With the decision by Astora Women’s Health to discontinue operations as of March 31, 2016, we have lost midurethral slings and pelvic organ prolapse repair mesh, technologies and kits that have been among the most widely used and studied (Steve Blum, Senior Vice President and General Manager, Astora Women’s Health, and Kathie J. Lenzen, Senior Vice President and General Manager, Endo Device Operations, e-mail communication to physician customers, February 29, 2016). US Food and Drug Administration (FDA)−mandated 522 postmarket surveillance studies on these products have stopped enrolling patients, and we will therefore never glean the full science from fully enrolled and completed studies. This is a horrible precedent. How did this happen, and what do we need to do now to prevent further loss of helpful innovative technologies that benefit our patients with pelvic floor disorders?

Liability challenges precipitated shut downEndo Pharmaceuticals, the parent company of Astora (previously American Medical Systems Women’s Health division), last year offered $1.5 billion to settle a majority of its pending mesh litigation cases. I was told that the company wanted to put all of the negative noise from the relentless plaintiff attorney public media campaign behind it and refocus its attention on helping women with pelvic floor disorders.

Over the past year, 4 interested and capable buyers have been in discussions with the company to purchase and continue its product line. The company’s recent decision to not sell its product line and discontinue all operations was based on “the current legal environment and the ongoing challenges associated with vaginal mesh product liability” (Astora Women’s Health, e-mail communication to physician customers, February 29, 2016). If it had chosen to sell its product line, the company always would have remained a potential deep-pocketed codefendant in any future litigation against the company that purchased its products, technologies, and intellectual properties.

This is a frightening scenario that threatens existing companies that want to remain in the prolapse and incontinence product space. This is a threat to all future innovation for pelvic floor disorder therapies, and it discourages anyone or any company to invest in innovative products that may help our patients. In addition, it is a threat to our mission as physicians and surgeons to provide the very best therapies to our patients who deserve and expect us to do so.

Let me be crystal clear: Currently available midurethral slings are also in the crosshairs of plaintiff attorneys, and we are at risk of losing them as well if we do not act quickly, decisively, and as a unified force. More than 60% of the mesh lawsuits have been against midurethral slings, not the prolapse mesh kits focused on in the FDA Public Health notice of July 2011.¹ In their class action lawsuits, plaintiff attorneys lumped together any procedure involving mesh in the pelvis to increase the number of their patient clients involved, which can drive up settlement awards, and they succeeded. In 2014, 128,030 sling procedures for incontinence were performed. Does anyone truly believe that the scientific literature supports that these patients would have been best served by 128,030 Burch procedures?

Some believe that Endo Pharmaceuticals’ placement of $1.5 billion in settlement funds was an error, “threw blood in the water,” and led to what has happened. Some believe that companies should fight every lawsuit to win and not settle. By the companies winning cases, the plaintiff attorneys lose their incentives to advertise and file more cases, as they only receive money if they win (or get a settlement) and are out of pocket for their costs and time if they lose.

Plaintiff attorneys have a responsibility to zealously advocate for their patient clients. Defense attorneys have a responsibility to zealously defend their corporate clients. We surgeons must realize that we have a responsibility to zealously advocate for our patients and do whatever is needed to best serve them and to protect the use (and development) of innovative products and therapies that give them value and a better quality of life.

Proactive steps surgeons can take

Implement expert oversight for litigation. Some of the large plaintiff awards were assisted by expert testimony based on a highly questionable scientific foundation. Judges give expert witnesses great latitude in their testimony, relying on the jury to discern the truth. I recommend that professional societies, such as the American College of Obstetricians and Gynecologists (ACOG), AmericanUrological Association (AUA), American Urogynecologic Society (AUGS), Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), and Society of Gynecologic Surgeons (SGS), establish a panel to review and carefully evaluate plaintiff expert testimony that has a questionable scientific foundation. If such a panel finds the scientific basis of testimony to be biased, untruthful, or unethical, the societies must publicly reprimand and sanction these experts. Only then would these experts no longer be used by the plaintiff attorneys.

Such an expert panel also could serve to educate the judges in federal and state courts on real science and not manufactured opinions.

We need juries that can understand the science so they truly can decide on cases involving complex technologies.

Support professional leadership efforts. I am encouraged that AUGS is working to establish guidelines for the management of mesh complications. I have seen cases in which a small amount of mesh exposure, best treated by limited local excision of the exposed mesh, instead has been treated by complete excision of every polypropylene fiber placed, resulting in an unnecessarily morbid surgery that leaves a scarred and small vagina. Notably, some of the surgeons who excise every polypropylene fiber are also working as plaintiff experts, who may then testify that the scarred, small vagina was caused by the mesh and the implanting surgeon.

Our professional society leadership and volunteer committees, especially from AUGS, have done a tremendous amount of work in assisting with the FDA-required 522 postmarket surveillance study research design; establishing a Pelvic Floor Disorders Registry (http://www.pfdr.org/) and a sling registry; and developing credentialing guidelines for sacrocolpopexy, transvaginal mesh, and slings. They deserve our gratitude and our participation in the registries. It would be a tragedy if all of this work does not lead to fully enrolled and completed 522 studies so that we can scientifically make decisions on products before any more treatment options are removed from the market.

Use video to scrutinize surgical outcomes data. The surgical literature shows extreme variance in outcomes and complications for vaginal mesh surgery, including exposure rates from 1% to 20% with the same mesh products. This only can be explained by depth of surgical dissection and implanting technique. Surgical outcomes have been shown to be related directly to surgical volumes and experience.² I propose that going forward, any authors who publish their study outcomes and complication data on a surgical procedure must submit a surgical video that demonstrates exactly how the surgery was done.

Best serve the patient. We all need to rigorously follow our own surgery results, improve our techniques, and keep within our surgical skill sets. We need to share our outcome and complication data with our patients during the informed consent process, since we, and not the surgical literature, are performing their surgeries.

We need to be transparent and respectful of our colleagues with different skill sets, putting what is best for patients ahead of everything else. We must be mindful of our inherent biases toward surgeries we are personally very good at and comfortable with. We must respect that other surgeons may achieve better clinical outcomes than us with the same surgery. We need to teach each other the best reproducible surgical techniques to maximize outcomes and minimize complications.

We must humbly accept that not every surgeon can do every surgery (and should not try). If a patient would be best served with a surgery we are not skilled in, we must refer that patient to a colleague who is.

Encourage industry’s part in training. As new technologies are developed, we must be brutally honest with ourselves about whether or not we have the skill sets to use them. Industry must gauge the complexity of the surgical skill set necessary to use their products and limit attendance at their teaching labs to surgeons who have the skills required to obtain good outcomes and minimize complications.

We have reached the tipping pointWe have seen the enemy, and it is us. We now need to advocate zealously for our patients. We will succeed only if we keep what is best for our patients at the forefront of everything we do. We must today decide to lead or be led. If we do not lead, we will be led by others—to places that may not best serve our patients. Make no mistake, this is a tipping point. The future of midurethral slings and potential future innovations lie in our hands right now.

Notably, just days prior to Astora’s letter to its physician customers announcing the decision to discontinue all of its operations, the transobturator postanal sling system (TOPAS) for fecal incontinence, a product in the pipeline at Astora, received 3 unanimous 8-0 votes from an FDA device advisory panel on safety, efficacy, and benefit outweighing risk.³ The future of this technology is now uncertain as well.

I ask Endo Pharmaceuticals to reconsider abandoning all of its products and intellectual properties. I ask it to entertain discussions with large companies that want its technologies and intellectual properties and can indemnify it from future litigation. While there never is a guarantee of complete indemnification and the company does have a fiduciary responsibility to its shareholders, industry also has a responsibility to patients and surgeons to allow helpful technologies to persist.

According to Astora’s letter to its physician customers, “Patient health has always been our number one priority. As such, the business closure has been expedited so that you and your patients have the opportunity to assess alternative treatment options as soon as possible.”

That letter was dated February 29. I do not feel that 31 days’ notice is enough time for surgeons to assess—let alone learn and master—new treatment options. It would have been helpful if Endo Pharmaceuticals had given more notice and would at least have allowed other interested companies the option to purchase useful technologies and intellectual property to mitigate its rapid departure from the space. The company remains in the health care arena with its pharmaceutical products, and how it behaves leaving the surgical space will be noted and impact its brand and reputation.

Lessons from the morcellation situationHow quickly the power morcellator disappeared is a lesson to note very carefully, and it has important parallels to what we now face. I highly recommend that you read and study Lisa Rosenbaum’s article in New England Journal of Medicine, “N-of-1 policymaking—tragedy, trade-offs, and the demise of morcellation.”⁴ She eloquently discusses how decisions to terminate technologies based on passionate anecdotal stories and media campaigns, and not scientific study, does not serve the greater good. She explores lessons learned from the silicone breast implant saga as well, stating “the tendency to focus on eliminating an immediate harm while failing to consider potentially greater harms caused by that reaction is heightened by the power of tragic stories.”⁴

We need a calmer, less emotional, and balanced scientific approach to evaluate technologies. We need to consider what harm is done by not allowing new technologies to be adequately studied, improved, and implemented. Dr. Rosenbaum discusses what Cass Sunstein and Timur Kuran call the “availability cascade,” “a phenomenon whereby stories inform public perceptions and anyone challenging those perceptions is vilified.”^4,5

No technology will ever be risk free, and there always will be some risks and complications that could be significant and chilling. However, patient autonomy requires a full discussion of a risk/benefit ratio that is based on science, and these scientific data must be allowed to be collected and learned. There even can be more significant and chilling complications from not using a technology as well.

It is challenging to speak science to emotion that is driven by tragic outcomes, but we can remain compassionate as we seek the science that will serve the greater good. Condemning proponents of carefully studied and properly implemented technologies as immoral is neither helpful nor constructive. Crushing the ability to thoroughly and scientifically study new technologies is not in the best interest of our patients with pelvic floor disorders.

It is time to reawaken the better angels of our natureWill we do the necessary work now no matter how uncomfortable it may make us feel? Or will we be intimidated and remain silent and disjointed? Will we participate in the registries and follow best clinical practice and credentialing guidelines? Will we hold ourselves and our colleagues accountable? It is time to remember why we became surgeons, and to start acting on our convictions.

To that end, we must ask ourselves, will we:

• honor the Hippocratic Oath that we took in medical school and “respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow”⁶
• “not be ashamed to say ‘I know not,’ nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery”⁶
• zealously advocate for our patients to ensure we can offer them the very best therapies
• honor and respect the sacred trust patients place in us when we take them to the operating room
• lead or be led?

This is personal for me. My mother struggled with pelvic floor disorders. I always felt it grossly unfair that women who chose to give us life could suffer for the rest of theirs for that decision. These women deserve our very best. The 40 million women with pelvic floor disorders deserve—and expect—that we lead. Will we?

I am hopeful that we will. I believe we will rise to today’s challenges and protect and fight for our patients. I believe that years from now we will look back and be proud that we did the right thing, and in so doing protected and encouraged innovations that significantly enhanced the quality of our patients’ lives. I believe patients will recognize our genuine efforts and in so doing give our profession the respect and trust that I feel has been diminished.

I believe we will draw the needed courage and resolve from the oath we recited in medical school and remember that, “If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.”⁶

I do believe we will.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

With the decision by Astora Women’s Health to discontinue operations as of March 31, 2016, we have lost midurethral slings and pelvic organ prolapse repair mesh, technologies and kits that have been among the most widely used and studied (Steve Blum, Senior Vice President and General Manager, Astora Women’s Health, and Kathie J. Lenzen, Senior Vice President and General Manager, Endo Device Operations, e-mail communication to physician customers, February 29, 2016). US Food and Drug Administration (FDA)−mandated 522 postmarket surveillance studies on these products have stopped enrolling patients, and we will therefore never glean the full science from fully enrolled and completed studies. This is a horrible precedent. How did this happen, and what do we need to do now to prevent further loss of helpful innovative technologies that benefit our patients with pelvic floor disorders?

Liability challenges precipitated shut downEndo Pharmaceuticals, the parent company of Astora (previously American Medical Systems Women’s Health division), last year offered $1.5 billion to settle a majority of its pending mesh litigation cases. I was told that the company wanted to put all of the negative noise from the relentless plaintiff attorney public media campaign behind it and refocus its attention on helping women with pelvic floor disorders.

Over the past year, 4 interested and capable buyers have been in discussions with the company to purchase and continue its product line. The company’s recent decision to not sell its product line and discontinue all operations was based on “the current legal environment and the ongoing challenges associated with vaginal mesh product liability” (Astora Women’s Health, e-mail communication to physician customers, February 29, 2016). If it had chosen to sell its product line, the company always would have remained a potential deep-pocketed codefendant in any future litigation against the company that purchased its products, technologies, and intellectual properties.

This is a frightening scenario that threatens existing companies that want to remain in the prolapse and incontinence product space. This is a threat to all future innovation for pelvic floor disorder therapies, and it discourages anyone or any company to invest in innovative products that may help our patients. In addition, it is a threat to our mission as physicians and surgeons to provide the very best therapies to our patients who deserve and expect us to do so.

Let me be crystal clear: Currently available midurethral slings are also in the crosshairs of plaintiff attorneys, and we are at risk of losing them as well if we do not act quickly, decisively, and as a unified force. More than 60% of the mesh lawsuits have been against midurethral slings, not the prolapse mesh kits focused on in the FDA Public Health notice of July 2011.¹ In their class action lawsuits, plaintiff attorneys lumped together any procedure involving mesh in the pelvis to increase the number of their patient clients involved, which can drive up settlement awards, and they succeeded. In 2014, 128,030 sling procedures for incontinence were performed. Does anyone truly believe that the scientific literature supports that these patients would have been best served by 128,030 Burch procedures?

Some believe that Endo Pharmaceuticals’ placement of $1.5 billion in settlement funds was an error, “threw blood in the water,” and led to what has happened. Some believe that companies should fight every lawsuit to win and not settle. By the companies winning cases, the plaintiff attorneys lose their incentives to advertise and file more cases, as they only receive money if they win (or get a settlement) and are out of pocket for their costs and time if they lose.

Plaintiff attorneys have a responsibility to zealously advocate for their patient clients. Defense attorneys have a responsibility to zealously defend their corporate clients. We surgeons must realize that we have a responsibility to zealously advocate for our patients and do whatever is needed to best serve them and to protect the use (and development) of innovative products and therapies that give them value and a better quality of life.

Proactive steps surgeons can take

Implement expert oversight for litigation. Some of the large plaintiff awards were assisted by expert testimony based on a highly questionable scientific foundation. Judges give expert witnesses great latitude in their testimony, relying on the jury to discern the truth. I recommend that professional societies, such as the American College of Obstetricians and Gynecologists (ACOG), AmericanUrological Association (AUA), American Urogynecologic Society (AUGS), Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), and Society of Gynecologic Surgeons (SGS), establish a panel to review and carefully evaluate plaintiff expert testimony that has a questionable scientific foundation. If such a panel finds the scientific basis of testimony to be biased, untruthful, or unethical, the societies must publicly reprimand and sanction these experts. Only then would these experts no longer be used by the plaintiff attorneys.

Such an expert panel also could serve to educate the judges in federal and state courts on real science and not manufactured opinions.

We need juries that can understand the science so they truly can decide on cases involving complex technologies.

Support professional leadership efforts. I am encouraged that AUGS is working to establish guidelines for the management of mesh complications. I have seen cases in which a small amount of mesh exposure, best treated by limited local excision of the exposed mesh, instead has been treated by complete excision of every polypropylene fiber placed, resulting in an unnecessarily morbid surgery that leaves a scarred and small vagina. Notably, some of the surgeons who excise every polypropylene fiber are also working as plaintiff experts, who may then testify that the scarred, small vagina was caused by the mesh and the implanting surgeon.

Our professional society leadership and volunteer committees, especially from AUGS, have done a tremendous amount of work in assisting with the FDA-required 522 postmarket surveillance study research design; establishing a Pelvic Floor Disorders Registry (http://www.pfdr.org/) and a sling registry; and developing credentialing guidelines for sacrocolpopexy, transvaginal mesh, and slings. They deserve our gratitude and our participation in the registries. It would be a tragedy if all of this work does not lead to fully enrolled and completed 522 studies so that we can scientifically make decisions on products before any more treatment options are removed from the market.

Use video to scrutinize surgical outcomes data. The surgical literature shows extreme variance in outcomes and complications for vaginal mesh surgery, including exposure rates from 1% to 20% with the same mesh products. This only can be explained by depth of surgical dissection and implanting technique. Surgical outcomes have been shown to be related directly to surgical volumes and experience.² I propose that going forward, any authors who publish their study outcomes and complication data on a surgical procedure must submit a surgical video that demonstrates exactly how the surgery was done.

Best serve the patient. We all need to rigorously follow our own surgery results, improve our techniques, and keep within our surgical skill sets. We need to share our outcome and complication data with our patients during the informed consent process, since we, and not the surgical literature, are performing their surgeries.

We need to be transparent and respectful of our colleagues with different skill sets, putting what is best for patients ahead of everything else. We must be mindful of our inherent biases toward surgeries we are personally very good at and comfortable with. We must respect that other surgeons may achieve better clinical outcomes than us with the same surgery. We need to teach each other the best reproducible surgical techniques to maximize outcomes and minimize complications.

We must humbly accept that not every surgeon can do every surgery (and should not try). If a patient would be best served with a surgery we are not skilled in, we must refer that patient to a colleague who is.

Encourage industry’s part in training. As new technologies are developed, we must be brutally honest with ourselves about whether or not we have the skill sets to use them. Industry must gauge the complexity of the surgical skill set necessary to use their products and limit attendance at their teaching labs to surgeons who have the skills required to obtain good outcomes and minimize complications.

We have reached the tipping pointWe have seen the enemy, and it is us. We now need to advocate zealously for our patients. We will succeed only if we keep what is best for our patients at the forefront of everything we do. We must today decide to lead or be led. If we do not lead, we will be led by others—to places that may not best serve our patients. Make no mistake, this is a tipping point. The future of midurethral slings and potential future innovations lie in our hands right now.

Notably, just days prior to Astora’s letter to its physician customers announcing the decision to discontinue all of its operations, the transobturator postanal sling system (TOPAS) for fecal incontinence, a product in the pipeline at Astora, received 3 unanimous 8-0 votes from an FDA device advisory panel on safety, efficacy, and benefit outweighing risk.³ The future of this technology is now uncertain as well.

I ask Endo Pharmaceuticals to reconsider abandoning all of its products and intellectual properties. I ask it to entertain discussions with large companies that want its technologies and intellectual properties and can indemnify it from future litigation. While there never is a guarantee of complete indemnification and the company does have a fiduciary responsibility to its shareholders, industry also has a responsibility to patients and surgeons to allow helpful technologies to persist.

According to Astora’s letter to its physician customers, “Patient health has always been our number one priority. As such, the business closure has been expedited so that you and your patients have the opportunity to assess alternative treatment options as soon as possible.”

That letter was dated February 29. I do not feel that 31 days’ notice is enough time for surgeons to assess—let alone learn and master—new treatment options. It would have been helpful if Endo Pharmaceuticals had given more notice and would at least have allowed other interested companies the option to purchase useful technologies and intellectual property to mitigate its rapid departure from the space. The company remains in the health care arena with its pharmaceutical products, and how it behaves leaving the surgical space will be noted and impact its brand and reputation.

Lessons from the morcellation situationHow quickly the power morcellator disappeared is a lesson to note very carefully, and it has important parallels to what we now face. I highly recommend that you read and study Lisa Rosenbaum’s article in New England Journal of Medicine, “N-of-1 policymaking—tragedy, trade-offs, and the demise of morcellation.”⁴ She eloquently discusses how decisions to terminate technologies based on passionate anecdotal stories and media campaigns, and not scientific study, does not serve the greater good. She explores lessons learned from the silicone breast implant saga as well, stating “the tendency to focus on eliminating an immediate harm while failing to consider potentially greater harms caused by that reaction is heightened by the power of tragic stories.”⁴

We need a calmer, less emotional, and balanced scientific approach to evaluate technologies. We need to consider what harm is done by not allowing new technologies to be adequately studied, improved, and implemented. Dr. Rosenbaum discusses what Cass Sunstein and Timur Kuran call the “availability cascade,” “a phenomenon whereby stories inform public perceptions and anyone challenging those perceptions is vilified.”^4,5

No technology will ever be risk free, and there always will be some risks and complications that could be significant and chilling. However, patient autonomy requires a full discussion of a risk/benefit ratio that is based on science, and these scientific data must be allowed to be collected and learned. There even can be more significant and chilling complications from not using a technology as well.

It is challenging to speak science to emotion that is driven by tragic outcomes, but we can remain compassionate as we seek the science that will serve the greater good. Condemning proponents of carefully studied and properly implemented technologies as immoral is neither helpful nor constructive. Crushing the ability to thoroughly and scientifically study new technologies is not in the best interest of our patients with pelvic floor disorders.

It is time to reawaken the better angels of our natureWill we do the necessary work now no matter how uncomfortable it may make us feel? Or will we be intimidated and remain silent and disjointed? Will we participate in the registries and follow best clinical practice and credentialing guidelines? Will we hold ourselves and our colleagues accountable? It is time to remember why we became surgeons, and to start acting on our convictions.

To that end, we must ask ourselves, will we:

• honor the Hippocratic Oath that we took in medical school and “respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow”⁶
• “not be ashamed to say ‘I know not,’ nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery”⁶
• zealously advocate for our patients to ensure we can offer them the very best therapies
• honor and respect the sacred trust patients place in us when we take them to the operating room
• lead or be led?

This is personal for me. My mother struggled with pelvic floor disorders. I always felt it grossly unfair that women who chose to give us life could suffer for the rest of theirs for that decision. These women deserve our very best. The 40 million women with pelvic floor disorders deserve—and expect—that we lead. Will we?

I am hopeful that we will. I believe we will rise to today’s challenges and protect and fight for our patients. I believe that years from now we will look back and be proud that we did the right thing, and in so doing protected and encouraged innovations that significantly enhanced the quality of our patients’ lives. I believe patients will recognize our genuine efforts and in so doing give our profession the respect and trust that I feel has been diminished.

I believe we will draw the needed courage and resolve from the oath we recited in medical school and remember that, “If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.”⁶

I do believe we will.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

With the decision by Astora Women’s Health to discontinue operations as of March 31, 2016, we have lost midurethral slings and pelvic organ prolapse repair mesh, technologies and kits that have been among the most widely used and studied (Steve Blum, Senior Vice President and General Manager, Astora Women’s Health, and Kathie J. Lenzen, Senior Vice President and General Manager, Endo Device Operations, e-mail communication to physician customers, February 29, 2016). US Food and Drug Administration (FDA)−mandated 522 postmarket surveillance studies on these products have stopped enrolling patients, and we will therefore never glean the full science from fully enrolled and completed studies. This is a horrible precedent. How did this happen, and what do we need to do now to prevent further loss of helpful innovative technologies that benefit our patients with pelvic floor disorders?

Liability challenges precipitated shut downEndo Pharmaceuticals, the parent company of Astora (previously American Medical Systems Women’s Health division), last year offered $1.5 billion to settle a majority of its pending mesh litigation cases. I was told that the company wanted to put all of the negative noise from the relentless plaintiff attorney public media campaign behind it and refocus its attention on helping women with pelvic floor disorders.

Over the past year, 4 interested and capable buyers have been in discussions with the company to purchase and continue its product line. The company’s recent decision to not sell its product line and discontinue all operations was based on “the current legal environment and the ongoing challenges associated with vaginal mesh product liability” (Astora Women’s Health, e-mail communication to physician customers, February 29, 2016). If it had chosen to sell its product line, the company always would have remained a potential deep-pocketed codefendant in any future litigation against the company that purchased its products, technologies, and intellectual properties.

This is a frightening scenario that threatens existing companies that want to remain in the prolapse and incontinence product space. This is a threat to all future innovation for pelvic floor disorder therapies, and it discourages anyone or any company to invest in innovative products that may help our patients. In addition, it is a threat to our mission as physicians and surgeons to provide the very best therapies to our patients who deserve and expect us to do so.

Let me be crystal clear: Currently available midurethral slings are also in the crosshairs of plaintiff attorneys, and we are at risk of losing them as well if we do not act quickly, decisively, and as a unified force. More than 60% of the mesh lawsuits have been against midurethral slings, not the prolapse mesh kits focused on in the FDA Public Health notice of July 2011.¹ In their class action lawsuits, plaintiff attorneys lumped together any procedure involving mesh in the pelvis to increase the number of their patient clients involved, which can drive up settlement awards, and they succeeded. In 2014, 128,030 sling procedures for incontinence were performed. Does anyone truly believe that the scientific literature supports that these patients would have been best served by 128,030 Burch procedures?

Some believe that Endo Pharmaceuticals’ placement of $1.5 billion in settlement funds was an error, “threw blood in the water,” and led to what has happened. Some believe that companies should fight every lawsuit to win and not settle. By the companies winning cases, the plaintiff attorneys lose their incentives to advertise and file more cases, as they only receive money if they win (or get a settlement) and are out of pocket for their costs and time if they lose.

Plaintiff attorneys have a responsibility to zealously advocate for their patient clients. Defense attorneys have a responsibility to zealously defend their corporate clients. We surgeons must realize that we have a responsibility to zealously advocate for our patients and do whatever is needed to best serve them and to protect the use (and development) of innovative products and therapies that give them value and a better quality of life.

Proactive steps surgeons can take

Implement expert oversight for litigation. Some of the large plaintiff awards were assisted by expert testimony based on a highly questionable scientific foundation. Judges give expert witnesses great latitude in their testimony, relying on the jury to discern the truth. I recommend that professional societies, such as the American College of Obstetricians and Gynecologists (ACOG), AmericanUrological Association (AUA), American Urogynecologic Society (AUGS), Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), and Society of Gynecologic Surgeons (SGS), establish a panel to review and carefully evaluate plaintiff expert testimony that has a questionable scientific foundation. If such a panel finds the scientific basis of testimony to be biased, untruthful, or unethical, the societies must publicly reprimand and sanction these experts. Only then would these experts no longer be used by the plaintiff attorneys.

Such an expert panel also could serve to educate the judges in federal and state courts on real science and not manufactured opinions.

We need juries that can understand the science so they truly can decide on cases involving complex technologies.

Support professional leadership efforts. I am encouraged that AUGS is working to establish guidelines for the management of mesh complications. I have seen cases in which a small amount of mesh exposure, best treated by limited local excision of the exposed mesh, instead has been treated by complete excision of every polypropylene fiber placed, resulting in an unnecessarily morbid surgery that leaves a scarred and small vagina. Notably, some of the surgeons who excise every polypropylene fiber are also working as plaintiff experts, who may then testify that the scarred, small vagina was caused by the mesh and the implanting surgeon.

Our professional society leadership and volunteer committees, especially from AUGS, have done a tremendous amount of work in assisting with the FDA-required 522 postmarket surveillance study research design; establishing a Pelvic Floor Disorders Registry (http://www.pfdr.org/) and a sling registry; and developing credentialing guidelines for sacrocolpopexy, transvaginal mesh, and slings. They deserve our gratitude and our participation in the registries. It would be a tragedy if all of this work does not lead to fully enrolled and completed 522 studies so that we can scientifically make decisions on products before any more treatment options are removed from the market.

Use video to scrutinize surgical outcomes data. The surgical literature shows extreme variance in outcomes and complications for vaginal mesh surgery, including exposure rates from 1% to 20% with the same mesh products. This only can be explained by depth of surgical dissection and implanting technique. Surgical outcomes have been shown to be related directly to surgical volumes and experience.² I propose that going forward, any authors who publish their study outcomes and complication data on a surgical procedure must submit a surgical video that demonstrates exactly how the surgery was done.

Best serve the patient. We all need to rigorously follow our own surgery results, improve our techniques, and keep within our surgical skill sets. We need to share our outcome and complication data with our patients during the informed consent process, since we, and not the surgical literature, are performing their surgeries.

We need to be transparent and respectful of our colleagues with different skill sets, putting what is best for patients ahead of everything else. We must be mindful of our inherent biases toward surgeries we are personally very good at and comfortable with. We must respect that other surgeons may achieve better clinical outcomes than us with the same surgery. We need to teach each other the best reproducible surgical techniques to maximize outcomes and minimize complications.

We must humbly accept that not every surgeon can do every surgery (and should not try). If a patient would be best served with a surgery we are not skilled in, we must refer that patient to a colleague who is.

Encourage industry’s part in training. As new technologies are developed, we must be brutally honest with ourselves about whether or not we have the skill sets to use them. Industry must gauge the complexity of the surgical skill set necessary to use their products and limit attendance at their teaching labs to surgeons who have the skills required to obtain good outcomes and minimize complications.

We have reached the tipping pointWe have seen the enemy, and it is us. We now need to advocate zealously for our patients. We will succeed only if we keep what is best for our patients at the forefront of everything we do. We must today decide to lead or be led. If we do not lead, we will be led by others—to places that may not best serve our patients. Make no mistake, this is a tipping point. The future of midurethral slings and potential future innovations lie in our hands right now.

Notably, just days prior to Astora’s letter to its physician customers announcing the decision to discontinue all of its operations, the transobturator postanal sling system (TOPAS) for fecal incontinence, a product in the pipeline at Astora, received 3 unanimous 8-0 votes from an FDA device advisory panel on safety, efficacy, and benefit outweighing risk.³ The future of this technology is now uncertain as well.

I ask Endo Pharmaceuticals to reconsider abandoning all of its products and intellectual properties. I ask it to entertain discussions with large companies that want its technologies and intellectual properties and can indemnify it from future litigation. While there never is a guarantee of complete indemnification and the company does have a fiduciary responsibility to its shareholders, industry also has a responsibility to patients and surgeons to allow helpful technologies to persist.

According to Astora’s letter to its physician customers, “Patient health has always been our number one priority. As such, the business closure has been expedited so that you and your patients have the opportunity to assess alternative treatment options as soon as possible.”

That letter was dated February 29. I do not feel that 31 days’ notice is enough time for surgeons to assess—let alone learn and master—new treatment options. It would have been helpful if Endo Pharmaceuticals had given more notice and would at least have allowed other interested companies the option to purchase useful technologies and intellectual property to mitigate its rapid departure from the space. The company remains in the health care arena with its pharmaceutical products, and how it behaves leaving the surgical space will be noted and impact its brand and reputation.

Lessons from the morcellation situationHow quickly the power morcellator disappeared is a lesson to note very carefully, and it has important parallels to what we now face. I highly recommend that you read and study Lisa Rosenbaum’s article in New England Journal of Medicine, “N-of-1 policymaking—tragedy, trade-offs, and the demise of morcellation.”⁴ She eloquently discusses how decisions to terminate technologies based on passionate anecdotal stories and media campaigns, and not scientific study, does not serve the greater good. She explores lessons learned from the silicone breast implant saga as well, stating “the tendency to focus on eliminating an immediate harm while failing to consider potentially greater harms caused by that reaction is heightened by the power of tragic stories.”⁴

We need a calmer, less emotional, and balanced scientific approach to evaluate technologies. We need to consider what harm is done by not allowing new technologies to be adequately studied, improved, and implemented. Dr. Rosenbaum discusses what Cass Sunstein and Timur Kuran call the “availability cascade,” “a phenomenon whereby stories inform public perceptions and anyone challenging those perceptions is vilified.”^4,5

No technology will ever be risk free, and there always will be some risks and complications that could be significant and chilling. However, patient autonomy requires a full discussion of a risk/benefit ratio that is based on science, and these scientific data must be allowed to be collected and learned. There even can be more significant and chilling complications from not using a technology as well.

It is challenging to speak science to emotion that is driven by tragic outcomes, but we can remain compassionate as we seek the science that will serve the greater good. Condemning proponents of carefully studied and properly implemented technologies as immoral is neither helpful nor constructive. Crushing the ability to thoroughly and scientifically study new technologies is not in the best interest of our patients with pelvic floor disorders.

It is time to reawaken the better angels of our natureWill we do the necessary work now no matter how uncomfortable it may make us feel? Or will we be intimidated and remain silent and disjointed? Will we participate in the registries and follow best clinical practice and credentialing guidelines? Will we hold ourselves and our colleagues accountable? It is time to remember why we became surgeons, and to start acting on our convictions.

To that end, we must ask ourselves, will we:

• honor the Hippocratic Oath that we took in medical school and “respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow”⁶
• “not be ashamed to say ‘I know not,’ nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery”⁶
• zealously advocate for our patients to ensure we can offer them the very best therapies
• honor and respect the sacred trust patients place in us when we take them to the operating room
• lead or be led?

This is personal for me. My mother struggled with pelvic floor disorders. I always felt it grossly unfair that women who chose to give us life could suffer for the rest of theirs for that decision. These women deserve our very best. The 40 million women with pelvic floor disorders deserve—and expect—that we lead. Will we?

I am hopeful that we will. I believe we will rise to today’s challenges and protect and fight for our patients. I believe that years from now we will look back and be proud that we did the right thing, and in so doing protected and encouraged innovations that significantly enhanced the quality of our patients’ lives. I believe patients will recognize our genuine efforts and in so doing give our profession the respect and trust that I feel has been diminished.

I believe we will draw the needed courage and resolve from the oath we recited in medical school and remember that, “If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.”⁶

I do believe we will.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

As readers of OBG Management, you are very familiar with the name Janelle Yates. Janelle was an editor and writer for the journal for more than 15 years. Her byline has graced articles on, among other topics, obstetrics, liability, menopause, and tissue extraction. You may recall the 3-part series on endometriosis she authored beginning in April 2015.¹ She worked with several expert surgeons to deliver an in-depth look at diagnosis, treatment, and related infertility. She interviewed presidents of the American Congress of Obstetricians and Gynecologists (ACOG)² and worked with ACOG staff, including Lucia DiVenere, MA, on legislative articles for OBG Management, helping to bring new policies and practice changes to the forefront for readers.^3,4

One topic that was of particular, personal interest to Janelle was breast cancer. She lived on and off with, but always under the shadow of, breast cancer for more than 8 years. This past December, Janelle developed a rare and incurable cancer of the nervous system, which took her life in January.

Janelle’s contributions to OBG Management Janelle worked closely with Robert L. Barbieri, MD, and the OBG Management Board of Editors on writing and editing projects. In fact, Janelle began as Senior Associate Editor with the journal in 2000, only a few months after Dr. Barbieri was inaugurated as Editor in Chief.

“Janelle was exceptionally skillful in polishing a rough manuscript into a superbly crafted article,” says Dr. Barbieri. “The physician authors with whom she collaborated were in awe of her talent and recognized the value of her contributions to advancing women’s health care.”

“Janelle approached the craft of writing like an artist, always searching for an additional layer of deeper meaning and insight. Her strength of character and myriad life experiences gave her unique skills in exploring, questioning, and improving the content that was brought forth.”

“She and I had an ongoing conversation on the pros and cons of being concise,” says Dr. Barbieri. “I would ask her the hypothetical, ‘If an author could effectively deliver his or her core message in a 1-page article, why take 3 pages to do so?’ As a counterpoint, her perspective was that if you could concisely make your point in 3 pages, it might be even better for an author to expand their article to 9 pages to help the reader achieve a deeper level of understanding and insight.”

In May 2013, Barbara S. Levy, MD, after serving for 17 years as an OBG Management Board of Editors member, assumed the position of Vice President for Health Policy at ACOG, and resigned her position on the journal’s editorial board. Janelle collaborated with Dr. Levy on an article commemorating her lifetime of service to women.⁵ Dr. Levy recalls that article, and the numerous others she partnered on with Janelle:

“She was the quintessential professional. We are professional doctors, but Janelle was a professional writer and editor. She had an ability to, when speaking with us, get the best out of us, and take what we said and translate that into a cogent, crisp presentation that was really meaningful to readers. Having her perspective as a partner in writing helped me reach a core in readers that I believe I otherwise would not have been able to reach.”

Andrew M. Kaunitz, MD, Board of Editors member since 2006, describes Janelle as “a wonderful colleague and person.”

“My early perceptions of Janelle,” he says, “relate to her tremendous skills as a medical writer. Over time, however, I recognized that, in addition to her wonderful talents as a writer, she brought what I can only call a sense of grace to each interaction that I had with her. I continue to find it hard to imagine a world without her.”

“During my 15-year excursion as the Editor in Chief of OBG Management,” says Dr. Barbieri, “Janelle was the perfect guide and travel companion. She will always be in my thoughts and heart.”

Janelle’s memory enduresJanelle’s colleagues at the journal office and the Board of Editors honor her dedication to OBG Management, and truly to women’s health in general, in a permanent way in the pages of OBG Management. Janelle’s name has been added to the journal’s staff masthead with the title, “Editor Emeritus.” We feel this is a small but sincere gesture from those of us who have had the immense pleasure and incredible honor to work with Janelle over the years. 

John Baranowski, who served as Editor of OBG Management from 2008 until mid-2012, eloquently states: “As her supervisor for several years, I was the initial recipient of tens of thousands of her well-ordered, well-chosen, and insightful words. At this time, it is hard for me to find words to offer on her behalf. Her outsized skill, her easeful manner, and her certain success at improving the care that physicians provide—those are humbling, silencing remembrances; things of such great value that words just do not work as tribute.”

Dianne Reynolds, Publisher of OBG Management, has known Janelle since 2008 and says that she feels blessed and fortunate to have had Janelle in her life on more than just a professional level. “I will cherish her memory forever,” she says.

OBG Management Managing Editor Deborah Reale joined the journal staff in 2010. “Words connected Janelle and I not only in our editorial work but also personally, through our shared love of poetry,” she says. Unbeknownst to many, Janelle was a published poet. She also wrote two biographies, of Woodie Guthrie and Zora Neale Hurston, while working many years ago as an editor for Ward Hill Press.

Like so many others, I feel privileged to have worked with Janelle. Her work was fearless. Whether it was an audio interview with gynecologic oncologist Eva Chalas, MD, on preserving minimally invasive approaches to gynecologic surgery⁶ or a Q&A article on liability claims in obstetrics,⁷ Janelle did it brilliantly. She applied her years of knowledge and experience to each piece she wrote or edited, always bringing an expert’s best voice forward. In fact, Dianne Reynolds says, “Janelle once told me that she had dreamed of being a doctor, and she imagined herself pushing through hospital doors on her way to treat patients. Instead, Janelle used her acquired medical knowledge in women’s health and writing acumen to assist physicians in explaining their techniques for the benefit of their colleagues.”

Janelle’s siblings Diana and Kent Yates, and her daughter Adrienne Cano, say they have been aware of how supportive the OBG Management extended team has been to Janelle. In speaking with Board of Editors member, Cheryl B. Iglesia, MD, Diana says, “This was such a blessing in her life. It was a rare thing, the kind of relationship she had with all of you. We appreciate so very much your nurturing of her talents and of her as a person.”

Janelle meant a great deal to her colleagues, of course because of her superb work and wise perspective, but also because of her warmth and gentle ease. Simply put, Janelle was a wonderful person to be near.

“She was absolutely amazing and will be greatly missed both personally and professionally,” says 10-year OBG Management board member JoAnn V. Pinkerton, MD.

Dr. Iglesia asserts, “Janelle never will be forgotten. She truly has left a legacy of very important articles for many generations.”

Janelle, we can only hope that with your name on the masthead, readers of OBG Management in future generations will have the privilege of your touch. May that touch bring them the gift of journalistic accuracy, professional integrity, spot-on syntax and, above all, compelling reading. 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

As readers of OBG Management, you are very familiar with the name Janelle Yates. Janelle was an editor and writer for the journal for more than 15 years. Her byline has graced articles on, among other topics, obstetrics, liability, menopause, and tissue extraction. You may recall the 3-part series on endometriosis she authored beginning in April 2015.¹ She worked with several expert surgeons to deliver an in-depth look at diagnosis, treatment, and related infertility. She interviewed presidents of the American Congress of Obstetricians and Gynecologists (ACOG)² and worked with ACOG staff, including Lucia DiVenere, MA, on legislative articles for OBG Management, helping to bring new policies and practice changes to the forefront for readers.^3,4

One topic that was of particular, personal interest to Janelle was breast cancer. She lived on and off with, but always under the shadow of, breast cancer for more than 8 years. This past December, Janelle developed a rare and incurable cancer of the nervous system, which took her life in January.

Janelle’s contributions to OBG Management Janelle worked closely with Robert L. Barbieri, MD, and the OBG Management Board of Editors on writing and editing projects. In fact, Janelle began as Senior Associate Editor with the journal in 2000, only a few months after Dr. Barbieri was inaugurated as Editor in Chief.

“Janelle was exceptionally skillful in polishing a rough manuscript into a superbly crafted article,” says Dr. Barbieri. “The physician authors with whom she collaborated were in awe of her talent and recognized the value of her contributions to advancing women’s health care.”

“Janelle approached the craft of writing like an artist, always searching for an additional layer of deeper meaning and insight. Her strength of character and myriad life experiences gave her unique skills in exploring, questioning, and improving the content that was brought forth.”

“She and I had an ongoing conversation on the pros and cons of being concise,” says Dr. Barbieri. “I would ask her the hypothetical, ‘If an author could effectively deliver his or her core message in a 1-page article, why take 3 pages to do so?’ As a counterpoint, her perspective was that if you could concisely make your point in 3 pages, it might be even better for an author to expand their article to 9 pages to help the reader achieve a deeper level of understanding and insight.”

In May 2013, Barbara S. Levy, MD, after serving for 17 years as an OBG Management Board of Editors member, assumed the position of Vice President for Health Policy at ACOG, and resigned her position on the journal’s editorial board. Janelle collaborated with Dr. Levy on an article commemorating her lifetime of service to women.⁵ Dr. Levy recalls that article, and the numerous others she partnered on with Janelle:

“She was the quintessential professional. We are professional doctors, but Janelle was a professional writer and editor. She had an ability to, when speaking with us, get the best out of us, and take what we said and translate that into a cogent, crisp presentation that was really meaningful to readers. Having her perspective as a partner in writing helped me reach a core in readers that I believe I otherwise would not have been able to reach.”

Andrew M. Kaunitz, MD, Board of Editors member since 2006, describes Janelle as “a wonderful colleague and person.”

“My early perceptions of Janelle,” he says, “relate to her tremendous skills as a medical writer. Over time, however, I recognized that, in addition to her wonderful talents as a writer, she brought what I can only call a sense of grace to each interaction that I had with her. I continue to find it hard to imagine a world without her.”

“During my 15-year excursion as the Editor in Chief of OBG Management,” says Dr. Barbieri, “Janelle was the perfect guide and travel companion. She will always be in my thoughts and heart.”

Janelle’s memory enduresJanelle’s colleagues at the journal office and the Board of Editors honor her dedication to OBG Management, and truly to women’s health in general, in a permanent way in the pages of OBG Management. Janelle’s name has been added to the journal’s staff masthead with the title, “Editor Emeritus.” We feel this is a small but sincere gesture from those of us who have had the immense pleasure and incredible honor to work with Janelle over the years. 

John Baranowski, who served as Editor of OBG Management from 2008 until mid-2012, eloquently states: “As her supervisor for several years, I was the initial recipient of tens of thousands of her well-ordered, well-chosen, and insightful words. At this time, it is hard for me to find words to offer on her behalf. Her outsized skill, her easeful manner, and her certain success at improving the care that physicians provide—those are humbling, silencing remembrances; things of such great value that words just do not work as tribute.”

Dianne Reynolds, Publisher of OBG Management, has known Janelle since 2008 and says that she feels blessed and fortunate to have had Janelle in her life on more than just a professional level. “I will cherish her memory forever,” she says.

OBG Management Managing Editor Deborah Reale joined the journal staff in 2010. “Words connected Janelle and I not only in our editorial work but also personally, through our shared love of poetry,” she says. Unbeknownst to many, Janelle was a published poet. She also wrote two biographies, of Woodie Guthrie and Zora Neale Hurston, while working many years ago as an editor for Ward Hill Press.

Like so many others, I feel privileged to have worked with Janelle. Her work was fearless. Whether it was an audio interview with gynecologic oncologist Eva Chalas, MD, on preserving minimally invasive approaches to gynecologic surgery⁶ or a Q&A article on liability claims in obstetrics,⁷ Janelle did it brilliantly. She applied her years of knowledge and experience to each piece she wrote or edited, always bringing an expert’s best voice forward. In fact, Dianne Reynolds says, “Janelle once told me that she had dreamed of being a doctor, and she imagined herself pushing through hospital doors on her way to treat patients. Instead, Janelle used her acquired medical knowledge in women’s health and writing acumen to assist physicians in explaining their techniques for the benefit of their colleagues.”

Janelle’s siblings Diana and Kent Yates, and her daughter Adrienne Cano, say they have been aware of how supportive the OBG Management extended team has been to Janelle. In speaking with Board of Editors member, Cheryl B. Iglesia, MD, Diana says, “This was such a blessing in her life. It was a rare thing, the kind of relationship she had with all of you. We appreciate so very much your nurturing of her talents and of her as a person.”

Janelle meant a great deal to her colleagues, of course because of her superb work and wise perspective, but also because of her warmth and gentle ease. Simply put, Janelle was a wonderful person to be near.

“She was absolutely amazing and will be greatly missed both personally and professionally,” says 10-year OBG Management board member JoAnn V. Pinkerton, MD.

Dr. Iglesia asserts, “Janelle never will be forgotten. She truly has left a legacy of very important articles for many generations.”

Janelle, we can only hope that with your name on the masthead, readers of OBG Management in future generations will have the privilege of your touch. May that touch bring them the gift of journalistic accuracy, professional integrity, spot-on syntax and, above all, compelling reading. 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

As readers of OBG Management, you are very familiar with the name Janelle Yates. Janelle was an editor and writer for the journal for more than 15 years. Her byline has graced articles on, among other topics, obstetrics, liability, menopause, and tissue extraction. You may recall the 3-part series on endometriosis she authored beginning in April 2015.¹ She worked with several expert surgeons to deliver an in-depth look at diagnosis, treatment, and related infertility. She interviewed presidents of the American Congress of Obstetricians and Gynecologists (ACOG)² and worked with ACOG staff, including Lucia DiVenere, MA, on legislative articles for OBG Management, helping to bring new policies and practice changes to the forefront for readers.^3,4

One topic that was of particular, personal interest to Janelle was breast cancer. She lived on and off with, but always under the shadow of, breast cancer for more than 8 years. This past December, Janelle developed a rare and incurable cancer of the nervous system, which took her life in January.

Janelle’s contributions to OBG Management Janelle worked closely with Robert L. Barbieri, MD, and the OBG Management Board of Editors on writing and editing projects. In fact, Janelle began as Senior Associate Editor with the journal in 2000, only a few months after Dr. Barbieri was inaugurated as Editor in Chief.

“Janelle was exceptionally skillful in polishing a rough manuscript into a superbly crafted article,” says Dr. Barbieri. “The physician authors with whom she collaborated were in awe of her talent and recognized the value of her contributions to advancing women’s health care.”

“Janelle approached the craft of writing like an artist, always searching for an additional layer of deeper meaning and insight. Her strength of character and myriad life experiences gave her unique skills in exploring, questioning, and improving the content that was brought forth.”

“She and I had an ongoing conversation on the pros and cons of being concise,” says Dr. Barbieri. “I would ask her the hypothetical, ‘If an author could effectively deliver his or her core message in a 1-page article, why take 3 pages to do so?’ As a counterpoint, her perspective was that if you could concisely make your point in 3 pages, it might be even better for an author to expand their article to 9 pages to help the reader achieve a deeper level of understanding and insight.”

In May 2013, Barbara S. Levy, MD, after serving for 17 years as an OBG Management Board of Editors member, assumed the position of Vice President for Health Policy at ACOG, and resigned her position on the journal’s editorial board. Janelle collaborated with Dr. Levy on an article commemorating her lifetime of service to women.⁵ Dr. Levy recalls that article, and the numerous others she partnered on with Janelle:

“She was the quintessential professional. We are professional doctors, but Janelle was a professional writer and editor. She had an ability to, when speaking with us, get the best out of us, and take what we said and translate that into a cogent, crisp presentation that was really meaningful to readers. Having her perspective as a partner in writing helped me reach a core in readers that I believe I otherwise would not have been able to reach.”

Andrew M. Kaunitz, MD, Board of Editors member since 2006, describes Janelle as “a wonderful colleague and person.”

“My early perceptions of Janelle,” he says, “relate to her tremendous skills as a medical writer. Over time, however, I recognized that, in addition to her wonderful talents as a writer, she brought what I can only call a sense of grace to each interaction that I had with her. I continue to find it hard to imagine a world without her.”

“During my 15-year excursion as the Editor in Chief of OBG Management,” says Dr. Barbieri, “Janelle was the perfect guide and travel companion. She will always be in my thoughts and heart.”

Janelle’s memory enduresJanelle’s colleagues at the journal office and the Board of Editors honor her dedication to OBG Management, and truly to women’s health in general, in a permanent way in the pages of OBG Management. Janelle’s name has been added to the journal’s staff masthead with the title, “Editor Emeritus.” We feel this is a small but sincere gesture from those of us who have had the immense pleasure and incredible honor to work with Janelle over the years. 

John Baranowski, who served as Editor of OBG Management from 2008 until mid-2012, eloquently states: “As her supervisor for several years, I was the initial recipient of tens of thousands of her well-ordered, well-chosen, and insightful words. At this time, it is hard for me to find words to offer on her behalf. Her outsized skill, her easeful manner, and her certain success at improving the care that physicians provide—those are humbling, silencing remembrances; things of such great value that words just do not work as tribute.”

Dianne Reynolds, Publisher of OBG Management, has known Janelle since 2008 and says that she feels blessed and fortunate to have had Janelle in her life on more than just a professional level. “I will cherish her memory forever,” she says.

OBG Management Managing Editor Deborah Reale joined the journal staff in 2010. “Words connected Janelle and I not only in our editorial work but also personally, through our shared love of poetry,” she says. Unbeknownst to many, Janelle was a published poet. She also wrote two biographies, of Woodie Guthrie and Zora Neale Hurston, while working many years ago as an editor for Ward Hill Press.

Like so many others, I feel privileged to have worked with Janelle. Her work was fearless. Whether it was an audio interview with gynecologic oncologist Eva Chalas, MD, on preserving minimally invasive approaches to gynecologic surgery⁶ or a Q&A article on liability claims in obstetrics,⁷ Janelle did it brilliantly. She applied her years of knowledge and experience to each piece she wrote or edited, always bringing an expert’s best voice forward. In fact, Dianne Reynolds says, “Janelle once told me that she had dreamed of being a doctor, and she imagined herself pushing through hospital doors on her way to treat patients. Instead, Janelle used her acquired medical knowledge in women’s health and writing acumen to assist physicians in explaining their techniques for the benefit of their colleagues.”

Janelle’s siblings Diana and Kent Yates, and her daughter Adrienne Cano, say they have been aware of how supportive the OBG Management extended team has been to Janelle. In speaking with Board of Editors member, Cheryl B. Iglesia, MD, Diana says, “This was such a blessing in her life. It was a rare thing, the kind of relationship she had with all of you. We appreciate so very much your nurturing of her talents and of her as a person.”

Janelle meant a great deal to her colleagues, of course because of her superb work and wise perspective, but also because of her warmth and gentle ease. Simply put, Janelle was a wonderful person to be near.

“She was absolutely amazing and will be greatly missed both personally and professionally,” says 10-year OBG Management board member JoAnn V. Pinkerton, MD.

Dr. Iglesia asserts, “Janelle never will be forgotten. She truly has left a legacy of very important articles for many generations.”

Janelle, we can only hope that with your name on the masthead, readers of OBG Management in future generations will have the privilege of your touch. May that touch bring them the gift of journalistic accuracy, professional integrity, spot-on syntax and, above all, compelling reading. 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“CAN WE SOLVE THE PROBLEM OF INADEQUATE CONTRACEPTION FOR WOMEN AT HIGH RISK FOR ADVERSE PREGNANCY OUTCOMES?”
ROBERT L. BARBIERI, MD (EDITORIAL; FEBRUARY 2016)

“Contraception as a vital sign”
In his recent Editorial Dr. Barbieri asked for ideas to improve contraception counseling for women with medical problems that put them at risk for adverse pregnancy outcomes. His idea of “contraception status as a vital sign” is applied in our very large group practice in Northern California using the electronic health record (EHR).

Over 10 years ago, I attempted to put a hard stop in the EHR to require documentation that women of reproductive age be evaluated for contraception. This scheme seemed to be too cumbersome and was rejected at the time.

The idea was not abandoned, however. Medical assistants must now document a means of contraception for each woman of reproductive age. This does not guarantee that a physician will look at the information, but it is a step in the right direction.

My hope is that someday we will have automatic contraception as a vital sign documentation for all reproductive-age women, including “children” who are documented as menstruating. In the meantime, thank you for highlighting this critical issue.

Tia Will, MD
Sacramento, California

Reduce reimbursement when standard of care is not met
When I read Dr. Barbieri’s Editorial, I was surprised that he avoided the elephant in the room: the current political climate of denying contraception to women, including the defunding of Planned Parenthood and the Supreme Court decision to allow corporations to deny contraceptive coverage for religious issues.

Although I am not currently involved in women’s health, I do work under the auspices of a large Catholic health care system in the United States. Here, all employees are prohibited from providing contraceptive procedures, prescriptions, or even counseling unless it is a Natural Family Planning/ Fertility Awareness Method. These employees also are not provided individual contraceptive health coverage by their employer; this coverage is provided by the federal government thanks to the Affordable Care Act.

Contraception is part of the standard of care for women. However, many women are denied this standard of care due to “religious” reasons, which I suspect may be partially financial and/or political in nature. 

This issue must therefore be addressed by political and financial means. My recommendation is for legislation that mandates lower reimbursement rates for health care systems and providers that refuse to offer full contraceptive options to women. If they do not provide full care, they do not get full payment for services. The money saved by reduced reimbursements could then fund federal women’s health clinics in areas dominated by “religious” health care systems that would guarantee full reproductive health options to all.

Name and practice location withheld

Remove Medicaid barriers to postpartum sterilization
An issue not addressed in Dr. Barbieri’s Editorial is that of women who, after appropriate and extensive counseling by a physician and with a full understanding of the reproductive implications and the possible adverse effect of additional pregnancies on their health and life, decide for permanent contraception. A woman’s opportunity to obtain postpartum or interval contraceptive procedure varies by her insurance coverage, which is indirectly associated with her ethnicity or race.

In 1979, Medicaid Title XIX imposed a 30-day interval between the signing of the sterilization informed consent by the patient and the performance of the procedure. These regulations are still in effect today. What was instituted to protect vulnerable populations from coerced methods in the 1970s represents an anachronistic and archaic approach in the 21st Century. This regulation discriminates against low-income and minority women whose health care is covered by public insurance yet who are frequently at highest risk for unintended and possible risky pregnancy or abortion. In simple words, this imposition violates the standards of justice, beneficence, and nonmaleficence as it treats publicly insured women differently from privately insured women.

The American Medical Association and the American College of Obstetricians and Gynecologists¹ state that this regulation must be revised and charged practitioners to develop policies and procedures to ensure all women who desire postpartum sterilization can receive it. It is incumbent upon all women’s health care physicians to see that this barrier is removed.

Federico G. Mariona, MD, MHSA
Dearborn, Michigan

Reference

Educate the sexual partners of at-risk women
It always strikes me how little emphasis is placed on including the sexual partners of women with serious medical problems in the dialogue about responsibility for at-risk pregnancy. As advocates for women’s health, we should educate the couple about vasectomy and liberally provide referrals. Community outreach to help men understand how they can protect their partner from potentially dangerous unwanted pregnancy is extremely important and not stressed enough. Vasectomy is a quick, safe procedure performed in a physician’s office under local anesthesia. Why should any woman who has already risked her life carrying and delivering a baby be required to bear the contraceptive burden when there is a safe and convenient alternative?

Emily Gubert, MD
East Islip, New York

Dr. Barbieri responds
I thank Drs. Will, Mariona, and Gubert and the anonymous author for their wonderful recommendations on approaches to help improve contraceptive care for women. I agree with Dr. Will that the EHR is a valuable tool to advance contraceptive care. The anonymous author and Dr. Mariona make the critically important point that all women should have access to desired contraception without any barriers based on institutional beliefs or government regulations. The patient’s needs should be prioritized in all medical decision making. I agree with Dr. Gubert that including the male partner in the care process is an important part of effective contraception for women. I enthusiastically agree with her that the best permanent contraceptive for a stable couple is vasectomy.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“CAN WE SOLVE THE PROBLEM OF INADEQUATE CONTRACEPTION FOR WOMEN AT HIGH RISK FOR ADVERSE PREGNANCY OUTCOMES?”
ROBERT L. BARBIERI, MD (EDITORIAL; FEBRUARY 2016)

“Contraception as a vital sign”
In his recent Editorial Dr. Barbieri asked for ideas to improve contraception counseling for women with medical problems that put them at risk for adverse pregnancy outcomes. His idea of “contraception status as a vital sign” is applied in our very large group practice in Northern California using the electronic health record (EHR).

Over 10 years ago, I attempted to put a hard stop in the EHR to require documentation that women of reproductive age be evaluated for contraception. This scheme seemed to be too cumbersome and was rejected at the time.

The idea was not abandoned, however. Medical assistants must now document a means of contraception for each woman of reproductive age. This does not guarantee that a physician will look at the information, but it is a step in the right direction.

My hope is that someday we will have automatic contraception as a vital sign documentation for all reproductive-age women, including “children” who are documented as menstruating. In the meantime, thank you for highlighting this critical issue.

Tia Will, MD
Sacramento, California

Reduce reimbursement when standard of care is not met
When I read Dr. Barbieri’s Editorial, I was surprised that he avoided the elephant in the room: the current political climate of denying contraception to women, including the defunding of Planned Parenthood and the Supreme Court decision to allow corporations to deny contraceptive coverage for religious issues.

Although I am not currently involved in women’s health, I do work under the auspices of a large Catholic health care system in the United States. Here, all employees are prohibited from providing contraceptive procedures, prescriptions, or even counseling unless it is a Natural Family Planning/ Fertility Awareness Method. These employees also are not provided individual contraceptive health coverage by their employer; this coverage is provided by the federal government thanks to the Affordable Care Act.

Contraception is part of the standard of care for women. However, many women are denied this standard of care due to “religious” reasons, which I suspect may be partially financial and/or political in nature. 

This issue must therefore be addressed by political and financial means. My recommendation is for legislation that mandates lower reimbursement rates for health care systems and providers that refuse to offer full contraceptive options to women. If they do not provide full care, they do not get full payment for services. The money saved by reduced reimbursements could then fund federal women’s health clinics in areas dominated by “religious” health care systems that would guarantee full reproductive health options to all.

Name and practice location withheld

Remove Medicaid barriers to postpartum sterilization
An issue not addressed in Dr. Barbieri’s Editorial is that of women who, after appropriate and extensive counseling by a physician and with a full understanding of the reproductive implications and the possible adverse effect of additional pregnancies on their health and life, decide for permanent contraception. A woman’s opportunity to obtain postpartum or interval contraceptive procedure varies by her insurance coverage, which is indirectly associated with her ethnicity or race.

In 1979, Medicaid Title XIX imposed a 30-day interval between the signing of the sterilization informed consent by the patient and the performance of the procedure. These regulations are still in effect today. What was instituted to protect vulnerable populations from coerced methods in the 1970s represents an anachronistic and archaic approach in the 21st Century. This regulation discriminates against low-income and minority women whose health care is covered by public insurance yet who are frequently at highest risk for unintended and possible risky pregnancy or abortion. In simple words, this imposition violates the standards of justice, beneficence, and nonmaleficence as it treats publicly insured women differently from privately insured women.

The American Medical Association and the American College of Obstetricians and Gynecologists¹ state that this regulation must be revised and charged practitioners to develop policies and procedures to ensure all women who desire postpartum sterilization can receive it. It is incumbent upon all women’s health care physicians to see that this barrier is removed.

Federico G. Mariona, MD, MHSA
Dearborn, Michigan

Reference

Educate the sexual partners of at-risk women
It always strikes me how little emphasis is placed on including the sexual partners of women with serious medical problems in the dialogue about responsibility for at-risk pregnancy. As advocates for women’s health, we should educate the couple about vasectomy and liberally provide referrals. Community outreach to help men understand how they can protect their partner from potentially dangerous unwanted pregnancy is extremely important and not stressed enough. Vasectomy is a quick, safe procedure performed in a physician’s office under local anesthesia. Why should any woman who has already risked her life carrying and delivering a baby be required to bear the contraceptive burden when there is a safe and convenient alternative?

Emily Gubert, MD
East Islip, New York

Dr. Barbieri responds
I thank Drs. Will, Mariona, and Gubert and the anonymous author for their wonderful recommendations on approaches to help improve contraceptive care for women. I agree with Dr. Will that the EHR is a valuable tool to advance contraceptive care. The anonymous author and Dr. Mariona make the critically important point that all women should have access to desired contraception without any barriers based on institutional beliefs or government regulations. The patient’s needs should be prioritized in all medical decision making. I agree with Dr. Gubert that including the male partner in the care process is an important part of effective contraception for women. I enthusiastically agree with her that the best permanent contraceptive for a stable couple is vasectomy.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“CAN WE SOLVE THE PROBLEM OF INADEQUATE CONTRACEPTION FOR WOMEN AT HIGH RISK FOR ADVERSE PREGNANCY OUTCOMES?”
ROBERT L. BARBIERI, MD (EDITORIAL; FEBRUARY 2016)

“Contraception as a vital sign”
In his recent Editorial Dr. Barbieri asked for ideas to improve contraception counseling for women with medical problems that put them at risk for adverse pregnancy outcomes. His idea of “contraception status as a vital sign” is applied in our very large group practice in Northern California using the electronic health record (EHR).

Over 10 years ago, I attempted to put a hard stop in the EHR to require documentation that women of reproductive age be evaluated for contraception. This scheme seemed to be too cumbersome and was rejected at the time.

The idea was not abandoned, however. Medical assistants must now document a means of contraception for each woman of reproductive age. This does not guarantee that a physician will look at the information, but it is a step in the right direction.

My hope is that someday we will have automatic contraception as a vital sign documentation for all reproductive-age women, including “children” who are documented as menstruating. In the meantime, thank you for highlighting this critical issue.

Tia Will, MD
Sacramento, California

Reduce reimbursement when standard of care is not met
When I read Dr. Barbieri’s Editorial, I was surprised that he avoided the elephant in the room: the current political climate of denying contraception to women, including the defunding of Planned Parenthood and the Supreme Court decision to allow corporations to deny contraceptive coverage for religious issues.

Although I am not currently involved in women’s health, I do work under the auspices of a large Catholic health care system in the United States. Here, all employees are prohibited from providing contraceptive procedures, prescriptions, or even counseling unless it is a Natural Family Planning/ Fertility Awareness Method. These employees also are not provided individual contraceptive health coverage by their employer; this coverage is provided by the federal government thanks to the Affordable Care Act.

Contraception is part of the standard of care for women. However, many women are denied this standard of care due to “religious” reasons, which I suspect may be partially financial and/or political in nature. 

This issue must therefore be addressed by political and financial means. My recommendation is for legislation that mandates lower reimbursement rates for health care systems and providers that refuse to offer full contraceptive options to women. If they do not provide full care, they do not get full payment for services. The money saved by reduced reimbursements could then fund federal women’s health clinics in areas dominated by “religious” health care systems that would guarantee full reproductive health options to all.

Name and practice location withheld

Remove Medicaid barriers to postpartum sterilization
An issue not addressed in Dr. Barbieri’s Editorial is that of women who, after appropriate and extensive counseling by a physician and with a full understanding of the reproductive implications and the possible adverse effect of additional pregnancies on their health and life, decide for permanent contraception. A woman’s opportunity to obtain postpartum or interval contraceptive procedure varies by her insurance coverage, which is indirectly associated with her ethnicity or race.

In 1979, Medicaid Title XIX imposed a 30-day interval between the signing of the sterilization informed consent by the patient and the performance of the procedure. These regulations are still in effect today. What was instituted to protect vulnerable populations from coerced methods in the 1970s represents an anachronistic and archaic approach in the 21st Century. This regulation discriminates against low-income and minority women whose health care is covered by public insurance yet who are frequently at highest risk for unintended and possible risky pregnancy or abortion. In simple words, this imposition violates the standards of justice, beneficence, and nonmaleficence as it treats publicly insured women differently from privately insured women.

The American Medical Association and the American College of Obstetricians and Gynecologists¹ state that this regulation must be revised and charged practitioners to develop policies and procedures to ensure all women who desire postpartum sterilization can receive it. It is incumbent upon all women’s health care physicians to see that this barrier is removed.

Federico G. Mariona, MD, MHSA
Dearborn, Michigan

Reference

Educate the sexual partners of at-risk women
It always strikes me how little emphasis is placed on including the sexual partners of women with serious medical problems in the dialogue about responsibility for at-risk pregnancy. As advocates for women’s health, we should educate the couple about vasectomy and liberally provide referrals. Community outreach to help men understand how they can protect their partner from potentially dangerous unwanted pregnancy is extremely important and not stressed enough. Vasectomy is a quick, safe procedure performed in a physician’s office under local anesthesia. Why should any woman who has already risked her life carrying and delivering a baby be required to bear the contraceptive burden when there is a safe and convenient alternative?

Emily Gubert, MD
East Islip, New York

Dr. Barbieri responds
I thank Drs. Will, Mariona, and Gubert and the anonymous author for their wonderful recommendations on approaches to help improve contraceptive care for women. I agree with Dr. Will that the EHR is a valuable tool to advance contraceptive care. The anonymous author and Dr. Mariona make the critically important point that all women should have access to desired contraception without any barriers based on institutional beliefs or government regulations. The patient’s needs should be prioritized in all medical decision making. I agree with Dr. Gubert that including the male partner in the care process is an important part of effective contraception for women. I enthusiastically agree with her that the best permanent contraceptive for a stable couple is vasectomy.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Presently it seems that anything a pregnant woman ingests can be correlated with a teratology or an unfortunate neurobehavioral outcome. In an era when up to 15% of pregnant women are taking antidepressant therapy, antidepressants are obvious drugs to be correlated with an untoward fetal outcome, despite the fact that untreated maternal depression itself is significantly worse.1

A recent retrospective secondary end point study by Boukhris and colleagues on antidepressant use in pregnancy and the risk of autism spectrum disorder (ASD) in children is an example of correlation without substantive evidence of causation. Although this study received media attention,² it is a “data-dredge” study. While the authors correctly note that the database is derived from a prospective registry-based population-based cohort study (the Quebec Pregnancy/Children Cohort), their study’s design more closely resembles a post hoc nested case-control study.

Details of the study
Researchers evaluated data from 145,456 singleton full-term infants born alive between January 1, 1998, and December 31, 2009, with antidepressant exposure during pregnancy defined according to trimester and specific antidepressant classes. Children were considered as having autism if they had received at least 1 autism diagnosis between their date of birth and the last date of follow-up.

We perceive several problems in the study’s design and the authors’ conclusions.

Shortcomings of study design
The study results are based on a post hoc analysis. Autism spectrum disorder was not the primary end point of interest in this database. Accordingly, in a secondary end point study, the risk for bias and confounding is substantial. This study design cannot prove causation.^3–5

Exposure is defined by number of antidepressant prescriptions filled. No data regarding adherence (true exposure) are provided. Many women will not take antidepressant drugs as prescribed during pregnancy. It has been reported that antidepressants dispensed to pregnant women during the last 2 trimesters of pregnancy were taken by only 55% of the women.⁶

The specific antidepressant agents and dosages used were not identified, and the study provided no good sense of duration of use. Is it biologically plausible, therefore, to suggest that all antidepressants—with their disparate structures and mechanisms, in all doses, and for various durations of use—have a uniform effect on fetal neurodevelopment?

Notably, in another prescription drug study of 668,468 pregnancies in 2013, investigators found no significant association between prenatal exposure to antidepressants and ASD.⁷

Some data suggest that ASD and depression may share preexisting risk factors.⁸ The increased risk for ASD proposed by Boukhris and colleagues’ study cannot likely be separated from the well-described genetic risk of ASD that might be shared with that of depression.^9,10

The stated hazard ratios (HRs) are all <2.2. Given this study’s design, it is plausible that various biases and confounders account for these findings. True significance of these HRs are suspect unless they exceed 3.0, and there is a greater probability of avoiding a type I error when the risk ratios are greater than 4 to 5.^3,4

What this evidence means for practice
In this registry-based study of an ongoing population-based cohort, the authors suggest a sensational 87% increased risk of ASD with use of antidepressants during pregnancy. While technically correct, the absolute risk (if real) is really less than 1%. Using sound epidemiologic principles, we would advise against speculating on a number needed to harm based on this study design. Such a projection would require a prospective randomized trial.
—Robert P. Kauffman, MD; Teresa Baker, MD; and Thomas W. Hale, PhD

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Presently it seems that anything a pregnant woman ingests can be correlated with a teratology or an unfortunate neurobehavioral outcome. In an era when up to 15% of pregnant women are taking antidepressant therapy, antidepressants are obvious drugs to be correlated with an untoward fetal outcome, despite the fact that untreated maternal depression itself is significantly worse.1

A recent retrospective secondary end point study by Boukhris and colleagues on antidepressant use in pregnancy and the risk of autism spectrum disorder (ASD) in children is an example of correlation without substantive evidence of causation. Although this study received media attention,² it is a “data-dredge” study. While the authors correctly note that the database is derived from a prospective registry-based population-based cohort study (the Quebec Pregnancy/Children Cohort), their study’s design more closely resembles a post hoc nested case-control study.

Details of the study
Researchers evaluated data from 145,456 singleton full-term infants born alive between January 1, 1998, and December 31, 2009, with antidepressant exposure during pregnancy defined according to trimester and specific antidepressant classes. Children were considered as having autism if they had received at least 1 autism diagnosis between their date of birth and the last date of follow-up.

We perceive several problems in the study’s design and the authors’ conclusions.

Shortcomings of study design
The study results are based on a post hoc analysis. Autism spectrum disorder was not the primary end point of interest in this database. Accordingly, in a secondary end point study, the risk for bias and confounding is substantial. This study design cannot prove causation.^3–5

Exposure is defined by number of antidepressant prescriptions filled. No data regarding adherence (true exposure) are provided. Many women will not take antidepressant drugs as prescribed during pregnancy. It has been reported that antidepressants dispensed to pregnant women during the last 2 trimesters of pregnancy were taken by only 55% of the women.⁶

The specific antidepressant agents and dosages used were not identified, and the study provided no good sense of duration of use. Is it biologically plausible, therefore, to suggest that all antidepressants—with their disparate structures and mechanisms, in all doses, and for various durations of use—have a uniform effect on fetal neurodevelopment?

Notably, in another prescription drug study of 668,468 pregnancies in 2013, investigators found no significant association between prenatal exposure to antidepressants and ASD.⁷

Some data suggest that ASD and depression may share preexisting risk factors.⁸ The increased risk for ASD proposed by Boukhris and colleagues’ study cannot likely be separated from the well-described genetic risk of ASD that might be shared with that of depression.^9,10

The stated hazard ratios (HRs) are all <2.2. Given this study’s design, it is plausible that various biases and confounders account for these findings. True significance of these HRs are suspect unless they exceed 3.0, and there is a greater probability of avoiding a type I error when the risk ratios are greater than 4 to 5.^3,4

What this evidence means for practice
In this registry-based study of an ongoing population-based cohort, the authors suggest a sensational 87% increased risk of ASD with use of antidepressants during pregnancy. While technically correct, the absolute risk (if real) is really less than 1%. Using sound epidemiologic principles, we would advise against speculating on a number needed to harm based on this study design. Such a projection would require a prospective randomized trial.
—Robert P. Kauffman, MD; Teresa Baker, MD; and Thomas W. Hale, PhD

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Presently it seems that anything a pregnant woman ingests can be correlated with a teratology or an unfortunate neurobehavioral outcome. In an era when up to 15% of pregnant women are taking antidepressant therapy, antidepressants are obvious drugs to be correlated with an untoward fetal outcome, despite the fact that untreated maternal depression itself is significantly worse.1

A recent retrospective secondary end point study by Boukhris and colleagues on antidepressant use in pregnancy and the risk of autism spectrum disorder (ASD) in children is an example of correlation without substantive evidence of causation. Although this study received media attention,² it is a “data-dredge” study. While the authors correctly note that the database is derived from a prospective registry-based population-based cohort study (the Quebec Pregnancy/Children Cohort), their study’s design more closely resembles a post hoc nested case-control study.

Details of the study
Researchers evaluated data from 145,456 singleton full-term infants born alive between January 1, 1998, and December 31, 2009, with antidepressant exposure during pregnancy defined according to trimester and specific antidepressant classes. Children were considered as having autism if they had received at least 1 autism diagnosis between their date of birth and the last date of follow-up.

We perceive several problems in the study’s design and the authors’ conclusions.

Shortcomings of study design
The study results are based on a post hoc analysis. Autism spectrum disorder was not the primary end point of interest in this database. Accordingly, in a secondary end point study, the risk for bias and confounding is substantial. This study design cannot prove causation.^3–5

Exposure is defined by number of antidepressant prescriptions filled. No data regarding adherence (true exposure) are provided. Many women will not take antidepressant drugs as prescribed during pregnancy. It has been reported that antidepressants dispensed to pregnant women during the last 2 trimesters of pregnancy were taken by only 55% of the women.⁶

The specific antidepressant agents and dosages used were not identified, and the study provided no good sense of duration of use. Is it biologically plausible, therefore, to suggest that all antidepressants—with their disparate structures and mechanisms, in all doses, and for various durations of use—have a uniform effect on fetal neurodevelopment?

Notably, in another prescription drug study of 668,468 pregnancies in 2013, investigators found no significant association between prenatal exposure to antidepressants and ASD.⁷

Some data suggest that ASD and depression may share preexisting risk factors.⁸ The increased risk for ASD proposed by Boukhris and colleagues’ study cannot likely be separated from the well-described genetic risk of ASD that might be shared with that of depression.^9,10

The stated hazard ratios (HRs) are all <2.2. Given this study’s design, it is plausible that various biases and confounders account for these findings. True significance of these HRs are suspect unless they exceed 3.0, and there is a greater probability of avoiding a type I error when the risk ratios are greater than 4 to 5.^3,4

What this evidence means for practice
In this registry-based study of an ongoing population-based cohort, the authors suggest a sensational 87% increased risk of ASD with use of antidepressants during pregnancy. While technically correct, the absolute risk (if real) is really less than 1%. Using sound epidemiologic principles, we would advise against speculating on a number needed to harm based on this study design. Such a projection would require a prospective randomized trial.
—Robert P. Kauffman, MD; Teresa Baker, MD; and Thomas W. Hale, PhD

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.

STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.

These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.

He reported having no financial conflicts regarding this National Institutes of Health–funded study.

bjancin@frontlinemedcom.com

CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.

STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.

These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.

He reported having no financial conflicts regarding this National Institutes of Health–funded study.

bjancin@frontlinemedcom.com

CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.

STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.

These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.

He reported having no financial conflicts regarding this National Institutes of Health–funded study.

bjancin@frontlinemedcom.com

CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.

STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.

These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.

He reported having no financial conflicts regarding this National Institutes of Health–funded study.

bjancin@frontlinemedcom.com

CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.

STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.

These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.

He reported having no financial conflicts regarding this National Institutes of Health–funded study.

bjancin@frontlinemedcom.com

CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.

STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.

These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.

He reported having no financial conflicts regarding this National Institutes of Health–funded study.

bjancin@frontlinemedcom.com

CHICAGO – A new American College of Cardiology expert consensus decision pathway for the use of nonstatin therapies to lower cholesterol in high-risk patients addresses situations not covered by an evidence-based 2013 guideline on managing atherosclerotic cardiovascular disease risk.

Like the 2013 guideline (the 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease Risk in Adults), the new guidance emphasizes the importance of a healthy lifestyle, but also addresses the use of two monoclonal antibodies–proprotein convertase subtilisin/kexon 9 (PCSK9) inhibitors–approved for certain patient groups since the 2013 guideline was released, as well as other nonstatin therapies, including ezetimibe and bile acid sequestrants.

“At the time [the 2013 guideline was published] the only really good outcomes data ... were for statin medication and there were no data from clinical trials that showed additional benefit of medications over and above being on the maximally tolerated dose of a statin,” according to Dr. Donald M. Lloyd-Jones, a professor at Northwestern University, Chicago and chair of the writing committee for the new guidance. “However, since 2013, a number of trials have been published that actually move the field forward in our understanding of which patients might benefit from adding non statin therapy on top of effective statin therapy.”

The guidance was developed to address gaps in care until the guidelines can be updated, which will likely take a few years.

Based on findings from recent studies, including the IMPROVE IT trial, which examined ezetimibe as statin add-on therapy after acute coronary syndromes, the HPS2-THRIVE study, which examined use of niacin in high-risk patients, and short-term outcomes studies of PCSK9 inhibitors, which have been shown to dramatically reduce low-density lipoprotein cholesterol levels beyond the lowering provided by statin therapy, the committee developed algorithms for the four main high-risk statin benefit patient groups:

•Adults aged 21 years and older with clinical atherosclerotic cardiovascular disease (ASCVD), on statin for secondary prevention.

•Adults aged 21 years and older with LDL-C greater than or equal to 190 mg/dL not due to secondary modifiable causes, on statin for primary prevention.

•Adults aged 40-75 years without ASCVD but with diabetes and LDL-C of 70-189 mg/dL, on statin for primary prevention.

•Adults aged 40-75 years without clinical ASCVD or diabetes, with LDL-C of 70-189 mg/dL and an estimated 10-year risk for ASCVD of at least 7.5%, on statin for primary prevention.

The guidance suggests a number of steps to take with patients who fail to achieve treatment goals (such as addressing treatment adherence, intensifying lifestyle modifications, using a high-intensity stain, and evaluating for statin intolerance), and lists “clinician-patient discussion factors” to consider for each of a number of patient scenarios (including the potential benefits and risks associated with nonstatin therapies, as well as patient preferences).

Included for each of the patient scenarios is an algorithm for which nonstatin therapies to use in which order, building on the “rock-solid confidence” that for the four statin benefit groups, statins remain the starting point, Dr. Lloyd-Jones said. He discussed the guidance in a video interview.

In general, ezetimibe for those patients who are not achieving the types of reduction in LDL or the amount of risk reduction desired, “should probably be the first choice,” he said.

Bile acid sequestrants can be considered in those who are ezetimibe intolerant and who have triglycerides less than 300 mg/dL.

PCSK9 inhibitors are suggested for consideration only in very high-risk patients with ASCVD or with the familial hypercholesterolemia phenotype who are still not achieving the goal (ideally, a 50% reduction in LDL cholesterol), he said.

The committee did not recommend use of niacin, stating that there is no clear indication for the routine use of niacin preparations as additional nonstatin therapies due to an unfavorable risk-benefit profile.

Additionally, PCSK9 inhibitors are not recommended in any primary prevention scenarios, he noted.

Dr. Neil J. Stone, chair of the 2013 guideline writing committee, said the new guidance provides a useful tool for clinicians, extending, in a practical way, the current guideline as the field awaits the long-term outcomes data for PCSK9 inhibitors.

Despite some backlash in the wake of the 2013 guideline, which marked a move away from specific cholesterol treatment targets to a cardiovascular disease risk-based approach, the cardiovascular risk calculation formula introduced in that guideline has been shown to be useful and accurate, said Dr. Stone, also of Northwestern University.

“[The new guidance] is simply an amplification and extension of the guideline,” he said, adding that “it’s about a risk discussion, not automatic treatment.”

Dr. Lloyd-Jones and Dr. Stone each reported having no disclosures.

sworcester@frontlinemedcom.com

CHICAGO – A new American College of Cardiology expert consensus decision pathway for the use of nonstatin therapies to lower cholesterol in high-risk patients addresses situations not covered by an evidence-based 2013 guideline on managing atherosclerotic cardiovascular disease risk.

Like the 2013 guideline (the 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease Risk in Adults), the new guidance emphasizes the importance of a healthy lifestyle, but also addresses the use of two monoclonal antibodies–proprotein convertase subtilisin/kexon 9 (PCSK9) inhibitors–approved for certain patient groups since the 2013 guideline was released, as well as other nonstatin therapies, including ezetimibe and bile acid sequestrants.

“At the time [the 2013 guideline was published] the only really good outcomes data ... were for statin medication and there were no data from clinical trials that showed additional benefit of medications over and above being on the maximally tolerated dose of a statin,” according to Dr. Donald M. Lloyd-Jones, a professor at Northwestern University, Chicago and chair of the writing committee for the new guidance. “However, since 2013, a number of trials have been published that actually move the field forward in our understanding of which patients might benefit from adding non statin therapy on top of effective statin therapy.”

The guidance was developed to address gaps in care until the guidelines can be updated, which will likely take a few years.

Based on findings from recent studies, including the IMPROVE IT trial, which examined ezetimibe as statin add-on therapy after acute coronary syndromes, the HPS2-THRIVE study, which examined use of niacin in high-risk patients, and short-term outcomes studies of PCSK9 inhibitors, which have been shown to dramatically reduce low-density lipoprotein cholesterol levels beyond the lowering provided by statin therapy, the committee developed algorithms for the four main high-risk statin benefit patient groups:

•Adults aged 21 years and older with clinical atherosclerotic cardiovascular disease (ASCVD), on statin for secondary prevention.

•Adults aged 21 years and older with LDL-C greater than or equal to 190 mg/dL not due to secondary modifiable causes, on statin for primary prevention.

•Adults aged 40-75 years without ASCVD but with diabetes and LDL-C of 70-189 mg/dL, on statin for primary prevention.

•Adults aged 40-75 years without clinical ASCVD or diabetes, with LDL-C of 70-189 mg/dL and an estimated 10-year risk for ASCVD of at least 7.5%, on statin for primary prevention.

The guidance suggests a number of steps to take with patients who fail to achieve treatment goals (such as addressing treatment adherence, intensifying lifestyle modifications, using a high-intensity stain, and evaluating for statin intolerance), and lists “clinician-patient discussion factors” to consider for each of a number of patient scenarios (including the potential benefits and risks associated with nonstatin therapies, as well as patient preferences).

Included for each of the patient scenarios is an algorithm for which nonstatin therapies to use in which order, building on the “rock-solid confidence” that for the four statin benefit groups, statins remain the starting point, Dr. Lloyd-Jones said. He discussed the guidance in a video interview.

In general, ezetimibe for those patients who are not achieving the types of reduction in LDL or the amount of risk reduction desired, “should probably be the first choice,” he said.

Bile acid sequestrants can be considered in those who are ezetimibe intolerant and who have triglycerides less than 300 mg/dL.

PCSK9 inhibitors are suggested for consideration only in very high-risk patients with ASCVD or with the familial hypercholesterolemia phenotype who are still not achieving the goal (ideally, a 50% reduction in LDL cholesterol), he said.

The committee did not recommend use of niacin, stating that there is no clear indication for the routine use of niacin preparations as additional nonstatin therapies due to an unfavorable risk-benefit profile.

Additionally, PCSK9 inhibitors are not recommended in any primary prevention scenarios, he noted.

Dr. Neil J. Stone, chair of the 2013 guideline writing committee, said the new guidance provides a useful tool for clinicians, extending, in a practical way, the current guideline as the field awaits the long-term outcomes data for PCSK9 inhibitors.

Despite some backlash in the wake of the 2013 guideline, which marked a move away from specific cholesterol treatment targets to a cardiovascular disease risk-based approach, the cardiovascular risk calculation formula introduced in that guideline has been shown to be useful and accurate, said Dr. Stone, also of Northwestern University.

“[The new guidance] is simply an amplification and extension of the guideline,” he said, adding that “it’s about a risk discussion, not automatic treatment.”

Dr. Lloyd-Jones and Dr. Stone each reported having no disclosures.

sworcester@frontlinemedcom.com

CHICAGO – A new American College of Cardiology expert consensus decision pathway for the use of nonstatin therapies to lower cholesterol in high-risk patients addresses situations not covered by an evidence-based 2013 guideline on managing atherosclerotic cardiovascular disease risk.

Like the 2013 guideline (the 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease Risk in Adults), the new guidance emphasizes the importance of a healthy lifestyle, but also addresses the use of two monoclonal antibodies–proprotein convertase subtilisin/kexon 9 (PCSK9) inhibitors–approved for certain patient groups since the 2013 guideline was released, as well as other nonstatin therapies, including ezetimibe and bile acid sequestrants.

“At the time [the 2013 guideline was published] the only really good outcomes data ... were for statin medication and there were no data from clinical trials that showed additional benefit of medications over and above being on the maximally tolerated dose of a statin,” according to Dr. Donald M. Lloyd-Jones, a professor at Northwestern University, Chicago and chair of the writing committee for the new guidance. “However, since 2013, a number of trials have been published that actually move the field forward in our understanding of which patients might benefit from adding non statin therapy on top of effective statin therapy.”

The guidance was developed to address gaps in care until the guidelines can be updated, which will likely take a few years.

Based on findings from recent studies, including the IMPROVE IT trial, which examined ezetimibe as statin add-on therapy after acute coronary syndromes, the HPS2-THRIVE study, which examined use of niacin in high-risk patients, and short-term outcomes studies of PCSK9 inhibitors, which have been shown to dramatically reduce low-density lipoprotein cholesterol levels beyond the lowering provided by statin therapy, the committee developed algorithms for the four main high-risk statin benefit patient groups:

•Adults aged 21 years and older with clinical atherosclerotic cardiovascular disease (ASCVD), on statin for secondary prevention.

•Adults aged 21 years and older with LDL-C greater than or equal to 190 mg/dL not due to secondary modifiable causes, on statin for primary prevention.

•Adults aged 40-75 years without ASCVD but with diabetes and LDL-C of 70-189 mg/dL, on statin for primary prevention.

•Adults aged 40-75 years without clinical ASCVD or diabetes, with LDL-C of 70-189 mg/dL and an estimated 10-year risk for ASCVD of at least 7.5%, on statin for primary prevention.

The guidance suggests a number of steps to take with patients who fail to achieve treatment goals (such as addressing treatment adherence, intensifying lifestyle modifications, using a high-intensity stain, and evaluating for statin intolerance), and lists “clinician-patient discussion factors” to consider for each of a number of patient scenarios (including the potential benefits and risks associated with nonstatin therapies, as well as patient preferences).

Included for each of the patient scenarios is an algorithm for which nonstatin therapies to use in which order, building on the “rock-solid confidence” that for the four statin benefit groups, statins remain the starting point, Dr. Lloyd-Jones said. He discussed the guidance in a video interview.

In general, ezetimibe for those patients who are not achieving the types of reduction in LDL or the amount of risk reduction desired, “should probably be the first choice,” he said.

Bile acid sequestrants can be considered in those who are ezetimibe intolerant and who have triglycerides less than 300 mg/dL.

PCSK9 inhibitors are suggested for consideration only in very high-risk patients with ASCVD or with the familial hypercholesterolemia phenotype who are still not achieving the goal (ideally, a 50% reduction in LDL cholesterol), he said.

The committee did not recommend use of niacin, stating that there is no clear indication for the routine use of niacin preparations as additional nonstatin therapies due to an unfavorable risk-benefit profile.

Additionally, PCSK9 inhibitors are not recommended in any primary prevention scenarios, he noted.

Dr. Neil J. Stone, chair of the 2013 guideline writing committee, said the new guidance provides a useful tool for clinicians, extending, in a practical way, the current guideline as the field awaits the long-term outcomes data for PCSK9 inhibitors.

Despite some backlash in the wake of the 2013 guideline, which marked a move away from specific cholesterol treatment targets to a cardiovascular disease risk-based approach, the cardiovascular risk calculation formula introduced in that guideline has been shown to be useful and accurate, said Dr. Stone, also of Northwestern University.

“[The new guidance] is simply an amplification and extension of the guideline,” he said, adding that “it’s about a risk discussion, not automatic treatment.”

Dr. Lloyd-Jones and Dr. Stone each reported having no disclosures.

sworcester@frontlinemedcom.com

Mona Hanna-Attisha, MD, MPH, the director of the pediatric residency program at Hurley Children’s Hospital and an assistant professor of pediatrics at Michigan State University, has been instrumental in the fight for clean and safe water for residents in Flint, Mich.

Dr. Hanna-Attisha has been a fundamental co-site leader with the SHM I-PASS mentored implementation program and minimized her role in the program as she became the unofficial spokesperson for the Flint water crisis. In January 2016, Dr. Hanna-Attisha took on the lead role for the Pediatric Public Health Initiative with Michigan State University and Hurley Children’s Hospital.

Dr. Hanna-Attisha is a Michigan native and completed her undergraduate degree at the University of Michigan in Ann Arbor. She completed medical school at Michigan State University College of Human Medicine, completed her residency and chief residency at the Children’s Hospital of Michigan, and earned her master’s degree at the University of Michigan School of Public Health.

Dr. Hanna-Attisha’s training and experience has focused heavily on environmental toxins and health disparities, so it’s no surprise that she is deeply involved with addressing the public health emergency in Flint as well as taking measures to ensure continued research and action regarding the impact the contaminated water had on the residents of Flint. Dr. Hanna-Attisha is working with a team of experts to develop evidence-based interventions that will aid in improving the health and development of children and families affected by Flint’s contaminated water. She is educating families on nutrition and diets high in iron, calcium, and vitamin C in order to help manage the effects of contamination.

A report from a Virginia Tech Research Team ignited the investigation into Flint’s water issues and also fueled Dr. Hanna-Attisha’s investigation into the blood-lead levels in the children of Flint. It has been close to two years that the residents of Flint have been exposed to severely toxic levels of lead from the city’s tap water, and Dr. Hanna-Attisha’s analysis of children’s blood-lead levels has been highlighted and published in numerous publications, including the American Journal of Public Health.

The water crisis in Flint hits close to home for Dr. Hanna-Attisha, and the dedication she has to her local community is astounding. It shows in the work she has been doing in her new role with the Pediatric Public Health Initiative.

SHM is proud of all the outstanding work she is doing and appreciates her contributions to the SHM I-PASS program. To keep up to date with Dr. Hanna-Attisha, follow her on Twitter @MonaHannaA.

Mobola Owolabi is senior project manager in SHM’s Center for Hospital Innovation and Improvement.

Mona Hanna-Attisha, MD, MPH, the director of the pediatric residency program at Hurley Children’s Hospital and an assistant professor of pediatrics at Michigan State University, has been instrumental in the fight for clean and safe water for residents in Flint, Mich.

Dr. Hanna-Attisha has been a fundamental co-site leader with the SHM I-PASS mentored implementation program and minimized her role in the program as she became the unofficial spokesperson for the Flint water crisis. In January 2016, Dr. Hanna-Attisha took on the lead role for the Pediatric Public Health Initiative with Michigan State University and Hurley Children’s Hospital.

Dr. Hanna-Attisha is a Michigan native and completed her undergraduate degree at the University of Michigan in Ann Arbor. She completed medical school at Michigan State University College of Human Medicine, completed her residency and chief residency at the Children’s Hospital of Michigan, and earned her master’s degree at the University of Michigan School of Public Health.

Dr. Hanna-Attisha’s training and experience has focused heavily on environmental toxins and health disparities, so it’s no surprise that she is deeply involved with addressing the public health emergency in Flint as well as taking measures to ensure continued research and action regarding the impact the contaminated water had on the residents of Flint. Dr. Hanna-Attisha is working with a team of experts to develop evidence-based interventions that will aid in improving the health and development of children and families affected by Flint’s contaminated water. She is educating families on nutrition and diets high in iron, calcium, and vitamin C in order to help manage the effects of contamination.

A report from a Virginia Tech Research Team ignited the investigation into Flint’s water issues and also fueled Dr. Hanna-Attisha’s investigation into the blood-lead levels in the children of Flint. It has been close to two years that the residents of Flint have been exposed to severely toxic levels of lead from the city’s tap water, and Dr. Hanna-Attisha’s analysis of children’s blood-lead levels has been highlighted and published in numerous publications, including the American Journal of Public Health.

The water crisis in Flint hits close to home for Dr. Hanna-Attisha, and the dedication she has to her local community is astounding. It shows in the work she has been doing in her new role with the Pediatric Public Health Initiative.

SHM is proud of all the outstanding work she is doing and appreciates her contributions to the SHM I-PASS program. To keep up to date with Dr. Hanna-Attisha, follow her on Twitter @MonaHannaA.

Mobola Owolabi is senior project manager in SHM’s Center for Hospital Innovation and Improvement.

Mona Hanna-Attisha, MD, MPH, the director of the pediatric residency program at Hurley Children’s Hospital and an assistant professor of pediatrics at Michigan State University, has been instrumental in the fight for clean and safe water for residents in Flint, Mich.

Dr. Hanna-Attisha has been a fundamental co-site leader with the SHM I-PASS mentored implementation program and minimized her role in the program as she became the unofficial spokesperson for the Flint water crisis. In January 2016, Dr. Hanna-Attisha took on the lead role for the Pediatric Public Health Initiative with Michigan State University and Hurley Children’s Hospital.

Dr. Hanna-Attisha is a Michigan native and completed her undergraduate degree at the University of Michigan in Ann Arbor. She completed medical school at Michigan State University College of Human Medicine, completed her residency and chief residency at the Children’s Hospital of Michigan, and earned her master’s degree at the University of Michigan School of Public Health.

Dr. Hanna-Attisha’s training and experience has focused heavily on environmental toxins and health disparities, so it’s no surprise that she is deeply involved with addressing the public health emergency in Flint as well as taking measures to ensure continued research and action regarding the impact the contaminated water had on the residents of Flint. Dr. Hanna-Attisha is working with a team of experts to develop evidence-based interventions that will aid in improving the health and development of children and families affected by Flint’s contaminated water. She is educating families on nutrition and diets high in iron, calcium, and vitamin C in order to help manage the effects of contamination.

A report from a Virginia Tech Research Team ignited the investigation into Flint’s water issues and also fueled Dr. Hanna-Attisha’s investigation into the blood-lead levels in the children of Flint. It has been close to two years that the residents of Flint have been exposed to severely toxic levels of lead from the city’s tap water, and Dr. Hanna-Attisha’s analysis of children’s blood-lead levels has been highlighted and published in numerous publications, including the American Journal of Public Health.

The water crisis in Flint hits close to home for Dr. Hanna-Attisha, and the dedication she has to her local community is astounding. It shows in the work she has been doing in her new role with the Pediatric Public Health Initiative.

SHM is proud of all the outstanding work she is doing and appreciates her contributions to the SHM I-PASS program. To keep up to date with Dr. Hanna-Attisha, follow her on Twitter @MonaHannaA.

Mobola Owolabi is senior project manager in SHM’s Center for Hospital Innovation and Improvement.