malaria Research Program at WRAIR, believes the investigators can use the results of this study to design a better vaccine for P vivax malaria.

“Findings from the analysis of the immune response of vaccinated subjects have given us clues to improve vaccine candidates,” he said. “[S]tudies are now underway at WRAIR to develop next-generation vivax vaccines.”

Clinical question: Does acetazolamide decrease the duration of mechanical ventilation for patients with chronic obstructive pulmonary disease and metabolic alkalosis?

Bottom line: Although acetazolamide effectively decreased the levels of serum bicarbonate and the number of days with metabolic alkalosis in critically ill patients with chronic obstructive pulmonary disease (COPD) on mechanical ventilation, it did not produce a statistically significant difference in the duration of mechanical ventilation. However, this lack of statistical significance may have been due to an underpowered study. (LOE = 1b-)

Reference: Faisy C, Meziani F, Planquette B, et al, for the DIABOLO Investigators. Effect of acetazolamide vs placebo on duration of invasive mechanical ventilation among patients with chronic obstructive pulmonary disease. JAMA 2016;315(5):480-488.

Study design: Randomized controlled trial (double-blinded)

Funding source: Industry + govt

Allocation: Concealed

Setting: Inpatient (ICU only)

Synopsis:

Acetazolamide is used as a respiratory stimulant for patients with COPD and metabolic alkalosis because of its ability to reduce serum bicarbonate, which may lead to a rise in minute ventilation. However, its clinical benefit has not been demonstrated previously in controlled trials.

Using concealed allocation, these investigators randomized patients with COPD who required invasive mechanical ventilation to receive either acetazolamide 500 mg intravenously twice daily (1000 mg if loop diuretics were also prescribed) or matching placebo up to 28 days. Only those patients found to have pure or mixed metabolic alkalosis received the treatment. The intention-to-treat population consisted of 380 patients and baseline characteristics were similar in both groups. The use of acetazolamide led to decreased levels of serum bicarbonate and fewer days with metabolic alkalosis but did not improve respiratory parameters such as respiratory rate, tidal volume, or minute ventilation.

For the primary outcome of duration of mechanical ventilation, the magnitude of the difference between the 2 groups was large, suggesting a clinically important effect, but the difference did not reach statistical significance (between-group difference -16 hours with acetazolamide; 95% CI -36.5 to 4.0 hours). The lack of statistical significance may be due to an underpowered study because of fewer-than-expected patients who received the treatment (more than 20% of patients in each group did not receive the assigned treatment because of lack of metabolic alkalosis or temporary contraindications) and a shorter-than-anticipated duration of mechanical ventilation in the placebo group.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question: Does acetazolamide decrease the duration of mechanical ventilation for patients with chronic obstructive pulmonary disease and metabolic alkalosis?

Bottom line: Although acetazolamide effectively decreased the levels of serum bicarbonate and the number of days with metabolic alkalosis in critically ill patients with chronic obstructive pulmonary disease (COPD) on mechanical ventilation, it did not produce a statistically significant difference in the duration of mechanical ventilation. However, this lack of statistical significance may have been due to an underpowered study. (LOE = 1b-)

Reference: Faisy C, Meziani F, Planquette B, et al, for the DIABOLO Investigators. Effect of acetazolamide vs placebo on duration of invasive mechanical ventilation among patients with chronic obstructive pulmonary disease. JAMA 2016;315(5):480-488.

Study design: Randomized controlled trial (double-blinded)

Funding source: Industry + govt

Allocation: Concealed

Setting: Inpatient (ICU only)

Synopsis:

Acetazolamide is used as a respiratory stimulant for patients with COPD and metabolic alkalosis because of its ability to reduce serum bicarbonate, which may lead to a rise in minute ventilation. However, its clinical benefit has not been demonstrated previously in controlled trials.

Using concealed allocation, these investigators randomized patients with COPD who required invasive mechanical ventilation to receive either acetazolamide 500 mg intravenously twice daily (1000 mg if loop diuretics were also prescribed) or matching placebo up to 28 days. Only those patients found to have pure or mixed metabolic alkalosis received the treatment. The intention-to-treat population consisted of 380 patients and baseline characteristics were similar in both groups. The use of acetazolamide led to decreased levels of serum bicarbonate and fewer days with metabolic alkalosis but did not improve respiratory parameters such as respiratory rate, tidal volume, or minute ventilation.

For the primary outcome of duration of mechanical ventilation, the magnitude of the difference between the 2 groups was large, suggesting a clinically important effect, but the difference did not reach statistical significance (between-group difference -16 hours with acetazolamide; 95% CI -36.5 to 4.0 hours). The lack of statistical significance may be due to an underpowered study because of fewer-than-expected patients who received the treatment (more than 20% of patients in each group did not receive the assigned treatment because of lack of metabolic alkalosis or temporary contraindications) and a shorter-than-anticipated duration of mechanical ventilation in the placebo group.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question: Does acetazolamide decrease the duration of mechanical ventilation for patients with chronic obstructive pulmonary disease and metabolic alkalosis?

Bottom line: Although acetazolamide effectively decreased the levels of serum bicarbonate and the number of days with metabolic alkalosis in critically ill patients with chronic obstructive pulmonary disease (COPD) on mechanical ventilation, it did not produce a statistically significant difference in the duration of mechanical ventilation. However, this lack of statistical significance may have been due to an underpowered study. (LOE = 1b-)

Reference: Faisy C, Meziani F, Planquette B, et al, for the DIABOLO Investigators. Effect of acetazolamide vs placebo on duration of invasive mechanical ventilation among patients with chronic obstructive pulmonary disease. JAMA 2016;315(5):480-488.

Study design: Randomized controlled trial (double-blinded)

Funding source: Industry + govt

Allocation: Concealed

Setting: Inpatient (ICU only)

Synopsis:

Acetazolamide is used as a respiratory stimulant for patients with COPD and metabolic alkalosis because of its ability to reduce serum bicarbonate, which may lead to a rise in minute ventilation. However, its clinical benefit has not been demonstrated previously in controlled trials.

Using concealed allocation, these investigators randomized patients with COPD who required invasive mechanical ventilation to receive either acetazolamide 500 mg intravenously twice daily (1000 mg if loop diuretics were also prescribed) or matching placebo up to 28 days. Only those patients found to have pure or mixed metabolic alkalosis received the treatment. The intention-to-treat population consisted of 380 patients and baseline characteristics were similar in both groups. The use of acetazolamide led to decreased levels of serum bicarbonate and fewer days with metabolic alkalosis but did not improve respiratory parameters such as respiratory rate, tidal volume, or minute ventilation.

For the primary outcome of duration of mechanical ventilation, the magnitude of the difference between the 2 groups was large, suggesting a clinically important effect, but the difference did not reach statistical significance (between-group difference -16 hours with acetazolamide; 95% CI -36.5 to 4.0 hours). The lack of statistical significance may be due to an underpowered study because of fewer-than-expected patients who received the treatment (more than 20% of patients in each group did not receive the assigned treatment because of lack of metabolic alkalosis or temporary contraindications) and a shorter-than-anticipated duration of mechanical ventilation in the placebo group.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question: Is tamsulosin effective in the management of distal ureteric stones?

Bottom line: Tamsulosin promotes stone passage of ureteric stones that are 5 mm to 10 mm. You would need to treat 5 patients with tamsulosin to cause the expulsion of one such stone. Stones smaller than 5 mm have a high rate of spontaneous passage without any intervention. (LOE = 1b-)

Reference: Furyk JS, Chu K, Banks C et al. Distal ureteric stones and tamsulosin: a double-blind, placebo-controlled, randomized, multicenter trial. Ann Emerg Med 2016;67(1):86-95.

Study design: Randomized controlled trial (double-blinded)

Funding source: Foundation

Allocation: Concealed

Setting: Outpatient (primary care)

Synopsis: These authors recruited adult patients who presented to the emergency department with symptoms and imaging consistent with distal ureteric stones. Patients with fever, hypotension, stones larger than 10 mm, or kidney disease were excluded. Using concealed allocation, the investigators randomized the patients to receive either tamsulosin 0.4 mg daily or matching placebo for 28 days or until stone passage. The 2 groups had similar baseline characteristics and analysis was by intention to treat.

The primary outcome was stone expulsion as confirmed by computed tomography (CT) and time to stone expulsion was defined by self-reported passage of stone or 48-hour pain-free period. Compliance to the study medications was poor in both groups, and almost one-fifth of the patients did not have follow-up imaging. Of the approximately 80% of patients in each group who underwent follow-up CT, there was no difference in the percentage of patients with passed stones (87% in the tamsulosin group vs 82% in the placebo group; P = .22). In the subset of patients with larger stones (5 mm -10 mm), the tamsulosin group had a significantly higher rate of stone passage than the placebo group (83% vs 61%; P = .03). There were no significant differences detected in time to stone passage, pain, analgesia requirements, need for urological intervention, or adverse events.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question: Is tamsulosin effective in the management of distal ureteric stones?

Bottom line: Tamsulosin promotes stone passage of ureteric stones that are 5 mm to 10 mm. You would need to treat 5 patients with tamsulosin to cause the expulsion of one such stone. Stones smaller than 5 mm have a high rate of spontaneous passage without any intervention. (LOE = 1b-)

Reference: Furyk JS, Chu K, Banks C et al. Distal ureteric stones and tamsulosin: a double-blind, placebo-controlled, randomized, multicenter trial. Ann Emerg Med 2016;67(1):86-95.

Study design: Randomized controlled trial (double-blinded)

Funding source: Foundation

Allocation: Concealed

Setting: Outpatient (primary care)

Synopsis: These authors recruited adult patients who presented to the emergency department with symptoms and imaging consistent with distal ureteric stones. Patients with fever, hypotension, stones larger than 10 mm, or kidney disease were excluded. Using concealed allocation, the investigators randomized the patients to receive either tamsulosin 0.4 mg daily or matching placebo for 28 days or until stone passage. The 2 groups had similar baseline characteristics and analysis was by intention to treat.

The primary outcome was stone expulsion as confirmed by computed tomography (CT) and time to stone expulsion was defined by self-reported passage of stone or 48-hour pain-free period. Compliance to the study medications was poor in both groups, and almost one-fifth of the patients did not have follow-up imaging. Of the approximately 80% of patients in each group who underwent follow-up CT, there was no difference in the percentage of patients with passed stones (87% in the tamsulosin group vs 82% in the placebo group; P = .22). In the subset of patients with larger stones (5 mm -10 mm), the tamsulosin group had a significantly higher rate of stone passage than the placebo group (83% vs 61%; P = .03). There were no significant differences detected in time to stone passage, pain, analgesia requirements, need for urological intervention, or adverse events.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question: Is tamsulosin effective in the management of distal ureteric stones?

Bottom line: Tamsulosin promotes stone passage of ureteric stones that are 5 mm to 10 mm. You would need to treat 5 patients with tamsulosin to cause the expulsion of one such stone. Stones smaller than 5 mm have a high rate of spontaneous passage without any intervention. (LOE = 1b-)

Reference: Furyk JS, Chu K, Banks C et al. Distal ureteric stones and tamsulosin: a double-blind, placebo-controlled, randomized, multicenter trial. Ann Emerg Med 2016;67(1):86-95.

Study design: Randomized controlled trial (double-blinded)

Funding source: Foundation

Allocation: Concealed

Setting: Outpatient (primary care)

Synopsis: These authors recruited adult patients who presented to the emergency department with symptoms and imaging consistent with distal ureteric stones. Patients with fever, hypotension, stones larger than 10 mm, or kidney disease were excluded. Using concealed allocation, the investigators randomized the patients to receive either tamsulosin 0.4 mg daily or matching placebo for 28 days or until stone passage. The 2 groups had similar baseline characteristics and analysis was by intention to treat.

The primary outcome was stone expulsion as confirmed by computed tomography (CT) and time to stone expulsion was defined by self-reported passage of stone or 48-hour pain-free period. Compliance to the study medications was poor in both groups, and almost one-fifth of the patients did not have follow-up imaging. Of the approximately 80% of patients in each group who underwent follow-up CT, there was no difference in the percentage of patients with passed stones (87% in the tamsulosin group vs 82% in the placebo group; P = .22). In the subset of patients with larger stones (5 mm -10 mm), the tamsulosin group had a significantly higher rate of stone passage than the placebo group (83% vs 61%; P = .03). There were no significant differences detected in time to stone passage, pain, analgesia requirements, need for urological intervention, or adverse events.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Embattled scope maker Olympus Corp., already under federal investigation for its role in superbug outbreaks, has agreed to pay $646 million to resolve criminal and civil probes into illegal kickbacks and bribes to doctors and hospitals.

Federal prosecutors said Tuesday that the company’s settlement is the largest ever for violations of the U.S. anti-kickback law. A portion of the company’s payout, $22.8 million, will resolve foreign bribery allegations in Latin America.

U.S. investigators said the company’s “greed-fueled kickback scheme” from 2006 to 2011 used grants, consulting deals, trips to Japan, lavish gifts, and free equipment to induce influential doctors to order more Olympus devices at prominent hospitals and keep out competitors.

After a key doctor for a Midwest hospital system took a week-long trip to Japan and received a company grant, an Olympus vice president wrote an internal email in 2006 that said, “We have received all of the orders expected and have kept (a competitor) completely out of the (Midwestern hospital) system. Hooray!”

The federal complaint against Olympus mentioned similar scenarios at a prominent California institution and a New York medical center, but the exact names were redacted.

The violations produced about $600 million in sales and $230 million in gross profits for Olympus, federal officials said.

Federal prosecutors credited the help of a former compliance officer at Olympus, John Slowik, who filed a whistle-blower case against the company under seal in 2010.

Olympus agreed to a corporate-integrity agreement and the appointment of an independent monitor.

“Olympus leadership acknowledges the company’s responsibility for the past conduct, which does not represent the values of Olympus or its employees,” Nacho Abia, chief executive of the Olympus Corp. of the Americas unit in Center Valley, Pa., said in a statement. “Olympus is committed to complying with all laws and regulations and to adhering to our own rigorous code of conduct.”

Olympus has come under fire for failing to alert U.S. regulators and hospitals sooner about the risks of infection from its duodenoscopes, a gastrointestinal scope that has proven difficult to clean of dangerous bacteria because of its intricate design.

A Senate investigation released in January identified 19 scope-related outbreaks at U.S. medical centers during 2012-2015 that sickened nearly 200 patients with drug-resistant infections.

Olympus announced in January it would recall its duodenoscopes nationwide and make repairs to improve patient safety. The company controls 85% of the U.S. market for gastrointestinal scopes.

Last year, the Tokyo company disclosed it had received a subpoena from federal prosecutors in March 2015 seeking “information relating to duodenoscopes that Olympus manufactures and sells.”

This article was originally published by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Embattled scope maker Olympus Corp., already under federal investigation for its role in superbug outbreaks, has agreed to pay $646 million to resolve criminal and civil probes into illegal kickbacks and bribes to doctors and hospitals.

Federal prosecutors said Tuesday that the company’s settlement is the largest ever for violations of the U.S. anti-kickback law. A portion of the company’s payout, $22.8 million, will resolve foreign bribery allegations in Latin America.

U.S. investigators said the company’s “greed-fueled kickback scheme” from 2006 to 2011 used grants, consulting deals, trips to Japan, lavish gifts, and free equipment to induce influential doctors to order more Olympus devices at prominent hospitals and keep out competitors.

After a key doctor for a Midwest hospital system took a week-long trip to Japan and received a company grant, an Olympus vice president wrote an internal email in 2006 that said, “We have received all of the orders expected and have kept (a competitor) completely out of the (Midwestern hospital) system. Hooray!”

The federal complaint against Olympus mentioned similar scenarios at a prominent California institution and a New York medical center, but the exact names were redacted.

The violations produced about $600 million in sales and $230 million in gross profits for Olympus, federal officials said.

Federal prosecutors credited the help of a former compliance officer at Olympus, John Slowik, who filed a whistle-blower case against the company under seal in 2010.

Olympus agreed to a corporate-integrity agreement and the appointment of an independent monitor.

“Olympus leadership acknowledges the company’s responsibility for the past conduct, which does not represent the values of Olympus or its employees,” Nacho Abia, chief executive of the Olympus Corp. of the Americas unit in Center Valley, Pa., said in a statement. “Olympus is committed to complying with all laws and regulations and to adhering to our own rigorous code of conduct.”

Olympus has come under fire for failing to alert U.S. regulators and hospitals sooner about the risks of infection from its duodenoscopes, a gastrointestinal scope that has proven difficult to clean of dangerous bacteria because of its intricate design.

A Senate investigation released in January identified 19 scope-related outbreaks at U.S. medical centers during 2012-2015 that sickened nearly 200 patients with drug-resistant infections.

Olympus announced in January it would recall its duodenoscopes nationwide and make repairs to improve patient safety. The company controls 85% of the U.S. market for gastrointestinal scopes.

Last year, the Tokyo company disclosed it had received a subpoena from federal prosecutors in March 2015 seeking “information relating to duodenoscopes that Olympus manufactures and sells.”

This article was originally published by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Embattled scope maker Olympus Corp., already under federal investigation for its role in superbug outbreaks, has agreed to pay $646 million to resolve criminal and civil probes into illegal kickbacks and bribes to doctors and hospitals.

Federal prosecutors said Tuesday that the company’s settlement is the largest ever for violations of the U.S. anti-kickback law. A portion of the company’s payout, $22.8 million, will resolve foreign bribery allegations in Latin America.

U.S. investigators said the company’s “greed-fueled kickback scheme” from 2006 to 2011 used grants, consulting deals, trips to Japan, lavish gifts, and free equipment to induce influential doctors to order more Olympus devices at prominent hospitals and keep out competitors.

After a key doctor for a Midwest hospital system took a week-long trip to Japan and received a company grant, an Olympus vice president wrote an internal email in 2006 that said, “We have received all of the orders expected and have kept (a competitor) completely out of the (Midwestern hospital) system. Hooray!”

The federal complaint against Olympus mentioned similar scenarios at a prominent California institution and a New York medical center, but the exact names were redacted.

The violations produced about $600 million in sales and $230 million in gross profits for Olympus, federal officials said.

Federal prosecutors credited the help of a former compliance officer at Olympus, John Slowik, who filed a whistle-blower case against the company under seal in 2010.

Olympus agreed to a corporate-integrity agreement and the appointment of an independent monitor.

“Olympus leadership acknowledges the company’s responsibility for the past conduct, which does not represent the values of Olympus or its employees,” Nacho Abia, chief executive of the Olympus Corp. of the Americas unit in Center Valley, Pa., said in a statement. “Olympus is committed to complying with all laws and regulations and to adhering to our own rigorous code of conduct.”

Olympus has come under fire for failing to alert U.S. regulators and hospitals sooner about the risks of infection from its duodenoscopes, a gastrointestinal scope that has proven difficult to clean of dangerous bacteria because of its intricate design.

A Senate investigation released in January identified 19 scope-related outbreaks at U.S. medical centers during 2012-2015 that sickened nearly 200 patients with drug-resistant infections.

Olympus announced in January it would recall its duodenoscopes nationwide and make repairs to improve patient safety. The company controls 85% of the U.S. market for gastrointestinal scopes.

Last year, the Tokyo company disclosed it had received a subpoena from federal prosecutors in March 2015 seeking “information relating to duodenoscopes that Olympus manufactures and sells.”

This article was originally published by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

AGA Legacy Society members are showing their gratitude for what funding and research has brought to our specialty by giving back.

Legacy Society members are the most generous individual donors to the AGA Research Foundation. Members of the AGA Legacy Society provide tax-deductible gifts to the AGA Research Foundation of $25,000 or more (payable over 5 years) or $50,000 or more in a planned gift, such as a bequest.

The AGA Research Foundation’s mission is to raise funds to support young researchers in gastroenterology and hepatology. Richard M. Peek, Jr., M.D., AGAF, Legacy Society member said, “I have a huge appreciation for the AGA Research Foundation, because they were the first foundation that really took a chance on my research. Today, I am proud to be a donor myself because I know it is making a difference [for] yet another young investigator.”

Donors who make gifts at the Legacy Society level before DDW will receive an invitation to the annual Benefactors’ Dinner at The Don Room and Terrace at El Cortez in San Diego. Individuals interested in learning more about Legacy Society membership may contact Stacey Hinton Tuneski, Senior Director of Development at [email protected] or via phone (301) 222-4005.

A celebration of research support

Beginning with a memorable gathering at the United States Library of Congress in 2007, the Benefactors’ Dinner has welcomed members of the AGA Legacy Society and other AGA dignitaries to special locations nationwide. The Don Room and Terrace at El Cortez will be the location of the 2016 AGA Research Foundation Benefactors’ Dinner during DDW in San Diego. Guests will enjoy a wonderful evening in the historic setting that has hosted dignitaries since 1927. Members of the AGA Legacy Society will be among the distinguished honorees at the annual event.

AGA Legacy Society members are showing their gratitude for what funding and research has brought to our specialty by giving back.

Legacy Society members are the most generous individual donors to the AGA Research Foundation. Members of the AGA Legacy Society provide tax-deductible gifts to the AGA Research Foundation of $25,000 or more (payable over 5 years) or $50,000 or more in a planned gift, such as a bequest.

The AGA Research Foundation’s mission is to raise funds to support young researchers in gastroenterology and hepatology. Richard M. Peek, Jr., M.D., AGAF, Legacy Society member said, “I have a huge appreciation for the AGA Research Foundation, because they were the first foundation that really took a chance on my research. Today, I am proud to be a donor myself because I know it is making a difference [for] yet another young investigator.”

Donors who make gifts at the Legacy Society level before DDW will receive an invitation to the annual Benefactors’ Dinner at The Don Room and Terrace at El Cortez in San Diego. Individuals interested in learning more about Legacy Society membership may contact Stacey Hinton Tuneski, Senior Director of Development at [email protected] or via phone (301) 222-4005.

A celebration of research support

Beginning with a memorable gathering at the United States Library of Congress in 2007, the Benefactors’ Dinner has welcomed members of the AGA Legacy Society and other AGA dignitaries to special locations nationwide. The Don Room and Terrace at El Cortez will be the location of the 2016 AGA Research Foundation Benefactors’ Dinner during DDW in San Diego. Guests will enjoy a wonderful evening in the historic setting that has hosted dignitaries since 1927. Members of the AGA Legacy Society will be among the distinguished honorees at the annual event.

AGA Legacy Society members are showing their gratitude for what funding and research has brought to our specialty by giving back.

Legacy Society members are the most generous individual donors to the AGA Research Foundation. Members of the AGA Legacy Society provide tax-deductible gifts to the AGA Research Foundation of $25,000 or more (payable over 5 years) or $50,000 or more in a planned gift, such as a bequest.

The AGA Research Foundation’s mission is to raise funds to support young researchers in gastroenterology and hepatology. Richard M. Peek, Jr., M.D., AGAF, Legacy Society member said, “I have a huge appreciation for the AGA Research Foundation, because they were the first foundation that really took a chance on my research. Today, I am proud to be a donor myself because I know it is making a difference [for] yet another young investigator.”

Donors who make gifts at the Legacy Society level before DDW will receive an invitation to the annual Benefactors’ Dinner at The Don Room and Terrace at El Cortez in San Diego. Individuals interested in learning more about Legacy Society membership may contact Stacey Hinton Tuneski, Senior Director of Development at [email protected] or via phone (301) 222-4005.

A celebration of research support

Beginning with a memorable gathering at the United States Library of Congress in 2007, the Benefactors’ Dinner has welcomed members of the AGA Legacy Society and other AGA dignitaries to special locations nationwide. The Don Room and Terrace at El Cortez will be the location of the 2016 AGA Research Foundation Benefactors’ Dinner during DDW in San Diego. Guests will enjoy a wonderful evening in the historic setting that has hosted dignitaries since 1927. Members of the AGA Legacy Society will be among the distinguished honorees at the annual event.

This January I was fortunate to spend a day on Capitol Hill meeting with AGA senior policy staff and key members of Congress who have jurisdiction over critical policy priorities for AGA and the profession of gastroenterology. It was an interesting and informative day. Among other things, I learned that individuals on Capitol Hill are interested in hearing from us to gain our insight and expertise on the practice and science of gastroenterology and patient care.

Senate

During my time visiting the Senate side of Capitol Hill, I met with the offices of Sen. Bill Cassidy (R-La.), Sen. Ben Cardin (D-Md.), Sen. Sherrod Brown (D-Ohio), and Sen. Amy Klobuchar (D-Minn). Sen. Cassidy, as you may be aware, has been an AGA member and champion for many of our policy priorities. Most recently, he, along with Sen. Cardin, spearheaded the Senate effort in contacting CMS and expressing concern over cuts in reimbursement for colonoscopy. Sen. Cassidy was critical in implementing the new transparency policy at CMS, which led to the announcement of changes in physician values in the proposed rule, instead of the final rule. This will ensure that stakeholders have the opportunity to participate in the rulemaking process.

We also discussed the AGA obesity initiative that is being developed. This is a multidisciplinary approach to treating the disease. I had the opportunity to educate Sen. Cassidy’s staff on some of the new drugs that have been approved to treat obesity and the emergence of new endoscopic procedures that could have an impact on how we treat this growing epidemic. I also learned about Sen. Cassidy’s legislation, S. 1509/H.R. 2404, Treat and Reduce Obesity Act, which would cover behavioral therapy, as well as drugs, to treat obesity under Medicare. Sen. Cassidy is very concerned with obesity, especially in Louisiana, where it is a major public health problem. We will continue to work with Sen. Cassidy on this important initiative, as well as other public health initiatives, given his role on the Senate Health, Education, Labor and Pensions Committee.

I also had the honor of meeting with Sen. Brown’s staff. Sen. Brown is the main sponsor of the Removing Barriers to Colorectal Cancer Screening Act legislation that would fix the current co-insurance problem requiring Medicare beneficiaries to face out-of-pocket expenses when their screening colonoscopy becomes therapeutic. We impressed upon the staff our concern that this is a deterrent to undergoing colonoscopy for colorectal cancer screening. One of the main obstacles to getting this bill over the finish line is a favorable “score” (or additional cost) from the Congressional Budget Office and finding an appropriate legislative vehicle given this year’s short legislative session. I was able to thank Sen. Brown for his support of NIH, given that Congress gave the institute a $2 billion budget increase last year as part of the Omnibus Appropriations Bill.

In my discussions with Sen. Klobuchar’s staff, I thanked her for her support of NIH and access to colorectal cancer screening. She has been a champion of repealing the medical device tax, which received a 2-year delay as part of the recent Omnibus Bill. Finally, I met with Sen. Cardin, who has a long history of supporting colorectal cancer screening and was instrumental in first implementing the benefit under Medicare, as part of the Balanced Budget Act. He continues to champion many of our priorities, including NIH funding, fair reimbursement for colonoscopy and fixing the coinsurance waiver.

House of Representatives

I was also fortunate to meet with the staff for several representatives on the House side, including those key individuals involved in health legislation. The staff to Labor, HHS Appropriations Subcommittee Chair Tom Coles (R-Okla.) who was critical in ensuring that NIH received a bump in funding, conveyed that they would like to continue with sustained funding just as Congress did during the period when the NIH budget was doubled. They were very interested in learning about my own research on obesity at Mayo Clinic and the implications it could have in more effectively treating the disease.

I also met with staff for Rep. Jim McGovern, (D-Mass.), a senior member of the House Rules Committee and a longtime supporter of improving access to colorectal cancer screening, and Rep. Tim Walz, (D-Minn.), who is a representative from my congressional district in Minnesota. Both are strong supporters of NIH funding and colorectal cancer screening.

My experience showed me how willing our lawmakers on Capitol Hill are to meet with gastroenterologists, to learn about our experiences and our patients, and to find ways to work with us to ensure the correct laws are in place to ensure our patients are receiving the best care.
Medical research advances and the practice of medicine affect everyone in this country. We need to work with Congress to continue to advocate for the programs and initiatives that are vital to our patients and to our specialty, gastroenterology.

This January I was fortunate to spend a day on Capitol Hill meeting with AGA senior policy staff and key members of Congress who have jurisdiction over critical policy priorities for AGA and the profession of gastroenterology. It was an interesting and informative day. Among other things, I learned that individuals on Capitol Hill are interested in hearing from us to gain our insight and expertise on the practice and science of gastroenterology and patient care.

Senate

During my time visiting the Senate side of Capitol Hill, I met with the offices of Sen. Bill Cassidy (R-La.), Sen. Ben Cardin (D-Md.), Sen. Sherrod Brown (D-Ohio), and Sen. Amy Klobuchar (D-Minn). Sen. Cassidy, as you may be aware, has been an AGA member and champion for many of our policy priorities. Most recently, he, along with Sen. Cardin, spearheaded the Senate effort in contacting CMS and expressing concern over cuts in reimbursement for colonoscopy. Sen. Cassidy was critical in implementing the new transparency policy at CMS, which led to the announcement of changes in physician values in the proposed rule, instead of the final rule. This will ensure that stakeholders have the opportunity to participate in the rulemaking process.

We also discussed the AGA obesity initiative that is being developed. This is a multidisciplinary approach to treating the disease. I had the opportunity to educate Sen. Cassidy’s staff on some of the new drugs that have been approved to treat obesity and the emergence of new endoscopic procedures that could have an impact on how we treat this growing epidemic. I also learned about Sen. Cassidy’s legislation, S. 1509/H.R. 2404, Treat and Reduce Obesity Act, which would cover behavioral therapy, as well as drugs, to treat obesity under Medicare. Sen. Cassidy is very concerned with obesity, especially in Louisiana, where it is a major public health problem. We will continue to work with Sen. Cassidy on this important initiative, as well as other public health initiatives, given his role on the Senate Health, Education, Labor and Pensions Committee.

I also had the honor of meeting with Sen. Brown’s staff. Sen. Brown is the main sponsor of the Removing Barriers to Colorectal Cancer Screening Act legislation that would fix the current co-insurance problem requiring Medicare beneficiaries to face out-of-pocket expenses when their screening colonoscopy becomes therapeutic. We impressed upon the staff our concern that this is a deterrent to undergoing colonoscopy for colorectal cancer screening. One of the main obstacles to getting this bill over the finish line is a favorable “score” (or additional cost) from the Congressional Budget Office and finding an appropriate legislative vehicle given this year’s short legislative session. I was able to thank Sen. Brown for his support of NIH, given that Congress gave the institute a $2 billion budget increase last year as part of the Omnibus Appropriations Bill.

In my discussions with Sen. Klobuchar’s staff, I thanked her for her support of NIH and access to colorectal cancer screening. She has been a champion of repealing the medical device tax, which received a 2-year delay as part of the recent Omnibus Bill. Finally, I met with Sen. Cardin, who has a long history of supporting colorectal cancer screening and was instrumental in first implementing the benefit under Medicare, as part of the Balanced Budget Act. He continues to champion many of our priorities, including NIH funding, fair reimbursement for colonoscopy and fixing the coinsurance waiver.

House of Representatives

I was also fortunate to meet with the staff for several representatives on the House side, including those key individuals involved in health legislation. The staff to Labor, HHS Appropriations Subcommittee Chair Tom Coles (R-Okla.) who was critical in ensuring that NIH received a bump in funding, conveyed that they would like to continue with sustained funding just as Congress did during the period when the NIH budget was doubled. They were very interested in learning about my own research on obesity at Mayo Clinic and the implications it could have in more effectively treating the disease.

I also met with staff for Rep. Jim McGovern, (D-Mass.), a senior member of the House Rules Committee and a longtime supporter of improving access to colorectal cancer screening, and Rep. Tim Walz, (D-Minn.), who is a representative from my congressional district in Minnesota. Both are strong supporters of NIH funding and colorectal cancer screening.

My experience showed me how willing our lawmakers on Capitol Hill are to meet with gastroenterologists, to learn about our experiences and our patients, and to find ways to work with us to ensure the correct laws are in place to ensure our patients are receiving the best care.
Medical research advances and the practice of medicine affect everyone in this country. We need to work with Congress to continue to advocate for the programs and initiatives that are vital to our patients and to our specialty, gastroenterology.

This January I was fortunate to spend a day on Capitol Hill meeting with AGA senior policy staff and key members of Congress who have jurisdiction over critical policy priorities for AGA and the profession of gastroenterology. It was an interesting and informative day. Among other things, I learned that individuals on Capitol Hill are interested in hearing from us to gain our insight and expertise on the practice and science of gastroenterology and patient care.

Senate

During my time visiting the Senate side of Capitol Hill, I met with the offices of Sen. Bill Cassidy (R-La.), Sen. Ben Cardin (D-Md.), Sen. Sherrod Brown (D-Ohio), and Sen. Amy Klobuchar (D-Minn). Sen. Cassidy, as you may be aware, has been an AGA member and champion for many of our policy priorities. Most recently, he, along with Sen. Cardin, spearheaded the Senate effort in contacting CMS and expressing concern over cuts in reimbursement for colonoscopy. Sen. Cassidy was critical in implementing the new transparency policy at CMS, which led to the announcement of changes in physician values in the proposed rule, instead of the final rule. This will ensure that stakeholders have the opportunity to participate in the rulemaking process.

We also discussed the AGA obesity initiative that is being developed. This is a multidisciplinary approach to treating the disease. I had the opportunity to educate Sen. Cassidy’s staff on some of the new drugs that have been approved to treat obesity and the emergence of new endoscopic procedures that could have an impact on how we treat this growing epidemic. I also learned about Sen. Cassidy’s legislation, S. 1509/H.R. 2404, Treat and Reduce Obesity Act, which would cover behavioral therapy, as well as drugs, to treat obesity under Medicare. Sen. Cassidy is very concerned with obesity, especially in Louisiana, where it is a major public health problem. We will continue to work with Sen. Cassidy on this important initiative, as well as other public health initiatives, given his role on the Senate Health, Education, Labor and Pensions Committee.

I also had the honor of meeting with Sen. Brown’s staff. Sen. Brown is the main sponsor of the Removing Barriers to Colorectal Cancer Screening Act legislation that would fix the current co-insurance problem requiring Medicare beneficiaries to face out-of-pocket expenses when their screening colonoscopy becomes therapeutic. We impressed upon the staff our concern that this is a deterrent to undergoing colonoscopy for colorectal cancer screening. One of the main obstacles to getting this bill over the finish line is a favorable “score” (or additional cost) from the Congressional Budget Office and finding an appropriate legislative vehicle given this year’s short legislative session. I was able to thank Sen. Brown for his support of NIH, given that Congress gave the institute a $2 billion budget increase last year as part of the Omnibus Appropriations Bill.

In my discussions with Sen. Klobuchar’s staff, I thanked her for her support of NIH and access to colorectal cancer screening. She has been a champion of repealing the medical device tax, which received a 2-year delay as part of the recent Omnibus Bill. Finally, I met with Sen. Cardin, who has a long history of supporting colorectal cancer screening and was instrumental in first implementing the benefit under Medicare, as part of the Balanced Budget Act. He continues to champion many of our priorities, including NIH funding, fair reimbursement for colonoscopy and fixing the coinsurance waiver.

House of Representatives

I was also fortunate to meet with the staff for several representatives on the House side, including those key individuals involved in health legislation. The staff to Labor, HHS Appropriations Subcommittee Chair Tom Coles (R-Okla.) who was critical in ensuring that NIH received a bump in funding, conveyed that they would like to continue with sustained funding just as Congress did during the period when the NIH budget was doubled. They were very interested in learning about my own research on obesity at Mayo Clinic and the implications it could have in more effectively treating the disease.

I also met with staff for Rep. Jim McGovern, (D-Mass.), a senior member of the House Rules Committee and a longtime supporter of improving access to colorectal cancer screening, and Rep. Tim Walz, (D-Minn.), who is a representative from my congressional district in Minnesota. Both are strong supporters of NIH funding and colorectal cancer screening.

My experience showed me how willing our lawmakers on Capitol Hill are to meet with gastroenterologists, to learn about our experiences and our patients, and to find ways to work with us to ensure the correct laws are in place to ensure our patients are receiving the best care.
Medical research advances and the practice of medicine affect everyone in this country. We need to work with Congress to continue to advocate for the programs and initiatives that are vital to our patients and to our specialty, gastroenterology.

You’ve heard the stats about Digestive Disease Week® (DDW) – top 50 medical meeting, nearly 15,000 attendees, more than 4,000 abstracts. The experts behind AGA’s programming – coined the AGA Institute Council – recently came together to put the finishing touches on this year’s agenda.

If you’re not yet registered for this year’s meeting, taking place May 21 through 24 in San Diego, you can do so by visiting www.ddw.org/registration.

• AGA Basic Science Zone: AGA will be co-locating basic science sessions. On Saturday, we will highlight the gut microbiome, and on Sunday we will focus on inflammation and GI cancers. Both days will have a mix of invited and abstract-based sessions.

• More microbiome programming: AGA’s coverage of the microbiome will extend beyond basic science, focusing on clinical topics such as obesity, IBD, and pediatric GI.

• Collaborative topic sessions: our council is comprised of 12 special interest groups, or sections, all covering different topic areas in GI/hepatology.

• Plenary sessions: our plenary sessions at DDW highlight the most novel and innovative studies presented at the meeting. Don’t miss  the AGA Presidential Plenary, the AGA Basic Science Plenary and the Distinguished Abstract Plenaries.

• For the second year in a row, the council will be awarding certificates of recognition in sessions that have a young investigator.

Visit www.ddw.org and review the preliminary program.

You’ve heard the stats about Digestive Disease Week® (DDW) – top 50 medical meeting, nearly 15,000 attendees, more than 4,000 abstracts. The experts behind AGA’s programming – coined the AGA Institute Council – recently came together to put the finishing touches on this year’s agenda.

If you’re not yet registered for this year’s meeting, taking place May 21 through 24 in San Diego, you can do so by visiting www.ddw.org/registration.

• AGA Basic Science Zone: AGA will be co-locating basic science sessions. On Saturday, we will highlight the gut microbiome, and on Sunday we will focus on inflammation and GI cancers. Both days will have a mix of invited and abstract-based sessions.

• More microbiome programming: AGA’s coverage of the microbiome will extend beyond basic science, focusing on clinical topics such as obesity, IBD, and pediatric GI.

• Collaborative topic sessions: our council is comprised of 12 special interest groups, or sections, all covering different topic areas in GI/hepatology.

• Plenary sessions: our plenary sessions at DDW highlight the most novel and innovative studies presented at the meeting. Don’t miss  the AGA Presidential Plenary, the AGA Basic Science Plenary and the Distinguished Abstract Plenaries.

• For the second year in a row, the council will be awarding certificates of recognition in sessions that have a young investigator.

Visit www.ddw.org and review the preliminary program.

You’ve heard the stats about Digestive Disease Week® (DDW) – top 50 medical meeting, nearly 15,000 attendees, more than 4,000 abstracts. The experts behind AGA’s programming – coined the AGA Institute Council – recently came together to put the finishing touches on this year’s agenda.

If you’re not yet registered for this year’s meeting, taking place May 21 through 24 in San Diego, you can do so by visiting www.ddw.org/registration.

• AGA Basic Science Zone: AGA will be co-locating basic science sessions. On Saturday, we will highlight the gut microbiome, and on Sunday we will focus on inflammation and GI cancers. Both days will have a mix of invited and abstract-based sessions.

• More microbiome programming: AGA’s coverage of the microbiome will extend beyond basic science, focusing on clinical topics such as obesity, IBD, and pediatric GI.

• Collaborative topic sessions: our council is comprised of 12 special interest groups, or sections, all covering different topic areas in GI/hepatology.

• Plenary sessions: our plenary sessions at DDW highlight the most novel and innovative studies presented at the meeting. Don’t miss  the AGA Presidential Plenary, the AGA Basic Science Plenary and the Distinguished Abstract Plenaries.

• For the second year in a row, the council will be awarding certificates of recognition in sessions that have a young investigator.

Visit www.ddw.org and review the preliminary program.

Children who were genetically susceptible to celiac disease and consumed high amounts of gluten at 12 months of age were at least twice as likely to develop the autoimmune disorder as genetically predisposed children who consumed less gluten, researchers reported in the March issue of Clinical Gastroenterology and Hepatology.

The association was similar among children who carried any of the major human leukocyte antigen (HLA) risk genotypes for celiac disease, said Dr. Carin Aronsson at Lund University in Sweden and her associates. “Because these HLA risk genotypes are widely distributed in the general population, these findings may have consequence for future infant feeding recommendations,” they said. They recommended repeating the study in other countries to confirm the link.

In order to develop celiac disease, patients must consume gluten and carry at least one of the relevant DR3-DQ2 and DR4-DQ8 HLA risk haplotypes. But because gluten is widely consumed in products containing wheat, rye, and barley, and because about half of whites have at least one of the two haplotypes, gluten intolerance probably depends on other environmental factors, the researchers said. To further study these factors, they compared 3-day food diaries collected at ages 9, 12, 18, and 24 months for 146 children with positive tissue transglutaminase autoantibody (tTGA) assays and biopsy-confirmed celiac disease (cases) and 436 tTGA-negative children (controls). Cases and controls were matched by age, sex, and HLA genotype (Clin Gastroenterol Hepatol. 2015 Oct 7. doi: 10.1016/j.cgh.2015.09.030).

The food diaries revealed higher gluten intake among cases, compared with controls, beginning at the age of 12 months, said the researchers. Notably, cases consumed a median of 4.9 g of gluten a day before tTGA seroconversion, 1 g more than the median amount for controls of the same age (odds ratio, 1.3; 95% confidence interval, 1.1-1.5; P = .0002). Furthermore, significantly more cases than controls consumed the highest tertile of gluten, more than 5 g per day, before seroconversion (OR, 2.7; 95% CI, 1.7-4.1; P less than .0001). These associations were similar among children of all haplotype profiles and trended in the same direction among children with and without first-degree relatives with celiac disease.

Cases and controls resembled each other in terms of breastfeeding duration, age at first introduction to gluten, and total daily caloric intake, the investigators noted. “The prospective design of this birth cohort study enabled us to obtain the diet information before seroconversion of tTGA as a marker of celiac disease,” they said. “This eliminated the risk of reporting biases or a change in feeding habits because of the knowledge of serology results or disease status.” But they did not analyze the number of daily servings of foods that contained gluten. “We cannot exclude the possibility that the number of portions given frequently during the course of the day may have different effects on disease risk,” they said.

The National Institutes of Health, Juvenile Diabetes Research Foundation, and the Centers for Disease Control and Prevention funded the study. The investigators had no disclosures.

Source: American Gastroenterological Association

Children who were genetically susceptible to celiac disease and consumed high amounts of gluten at 12 months of age were at least twice as likely to develop the autoimmune disorder as genetically predisposed children who consumed less gluten, researchers reported in the March issue of Clinical Gastroenterology and Hepatology.

The association was similar among children who carried any of the major human leukocyte antigen (HLA) risk genotypes for celiac disease, said Dr. Carin Aronsson at Lund University in Sweden and her associates. “Because these HLA risk genotypes are widely distributed in the general population, these findings may have consequence for future infant feeding recommendations,” they said. They recommended repeating the study in other countries to confirm the link.

In order to develop celiac disease, patients must consume gluten and carry at least one of the relevant DR3-DQ2 and DR4-DQ8 HLA risk haplotypes. But because gluten is widely consumed in products containing wheat, rye, and barley, and because about half of whites have at least one of the two haplotypes, gluten intolerance probably depends on other environmental factors, the researchers said. To further study these factors, they compared 3-day food diaries collected at ages 9, 12, 18, and 24 months for 146 children with positive tissue transglutaminase autoantibody (tTGA) assays and biopsy-confirmed celiac disease (cases) and 436 tTGA-negative children (controls). Cases and controls were matched by age, sex, and HLA genotype (Clin Gastroenterol Hepatol. 2015 Oct 7. doi: 10.1016/j.cgh.2015.09.030).

The food diaries revealed higher gluten intake among cases, compared with controls, beginning at the age of 12 months, said the researchers. Notably, cases consumed a median of 4.9 g of gluten a day before tTGA seroconversion, 1 g more than the median amount for controls of the same age (odds ratio, 1.3; 95% confidence interval, 1.1-1.5; P = .0002). Furthermore, significantly more cases than controls consumed the highest tertile of gluten, more than 5 g per day, before seroconversion (OR, 2.7; 95% CI, 1.7-4.1; P less than .0001). These associations were similar among children of all haplotype profiles and trended in the same direction among children with and without first-degree relatives with celiac disease.

Cases and controls resembled each other in terms of breastfeeding duration, age at first introduction to gluten, and total daily caloric intake, the investigators noted. “The prospective design of this birth cohort study enabled us to obtain the diet information before seroconversion of tTGA as a marker of celiac disease,” they said. “This eliminated the risk of reporting biases or a change in feeding habits because of the knowledge of serology results or disease status.” But they did not analyze the number of daily servings of foods that contained gluten. “We cannot exclude the possibility that the number of portions given frequently during the course of the day may have different effects on disease risk,” they said.

The National Institutes of Health, Juvenile Diabetes Research Foundation, and the Centers for Disease Control and Prevention funded the study. The investigators had no disclosures.

Source: American Gastroenterological Association

Children who were genetically susceptible to celiac disease and consumed high amounts of gluten at 12 months of age were at least twice as likely to develop the autoimmune disorder as genetically predisposed children who consumed less gluten, researchers reported in the March issue of Clinical Gastroenterology and Hepatology.

The association was similar among children who carried any of the major human leukocyte antigen (HLA) risk genotypes for celiac disease, said Dr. Carin Aronsson at Lund University in Sweden and her associates. “Because these HLA risk genotypes are widely distributed in the general population, these findings may have consequence for future infant feeding recommendations,” they said. They recommended repeating the study in other countries to confirm the link.

In order to develop celiac disease, patients must consume gluten and carry at least one of the relevant DR3-DQ2 and DR4-DQ8 HLA risk haplotypes. But because gluten is widely consumed in products containing wheat, rye, and barley, and because about half of whites have at least one of the two haplotypes, gluten intolerance probably depends on other environmental factors, the researchers said. To further study these factors, they compared 3-day food diaries collected at ages 9, 12, 18, and 24 months for 146 children with positive tissue transglutaminase autoantibody (tTGA) assays and biopsy-confirmed celiac disease (cases) and 436 tTGA-negative children (controls). Cases and controls were matched by age, sex, and HLA genotype (Clin Gastroenterol Hepatol. 2015 Oct 7. doi: 10.1016/j.cgh.2015.09.030).

The food diaries revealed higher gluten intake among cases, compared with controls, beginning at the age of 12 months, said the researchers. Notably, cases consumed a median of 4.9 g of gluten a day before tTGA seroconversion, 1 g more than the median amount for controls of the same age (odds ratio, 1.3; 95% confidence interval, 1.1-1.5; P = .0002). Furthermore, significantly more cases than controls consumed the highest tertile of gluten, more than 5 g per day, before seroconversion (OR, 2.7; 95% CI, 1.7-4.1; P less than .0001). These associations were similar among children of all haplotype profiles and trended in the same direction among children with and without first-degree relatives with celiac disease.

Cases and controls resembled each other in terms of breastfeeding duration, age at first introduction to gluten, and total daily caloric intake, the investigators noted. “The prospective design of this birth cohort study enabled us to obtain the diet information before seroconversion of tTGA as a marker of celiac disease,” they said. “This eliminated the risk of reporting biases or a change in feeding habits because of the knowledge of serology results or disease status.” But they did not analyze the number of daily servings of foods that contained gluten. “We cannot exclude the possibility that the number of portions given frequently during the course of the day may have different effects on disease risk,” they said.

The National Institutes of Health, Juvenile Diabetes Research Foundation, and the Centers for Disease Control and Prevention funded the study. The investigators had no disclosures.

Source: American Gastroenterological Association

How does one of the smartest and most well-known men of his time become almost forgotten in history? Dr. Alexis Carrel’s contributions to medicine brought him to the height of fame in the worlds of surgery and science. By designing a curved needle coated in Vaseline, Carrel developed a new method of blood-vessel anastomosis that created a new standard for vascular surgery. This development earned him the Nobel Prize in Medicine or Physiology in 1912, making Carrel the second surgeon and youngest scientist at that time to earn this recognition. The ability to repair, reconnect, or attach blood vessels to one another opened the door for open heart surgery, coronary artery bypass grafts, transplantation, and countless other procedures. He further gained respect while working with Henry Drysdale Dakin in the French Army Medical Corps by revolutionizing the treatment of major wounds with wound antisepsis in the form of Carrel-Dakin fluid. This contribution alone earned him the Cross of the Legion of Honor.

However, by the time of the 52nd Vascular Annual Meeting in 1998, Dr. William Abbott in his SVS Presidential Address would focus on Carrel as an example of a surgeon with vast achievements who had come to be underrecognized. Despite Carrel’s amazing accomplishments throughout his life, the choices he ultimately made later significantly affected his legacy. Dr. Abbott attributes this to Carrel’s “unfortunate leadership decisions, in both boldness and judgment.”

Similar issues affected the legacy of Carrel’s close friend and colleague, Charles Lindbergh. The relationship between these two legendary men demonstrates the serendipity of history, the power of partnerships, and the importance of one’s choices, as well as the fleeting nature of fame. Both men reached the heights of praise and public admiration, then tumbled in a downward spiral of public condemnation.

Lindbergh, America’s golden boy aviator, had won the hearts of the world after he became the first to fly solo from New York to Paris in 1927. On Nov. 28, 1930, the American hero met the pioneering scientist Carrel through the auspices of Dr. Charles Flagg, a caretaker for Elisabeth Morrow, Lindbergh’s chronically ill sister-in-law. He and Carrel met at the Rockefeller Institute for Medical Research and formed a quick bond of mutual respect and admiration. Lindbergh was interested in questioning Carrel on potential treatments for his sister-in-law’s diseased heart valves: “Why could not a part of the body be kept alive indefinitely if a mechanical heart was attached to it – an arm, or even a head?… Why would not a mechanical heart be valuable for certain surgical operations?”

For his part, Carrel, a firm believer in “physiognomy,” the assessment of a person’s character from their outer appearance, and eugenics, the science of improving a population through controlled breeding, viewed Lindbergh as the perfect human specimen.

He interpreted the tall and handsome American hero as one of the elite selected by nature to play a role in society by promoting the production of the fit.

It was after this meeting that Lindbergh was invited to work in Carrel’s lab at the Rockefeller Institute. Lindbergh was enthralled with Carrel’s intellect, stating that his friend’s “mind flashed with the speed of light in space between the logical world of science and the mystical world of God.” Through Carrel’s tutelage and supervision, Lindbergh became focused on research on organ preservation.

During the mid-1930s, Lindbergh’s contribution to Carrel’s laboratory culminated in the design and production of the first efficient perfusion pump. This pump was intended to perfuse organs with pulsatile flow while maintaining a sterile environment free from contamination. The two men coauthored a book, “The Culture of Organs,” which detailed the process and theories for allowing living organs to exist outside the body during surgery. Their combined work is said to have been a crucial step in the later development of open heart surgery and organ transplantation, as well as to have laid the groundwork for the development of the artificial heart. Their collaboration raised their combined fame to the point where both men appeared on the cover of Time magazine on June 13, 1938, highlighting their heart perfusion work.

However, the very ideas that bonded the two famed men in mutual admiration would come to be unpopular, if not reviled, and led to their mutual downfall. Carrel’s views stating the superiority of evolution, survival of the fittest, and thoughts of eugenics paralleled Lindbergh’s thoughts of heredity and evolution. Lindbergh grew up on a farm and knew about breeding livestock and was comfortable with Carrel’s philosophy of racial superiority.

Therefore, despite the incredible accomplishments of both men, these jointly held views and their later affiliation with Nazi Germany and its principles tarnished their legacy.

Lindbergh, one of the few men with his level of fame who had lived among people of all skin colors in many cultures, was constantly being charged with racism and antisemitism. And even though he had previously stated, “I can’t feel inferior or superior to another man because of race, or in any way antagonistic to him. I judge the individual not by his race, and have always done so,” he constantly spoke of the value of genetics in promoting individual importance. And this talk of race betterment was a concept synonymous with the growing Nazi movement in Germany.

To make matters worse, Lindbergh had openly admired the Third Reich after having received the German Medal of Honor in 1938, bestowed by Herman Goering. This combined with Lindbergh’s past appreciation of Germany and his well-known views on eugenics caused many to view him as a Nazi sympathizer. It didn’t help that Lindbergh was also a great isolationist during World War II and acted as a spokesperson for the “America First” committee, which believed that the United States should not intervene. The once great man was denounced within his own country in a manner that would parallel what would happen to Carrel.

During the same period, Carrel returned to France to display his patriotism. In support of the war effort, Carrel volunteered his time toward supporting and designing mobile military hospitals and combating malnutrition. However, in the early 1940s, Germany conquered France and set up a puppet French government at Vichy. The new government offered Carrel the opportunity to continue his research at his own “Institute of Man.” Because of his past sentiments and this relationship formed with the Nazi-supported Vichy government, Carrel would come to be seen as a Nazi collaborator as well.

After the liberation of France in 1944, Carrel was dismissed from the institute and placed under surveillance to investigate his collaboration with the Nazis. Although no conclusions were ever reached, Carrel’s reputation was further destroyed by the press; this left him depressed and ruined. He died later that year on Nov. 5 (J Vasc Surg. 1999;29[1]:1-7).

Through their similar political views, Lindbergh and Carrel became despised in their own countries. Lindbergh would later regain his stature as an American hero and icon after advising the Army and Navy in World War II and continuing his work in the aeronautics industry. But his reputation remained forever tarnished as a Nazi sympathizer, and he died with his legacy disgraced in the eyes of many.

Lindbergh and Carrel’s contributions, despite their personal choices and judgments throughout life, have not been forgotten. There are many who still appreciate and remember the advances that both brought to the fields of medicine and science. Their legacies remain linked through the Lindbergh-Carrel Prize, established at the Medical University of South Carolina in Charleston. The award celebrates their contributions to the “development of perfusion and bioreactor technologies for organ preservation and growth.”

Lindbergh and Carrel exemplify the idea that one must consider the legacy that individuals leave behind in the context of their overall interactions and influences on the society in which they lived. Both men had significant individual failings and made choices that tarnished their public image and affected their legacies. With regard to Carrel, his opinions regarding the superiority of the white man and his proclamation of his mystical views alienated him from the public and the scientific community. Lindbergh’s alleged racism and antisemitism tarnished his image as a true American hero. Whatever their personal failings, however, medicine was forever changed by the impact of the great surgeon and the pilot.

Sources:

Berg AS. Lindbergh, Putman Adult Press, 1998.

Friedman DM. The Immortalists: Charles Lindbergh, Dr. Alexis Carrel, and Their Daring Quest to Live Forever. Ecco Publishing, 2007.

Presidential address: Legend, leadership, legacy. Abbott WM. J Vasc Surg. 1999;29:1-7.

Chaudhuri J, Al-Rubeai M. Bioreactors for Tissue Engineering: Principles, Design and Operation. Springer Publishing, 2005.

Dr. Phair is at the Department of Cardiovascular and Thoracic Surgery, Division of Vascular and Endovascular Surgery, Montefiore Medical Center, Bronx, N.Y.

How does one of the smartest and most well-known men of his time become almost forgotten in history? Dr. Alexis Carrel’s contributions to medicine brought him to the height of fame in the worlds of surgery and science. By designing a curved needle coated in Vaseline, Carrel developed a new method of blood-vessel anastomosis that created a new standard for vascular surgery. This development earned him the Nobel Prize in Medicine or Physiology in 1912, making Carrel the second surgeon and youngest scientist at that time to earn this recognition. The ability to repair, reconnect, or attach blood vessels to one another opened the door for open heart surgery, coronary artery bypass grafts, transplantation, and countless other procedures. He further gained respect while working with Henry Drysdale Dakin in the French Army Medical Corps by revolutionizing the treatment of major wounds with wound antisepsis in the form of Carrel-Dakin fluid. This contribution alone earned him the Cross of the Legion of Honor.

However, by the time of the 52nd Vascular Annual Meeting in 1998, Dr. William Abbott in his SVS Presidential Address would focus on Carrel as an example of a surgeon with vast achievements who had come to be underrecognized. Despite Carrel’s amazing accomplishments throughout his life, the choices he ultimately made later significantly affected his legacy. Dr. Abbott attributes this to Carrel’s “unfortunate leadership decisions, in both boldness and judgment.”

Similar issues affected the legacy of Carrel’s close friend and colleague, Charles Lindbergh. The relationship between these two legendary men demonstrates the serendipity of history, the power of partnerships, and the importance of one’s choices, as well as the fleeting nature of fame. Both men reached the heights of praise and public admiration, then tumbled in a downward spiral of public condemnation.

Lindbergh, America’s golden boy aviator, had won the hearts of the world after he became the first to fly solo from New York to Paris in 1927. On Nov. 28, 1930, the American hero met the pioneering scientist Carrel through the auspices of Dr. Charles Flagg, a caretaker for Elisabeth Morrow, Lindbergh’s chronically ill sister-in-law. He and Carrel met at the Rockefeller Institute for Medical Research and formed a quick bond of mutual respect and admiration. Lindbergh was interested in questioning Carrel on potential treatments for his sister-in-law’s diseased heart valves: “Why could not a part of the body be kept alive indefinitely if a mechanical heart was attached to it – an arm, or even a head?… Why would not a mechanical heart be valuable for certain surgical operations?”

For his part, Carrel, a firm believer in “physiognomy,” the assessment of a person’s character from their outer appearance, and eugenics, the science of improving a population through controlled breeding, viewed Lindbergh as the perfect human specimen.

He interpreted the tall and handsome American hero as one of the elite selected by nature to play a role in society by promoting the production of the fit.

It was after this meeting that Lindbergh was invited to work in Carrel’s lab at the Rockefeller Institute. Lindbergh was enthralled with Carrel’s intellect, stating that his friend’s “mind flashed with the speed of light in space between the logical world of science and the mystical world of God.” Through Carrel’s tutelage and supervision, Lindbergh became focused on research on organ preservation.

During the mid-1930s, Lindbergh’s contribution to Carrel’s laboratory culminated in the design and production of the first efficient perfusion pump. This pump was intended to perfuse organs with pulsatile flow while maintaining a sterile environment free from contamination. The two men coauthored a book, “The Culture of Organs,” which detailed the process and theories for allowing living organs to exist outside the body during surgery. Their combined work is said to have been a crucial step in the later development of open heart surgery and organ transplantation, as well as to have laid the groundwork for the development of the artificial heart. Their collaboration raised their combined fame to the point where both men appeared on the cover of Time magazine on June 13, 1938, highlighting their heart perfusion work.

However, the very ideas that bonded the two famed men in mutual admiration would come to be unpopular, if not reviled, and led to their mutual downfall. Carrel’s views stating the superiority of evolution, survival of the fittest, and thoughts of eugenics paralleled Lindbergh’s thoughts of heredity and evolution. Lindbergh grew up on a farm and knew about breeding livestock and was comfortable with Carrel’s philosophy of racial superiority.

Therefore, despite the incredible accomplishments of both men, these jointly held views and their later affiliation with Nazi Germany and its principles tarnished their legacy.

Lindbergh, one of the few men with his level of fame who had lived among people of all skin colors in many cultures, was constantly being charged with racism and antisemitism. And even though he had previously stated, “I can’t feel inferior or superior to another man because of race, or in any way antagonistic to him. I judge the individual not by his race, and have always done so,” he constantly spoke of the value of genetics in promoting individual importance. And this talk of race betterment was a concept synonymous with the growing Nazi movement in Germany.

To make matters worse, Lindbergh had openly admired the Third Reich after having received the German Medal of Honor in 1938, bestowed by Herman Goering. This combined with Lindbergh’s past appreciation of Germany and his well-known views on eugenics caused many to view him as a Nazi sympathizer. It didn’t help that Lindbergh was also a great isolationist during World War II and acted as a spokesperson for the “America First” committee, which believed that the United States should not intervene. The once great man was denounced within his own country in a manner that would parallel what would happen to Carrel.

During the same period, Carrel returned to France to display his patriotism. In support of the war effort, Carrel volunteered his time toward supporting and designing mobile military hospitals and combating malnutrition. However, in the early 1940s, Germany conquered France and set up a puppet French government at Vichy. The new government offered Carrel the opportunity to continue his research at his own “Institute of Man.” Because of his past sentiments and this relationship formed with the Nazi-supported Vichy government, Carrel would come to be seen as a Nazi collaborator as well.

After the liberation of France in 1944, Carrel was dismissed from the institute and placed under surveillance to investigate his collaboration with the Nazis. Although no conclusions were ever reached, Carrel’s reputation was further destroyed by the press; this left him depressed and ruined. He died later that year on Nov. 5 (J Vasc Surg. 1999;29[1]:1-7).

Through their similar political views, Lindbergh and Carrel became despised in their own countries. Lindbergh would later regain his stature as an American hero and icon after advising the Army and Navy in World War II and continuing his work in the aeronautics industry. But his reputation remained forever tarnished as a Nazi sympathizer, and he died with his legacy disgraced in the eyes of many.

Lindbergh and Carrel’s contributions, despite their personal choices and judgments throughout life, have not been forgotten. There are many who still appreciate and remember the advances that both brought to the fields of medicine and science. Their legacies remain linked through the Lindbergh-Carrel Prize, established at the Medical University of South Carolina in Charleston. The award celebrates their contributions to the “development of perfusion and bioreactor technologies for organ preservation and growth.”

Lindbergh and Carrel exemplify the idea that one must consider the legacy that individuals leave behind in the context of their overall interactions and influences on the society in which they lived. Both men had significant individual failings and made choices that tarnished their public image and affected their legacies. With regard to Carrel, his opinions regarding the superiority of the white man and his proclamation of his mystical views alienated him from the public and the scientific community. Lindbergh’s alleged racism and antisemitism tarnished his image as a true American hero. Whatever their personal failings, however, medicine was forever changed by the impact of the great surgeon and the pilot.

Sources:

Berg AS. Lindbergh, Putman Adult Press, 1998.

Friedman DM. The Immortalists: Charles Lindbergh, Dr. Alexis Carrel, and Their Daring Quest to Live Forever. Ecco Publishing, 2007.

Presidential address: Legend, leadership, legacy. Abbott WM. J Vasc Surg. 1999;29:1-7.

Chaudhuri J, Al-Rubeai M. Bioreactors for Tissue Engineering: Principles, Design and Operation. Springer Publishing, 2005.

Dr. Phair is at the Department of Cardiovascular and Thoracic Surgery, Division of Vascular and Endovascular Surgery, Montefiore Medical Center, Bronx, N.Y.

How does one of the smartest and most well-known men of his time become almost forgotten in history? Dr. Alexis Carrel’s contributions to medicine brought him to the height of fame in the worlds of surgery and science. By designing a curved needle coated in Vaseline, Carrel developed a new method of blood-vessel anastomosis that created a new standard for vascular surgery. This development earned him the Nobel Prize in Medicine or Physiology in 1912, making Carrel the second surgeon and youngest scientist at that time to earn this recognition. The ability to repair, reconnect, or attach blood vessels to one another opened the door for open heart surgery, coronary artery bypass grafts, transplantation, and countless other procedures. He further gained respect while working with Henry Drysdale Dakin in the French Army Medical Corps by revolutionizing the treatment of major wounds with wound antisepsis in the form of Carrel-Dakin fluid. This contribution alone earned him the Cross of the Legion of Honor.

However, by the time of the 52nd Vascular Annual Meeting in 1998, Dr. William Abbott in his SVS Presidential Address would focus on Carrel as an example of a surgeon with vast achievements who had come to be underrecognized. Despite Carrel’s amazing accomplishments throughout his life, the choices he ultimately made later significantly affected his legacy. Dr. Abbott attributes this to Carrel’s “unfortunate leadership decisions, in both boldness and judgment.”

Similar issues affected the legacy of Carrel’s close friend and colleague, Charles Lindbergh. The relationship between these two legendary men demonstrates the serendipity of history, the power of partnerships, and the importance of one’s choices, as well as the fleeting nature of fame. Both men reached the heights of praise and public admiration, then tumbled in a downward spiral of public condemnation.

Lindbergh, America’s golden boy aviator, had won the hearts of the world after he became the first to fly solo from New York to Paris in 1927. On Nov. 28, 1930, the American hero met the pioneering scientist Carrel through the auspices of Dr. Charles Flagg, a caretaker for Elisabeth Morrow, Lindbergh’s chronically ill sister-in-law. He and Carrel met at the Rockefeller Institute for Medical Research and formed a quick bond of mutual respect and admiration. Lindbergh was interested in questioning Carrel on potential treatments for his sister-in-law’s diseased heart valves: “Why could not a part of the body be kept alive indefinitely if a mechanical heart was attached to it – an arm, or even a head?… Why would not a mechanical heart be valuable for certain surgical operations?”

For his part, Carrel, a firm believer in “physiognomy,” the assessment of a person’s character from their outer appearance, and eugenics, the science of improving a population through controlled breeding, viewed Lindbergh as the perfect human specimen.

He interpreted the tall and handsome American hero as one of the elite selected by nature to play a role in society by promoting the production of the fit.

It was after this meeting that Lindbergh was invited to work in Carrel’s lab at the Rockefeller Institute. Lindbergh was enthralled with Carrel’s intellect, stating that his friend’s “mind flashed with the speed of light in space between the logical world of science and the mystical world of God.” Through Carrel’s tutelage and supervision, Lindbergh became focused on research on organ preservation.

During the mid-1930s, Lindbergh’s contribution to Carrel’s laboratory culminated in the design and production of the first efficient perfusion pump. This pump was intended to perfuse organs with pulsatile flow while maintaining a sterile environment free from contamination. The two men coauthored a book, “The Culture of Organs,” which detailed the process and theories for allowing living organs to exist outside the body during surgery. Their combined work is said to have been a crucial step in the later development of open heart surgery and organ transplantation, as well as to have laid the groundwork for the development of the artificial heart. Their collaboration raised their combined fame to the point where both men appeared on the cover of Time magazine on June 13, 1938, highlighting their heart perfusion work.

However, the very ideas that bonded the two famed men in mutual admiration would come to be unpopular, if not reviled, and led to their mutual downfall. Carrel’s views stating the superiority of evolution, survival of the fittest, and thoughts of eugenics paralleled Lindbergh’s thoughts of heredity and evolution. Lindbergh grew up on a farm and knew about breeding livestock and was comfortable with Carrel’s philosophy of racial superiority.

Therefore, despite the incredible accomplishments of both men, these jointly held views and their later affiliation with Nazi Germany and its principles tarnished their legacy.

Lindbergh, one of the few men with his level of fame who had lived among people of all skin colors in many cultures, was constantly being charged with racism and antisemitism. And even though he had previously stated, “I can’t feel inferior or superior to another man because of race, or in any way antagonistic to him. I judge the individual not by his race, and have always done so,” he constantly spoke of the value of genetics in promoting individual importance. And this talk of race betterment was a concept synonymous with the growing Nazi movement in Germany.

To make matters worse, Lindbergh had openly admired the Third Reich after having received the German Medal of Honor in 1938, bestowed by Herman Goering. This combined with Lindbergh’s past appreciation of Germany and his well-known views on eugenics caused many to view him as a Nazi sympathizer. It didn’t help that Lindbergh was also a great isolationist during World War II and acted as a spokesperson for the “America First” committee, which believed that the United States should not intervene. The once great man was denounced within his own country in a manner that would parallel what would happen to Carrel.

During the same period, Carrel returned to France to display his patriotism. In support of the war effort, Carrel volunteered his time toward supporting and designing mobile military hospitals and combating malnutrition. However, in the early 1940s, Germany conquered France and set up a puppet French government at Vichy. The new government offered Carrel the opportunity to continue his research at his own “Institute of Man.” Because of his past sentiments and this relationship formed with the Nazi-supported Vichy government, Carrel would come to be seen as a Nazi collaborator as well.

After the liberation of France in 1944, Carrel was dismissed from the institute and placed under surveillance to investigate his collaboration with the Nazis. Although no conclusions were ever reached, Carrel’s reputation was further destroyed by the press; this left him depressed and ruined. He died later that year on Nov. 5 (J Vasc Surg. 1999;29[1]:1-7).

Through their similar political views, Lindbergh and Carrel became despised in their own countries. Lindbergh would later regain his stature as an American hero and icon after advising the Army and Navy in World War II and continuing his work in the aeronautics industry. But his reputation remained forever tarnished as a Nazi sympathizer, and he died with his legacy disgraced in the eyes of many.

Lindbergh and Carrel’s contributions, despite their personal choices and judgments throughout life, have not been forgotten. There are many who still appreciate and remember the advances that both brought to the fields of medicine and science. Their legacies remain linked through the Lindbergh-Carrel Prize, established at the Medical University of South Carolina in Charleston. The award celebrates their contributions to the “development of perfusion and bioreactor technologies for organ preservation and growth.”

Lindbergh and Carrel exemplify the idea that one must consider the legacy that individuals leave behind in the context of their overall interactions and influences on the society in which they lived. Both men had significant individual failings and made choices that tarnished their public image and affected their legacies. With regard to Carrel, his opinions regarding the superiority of the white man and his proclamation of his mystical views alienated him from the public and the scientific community. Lindbergh’s alleged racism and antisemitism tarnished his image as a true American hero. Whatever their personal failings, however, medicine was forever changed by the impact of the great surgeon and the pilot.

Sources:

Berg AS. Lindbergh, Putman Adult Press, 1998.

Friedman DM. The Immortalists: Charles Lindbergh, Dr. Alexis Carrel, and Their Daring Quest to Live Forever. Ecco Publishing, 2007.

Presidential address: Legend, leadership, legacy. Abbott WM. J Vasc Surg. 1999;29:1-7.

Chaudhuri J, Al-Rubeai M. Bioreactors for Tissue Engineering: Principles, Design and Operation. Springer Publishing, 2005.

Dr. Phair is at the Department of Cardiovascular and Thoracic Surgery, Division of Vascular and Endovascular Surgery, Montefiore Medical Center, Bronx, N.Y.