Commentary

No matter how hard we try to run on-schedule, most patients usually experience some down time in our waiting rooms. So, in the honored tradition of our ancestors, we supply magazines to read.

These days – the era of iPads – many bring their own reading material, but a good percentage still don’t and leaf through the glossies out there.

I try not to subject them to much. You won’t see drug rep pamphlets in my lobby. I get a free subscription to a celebrity gossip rag (thanks, pharma), but it goes straight to recycling on arrival. Many of my patients are seriously ill, and the last thing I want to do is have them read about people who think the worst thing in the world is to have make-up with the wrong foundation color. If professional celebrities want to see real problems, they can hang out at my office, or (better yet) an oncologist’s.

So what do I put out? I get a local parenting magazine, and my mother’s friend donates recent issues of Sunset and Good Housekeeping (thanks, Nancy). People are okay with them.

My dad once got me a big coffee table book about the history of medicine. He found it at a garage sale for 25 cents. On a whim, I put it out, and it’s been surprisingly popular. I even have a patient who makes a note of where he left off when called back, so that he can resume at his next visit.

Six months ago, while straightening up a home bookcase, I found a few "Far Side" collections, and put them out in my lobby. They quickly passed the magazines in popularity, and cemented my already solid reputation as an eccentric.

I don’t know how many other doctors have done this. I’ve heard there’s a doc on the west side of town who only has the complete P.G. Wodehouse "Bertie & Jeeves" series in his lobby. I think that would be perfectly fine, too, but takes longer to read, and I try to minimize waiting room time.

One of my strangest discoveries about private practice is that my most popular lobby magazines aren’t magazines at all. And I found them on my own bookshelf.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

No matter how hard we try to run on-schedule, most patients usually experience some down time in our waiting rooms. So, in the honored tradition of our ancestors, we supply magazines to read.

These days – the era of iPads – many bring their own reading material, but a good percentage still don’t and leaf through the glossies out there.

I try not to subject them to much. You won’t see drug rep pamphlets in my lobby. I get a free subscription to a celebrity gossip rag (thanks, pharma), but it goes straight to recycling on arrival. Many of my patients are seriously ill, and the last thing I want to do is have them read about people who think the worst thing in the world is to have make-up with the wrong foundation color. If professional celebrities want to see real problems, they can hang out at my office, or (better yet) an oncologist’s.

So what do I put out? I get a local parenting magazine, and my mother’s friend donates recent issues of Sunset and Good Housekeeping (thanks, Nancy). People are okay with them.

My dad once got me a big coffee table book about the history of medicine. He found it at a garage sale for 25 cents. On a whim, I put it out, and it’s been surprisingly popular. I even have a patient who makes a note of where he left off when called back, so that he can resume at his next visit.

Six months ago, while straightening up a home bookcase, I found a few "Far Side" collections, and put them out in my lobby. They quickly passed the magazines in popularity, and cemented my already solid reputation as an eccentric.

I don’t know how many other doctors have done this. I’ve heard there’s a doc on the west side of town who only has the complete P.G. Wodehouse "Bertie & Jeeves" series in his lobby. I think that would be perfectly fine, too, but takes longer to read, and I try to minimize waiting room time.

One of my strangest discoveries about private practice is that my most popular lobby magazines aren’t magazines at all. And I found them on my own bookshelf.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

No matter how hard we try to run on-schedule, most patients usually experience some down time in our waiting rooms. So, in the honored tradition of our ancestors, we supply magazines to read.

These days – the era of iPads – many bring their own reading material, but a good percentage still don’t and leaf through the glossies out there.

I try not to subject them to much. You won’t see drug rep pamphlets in my lobby. I get a free subscription to a celebrity gossip rag (thanks, pharma), but it goes straight to recycling on arrival. Many of my patients are seriously ill, and the last thing I want to do is have them read about people who think the worst thing in the world is to have make-up with the wrong foundation color. If professional celebrities want to see real problems, they can hang out at my office, or (better yet) an oncologist’s.

So what do I put out? I get a local parenting magazine, and my mother’s friend donates recent issues of Sunset and Good Housekeeping (thanks, Nancy). People are okay with them.

My dad once got me a big coffee table book about the history of medicine. He found it at a garage sale for 25 cents. On a whim, I put it out, and it’s been surprisingly popular. I even have a patient who makes a note of where he left off when called back, so that he can resume at his next visit.

Six months ago, while straightening up a home bookcase, I found a few "Far Side" collections, and put them out in my lobby. They quickly passed the magazines in popularity, and cemented my already solid reputation as an eccentric.

I don’t know how many other doctors have done this. I’ve heard there’s a doc on the west side of town who only has the complete P.G. Wodehouse "Bertie & Jeeves" series in his lobby. I think that would be perfectly fine, too, but takes longer to read, and I try to minimize waiting room time.

One of my strangest discoveries about private practice is that my most popular lobby magazines aren’t magazines at all. And I found them on my own bookshelf.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Question: Which of the following statements regarding medical peer review is best?

A) The purpose is to evaluate quality of patient care and monitor physician performance.

B) A physician under peer review must be accorded due process, which at a minimum includes notice and opportunity to be heard.

C) Proceedings are confidential and nondiscoverable.

D) Medical peer review has been criticized for being biased, inconsistent, and lacking transparency.

E) All are correct.

Answer: E. Medical peer review, a requirement of the Joint Commission, has been called the cornerstone of quality assurance. A committee of doctors typically reviews applications for hospital staff membership, reappointments, and medical care rendered. To encourage candid, effective, and meaningful discussions, federal and state laws shield committee members from liability by granting qualified immunity and protecting the confidential information from discovery.

Due process, antitrust liability, and records protection are three issues in peer review deserving of special attention.

The requirements of procedural due process are typically spelled out in hospital medical staff bylaws. In addition, peer review deliberations and decisions are expected, as specifically outlined at Yale-New Haven (Conn.) Hospital, to be consistent, timely, rational, defensible, balanced, and useful.¹

One of the earlier litigated cases was Silver v. Castle Memorial Hospital,² which involved a Hawaii neurosurgeon whose hospital privileges were not renewed after a 1-year probationary period. The court found that prior to his termination, Dr. Silver was never provided with specific written charges as to why his performance was not deemed acceptable, and the hospital board made its decision prior to an ineffective hearing. The court emphasized that due process required fair and thorough consideration. The doctor must be on notice that a hearing is available to him, and be given timely notification sufficiently prior to the hearing for him to adequately prepare a defense.

Other requirements include the provision of a written statement specifying the reasons for any adverse decision, which must come from substantial evidence produced at the hearing. As such, the board cannot rely on ex parte communications that were not made known to the doctor in question.

The doctor who is judged wanting in peer review not infrequently files an antitrust lawsuit in retaliation, claiming an anticompetitive intent.

The most publicized case is Patrick v. Burget,³ which dealt with an adverse peer review action against Dr. Timothy Patrick, a vascular surgeon. His decision to leave the Astoria Clinic in Oregon for an independent practice was followed by revocation of his hospital privileges for alleged substandard care, but Dr. Patrick claimed that the medical staff’s true purpose was to eliminate him as a competitor.

After Dr. Patrick won a $2.1 million jury verdict, the hospital appealed the decision and was initially successful in invoking the so-called "state action doctrine" immunity against antitrust liability. However, the U.S. Supreme Court unanimously found that the "state action doctrine" required proof of active state supervision of the peer review process, which was not evident in the case.

Following Burget, the U.S. Congress enacted the Health Care Quality Improvement Act of 1986,⁴ in the belief that the threat of liability under federal antitrust laws unreasonably discouraged physicians from participating in effective professional peer review. The act confers immunity upon participants sitting in judgment so long as the action taken was in the furtherance of quality health care, and the process carried out in a legitimate fashion with appropriate due process safeguards. These safeguards include, among others, a reasonable effort to obtain the facts, an adequate notice and hearing procedure, a reasonable belief that the action was warranted, and reporting any adverse outcome to the National Practitioner Data Bank.

A third issue in peer review involves disclosure. State statutes universally require that peer review be carried out in confidence, and committee minutes are to be nondiscoverable. This is to allow participants to speak freely and candidly without risk of legal discovery in the event there is an accompanying or subsequent malpractice lawsuit.

However, motions by plaintiff attorneys for production of supposedly protected documents may occasionally prove successful. Where federal laws conflict with state statutes, one federal court has asserted that its interests in "ascertaining the truth through an examination of all the available facts" would trump a state’s concern for privacy.

Courts have also found certain clinical information to be beyond statutory protection. For example, a Missouri appellate court ordered the production of hospital quality assurance and infection control records sought by the plaintiff. The Connecticut Supreme Court has made a similar determination, and the Nevada Supreme Court has ruled that hospital incident reports are not covered by the state peer review privilege.

What about an aggrieved physician who sues the committee members and hospital? Is he/she entitled to the records?

The Supreme Court of Pennsylvania has held that there was no statutory protection of such records where a physician challenged his own peer review process, because the statute’s intent was directed only at preventing disclosure to outside litigants in negligence actions.

West Covino Hospital v. Superior Court⁵ went even further. In that malpractice case against a surgeon, the California Supreme Court allowed a physician who served on the peer review committee to voluntarily testify about the confidential proceedings, to the obvious distress of the hospital as well as other members who had neither volunteered nor agreed to such disclosure. The court reasoned that the confidentiality rule was intended to preclude involuntary testimony, not that given voluntarily by one with access to peer review information.

Unfortunately, the decision may spawn unintended consequences. For example, the Joint Commission has instituted confidential medical error reporting systems designed to improve patient safety. These programs are unlikely to go very far if physicians were to fear disclosure without consent.

Peer review is an integral part of medical practice, and self-scrutiny is a laudable expression of quality assurance. Professional organizations such as the Joint Commission and the American Medical Association understandably support the practice.

The AMA, for example, subscribes to the view that peer review, which "balances the physician’s rights to exercise medical judgment freely with the obligation to do so wisely and temperately," is both necessary and ethical, so long as principles of due process are observed.⁶

Still, some observers both inside and outside the profession are skeptical. They believe that deliberations by a commonly transient, unschooled, and inexperienced committee sitting in judgment are too often tainted by conflicts of interest, refusal to censure a colleague, or a punitive agenda based on biases and/or anticompetitive motives.

In 2008, Lumetra, a nonprofit health care consulting organization, completed a legislature-sponsored study of medical peer review in the state of California.⁷ It found a "broken" system that needed a "major fix." There were significant inconsistencies in the way entities conducted peer review, variations in the selection and application of criteria, and confusion over reporting requirements. The authors felt that these variations could result in the perpetuation of the provision of substandard care, which in turn imperiled public safety.

Among its recommendations was a redesign of the peer review process to include establishing a separate, independent peer review organization with no vested interest in the review outcome except the protection of the public, improved physician education of the process, and public disclosure.

References

1. Yale-New Haven Hospital, Department of Physician Services: www.ynhh.org/vSiteManager/Upload/Images/Professionals/OPPE.pdf.

2. Silver v. Castle Memorial Hospital, 497 P.2d 564 (Haw. 1972).

3. Patrick v. Burget, 108 S. Ct. 1658 (1988).

4. 42 U.S.C.A. Sections 11101-11152.

5. West Covino Hospital v. Superior Court, 718 P.2d 119 (Cal 1986).

6. Code of Medical Ethics of the American Medical Association, 2012-2013 edition, section 9.10.

7. Comprehensive Study of Peer Review in California Final Report. Available at www.mbc.ca.gov/publications/peer_review.pdf.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk," and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].

Question: Which of the following statements regarding medical peer review is best?

A) The purpose is to evaluate quality of patient care and monitor physician performance.

B) A physician under peer review must be accorded due process, which at a minimum includes notice and opportunity to be heard.

C) Proceedings are confidential and nondiscoverable.

D) Medical peer review has been criticized for being biased, inconsistent, and lacking transparency.

E) All are correct.

Answer: E. Medical peer review, a requirement of the Joint Commission, has been called the cornerstone of quality assurance. A committee of doctors typically reviews applications for hospital staff membership, reappointments, and medical care rendered. To encourage candid, effective, and meaningful discussions, federal and state laws shield committee members from liability by granting qualified immunity and protecting the confidential information from discovery.

Due process, antitrust liability, and records protection are three issues in peer review deserving of special attention.

The requirements of procedural due process are typically spelled out in hospital medical staff bylaws. In addition, peer review deliberations and decisions are expected, as specifically outlined at Yale-New Haven (Conn.) Hospital, to be consistent, timely, rational, defensible, balanced, and useful.¹

One of the earlier litigated cases was Silver v. Castle Memorial Hospital,² which involved a Hawaii neurosurgeon whose hospital privileges were not renewed after a 1-year probationary period. The court found that prior to his termination, Dr. Silver was never provided with specific written charges as to why his performance was not deemed acceptable, and the hospital board made its decision prior to an ineffective hearing. The court emphasized that due process required fair and thorough consideration. The doctor must be on notice that a hearing is available to him, and be given timely notification sufficiently prior to the hearing for him to adequately prepare a defense.

Other requirements include the provision of a written statement specifying the reasons for any adverse decision, which must come from substantial evidence produced at the hearing. As such, the board cannot rely on ex parte communications that were not made known to the doctor in question.

The doctor who is judged wanting in peer review not infrequently files an antitrust lawsuit in retaliation, claiming an anticompetitive intent.

The most publicized case is Patrick v. Burget,³ which dealt with an adverse peer review action against Dr. Timothy Patrick, a vascular surgeon. His decision to leave the Astoria Clinic in Oregon for an independent practice was followed by revocation of his hospital privileges for alleged substandard care, but Dr. Patrick claimed that the medical staff’s true purpose was to eliminate him as a competitor.

After Dr. Patrick won a $2.1 million jury verdict, the hospital appealed the decision and was initially successful in invoking the so-called "state action doctrine" immunity against antitrust liability. However, the U.S. Supreme Court unanimously found that the "state action doctrine" required proof of active state supervision of the peer review process, which was not evident in the case.

Following Burget, the U.S. Congress enacted the Health Care Quality Improvement Act of 1986,⁴ in the belief that the threat of liability under federal antitrust laws unreasonably discouraged physicians from participating in effective professional peer review. The act confers immunity upon participants sitting in judgment so long as the action taken was in the furtherance of quality health care, and the process carried out in a legitimate fashion with appropriate due process safeguards. These safeguards include, among others, a reasonable effort to obtain the facts, an adequate notice and hearing procedure, a reasonable belief that the action was warranted, and reporting any adverse outcome to the National Practitioner Data Bank.

A third issue in peer review involves disclosure. State statutes universally require that peer review be carried out in confidence, and committee minutes are to be nondiscoverable. This is to allow participants to speak freely and candidly without risk of legal discovery in the event there is an accompanying or subsequent malpractice lawsuit.

However, motions by plaintiff attorneys for production of supposedly protected documents may occasionally prove successful. Where federal laws conflict with state statutes, one federal court has asserted that its interests in "ascertaining the truth through an examination of all the available facts" would trump a state’s concern for privacy.

Courts have also found certain clinical information to be beyond statutory protection. For example, a Missouri appellate court ordered the production of hospital quality assurance and infection control records sought by the plaintiff. The Connecticut Supreme Court has made a similar determination, and the Nevada Supreme Court has ruled that hospital incident reports are not covered by the state peer review privilege.

What about an aggrieved physician who sues the committee members and hospital? Is he/she entitled to the records?

The Supreme Court of Pennsylvania has held that there was no statutory protection of such records where a physician challenged his own peer review process, because the statute’s intent was directed only at preventing disclosure to outside litigants in negligence actions.

West Covino Hospital v. Superior Court⁵ went even further. In that malpractice case against a surgeon, the California Supreme Court allowed a physician who served on the peer review committee to voluntarily testify about the confidential proceedings, to the obvious distress of the hospital as well as other members who had neither volunteered nor agreed to such disclosure. The court reasoned that the confidentiality rule was intended to preclude involuntary testimony, not that given voluntarily by one with access to peer review information.

Unfortunately, the decision may spawn unintended consequences. For example, the Joint Commission has instituted confidential medical error reporting systems designed to improve patient safety. These programs are unlikely to go very far if physicians were to fear disclosure without consent.

Peer review is an integral part of medical practice, and self-scrutiny is a laudable expression of quality assurance. Professional organizations such as the Joint Commission and the American Medical Association understandably support the practice.

The AMA, for example, subscribes to the view that peer review, which "balances the physician’s rights to exercise medical judgment freely with the obligation to do so wisely and temperately," is both necessary and ethical, so long as principles of due process are observed.⁶

Still, some observers both inside and outside the profession are skeptical. They believe that deliberations by a commonly transient, unschooled, and inexperienced committee sitting in judgment are too often tainted by conflicts of interest, refusal to censure a colleague, or a punitive agenda based on biases and/or anticompetitive motives.

In 2008, Lumetra, a nonprofit health care consulting organization, completed a legislature-sponsored study of medical peer review in the state of California.⁷ It found a "broken" system that needed a "major fix." There were significant inconsistencies in the way entities conducted peer review, variations in the selection and application of criteria, and confusion over reporting requirements. The authors felt that these variations could result in the perpetuation of the provision of substandard care, which in turn imperiled public safety.

Among its recommendations was a redesign of the peer review process to include establishing a separate, independent peer review organization with no vested interest in the review outcome except the protection of the public, improved physician education of the process, and public disclosure.

References

1. Yale-New Haven Hospital, Department of Physician Services: www.ynhh.org/vSiteManager/Upload/Images/Professionals/OPPE.pdf.

2. Silver v. Castle Memorial Hospital, 497 P.2d 564 (Haw. 1972).

3. Patrick v. Burget, 108 S. Ct. 1658 (1988).

4. 42 U.S.C.A. Sections 11101-11152.

5. West Covino Hospital v. Superior Court, 718 P.2d 119 (Cal 1986).

6. Code of Medical Ethics of the American Medical Association, 2012-2013 edition, section 9.10.

7. Comprehensive Study of Peer Review in California Final Report. Available at www.mbc.ca.gov/publications/peer_review.pdf.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk," and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].

Question: Which of the following statements regarding medical peer review is best?

A) The purpose is to evaluate quality of patient care and monitor physician performance.

B) A physician under peer review must be accorded due process, which at a minimum includes notice and opportunity to be heard.

C) Proceedings are confidential and nondiscoverable.

D) Medical peer review has been criticized for being biased, inconsistent, and lacking transparency.

E) All are correct.

Answer: E. Medical peer review, a requirement of the Joint Commission, has been called the cornerstone of quality assurance. A committee of doctors typically reviews applications for hospital staff membership, reappointments, and medical care rendered. To encourage candid, effective, and meaningful discussions, federal and state laws shield committee members from liability by granting qualified immunity and protecting the confidential information from discovery.

Due process, antitrust liability, and records protection are three issues in peer review deserving of special attention.

The requirements of procedural due process are typically spelled out in hospital medical staff bylaws. In addition, peer review deliberations and decisions are expected, as specifically outlined at Yale-New Haven (Conn.) Hospital, to be consistent, timely, rational, defensible, balanced, and useful.¹

One of the earlier litigated cases was Silver v. Castle Memorial Hospital,² which involved a Hawaii neurosurgeon whose hospital privileges were not renewed after a 1-year probationary period. The court found that prior to his termination, Dr. Silver was never provided with specific written charges as to why his performance was not deemed acceptable, and the hospital board made its decision prior to an ineffective hearing. The court emphasized that due process required fair and thorough consideration. The doctor must be on notice that a hearing is available to him, and be given timely notification sufficiently prior to the hearing for him to adequately prepare a defense.

Other requirements include the provision of a written statement specifying the reasons for any adverse decision, which must come from substantial evidence produced at the hearing. As such, the board cannot rely on ex parte communications that were not made known to the doctor in question.

The doctor who is judged wanting in peer review not infrequently files an antitrust lawsuit in retaliation, claiming an anticompetitive intent.

The most publicized case is Patrick v. Burget,³ which dealt with an adverse peer review action against Dr. Timothy Patrick, a vascular surgeon. His decision to leave the Astoria Clinic in Oregon for an independent practice was followed by revocation of his hospital privileges for alleged substandard care, but Dr. Patrick claimed that the medical staff’s true purpose was to eliminate him as a competitor.

After Dr. Patrick won a $2.1 million jury verdict, the hospital appealed the decision and was initially successful in invoking the so-called "state action doctrine" immunity against antitrust liability. However, the U.S. Supreme Court unanimously found that the "state action doctrine" required proof of active state supervision of the peer review process, which was not evident in the case.

Following Burget, the U.S. Congress enacted the Health Care Quality Improvement Act of 1986,⁴ in the belief that the threat of liability under federal antitrust laws unreasonably discouraged physicians from participating in effective professional peer review. The act confers immunity upon participants sitting in judgment so long as the action taken was in the furtherance of quality health care, and the process carried out in a legitimate fashion with appropriate due process safeguards. These safeguards include, among others, a reasonable effort to obtain the facts, an adequate notice and hearing procedure, a reasonable belief that the action was warranted, and reporting any adverse outcome to the National Practitioner Data Bank.

A third issue in peer review involves disclosure. State statutes universally require that peer review be carried out in confidence, and committee minutes are to be nondiscoverable. This is to allow participants to speak freely and candidly without risk of legal discovery in the event there is an accompanying or subsequent malpractice lawsuit.

However, motions by plaintiff attorneys for production of supposedly protected documents may occasionally prove successful. Where federal laws conflict with state statutes, one federal court has asserted that its interests in "ascertaining the truth through an examination of all the available facts" would trump a state’s concern for privacy.

Courts have also found certain clinical information to be beyond statutory protection. For example, a Missouri appellate court ordered the production of hospital quality assurance and infection control records sought by the plaintiff. The Connecticut Supreme Court has made a similar determination, and the Nevada Supreme Court has ruled that hospital incident reports are not covered by the state peer review privilege.

What about an aggrieved physician who sues the committee members and hospital? Is he/she entitled to the records?

The Supreme Court of Pennsylvania has held that there was no statutory protection of such records where a physician challenged his own peer review process, because the statute’s intent was directed only at preventing disclosure to outside litigants in negligence actions.

West Covino Hospital v. Superior Court⁵ went even further. In that malpractice case against a surgeon, the California Supreme Court allowed a physician who served on the peer review committee to voluntarily testify about the confidential proceedings, to the obvious distress of the hospital as well as other members who had neither volunteered nor agreed to such disclosure. The court reasoned that the confidentiality rule was intended to preclude involuntary testimony, not that given voluntarily by one with access to peer review information.

Unfortunately, the decision may spawn unintended consequences. For example, the Joint Commission has instituted confidential medical error reporting systems designed to improve patient safety. These programs are unlikely to go very far if physicians were to fear disclosure without consent.

Peer review is an integral part of medical practice, and self-scrutiny is a laudable expression of quality assurance. Professional organizations such as the Joint Commission and the American Medical Association understandably support the practice.

The AMA, for example, subscribes to the view that peer review, which "balances the physician’s rights to exercise medical judgment freely with the obligation to do so wisely and temperately," is both necessary and ethical, so long as principles of due process are observed.⁶

Still, some observers both inside and outside the profession are skeptical. They believe that deliberations by a commonly transient, unschooled, and inexperienced committee sitting in judgment are too often tainted by conflicts of interest, refusal to censure a colleague, or a punitive agenda based on biases and/or anticompetitive motives.

In 2008, Lumetra, a nonprofit health care consulting organization, completed a legislature-sponsored study of medical peer review in the state of California.⁷ It found a "broken" system that needed a "major fix." There were significant inconsistencies in the way entities conducted peer review, variations in the selection and application of criteria, and confusion over reporting requirements. The authors felt that these variations could result in the perpetuation of the provision of substandard care, which in turn imperiled public safety.

Among its recommendations was a redesign of the peer review process to include establishing a separate, independent peer review organization with no vested interest in the review outcome except the protection of the public, improved physician education of the process, and public disclosure.

References

1. Yale-New Haven Hospital, Department of Physician Services: www.ynhh.org/vSiteManager/Upload/Images/Professionals/OPPE.pdf.

2. Silver v. Castle Memorial Hospital, 497 P.2d 564 (Haw. 1972).

3. Patrick v. Burget, 108 S. Ct. 1658 (1988).

4. 42 U.S.C.A. Sections 11101-11152.

5. West Covino Hospital v. Superior Court, 718 P.2d 119 (Cal 1986).

6. Code of Medical Ethics of the American Medical Association, 2012-2013 edition, section 9.10.

7. Comprehensive Study of Peer Review in California Final Report. Available at www.mbc.ca.gov/publications/peer_review.pdf.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk," and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].

Who in their right mind would organize the main event of a surgeons’ convention around the topic of unnecessary procedures? Surely this would almost certainly guarantee an empty auditorium. But Dr. Peter F. Lawrence, President of the Society for Vascular Surgery, had the wisdom and courage to do just that when he organized the Stanley Crawford Symposium at the recent Vascular Annual Meeting. Amazingly, he was rewarded not with approbation but rather with a standing-room turnout and congratulatory remarks. For Dr. Lawrence had the foresight to realize that vascular surgeons acknowledge that it is not only physicians from other specialties who are guilty of performing unnecessary procedures but also some of our own. Further, he had the insight that the attendees would share his desire to discuss what, in prior years, may have been a taboo subject.

When he first approached me to present at that symposium on the ethics of unnecessary procedures I thought I would produce a talk that would point out how the SVS could help its members reach an ethical high ground. But I soon realized that the SVS cannot be responsible for its members’ ethics. Ethics is, after all, an individual matter. Yes, I am certain that the vast majority of our members are indeed ethical and place their patients’ interests ahead of their own.

However, as in any large group, there will be individuals who value "I" in the word "Individual" as being more important than the "i" in the word "Ethics." "I" becomes "Me" and, unfortunately, "Me" becomes the defining factor in the equation that describes the doctor and patient relationship.

In preparing the talk I was struck that the word Individual provides clues to unethical behavior. The word contains three I’s, and three words that begin with the letter I are primarily responsible for unethical and unnecessary procedures. They are Indifference, Ignorance, and Incompetence. Perhaps the most unethical is the physician who is Indifferent: Indifferent to data, indifferent to results, indifferent to complaints, indifferent to patient suffering. This physician has no moral compass and will do whatever he or she pleases.

However, let’s start with Ignorance. I don’t want to come across as biased against other specialties, but I will not step away from a position I have frequently stated: Some of our colleagues in other specialties are not sufficiently educated in vascular diseases to be able to recognize that they do not have the judgment or skills to offer appropriate treatment. Nor do they recognize when they should refer to a vascular surgeon rather than attempt a procedure they should not be doing. How else can we explain the full metal jacket superficial femoral artery in a patient who was not even complaining of anything but was found to have a stenotic artery on routine testing?

Well, I’ll give the physician the benefit of the doubt. Perhaps the physician is uneducated about the natural history of peripheral arterial disease and believes that he or she was preventing an amputation. However, with some physicians I believe ignorance is not only a choice but an excuse!

Similarly, Incompetence is an individual problem. It seems it is a little-appreciated fact that surgery and endovascular procedures are not generic. Just as not every golfer can play scratch golf and join the professional circuit, not every surgeon or interventionalist is proficient. Rather, some will have bad results and bad results cause more procedures.

By coincidence, there are other factors that begin with the letter I that may promote unnecessary procedures and that are not necessarily related to individual mischief. Perhaps the most important I word is Insensitivity. It is the inability to recognize that one actually is ignorant, incompetent, or lacking in strength of character to the point of being indifferent to the effects of unethical behavior; that one is indifferent to the suffering of others or the moral responsibility of being an ethical physician.

But it’s not only self-driven issues that promote unethical procedures. It’s those other I’s, and first amongst all must be Income, or rather, lack of it. As long as our government does not adequately reimburse us for our work, some physicians will see volume as the only method to rectify the disparity. I believe that there were fewer inappropriate procedures when there were not as many surgeons, cardiologists, and radiologists and when they were all paid more appropriately. Related to Income is the I of Insurance reimbursement, which also drives procedures. We have only to see what happened to atherectomy after it was finally reimbursed. I am not necessarily implying that the tremendous increase in volume is inappropriate but surely it can be explained only by the fact that we are now being paid for a procedure that previously was not being compensated.

I was consulted on a patient who exemplified this point. He had no complaints whatsoever but during a cardiac evaluation was found to have an absent dorsalis pedis pulse. For no apparent reason, he was taken to the privately-owned angiography suite where he had a pedal access procedure to atherectomize an occluded anterior tibial artery. This resulted in an anterior compartment syndrome, yet the interventionalist was still enriched by many thousands of dollars. Of course, Innovations such as atherectomy may be important clinically but they invariably spur increased utilization. There is pressure to be the first to bring a new advance to the community. This may be entirely ethical if one is well trained in the procedure, but is not so if the physician jumps on the bandwagon with minimal instruction. Furthermore, Industry may also be guilty in promoting overuse by advertising benefits beyond what is known about these new procedures and by encouraging adoption with minimal oversight as to credentials. I may be overly cynical but why should Industry care who uses its device as long as it is used?

Inefficient treatments with unacceptable long-term outcomes also pose an ethical dilemma. Perform a highly compensated atherectomy, angioplasty, and stent of a totally occluded tibial artery knowing that one will be back for the next procedure in the not-too-distant future? Alternatively, bypass the blocked artery with a less well paid and time-consuming autogenous vein graft that may last for years?

Further, at first glance you may wonder how I consider Indications as driving unnecessary procedures. But consider a procedure such as renal artery denervation for treatment of hypertension that has, as yet, not proved to be worthwhile.

Couldn’t a physician justify performing it until such time as it is shown to be inappropriate even if that physician may not have much faith in its benefits?

Dr. Lawrence also charged me with evaluating whether there were differences in ethical issues between employed physicians (at universities, for example) and those in community practice who are self-employed. I would suggest that there is such a difference, especially when we evaluate the I of Incentives. And here I refer specifically to relative-value units and academic promotion.

Although I do not have a better method of evaluating work, I believe that institutions that reward employed physicians based on RVUs cause a perverse incentive to do more. Certainly the single physician is not going to be enticed by this manufactured number. Academic promotion may also incentivize a surgeon to do more, especially if it is in the area of research for which the surgeon is renowned. The surgeon who has made a reputation studying surgery for small aneurysms may find the need to operate on ever smaller ones!

Perhaps one of the most important causes of ethical lapses is the absence of oversight in Independent outpatient environments separate from hospitals. This is where most bad things are happening. Here anyone can do anything and the intervention occurs only when a major complication sends the patient to a hospital or a negligent act results in a malpractice suit. As long as the government refuses to credential who can do what in the outpatient setting we may have poorly qualified, immoral doctors let loose on their unsuspecting prey. Physicians from almost every medical specialty are ablating saphenous veins in so-called "vein centers."

Further, some cardiologists without vascular training – and even some surgeons – with little indication are lasering tibials or inserting stents into every known artery in outpatient cath labs.

Fortunately, although the three I’s in the word Individual may explain unnecessary procedures, there is one I word derived from the single I in Ethics that denotes why almost all of us will do what is right. That word is Integrity – the quality of being honest and having strong moral principles – that will prevent us from doing what we know is wrong.

So this leads to Dr. Lawrence’s final charge to the speakers: to come up with three suggestions to help reduce unethical procedures. Although there must be many more, I would suggest the three most important would be the following:

• Only physicians who are board certified by a recognized specialty and who have been appropriately trained and credentialed should be allowed to perform procedures in hospitals and independent facilities.

• Payment must ultimately be based on outcomes where not only the result but also the indication needs to be taken into consideration.

• Medical schools need to provide courses in ethical behavior, which must be conceived as being equally as important as anatomy and physiology.

In conclusion, I congratulate Dr. Lawrence and the SVS VAM organizing committee under the leadership of Dr. Ronald M. Fairman for putting this potentially contentious subject on the program. For by so doing, vascular surgeons demonstrate that we have the courage and ethics to acknowledge some of our shortcomings. At the same time we prove our leadership as the specialty most suited to treat and protect patients with vascular disease.

Who in their right mind would organize the main event of a surgeons’ convention around the topic of unnecessary procedures? Surely this would almost certainly guarantee an empty auditorium. But Dr. Peter F. Lawrence, President of the Society for Vascular Surgery, had the wisdom and courage to do just that when he organized the Stanley Crawford Symposium at the recent Vascular Annual Meeting. Amazingly, he was rewarded not with approbation but rather with a standing-room turnout and congratulatory remarks. For Dr. Lawrence had the foresight to realize that vascular surgeons acknowledge that it is not only physicians from other specialties who are guilty of performing unnecessary procedures but also some of our own. Further, he had the insight that the attendees would share his desire to discuss what, in prior years, may have been a taboo subject.

When he first approached me to present at that symposium on the ethics of unnecessary procedures I thought I would produce a talk that would point out how the SVS could help its members reach an ethical high ground. But I soon realized that the SVS cannot be responsible for its members’ ethics. Ethics is, after all, an individual matter. Yes, I am certain that the vast majority of our members are indeed ethical and place their patients’ interests ahead of their own.

However, as in any large group, there will be individuals who value "I" in the word "Individual" as being more important than the "i" in the word "Ethics." "I" becomes "Me" and, unfortunately, "Me" becomes the defining factor in the equation that describes the doctor and patient relationship.

In preparing the talk I was struck that the word Individual provides clues to unethical behavior. The word contains three I’s, and three words that begin with the letter I are primarily responsible for unethical and unnecessary procedures. They are Indifference, Ignorance, and Incompetence. Perhaps the most unethical is the physician who is Indifferent: Indifferent to data, indifferent to results, indifferent to complaints, indifferent to patient suffering. This physician has no moral compass and will do whatever he or she pleases.

However, let’s start with Ignorance. I don’t want to come across as biased against other specialties, but I will not step away from a position I have frequently stated: Some of our colleagues in other specialties are not sufficiently educated in vascular diseases to be able to recognize that they do not have the judgment or skills to offer appropriate treatment. Nor do they recognize when they should refer to a vascular surgeon rather than attempt a procedure they should not be doing. How else can we explain the full metal jacket superficial femoral artery in a patient who was not even complaining of anything but was found to have a stenotic artery on routine testing?

Well, I’ll give the physician the benefit of the doubt. Perhaps the physician is uneducated about the natural history of peripheral arterial disease and believes that he or she was preventing an amputation. However, with some physicians I believe ignorance is not only a choice but an excuse!

Similarly, Incompetence is an individual problem. It seems it is a little-appreciated fact that surgery and endovascular procedures are not generic. Just as not every golfer can play scratch golf and join the professional circuit, not every surgeon or interventionalist is proficient. Rather, some will have bad results and bad results cause more procedures.

By coincidence, there are other factors that begin with the letter I that may promote unnecessary procedures and that are not necessarily related to individual mischief. Perhaps the most important I word is Insensitivity. It is the inability to recognize that one actually is ignorant, incompetent, or lacking in strength of character to the point of being indifferent to the effects of unethical behavior; that one is indifferent to the suffering of others or the moral responsibility of being an ethical physician.

But it’s not only self-driven issues that promote unethical procedures. It’s those other I’s, and first amongst all must be Income, or rather, lack of it. As long as our government does not adequately reimburse us for our work, some physicians will see volume as the only method to rectify the disparity. I believe that there were fewer inappropriate procedures when there were not as many surgeons, cardiologists, and radiologists and when they were all paid more appropriately. Related to Income is the I of Insurance reimbursement, which also drives procedures. We have only to see what happened to atherectomy after it was finally reimbursed. I am not necessarily implying that the tremendous increase in volume is inappropriate but surely it can be explained only by the fact that we are now being paid for a procedure that previously was not being compensated.

I was consulted on a patient who exemplified this point. He had no complaints whatsoever but during a cardiac evaluation was found to have an absent dorsalis pedis pulse. For no apparent reason, he was taken to the privately-owned angiography suite where he had a pedal access procedure to atherectomize an occluded anterior tibial artery. This resulted in an anterior compartment syndrome, yet the interventionalist was still enriched by many thousands of dollars. Of course, Innovations such as atherectomy may be important clinically but they invariably spur increased utilization. There is pressure to be the first to bring a new advance to the community. This may be entirely ethical if one is well trained in the procedure, but is not so if the physician jumps on the bandwagon with minimal instruction. Furthermore, Industry may also be guilty in promoting overuse by advertising benefits beyond what is known about these new procedures and by encouraging adoption with minimal oversight as to credentials. I may be overly cynical but why should Industry care who uses its device as long as it is used?

Inefficient treatments with unacceptable long-term outcomes also pose an ethical dilemma. Perform a highly compensated atherectomy, angioplasty, and stent of a totally occluded tibial artery knowing that one will be back for the next procedure in the not-too-distant future? Alternatively, bypass the blocked artery with a less well paid and time-consuming autogenous vein graft that may last for years?

Further, at first glance you may wonder how I consider Indications as driving unnecessary procedures. But consider a procedure such as renal artery denervation for treatment of hypertension that has, as yet, not proved to be worthwhile.

Couldn’t a physician justify performing it until such time as it is shown to be inappropriate even if that physician may not have much faith in its benefits?

Dr. Lawrence also charged me with evaluating whether there were differences in ethical issues between employed physicians (at universities, for example) and those in community practice who are self-employed. I would suggest that there is such a difference, especially when we evaluate the I of Incentives. And here I refer specifically to relative-value units and academic promotion.

Although I do not have a better method of evaluating work, I believe that institutions that reward employed physicians based on RVUs cause a perverse incentive to do more. Certainly the single physician is not going to be enticed by this manufactured number. Academic promotion may also incentivize a surgeon to do more, especially if it is in the area of research for which the surgeon is renowned. The surgeon who has made a reputation studying surgery for small aneurysms may find the need to operate on ever smaller ones!

Perhaps one of the most important causes of ethical lapses is the absence of oversight in Independent outpatient environments separate from hospitals. This is where most bad things are happening. Here anyone can do anything and the intervention occurs only when a major complication sends the patient to a hospital or a negligent act results in a malpractice suit. As long as the government refuses to credential who can do what in the outpatient setting we may have poorly qualified, immoral doctors let loose on their unsuspecting prey. Physicians from almost every medical specialty are ablating saphenous veins in so-called "vein centers."

Further, some cardiologists without vascular training – and even some surgeons – with little indication are lasering tibials or inserting stents into every known artery in outpatient cath labs.

Fortunately, although the three I’s in the word Individual may explain unnecessary procedures, there is one I word derived from the single I in Ethics that denotes why almost all of us will do what is right. That word is Integrity – the quality of being honest and having strong moral principles – that will prevent us from doing what we know is wrong.

So this leads to Dr. Lawrence’s final charge to the speakers: to come up with three suggestions to help reduce unethical procedures. Although there must be many more, I would suggest the three most important would be the following:

• Only physicians who are board certified by a recognized specialty and who have been appropriately trained and credentialed should be allowed to perform procedures in hospitals and independent facilities.

• Payment must ultimately be based on outcomes where not only the result but also the indication needs to be taken into consideration.

• Medical schools need to provide courses in ethical behavior, which must be conceived as being equally as important as anatomy and physiology.

In conclusion, I congratulate Dr. Lawrence and the SVS VAM organizing committee under the leadership of Dr. Ronald M. Fairman for putting this potentially contentious subject on the program. For by so doing, vascular surgeons demonstrate that we have the courage and ethics to acknowledge some of our shortcomings. At the same time we prove our leadership as the specialty most suited to treat and protect patients with vascular disease.

Who in their right mind would organize the main event of a surgeons’ convention around the topic of unnecessary procedures? Surely this would almost certainly guarantee an empty auditorium. But Dr. Peter F. Lawrence, President of the Society for Vascular Surgery, had the wisdom and courage to do just that when he organized the Stanley Crawford Symposium at the recent Vascular Annual Meeting. Amazingly, he was rewarded not with approbation but rather with a standing-room turnout and congratulatory remarks. For Dr. Lawrence had the foresight to realize that vascular surgeons acknowledge that it is not only physicians from other specialties who are guilty of performing unnecessary procedures but also some of our own. Further, he had the insight that the attendees would share his desire to discuss what, in prior years, may have been a taboo subject.

When he first approached me to present at that symposium on the ethics of unnecessary procedures I thought I would produce a talk that would point out how the SVS could help its members reach an ethical high ground. But I soon realized that the SVS cannot be responsible for its members’ ethics. Ethics is, after all, an individual matter. Yes, I am certain that the vast majority of our members are indeed ethical and place their patients’ interests ahead of their own.

However, as in any large group, there will be individuals who value "I" in the word "Individual" as being more important than the "i" in the word "Ethics." "I" becomes "Me" and, unfortunately, "Me" becomes the defining factor in the equation that describes the doctor and patient relationship.

In preparing the talk I was struck that the word Individual provides clues to unethical behavior. The word contains three I’s, and three words that begin with the letter I are primarily responsible for unethical and unnecessary procedures. They are Indifference, Ignorance, and Incompetence. Perhaps the most unethical is the physician who is Indifferent: Indifferent to data, indifferent to results, indifferent to complaints, indifferent to patient suffering. This physician has no moral compass and will do whatever he or she pleases.

However, let’s start with Ignorance. I don’t want to come across as biased against other specialties, but I will not step away from a position I have frequently stated: Some of our colleagues in other specialties are not sufficiently educated in vascular diseases to be able to recognize that they do not have the judgment or skills to offer appropriate treatment. Nor do they recognize when they should refer to a vascular surgeon rather than attempt a procedure they should not be doing. How else can we explain the full metal jacket superficial femoral artery in a patient who was not even complaining of anything but was found to have a stenotic artery on routine testing?

Well, I’ll give the physician the benefit of the doubt. Perhaps the physician is uneducated about the natural history of peripheral arterial disease and believes that he or she was preventing an amputation. However, with some physicians I believe ignorance is not only a choice but an excuse!

Similarly, Incompetence is an individual problem. It seems it is a little-appreciated fact that surgery and endovascular procedures are not generic. Just as not every golfer can play scratch golf and join the professional circuit, not every surgeon or interventionalist is proficient. Rather, some will have bad results and bad results cause more procedures.

By coincidence, there are other factors that begin with the letter I that may promote unnecessary procedures and that are not necessarily related to individual mischief. Perhaps the most important I word is Insensitivity. It is the inability to recognize that one actually is ignorant, incompetent, or lacking in strength of character to the point of being indifferent to the effects of unethical behavior; that one is indifferent to the suffering of others or the moral responsibility of being an ethical physician.

But it’s not only self-driven issues that promote unethical procedures. It’s those other I’s, and first amongst all must be Income, or rather, lack of it. As long as our government does not adequately reimburse us for our work, some physicians will see volume as the only method to rectify the disparity. I believe that there were fewer inappropriate procedures when there were not as many surgeons, cardiologists, and radiologists and when they were all paid more appropriately. Related to Income is the I of Insurance reimbursement, which also drives procedures. We have only to see what happened to atherectomy after it was finally reimbursed. I am not necessarily implying that the tremendous increase in volume is inappropriate but surely it can be explained only by the fact that we are now being paid for a procedure that previously was not being compensated.

I was consulted on a patient who exemplified this point. He had no complaints whatsoever but during a cardiac evaluation was found to have an absent dorsalis pedis pulse. For no apparent reason, he was taken to the privately-owned angiography suite where he had a pedal access procedure to atherectomize an occluded anterior tibial artery. This resulted in an anterior compartment syndrome, yet the interventionalist was still enriched by many thousands of dollars. Of course, Innovations such as atherectomy may be important clinically but they invariably spur increased utilization. There is pressure to be the first to bring a new advance to the community. This may be entirely ethical if one is well trained in the procedure, but is not so if the physician jumps on the bandwagon with minimal instruction. Furthermore, Industry may also be guilty in promoting overuse by advertising benefits beyond what is known about these new procedures and by encouraging adoption with minimal oversight as to credentials. I may be overly cynical but why should Industry care who uses its device as long as it is used?

Inefficient treatments with unacceptable long-term outcomes also pose an ethical dilemma. Perform a highly compensated atherectomy, angioplasty, and stent of a totally occluded tibial artery knowing that one will be back for the next procedure in the not-too-distant future? Alternatively, bypass the blocked artery with a less well paid and time-consuming autogenous vein graft that may last for years?

Further, at first glance you may wonder how I consider Indications as driving unnecessary procedures. But consider a procedure such as renal artery denervation for treatment of hypertension that has, as yet, not proved to be worthwhile.

Couldn’t a physician justify performing it until such time as it is shown to be inappropriate even if that physician may not have much faith in its benefits?

Dr. Lawrence also charged me with evaluating whether there were differences in ethical issues between employed physicians (at universities, for example) and those in community practice who are self-employed. I would suggest that there is such a difference, especially when we evaluate the I of Incentives. And here I refer specifically to relative-value units and academic promotion.

Although I do not have a better method of evaluating work, I believe that institutions that reward employed physicians based on RVUs cause a perverse incentive to do more. Certainly the single physician is not going to be enticed by this manufactured number. Academic promotion may also incentivize a surgeon to do more, especially if it is in the area of research for which the surgeon is renowned. The surgeon who has made a reputation studying surgery for small aneurysms may find the need to operate on ever smaller ones!

Perhaps one of the most important causes of ethical lapses is the absence of oversight in Independent outpatient environments separate from hospitals. This is where most bad things are happening. Here anyone can do anything and the intervention occurs only when a major complication sends the patient to a hospital or a negligent act results in a malpractice suit. As long as the government refuses to credential who can do what in the outpatient setting we may have poorly qualified, immoral doctors let loose on their unsuspecting prey. Physicians from almost every medical specialty are ablating saphenous veins in so-called "vein centers."

Further, some cardiologists without vascular training – and even some surgeons – with little indication are lasering tibials or inserting stents into every known artery in outpatient cath labs.

Fortunately, although the three I’s in the word Individual may explain unnecessary procedures, there is one I word derived from the single I in Ethics that denotes why almost all of us will do what is right. That word is Integrity – the quality of being honest and having strong moral principles – that will prevent us from doing what we know is wrong.

So this leads to Dr. Lawrence’s final charge to the speakers: to come up with three suggestions to help reduce unethical procedures. Although there must be many more, I would suggest the three most important would be the following:

• Only physicians who are board certified by a recognized specialty and who have been appropriately trained and credentialed should be allowed to perform procedures in hospitals and independent facilities.

• Payment must ultimately be based on outcomes where not only the result but also the indication needs to be taken into consideration.

• Medical schools need to provide courses in ethical behavior, which must be conceived as being equally as important as anatomy and physiology.

In conclusion, I congratulate Dr. Lawrence and the SVS VAM organizing committee under the leadership of Dr. Ronald M. Fairman for putting this potentially contentious subject on the program. For by so doing, vascular surgeons demonstrate that we have the courage and ethics to acknowledge some of our shortcomings. At the same time we prove our leadership as the specialty most suited to treat and protect patients with vascular disease.

The need for more and better quality data on medication safety in human pregnancy has been in the public and regulatory spotlight for decades. The issue is becoming even more urgent with the impending revisions to the product label format that will eliminate the traditional A, B, C, D, X pregnancy categories, and substitute more data-driven narratives.

In response to this need, over the last several years there has been a steady increase in the number of regulatory requests/requirements for postmarketing surveillance studies for new medications likely to be used by women of reproductive age or by pregnant women. These requests most often have been fulfilled by the initiation of pregnancy registries. However, concern has been raised that pregnancy registries by and large have been challenged to recruit sufficient numbers of study subjects, and the time to completion of these studies is typically longer than desirable. Other questions have been raised about the adequacy of pregnancy registries alone (especially those with small sample sizes and no internal comparison groups) to test hypotheses related to birth outcomes.

In May 2014, the Food and Drug Administration hosted a public meeting to highlight some of these issues and to seek advice and solutions, titled "Study Approaches and Methods to Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-Approval Setting." Panelists included representation from federal agencies including the Centers for Disease Control and Prevention, Department of Defense Naval Health Research Center, the Agency for Healthcare Research and Quality, and the Food and Drug Administration. Other panelists represented academic and HMO-based research networks, contract research organizations, the pharmaceutical industry, obstetric providers, and patients. Comments also were provided by audience members who represented a variety of entities including academic societies, professional associations, and advocacy groups.

Specific strategies for obtaining better data in a more timely fashion were presented by the panelists. These included the value and efficiency of utilizing large administrative claims databases or systemwide electronic capture of pregnancy exposure and outcome data. Using this approach, representative samples of patients can be accrued while not requiring individual active informed consent. Limitations of such sources of data also were mentioned, including inability to validate that the pregnant woman actually took a medication of interest, when, and at what dose, and the usual absence of information in claims data on some important confounders such as alcohol use and folic acid supplementation.

Panelists representing various pregnancy registry study designs described approaches to addressing some of the limitations of these studies. For example, some panelists emphasized that "disease-based" registries that involve examination of birth outcomes for several medications used for the treatment of one or more similar maternal conditions have several distinct advantages. These include a more streamlined referral process, whereby clinicians can more easily identify and refer all pregnant patients who have the same underlying condition, irrespective of treatment with any specific medication under study. Examples of successful disease-based approaches that were highlighted by panelists included the Antiretroviral Drugs in Pregnancy Registry, the North American Antiepileptic Drug Pregnancy Registry, and the OTIS/MotherToBaby Autoimmune Diseases in Pregnancy Project. Each of these studies allows for comparison of outcomes across various treatments, while accounting for the possible contribution of the underlying maternal condition to adverse pregnancy outcomes.

Panelists also emphasized that more effective methods are needed for raising awareness of the existence and value of pregnancy registries for providers and consumers alike, including more efficient and extensive use of social media. Panelists, and in particular obstetric providers, indicated a need for better methods of identifying women who are eligible for participation in a pregnancy study, and facilitating the referral process. The obstetric provider panelist suggested that existing electronic medical records systems could be adapted to generate automated alerts to providers regarding patients who qualify for referral to a registry.

The patient representative panelist emphasized the need to engage the pregnant woman in the research process. This was confirmed by research groups whose primary interaction in pregnancy studies is with the pregnant woman herself, resulting in minimal loss-to-follow-up and high participant satisfaction.

Last, there was extensive discussion about the use of other alternative study designs, such as case-control studies, that could help address the limitations of pregnancy registries, especially in terms of statistical power for evaluating rare outcomes such as specific birth defects. The Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) was described as one such alternative, combining the benefits of a cohort (registry-type) study with a concurrent case-control study to address the same exposures in pregnancy.

There was general consensus among panel members that no single approach to postmarketing safety studies would likely be sufficient to evaluate new or existing products, and that complementary approaches are needed.

A complete set of the panelists’ slide presentations from the public meeting as well as webcasts of the 2-day proceedings in their entirety are available for viewing here.

Dr. Chambers is a professor of pediatrics and director of clinical research at Rady Children’s Hospital, and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is director of MotherToBaby California, a past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She said that she had no relevant financial disclosures. To comment, e-mail her at [email protected].

The need for more and better quality data on medication safety in human pregnancy has been in the public and regulatory spotlight for decades. The issue is becoming even more urgent with the impending revisions to the product label format that will eliminate the traditional A, B, C, D, X pregnancy categories, and substitute more data-driven narratives.

In response to this need, over the last several years there has been a steady increase in the number of regulatory requests/requirements for postmarketing surveillance studies for new medications likely to be used by women of reproductive age or by pregnant women. These requests most often have been fulfilled by the initiation of pregnancy registries. However, concern has been raised that pregnancy registries by and large have been challenged to recruit sufficient numbers of study subjects, and the time to completion of these studies is typically longer than desirable. Other questions have been raised about the adequacy of pregnancy registries alone (especially those with small sample sizes and no internal comparison groups) to test hypotheses related to birth outcomes.

In May 2014, the Food and Drug Administration hosted a public meeting to highlight some of these issues and to seek advice and solutions, titled "Study Approaches and Methods to Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-Approval Setting." Panelists included representation from federal agencies including the Centers for Disease Control and Prevention, Department of Defense Naval Health Research Center, the Agency for Healthcare Research and Quality, and the Food and Drug Administration. Other panelists represented academic and HMO-based research networks, contract research organizations, the pharmaceutical industry, obstetric providers, and patients. Comments also were provided by audience members who represented a variety of entities including academic societies, professional associations, and advocacy groups.

Specific strategies for obtaining better data in a more timely fashion were presented by the panelists. These included the value and efficiency of utilizing large administrative claims databases or systemwide electronic capture of pregnancy exposure and outcome data. Using this approach, representative samples of patients can be accrued while not requiring individual active informed consent. Limitations of such sources of data also were mentioned, including inability to validate that the pregnant woman actually took a medication of interest, when, and at what dose, and the usual absence of information in claims data on some important confounders such as alcohol use and folic acid supplementation.

Panelists representing various pregnancy registry study designs described approaches to addressing some of the limitations of these studies. For example, some panelists emphasized that "disease-based" registries that involve examination of birth outcomes for several medications used for the treatment of one or more similar maternal conditions have several distinct advantages. These include a more streamlined referral process, whereby clinicians can more easily identify and refer all pregnant patients who have the same underlying condition, irrespective of treatment with any specific medication under study. Examples of successful disease-based approaches that were highlighted by panelists included the Antiretroviral Drugs in Pregnancy Registry, the North American Antiepileptic Drug Pregnancy Registry, and the OTIS/MotherToBaby Autoimmune Diseases in Pregnancy Project. Each of these studies allows for comparison of outcomes across various treatments, while accounting for the possible contribution of the underlying maternal condition to adverse pregnancy outcomes.

Panelists also emphasized that more effective methods are needed for raising awareness of the existence and value of pregnancy registries for providers and consumers alike, including more efficient and extensive use of social media. Panelists, and in particular obstetric providers, indicated a need for better methods of identifying women who are eligible for participation in a pregnancy study, and facilitating the referral process. The obstetric provider panelist suggested that existing electronic medical records systems could be adapted to generate automated alerts to providers regarding patients who qualify for referral to a registry.

The patient representative panelist emphasized the need to engage the pregnant woman in the research process. This was confirmed by research groups whose primary interaction in pregnancy studies is with the pregnant woman herself, resulting in minimal loss-to-follow-up and high participant satisfaction.

Last, there was extensive discussion about the use of other alternative study designs, such as case-control studies, that could help address the limitations of pregnancy registries, especially in terms of statistical power for evaluating rare outcomes such as specific birth defects. The Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) was described as one such alternative, combining the benefits of a cohort (registry-type) study with a concurrent case-control study to address the same exposures in pregnancy.

There was general consensus among panel members that no single approach to postmarketing safety studies would likely be sufficient to evaluate new or existing products, and that complementary approaches are needed.

A complete set of the panelists’ slide presentations from the public meeting as well as webcasts of the 2-day proceedings in their entirety are available for viewing here.

Dr. Chambers is a professor of pediatrics and director of clinical research at Rady Children’s Hospital, and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is director of MotherToBaby California, a past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She said that she had no relevant financial disclosures. To comment, e-mail her at [email protected].

The need for more and better quality data on medication safety in human pregnancy has been in the public and regulatory spotlight for decades. The issue is becoming even more urgent with the impending revisions to the product label format that will eliminate the traditional A, B, C, D, X pregnancy categories, and substitute more data-driven narratives.

In response to this need, over the last several years there has been a steady increase in the number of regulatory requests/requirements for postmarketing surveillance studies for new medications likely to be used by women of reproductive age or by pregnant women. These requests most often have been fulfilled by the initiation of pregnancy registries. However, concern has been raised that pregnancy registries by and large have been challenged to recruit sufficient numbers of study subjects, and the time to completion of these studies is typically longer than desirable. Other questions have been raised about the adequacy of pregnancy registries alone (especially those with small sample sizes and no internal comparison groups) to test hypotheses related to birth outcomes.

In May 2014, the Food and Drug Administration hosted a public meeting to highlight some of these issues and to seek advice and solutions, titled "Study Approaches and Methods to Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-Approval Setting." Panelists included representation from federal agencies including the Centers for Disease Control and Prevention, Department of Defense Naval Health Research Center, the Agency for Healthcare Research and Quality, and the Food and Drug Administration. Other panelists represented academic and HMO-based research networks, contract research organizations, the pharmaceutical industry, obstetric providers, and patients. Comments also were provided by audience members who represented a variety of entities including academic societies, professional associations, and advocacy groups.

Specific strategies for obtaining better data in a more timely fashion were presented by the panelists. These included the value and efficiency of utilizing large administrative claims databases or systemwide electronic capture of pregnancy exposure and outcome data. Using this approach, representative samples of patients can be accrued while not requiring individual active informed consent. Limitations of such sources of data also were mentioned, including inability to validate that the pregnant woman actually took a medication of interest, when, and at what dose, and the usual absence of information in claims data on some important confounders such as alcohol use and folic acid supplementation.

Panelists representing various pregnancy registry study designs described approaches to addressing some of the limitations of these studies. For example, some panelists emphasized that "disease-based" registries that involve examination of birth outcomes for several medications used for the treatment of one or more similar maternal conditions have several distinct advantages. These include a more streamlined referral process, whereby clinicians can more easily identify and refer all pregnant patients who have the same underlying condition, irrespective of treatment with any specific medication under study. Examples of successful disease-based approaches that were highlighted by panelists included the Antiretroviral Drugs in Pregnancy Registry, the North American Antiepileptic Drug Pregnancy Registry, and the OTIS/MotherToBaby Autoimmune Diseases in Pregnancy Project. Each of these studies allows for comparison of outcomes across various treatments, while accounting for the possible contribution of the underlying maternal condition to adverse pregnancy outcomes.

Panelists also emphasized that more effective methods are needed for raising awareness of the existence and value of pregnancy registries for providers and consumers alike, including more efficient and extensive use of social media. Panelists, and in particular obstetric providers, indicated a need for better methods of identifying women who are eligible for participation in a pregnancy study, and facilitating the referral process. The obstetric provider panelist suggested that existing electronic medical records systems could be adapted to generate automated alerts to providers regarding patients who qualify for referral to a registry.

The patient representative panelist emphasized the need to engage the pregnant woman in the research process. This was confirmed by research groups whose primary interaction in pregnancy studies is with the pregnant woman herself, resulting in minimal loss-to-follow-up and high participant satisfaction.

Last, there was extensive discussion about the use of other alternative study designs, such as case-control studies, that could help address the limitations of pregnancy registries, especially in terms of statistical power for evaluating rare outcomes such as specific birth defects. The Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) was described as one such alternative, combining the benefits of a cohort (registry-type) study with a concurrent case-control study to address the same exposures in pregnancy.

There was general consensus among panel members that no single approach to postmarketing safety studies would likely be sufficient to evaluate new or existing products, and that complementary approaches are needed.

A complete set of the panelists’ slide presentations from the public meeting as well as webcasts of the 2-day proceedings in their entirety are available for viewing here.

Dr. Chambers is a professor of pediatrics and director of clinical research at Rady Children’s Hospital, and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is director of MotherToBaby California, a past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She said that she had no relevant financial disclosures. To comment, e-mail her at [email protected].

It’s late August, and finally I feel ready for summer. You don’t need to remind me that I’m late: Our five children have no fewer than eight school orientations this week. The extras are because new high schoolers need two sessions, one for their parents and another just for students, where they tell them all the really important stuff, which the kids then forget until second semester when it’s too late. Can I go to the beach now? 

Of course the orientations are mainly just a chance for teachers to pass out supply lists, which, with severe budget cuts in our state, now include items like, “one bottle of hand sanitizer, five dry-erase markers in various colors, one qualified teaching assistant.” Also, I know why my 4th-grader needs to start the year with 24 #2 pencils: He chews them. But do all the kids have an oral fixation? Or is it that when my son has polished off his small forest of Ticonderogas, his classmates are expected to lend him theirs? I guess I’ll ask at orientation.

Hand-me-downs

Fuse

Here’s my question: If we saved all the money parents are about to spend on classroom hand sanitizer, could we actually afford a teaching assistant? Or at least a few more dry-erase markers? Because a study from New Zealand suggests that as long as soap and water are available, hand sanitizer does nothing but to give schoolchildren another excuse to get up out of their seats.

Patricia Priest and her colleagues from the University of Otego in Dunedin (I, too think it sounds made up) studied school absences among 2,443 students aged 5 to 11 in 68 schools. They performed the experiment during the winter (read “summer”), placing alcohol-based hand sanitizers in half the schools and relying on soap, water, and Kiwi common sense in the other half. Then they sat back and counted the absences, going as far as to call parents and force them to invent diseases for children who were actually playing hooky to quest after the One Ring to Rule Them All.

When the investigators tallied everything up, hand sanitizer appeared to make no difference in the number of absences from all illnesses or from any specific illness (respiratory or GI). Also unaffected were the length of illness, the length of the absence, or the likelihood of another family member contracting the illness. (That last endpoint confuses me, unless the kids were taking hand sanitizer home every night.) What this study proved was that whether or not children in New Zealand have access to hand sanitizer, they will still all be mistaken for Australians.

I think we’re alone now

If you can just spend a little one-on-one time with teenagers, they’ll reveal the most amazing things about their lives. That’s why I have five children: to make sure that kind of thing never happens. But in the pediatrician’s office, it’s a good thing. We need to know what’s going on in adolescents’ lives in order to help them avoid the dangers of substance abuse, high-risk sexual behavior, and whatever boneheaded dare has been going around YouTube this week. A new study out of Indianapolis confirms what common sense already tells us: If you don’t talk with teens’ parents out of the exam room for a few minutes, you miss the good stuff, (read “the bad stuff”). 

To prove it, the researchers surveyed around 500 adolescents (ages 13-17 years) and their parents regarding conversations they had with providers during their wellness exams. The best single statistic from their study was this: 89% of parents believed adolescents should be able to talk with their doctors privately, while 61% of parents preferred to stay in the exam room for the entire visit. That means that 50% of parents misunderstand one of the following terms: adolescent, private, or exam room.

Kids who did get to talk to their doctors alone discussed almost twice as many sensitive topics as did kids whose parents policed their conversations. On the up side, when parents refused to leave, kids were more likely to say “ma’am” and “sir,” to sit up straight for once please, and to brush that hair out of their eyes so the doctor can tell you’re looking at them, honey, thank you.

Call me maybe

Speaking of counseling teens and parents, do you sometimes think we’re talking with the wrong person? The National Institutes of Health just completed a study of distracted driving, a cause of 11% of fatal crashes among adolescents. Since 21% of those crashes involve mobile phone use, researchers asked 400 15- to 18-year-old drivers who in the heck they were talking to on the phone that made it worth risking their lives. Of the 86% of teens who reported talking on the phone while driving, 100% of them said the people they were talking to were their parents.

Fellow parents of teens, this does not make us look good. I like chatting with my kids, too, but it’s easier to converse with them when they’re alive, or at least not in a coma (if you can’t tell whether or not your adolescent is in a coma, have him brush that hair out of his eyes). We’ve got to do better, y’all; no one really wants to miss out on next year’s school orientation.

David L. Hill, M.D., FAAP, is the author of Dad to Dad: Parenting Like a Pro (AAP Publishing, 2012). He is also vice president of Cape Fear Pediatrics in Wilmington, N.C., and  adjunct assistant professor of pediatrics at the University of North Carolina at Chapel Hill. He serves as Program Director for the AAP Council on Communications and Media and as an executive committee member of the North Carolina Pediatric Society. He has recorded commentaries for NPR's All Things Considered and provided content for various print, television, and Internet outlets.

It’s late August, and finally I feel ready for summer. You don’t need to remind me that I’m late: Our five children have no fewer than eight school orientations this week. The extras are because new high schoolers need two sessions, one for their parents and another just for students, where they tell them all the really important stuff, which the kids then forget until second semester when it’s too late. Can I go to the beach now? 

Of course the orientations are mainly just a chance for teachers to pass out supply lists, which, with severe budget cuts in our state, now include items like, “one bottle of hand sanitizer, five dry-erase markers in various colors, one qualified teaching assistant.” Also, I know why my 4th-grader needs to start the year with 24 #2 pencils: He chews them. But do all the kids have an oral fixation? Or is it that when my son has polished off his small forest of Ticonderogas, his classmates are expected to lend him theirs? I guess I’ll ask at orientation.

Hand-me-downs

Fuse

Here’s my question: If we saved all the money parents are about to spend on classroom hand sanitizer, could we actually afford a teaching assistant? Or at least a few more dry-erase markers? Because a study from New Zealand suggests that as long as soap and water are available, hand sanitizer does nothing but to give schoolchildren another excuse to get up out of their seats.

Patricia Priest and her colleagues from the University of Otego in Dunedin (I, too think it sounds made up) studied school absences among 2,443 students aged 5 to 11 in 68 schools. They performed the experiment during the winter (read “summer”), placing alcohol-based hand sanitizers in half the schools and relying on soap, water, and Kiwi common sense in the other half. Then they sat back and counted the absences, going as far as to call parents and force them to invent diseases for children who were actually playing hooky to quest after the One Ring to Rule Them All.

When the investigators tallied everything up, hand sanitizer appeared to make no difference in the number of absences from all illnesses or from any specific illness (respiratory or GI). Also unaffected were the length of illness, the length of the absence, or the likelihood of another family member contracting the illness. (That last endpoint confuses me, unless the kids were taking hand sanitizer home every night.) What this study proved was that whether or not children in New Zealand have access to hand sanitizer, they will still all be mistaken for Australians.

I think we’re alone now

If you can just spend a little one-on-one time with teenagers, they’ll reveal the most amazing things about their lives. That’s why I have five children: to make sure that kind of thing never happens. But in the pediatrician’s office, it’s a good thing. We need to know what’s going on in adolescents’ lives in order to help them avoid the dangers of substance abuse, high-risk sexual behavior, and whatever boneheaded dare has been going around YouTube this week. A new study out of Indianapolis confirms what common sense already tells us: If you don’t talk with teens’ parents out of the exam room for a few minutes, you miss the good stuff, (read “the bad stuff”). 

To prove it, the researchers surveyed around 500 adolescents (ages 13-17 years) and their parents regarding conversations they had with providers during their wellness exams. The best single statistic from their study was this: 89% of parents believed adolescents should be able to talk with their doctors privately, while 61% of parents preferred to stay in the exam room for the entire visit. That means that 50% of parents misunderstand one of the following terms: adolescent, private, or exam room.

Kids who did get to talk to their doctors alone discussed almost twice as many sensitive topics as did kids whose parents policed their conversations. On the up side, when parents refused to leave, kids were more likely to say “ma’am” and “sir,” to sit up straight for once please, and to brush that hair out of their eyes so the doctor can tell you’re looking at them, honey, thank you.

Call me maybe

Speaking of counseling teens and parents, do you sometimes think we’re talking with the wrong person? The National Institutes of Health just completed a study of distracted driving, a cause of 11% of fatal crashes among adolescents. Since 21% of those crashes involve mobile phone use, researchers asked 400 15- to 18-year-old drivers who in the heck they were talking to on the phone that made it worth risking their lives. Of the 86% of teens who reported talking on the phone while driving, 100% of them said the people they were talking to were their parents.

Fellow parents of teens, this does not make us look good. I like chatting with my kids, too, but it’s easier to converse with them when they’re alive, or at least not in a coma (if you can’t tell whether or not your adolescent is in a coma, have him brush that hair out of his eyes). We’ve got to do better, y’all; no one really wants to miss out on next year’s school orientation.

David L. Hill, M.D., FAAP, is the author of Dad to Dad: Parenting Like a Pro (AAP Publishing, 2012). He is also vice president of Cape Fear Pediatrics in Wilmington, N.C., and  adjunct assistant professor of pediatrics at the University of North Carolina at Chapel Hill. He serves as Program Director for the AAP Council on Communications and Media and as an executive committee member of the North Carolina Pediatric Society. He has recorded commentaries for NPR's All Things Considered and provided content for various print, television, and Internet outlets.

It’s late August, and finally I feel ready for summer. You don’t need to remind me that I’m late: Our five children have no fewer than eight school orientations this week. The extras are because new high schoolers need two sessions, one for their parents and another just for students, where they tell them all the really important stuff, which the kids then forget until second semester when it’s too late. Can I go to the beach now? 

Of course the orientations are mainly just a chance for teachers to pass out supply lists, which, with severe budget cuts in our state, now include items like, “one bottle of hand sanitizer, five dry-erase markers in various colors, one qualified teaching assistant.” Also, I know why my 4th-grader needs to start the year with 24 #2 pencils: He chews them. But do all the kids have an oral fixation? Or is it that when my son has polished off his small forest of Ticonderogas, his classmates are expected to lend him theirs? I guess I’ll ask at orientation.

Hand-me-downs

Fuse

Here’s my question: If we saved all the money parents are about to spend on classroom hand sanitizer, could we actually afford a teaching assistant? Or at least a few more dry-erase markers? Because a study from New Zealand suggests that as long as soap and water are available, hand sanitizer does nothing but to give schoolchildren another excuse to get up out of their seats.

Patricia Priest and her colleagues from the University of Otego in Dunedin (I, too think it sounds made up) studied school absences among 2,443 students aged 5 to 11 in 68 schools. They performed the experiment during the winter (read “summer”), placing alcohol-based hand sanitizers in half the schools and relying on soap, water, and Kiwi common sense in the other half. Then they sat back and counted the absences, going as far as to call parents and force them to invent diseases for children who were actually playing hooky to quest after the One Ring to Rule Them All.

When the investigators tallied everything up, hand sanitizer appeared to make no difference in the number of absences from all illnesses or from any specific illness (respiratory or GI). Also unaffected were the length of illness, the length of the absence, or the likelihood of another family member contracting the illness. (That last endpoint confuses me, unless the kids were taking hand sanitizer home every night.) What this study proved was that whether or not children in New Zealand have access to hand sanitizer, they will still all be mistaken for Australians.

I think we’re alone now

If you can just spend a little one-on-one time with teenagers, they’ll reveal the most amazing things about their lives. That’s why I have five children: to make sure that kind of thing never happens. But in the pediatrician’s office, it’s a good thing. We need to know what’s going on in adolescents’ lives in order to help them avoid the dangers of substance abuse, high-risk sexual behavior, and whatever boneheaded dare has been going around YouTube this week. A new study out of Indianapolis confirms what common sense already tells us: If you don’t talk with teens’ parents out of the exam room for a few minutes, you miss the good stuff, (read “the bad stuff”). 

To prove it, the researchers surveyed around 500 adolescents (ages 13-17 years) and their parents regarding conversations they had with providers during their wellness exams. The best single statistic from their study was this: 89% of parents believed adolescents should be able to talk with their doctors privately, while 61% of parents preferred to stay in the exam room for the entire visit. That means that 50% of parents misunderstand one of the following terms: adolescent, private, or exam room.

Kids who did get to talk to their doctors alone discussed almost twice as many sensitive topics as did kids whose parents policed their conversations. On the up side, when parents refused to leave, kids were more likely to say “ma’am” and “sir,” to sit up straight for once please, and to brush that hair out of their eyes so the doctor can tell you’re looking at them, honey, thank you.

Call me maybe

Speaking of counseling teens and parents, do you sometimes think we’re talking with the wrong person? The National Institutes of Health just completed a study of distracted driving, a cause of 11% of fatal crashes among adolescents. Since 21% of those crashes involve mobile phone use, researchers asked 400 15- to 18-year-old drivers who in the heck they were talking to on the phone that made it worth risking their lives. Of the 86% of teens who reported talking on the phone while driving, 100% of them said the people they were talking to were their parents.

Fellow parents of teens, this does not make us look good. I like chatting with my kids, too, but it’s easier to converse with them when they’re alive, or at least not in a coma (if you can’t tell whether or not your adolescent is in a coma, have him brush that hair out of his eyes). We’ve got to do better, y’all; no one really wants to miss out on next year’s school orientation.

David L. Hill, M.D., FAAP, is the author of Dad to Dad: Parenting Like a Pro (AAP Publishing, 2012). He is also vice president of Cape Fear Pediatrics in Wilmington, N.C., and  adjunct assistant professor of pediatrics at the University of North Carolina at Chapel Hill. He serves as Program Director for the AAP Council on Communications and Media and as an executive committee member of the North Carolina Pediatric Society. He has recorded commentaries for NPR's All Things Considered and provided content for various print, television, and Internet outlets.

“OOPHORECTOMY OR SALPINGECTOMY—WHICH MAKES MORE SENSE?”
William H. Parker, MD (March 2014)

Estrogen does not cause breast cancer
Excellent article by Dr. Parker, with one exception—he continues to promulgate the erroneous misconception that estrogen is what causes breast cancer. He repeats the inaccurate early conclusion of the Women’s Health Initiative (WHI) in 2002 that reported an increased risk of breast cancer. Yet review of that early data suggested that progestin was responsible for the increase, because patients taking estrogen alone had a lower breast cancer risk. Indeed, final and comprehensive review of the WHI studies in 2011 indicates that the estrogen-only arm of the study demonstrated lower breast cancer risks than the placebo group; that distinction continued in the post-intervention period as well.

We need to stop perpetuating the misconception that estrogen causes breast cancer, as the idea continues to be a major deterrent for patients to take estrogen during menopause, to the detriment of their health.

Rafael Haciski, MD
Naples, Florida

‡‡Dr. Parker responds:
Dr. Haciski is absolutely right about the fact that the estrogen-only arm of the WHI found a lower risk of breast cancer. The point I was trying to make, perhaps unsuccessfully, was that, in response to the 2002 WHI publication findings of an increased risk of breast cancer after estrogen and progesterone administration, the rate of oophorectomy declined. One interpretation of this trend toward ovarian conservation is that it reflected women deciding to keep their own ovarian hormones, rather than take exogenous hormones associated with health-related risks. While the 2004 WHI estrogen-only publication found a trend toward lower breast cancer risk, this association was not fully confirmed until 2012.¹ Even now, many women find the WHI estrogen-progestin and the estrogen-only publications confusing. It was not my intention to add to that confusion.

Reference

1. Anderson GL, Chlebowski RT, Aragaki AK, et al. Conjugated equine oestrogen and breast cancer incidence and mortality in postmenopausal women with hysterectomy: extended follow-up of the Women’s Health Initiative randomised placebo-controlled trial. Lancet Oncol. 2012;13(5):476–486.

“UPDATE ON MINIMALLY INVASIVE GYNECOLOGY”
Amy Garcia, MD (April 2014) 

Terminology is important: A cesarean scar pregnancy is not an ectopic pregnancy
I read with great interest the excellent “Update on minimally invasive gynecology,” by Amy Garcia, MD, co-member of OBG Management’s Board of Editors. In it she gives an excellent definition and discussion of an increase in the epidemic of cesarean scar defects (CSD). Her update focuses on intermenstrual bleeding when the menstrual blood presumably collects in the defect and comes out externally, and unpredictably, as old dark blood. I strongly agree with how she managed her clinical case, as I too have had success in such cases using the lowest dosed birth control pills.

My concern, however, is for a potentially fatal outcome because of our use of the term “cesarean scar ectopic pregnancy,” which she mentions as being an additional clinical outcome as described in the review article by Tower and colleagues.¹ The strictest definition of ectopic pregnancy is “a pregnancy that occurs outside the uterus.” Many clinicians, however, refer to any pregnancy outside the normal endometrial cavity as being “ectopic.” Regardless of the definition used, I am aware of cases when this nomenclature has been responsible (at least in part) for maternal mortality.

Here is a scenario: A clinician gets an imaging report that there is a cesarean scar ectopic pregnancy. The patient is then treated with a methotrexate protocol² for the ectopic pregnancy, even though the sac size is small and there is no embryo or cardiac activity.

This patient did not actually have a cesarean scar ectopic pregnancy. Ninety-eight percent of ectopic pregnancies are tubal and these are the ones in which methotrexate has been studied adequately and used. Cesarean scar pregnancies (and, in my opinion, cervical pregnancies as well as cornual pregnancies) are very different from “garden variety” tubal ectopic pregnancies, and should not automatically be plugged into existing methotrexate protocols. In my experience, the existing methotrexate protocols do not work for cesarean scar pregnancies, and place these women at risk for potential harm, such as severe hemorrhage.

We should be meticulous in referring to these as cesarean scar pregnancies—not cesarean scar ectopic pregnancies—to help keep well-meaning clinicians from being misled.

Steven R. Goldstein, MD
Professor, Department of Obstetrics and Gynecology
New York University School of Medicine, New York, New York

References

1. Tower AM, Frishman GN. Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications.
J Minim Invasive Gynecol. 2013;20(5):562–572.

2. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 94: Medical management of ectopic pregnancy. Obstet Gynecol. 2008;111(6):1479–1485.

‡‡Dr. Garcia responds:
While I can appreciate the comments from my co-editor, Dr. Goldstein, I believe he is defocusing the real issue regarding pregnancies occurring in scar defects caused by previous cesarean section. Rather than creating an issue with the semantics of “ectopic,” I would have preferred to read that Dr. Goldstein was emphasizing the potentially significant, if not fatal, complications and management of cesarean scar pregnancies as he did with co-authors Dr. Timor-Trisch and Dr. Monteagudo in a recent OBG Management article.¹

To clarify the terminology, I used “cesarean scar ectopic pregnancy” as it was quoted from the work of Tower and colleagues.² This terminology adequately describes the location of the pregnancy, as many cesarean scar defects are not just located in the isthmus of the uterus but in the cervix itself.³ And by all accounts a pregnancy at this location would be considered to be a cervical pregnancy, which ACOG defines as ectopic. The following definition of ectopic pregnancy is taken from Dr. Goldstein’s reference to ACOG Practice Bulletin #94: “Nearly all ectopic pregnancies (97%) are implanted within the fallopian tube, although implantation can occur within the abdomen, cervix, ovary, or uterine cornua.”⁴ Indeed if ACOG uses “ectopic” to describe a pregnancy within the cervix, then “cesarean scar ectopic pregnancy” should be adequate to describe the location of a potentially dangerous pregnancy.

Dr. Goldstein is concerned that our colleagues may become confused by the terminology “cesarean scar ectopic pregnancy” because the word “ectopic” might denote a less clinically significant scenario. Yet I say that anyone confused by the location of the pregnancy has not understood the part of the descriptive term that is “cesarean scar” regardless of the use of “ectopic.” Any clinician treating a patient with a cesarean scar pregnancy would benefit from Dr. ­Goldstein and his colleagues’ article for diagnosis and management of this critical and potentially life-threatening scenario.

References

1. Timor-Trisch IE, Monteagudo A, Goldstein SR. How to identify and manage cesarean scar pregnancy. OBG Manag. 2014;26(6):19–27. 

2. Tower AM, Frishman GN. Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications. J Minim Invasive Gynecol. 2013;20(5):562–572.

3. Garcia A. Update on minimally invasive gynecology. OBG Manag. 2014;26(4):18–32.

4. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 94: Medical management of ectopic pregnancy. Obstet Gynecol.  2008;111(6):1479–1485.

Totally painless birth: A new concept in obstetrical anesthesia and labor management

A recent review on epidural anesthesia for pain management during labor, which was published in the New England Journal of Medicine,¹ starts with the following case presentation: “A 30-year-old nulliparous woman at 39 weeks gestation is undergoing induction of labor for premature rupture of membranes. She is currently receiving an oxytocin infusion, and her cervical dilatation is 1 cm. Her obstetrician has ordered intermittent intravenous administration of Fentanyl for pain relief, but she feels nauseated, has been unable to rest, and describes her pain as 9 on scale of 10.”

The case we present in this letter sounds totally different: A 26-year-old multiparous woman at 39 weeks’ gestation is scheduled for induction of labor because of a decreased amount of amniotic fluid detected on prenatal ultrasonography. On admission, her cervix is 1-cm dilated and 60% effaced. She has no uterine contractions, and she describes her pain as 0 on the scale of 10. Anticipating a long induction and unwilling to experience any pain, the patient requests and is offered epidural anesthesia prior to oxytocin administration. Labor takes longer than expected but ultimately results in the birth of a healthy child. At no time during the course of labor and delivery does the mother experience any pain or discomfort, and she reports an extremely satisfying experience.

Traditionally, epidural anesthesia is administered upon maternal request when labor pain becomes difficult or intolerable. Many obstetricians discourage the use of epidural anesthesia prior to the onset of the active stage of labor, where the cervix is 4- to 6-cm dilated and the patient is in a great deal of pain.

This concept of administering an analgesic after the onset of pain is very different from the one where anesthesia is provided to patients prior to surgical procedures. No physician would begin a scheduled surgical procedure before confirming administration of adequate anesthesia. Why should labor be any different?

The pain of labor caused by uterine contractions and cervical dilatation is transmitted through visceral afferent nerves entering the spinal cord from T10 through L1. Perineal stretching transmits pain through the pudendal and sacral nerves. Epidural analgesia for labor and delivery involves injection of a local anesthetic agent and an opioid analgesic into the lumbar epidural space. The injected agents gradually diffuse across the dura into the subarachnoid cavity. In spinal analgesia, which is often combined with epidural analgesia, the medication is injected directly into the subarachnoid cavity, resulting in a more rapid effect.²

The American Society of Anesthesiologists and the American College of Obstetrics and Gynecology jointly state, “Labor causes severe pain for many women. There is no other circumstance where it is considered acceptable for an individual to experience severe pain, untreated. In the absence of medical contraindications, maternal request is a sufficient medical indication for pain relief during labor.”³

We decided to stretch this concept by allowing epidural anesthesia to be administered upon maternal consent in anticipation of pain, prior to onset. Our extensive literature search failed to find any comprehensive studies on the use of epidural anesthesia in anticipation of labor pain.

In theory, neuraxial local anesthetic in clinically relevant doses affect only skeletal muscles, not smooth muscles; therefore, this agent should not significantly decrease the amplitude or frequency of contractions in the myometrium.⁴ Randomized controlled trials of the effects of analgesia during labor do not exist since it is impossible to randomly assign women to a placebo group (no pain relief). Most trials have compared the use of epidural analgesia with that of systemic narcotics. In one large trial, 992 multiparous women were randomly assigned to either epidural analgesia or midwifery support supplemented by intramuscular narcotic injections. When pain was rated on a scale of 0–100 (100 is high), the median score before the study interventions was 80 in the group of patients who did not receive an epidural analgesia. With the administration of epidural analgesia, the median score was 27.⁵

Clinicians and patients also have been concerned about whether the use of epidural analgesia increases the risk of cesarean delivery. The results of three randomized controlled trials demonstrated that early administration of epidural analgesia does not increase the rate of cesarean delivery among women with spontaneous or induced labor as compared with early initiation of opioids.^6–8 The fact that early epidural placement does not appear to increase the incidence of cesarean delivery is encouraging for our ongoing study but doesn’t necessarily mean that epidural analgesia prior to the onset of pain (preventive epidural) will have the same outcome. More research is needed.

Boris M. Petrikovsky, MD, PhD; Elya Kozlov, MD; Matthew Ackert, MD; Ralph Ruggiero, MD; and Crystal Behofsits, DO
Wyckoff Heights Medical Center, Brooklyn NY

References

1. Haukins GL. Epidural analgesia for labor and delivery. N Engl J Med. 2010;362(16):1502–1510.

2. Catterall WA, Mackie K. Local anesthetics. In: Brunton LL, Lazo JS, Parker KL, eds. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 11th ed. New York, New York: McGraw-Hill; 2005;369–386.

3. American College of Obstetricians and Gynecologists. ACOG Committee Opinion #295: pain relief during labor. Obstet Gynecol. 2004;104(1):213.

4. Fanning RA, Campion DP, Collins CB, et al. A comparison of the inhibitory effects of bupivacaine and levobupivacaine on isolated human pregnant myometrium contractility. Anesth Analg. 2008;107(4):1303–1307.

5. Dickinson JE, Paech MJ, McDonald SJ, Evans SF. Maternal satisfaction with childbirth and intrapartum analgesia in nulliparous labor. Aust N Z J Obstet Gynecol. 2003;43(6):463–468.

6. Wong CA, Scavone BM, Peaceman AM, et al. The risk of cesarean delivery with neuraxial analgesia in labor. N Engl J Med. 2005;352(7):655–665.

7. Ohel G, Gonen R, Vaida S, Barak S, Gaitini L. Early versus late initiation of epidural analgesia in labor: does it increase the risk of cesarean section? A randomized trial. Am J Obstet Gynecol. 2006:194(3):600–605.

8. Wong CA, McCarthy RJ, Sullivan JT, Scavone BM, Gerber SE, Yaghmour EA. Early compared with late neuraxial analgesia in nulliparous labor induction: a randomized controlled trial. Obstet Gynecol. 2009;113(5):1066–1074.  

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

“OOPHORECTOMY OR SALPINGECTOMY—WHICH MAKES MORE SENSE?”
William H. Parker, MD (March 2014)

Estrogen does not cause breast cancer
Excellent article by Dr. Parker, with one exception—he continues to promulgate the erroneous misconception that estrogen is what causes breast cancer. He repeats the inaccurate early conclusion of the Women’s Health Initiative (WHI) in 2002 that reported an increased risk of breast cancer. Yet review of that early data suggested that progestin was responsible for the increase, because patients taking estrogen alone had a lower breast cancer risk. Indeed, final and comprehensive review of the WHI studies in 2011 indicates that the estrogen-only arm of the study demonstrated lower breast cancer risks than the placebo group; that distinction continued in the post-intervention period as well.

We need to stop perpetuating the misconception that estrogen causes breast cancer, as the idea continues to be a major deterrent for patients to take estrogen during menopause, to the detriment of their health.

Rafael Haciski, MD
Naples, Florida

‡‡Dr. Parker responds:
Dr. Haciski is absolutely right about the fact that the estrogen-only arm of the WHI found a lower risk of breast cancer. The point I was trying to make, perhaps unsuccessfully, was that, in response to the 2002 WHI publication findings of an increased risk of breast cancer after estrogen and progesterone administration, the rate of oophorectomy declined. One interpretation of this trend toward ovarian conservation is that it reflected women deciding to keep their own ovarian hormones, rather than take exogenous hormones associated with health-related risks. While the 2004 WHI estrogen-only publication found a trend toward lower breast cancer risk, this association was not fully confirmed until 2012.¹ Even now, many women find the WHI estrogen-progestin and the estrogen-only publications confusing. It was not my intention to add to that confusion.

Reference

1. Anderson GL, Chlebowski RT, Aragaki AK, et al. Conjugated equine oestrogen and breast cancer incidence and mortality in postmenopausal women with hysterectomy: extended follow-up of the Women’s Health Initiative randomised placebo-controlled trial. Lancet Oncol. 2012;13(5):476–486.

“UPDATE ON MINIMALLY INVASIVE GYNECOLOGY”
Amy Garcia, MD (April 2014) 

Terminology is important: A cesarean scar pregnancy is not an ectopic pregnancy
I read with great interest the excellent “Update on minimally invasive gynecology,” by Amy Garcia, MD, co-member of OBG Management’s Board of Editors. In it she gives an excellent definition and discussion of an increase in the epidemic of cesarean scar defects (CSD). Her update focuses on intermenstrual bleeding when the menstrual blood presumably collects in the defect and comes out externally, and unpredictably, as old dark blood. I strongly agree with how she managed her clinical case, as I too have had success in such cases using the lowest dosed birth control pills.

My concern, however, is for a potentially fatal outcome because of our use of the term “cesarean scar ectopic pregnancy,” which she mentions as being an additional clinical outcome as described in the review article by Tower and colleagues.¹ The strictest definition of ectopic pregnancy is “a pregnancy that occurs outside the uterus.” Many clinicians, however, refer to any pregnancy outside the normal endometrial cavity as being “ectopic.” Regardless of the definition used, I am aware of cases when this nomenclature has been responsible (at least in part) for maternal mortality.

Here is a scenario: A clinician gets an imaging report that there is a cesarean scar ectopic pregnancy. The patient is then treated with a methotrexate protocol² for the ectopic pregnancy, even though the sac size is small and there is no embryo or cardiac activity.

This patient did not actually have a cesarean scar ectopic pregnancy. Ninety-eight percent of ectopic pregnancies are tubal and these are the ones in which methotrexate has been studied adequately and used. Cesarean scar pregnancies (and, in my opinion, cervical pregnancies as well as cornual pregnancies) are very different from “garden variety” tubal ectopic pregnancies, and should not automatically be plugged into existing methotrexate protocols. In my experience, the existing methotrexate protocols do not work for cesarean scar pregnancies, and place these women at risk for potential harm, such as severe hemorrhage.

We should be meticulous in referring to these as cesarean scar pregnancies—not cesarean scar ectopic pregnancies—to help keep well-meaning clinicians from being misled.

Steven R. Goldstein, MD
Professor, Department of Obstetrics and Gynecology
New York University School of Medicine, New York, New York

References

1. Tower AM, Frishman GN. Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications.
J Minim Invasive Gynecol. 2013;20(5):562–572.

2. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 94: Medical management of ectopic pregnancy. Obstet Gynecol. 2008;111(6):1479–1485.

‡‡Dr. Garcia responds:
While I can appreciate the comments from my co-editor, Dr. Goldstein, I believe he is defocusing the real issue regarding pregnancies occurring in scar defects caused by previous cesarean section. Rather than creating an issue with the semantics of “ectopic,” I would have preferred to read that Dr. Goldstein was emphasizing the potentially significant, if not fatal, complications and management of cesarean scar pregnancies as he did with co-authors Dr. Timor-Trisch and Dr. Monteagudo in a recent OBG Management article.¹

To clarify the terminology, I used “cesarean scar ectopic pregnancy” as it was quoted from the work of Tower and colleagues.² This terminology adequately describes the location of the pregnancy, as many cesarean scar defects are not just located in the isthmus of the uterus but in the cervix itself.³ And by all accounts a pregnancy at this location would be considered to be a cervical pregnancy, which ACOG defines as ectopic. The following definition of ectopic pregnancy is taken from Dr. Goldstein’s reference to ACOG Practice Bulletin #94: “Nearly all ectopic pregnancies (97%) are implanted within the fallopian tube, although implantation can occur within the abdomen, cervix, ovary, or uterine cornua.”⁴ Indeed if ACOG uses “ectopic” to describe a pregnancy within the cervix, then “cesarean scar ectopic pregnancy” should be adequate to describe the location of a potentially dangerous pregnancy.

Dr. Goldstein is concerned that our colleagues may become confused by the terminology “cesarean scar ectopic pregnancy” because the word “ectopic” might denote a less clinically significant scenario. Yet I say that anyone confused by the location of the pregnancy has not understood the part of the descriptive term that is “cesarean scar” regardless of the use of “ectopic.” Any clinician treating a patient with a cesarean scar pregnancy would benefit from Dr. ­Goldstein and his colleagues’ article for diagnosis and management of this critical and potentially life-threatening scenario.

References

1. Timor-Trisch IE, Monteagudo A, Goldstein SR. How to identify and manage cesarean scar pregnancy. OBG Manag. 2014;26(6):19–27. 

2. Tower AM, Frishman GN. Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications. J Minim Invasive Gynecol. 2013;20(5):562–572.

3. Garcia A. Update on minimally invasive gynecology. OBG Manag. 2014;26(4):18–32.

4. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 94: Medical management of ectopic pregnancy. Obstet Gynecol.  2008;111(6):1479–1485.

Totally painless birth: A new concept in obstetrical anesthesia and labor management

A recent review on epidural anesthesia for pain management during labor, which was published in the New England Journal of Medicine,¹ starts with the following case presentation: “A 30-year-old nulliparous woman at 39 weeks gestation is undergoing induction of labor for premature rupture of membranes. She is currently receiving an oxytocin infusion, and her cervical dilatation is 1 cm. Her obstetrician has ordered intermittent intravenous administration of Fentanyl for pain relief, but she feels nauseated, has been unable to rest, and describes her pain as 9 on scale of 10.”

The case we present in this letter sounds totally different: A 26-year-old multiparous woman at 39 weeks’ gestation is scheduled for induction of labor because of a decreased amount of amniotic fluid detected on prenatal ultrasonography. On admission, her cervix is 1-cm dilated and 60% effaced. She has no uterine contractions, and she describes her pain as 0 on the scale of 10. Anticipating a long induction and unwilling to experience any pain, the patient requests and is offered epidural anesthesia prior to oxytocin administration. Labor takes longer than expected but ultimately results in the birth of a healthy child. At no time during the course of labor and delivery does the mother experience any pain or discomfort, and she reports an extremely satisfying experience.

Traditionally, epidural anesthesia is administered upon maternal request when labor pain becomes difficult or intolerable. Many obstetricians discourage the use of epidural anesthesia prior to the onset of the active stage of labor, where the cervix is 4- to 6-cm dilated and the patient is in a great deal of pain.

This concept of administering an analgesic after the onset of pain is very different from the one where anesthesia is provided to patients prior to surgical procedures. No physician would begin a scheduled surgical procedure before confirming administration of adequate anesthesia. Why should labor be any different?

The pain of labor caused by uterine contractions and cervical dilatation is transmitted through visceral afferent nerves entering the spinal cord from T10 through L1. Perineal stretching transmits pain through the pudendal and sacral nerves. Epidural analgesia for labor and delivery involves injection of a local anesthetic agent and an opioid analgesic into the lumbar epidural space. The injected agents gradually diffuse across the dura into the subarachnoid cavity. In spinal analgesia, which is often combined with epidural analgesia, the medication is injected directly into the subarachnoid cavity, resulting in a more rapid effect.²

The American Society of Anesthesiologists and the American College of Obstetrics and Gynecology jointly state, “Labor causes severe pain for many women. There is no other circumstance where it is considered acceptable for an individual to experience severe pain, untreated. In the absence of medical contraindications, maternal request is a sufficient medical indication for pain relief during labor.”³

We decided to stretch this concept by allowing epidural anesthesia to be administered upon maternal consent in anticipation of pain, prior to onset. Our extensive literature search failed to find any comprehensive studies on the use of epidural anesthesia in anticipation of labor pain.

In theory, neuraxial local anesthetic in clinically relevant doses affect only skeletal muscles, not smooth muscles; therefore, this agent should not significantly decrease the amplitude or frequency of contractions in the myometrium.⁴ Randomized controlled trials of the effects of analgesia during labor do not exist since it is impossible to randomly assign women to a placebo group (no pain relief). Most trials have compared the use of epidural analgesia with that of systemic narcotics. In one large trial, 992 multiparous women were randomly assigned to either epidural analgesia or midwifery support supplemented by intramuscular narcotic injections. When pain was rated on a scale of 0–100 (100 is high), the median score before the study interventions was 80 in the group of patients who did not receive an epidural analgesia. With the administration of epidural analgesia, the median score was 27.⁵

Clinicians and patients also have been concerned about whether the use of epidural analgesia increases the risk of cesarean delivery. The results of three randomized controlled trials demonstrated that early administration of epidural analgesia does not increase the rate of cesarean delivery among women with spontaneous or induced labor as compared with early initiation of opioids.^6–8 The fact that early epidural placement does not appear to increase the incidence of cesarean delivery is encouraging for our ongoing study but doesn’t necessarily mean that epidural analgesia prior to the onset of pain (preventive epidural) will have the same outcome. More research is needed.

Boris M. Petrikovsky, MD, PhD; Elya Kozlov, MD; Matthew Ackert, MD; Ralph Ruggiero, MD; and Crystal Behofsits, DO
Wyckoff Heights Medical Center, Brooklyn NY

References

1. Haukins GL. Epidural analgesia for labor and delivery. N Engl J Med. 2010;362(16):1502–1510.

2. Catterall WA, Mackie K. Local anesthetics. In: Brunton LL, Lazo JS, Parker KL, eds. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 11th ed. New York, New York: McGraw-Hill; 2005;369–386.

3. American College of Obstetricians and Gynecologists. ACOG Committee Opinion #295: pain relief during labor. Obstet Gynecol. 2004;104(1):213.

4. Fanning RA, Campion DP, Collins CB, et al. A comparison of the inhibitory effects of bupivacaine and levobupivacaine on isolated human pregnant myometrium contractility. Anesth Analg. 2008;107(4):1303–1307.

5. Dickinson JE, Paech MJ, McDonald SJ, Evans SF. Maternal satisfaction with childbirth and intrapartum analgesia in nulliparous labor. Aust N Z J Obstet Gynecol. 2003;43(6):463–468.

6. Wong CA, Scavone BM, Peaceman AM, et al. The risk of cesarean delivery with neuraxial analgesia in labor. N Engl J Med. 2005;352(7):655–665.

7. Ohel G, Gonen R, Vaida S, Barak S, Gaitini L. Early versus late initiation of epidural analgesia in labor: does it increase the risk of cesarean section? A randomized trial. Am J Obstet Gynecol. 2006:194(3):600–605.

8. Wong CA, McCarthy RJ, Sullivan JT, Scavone BM, Gerber SE, Yaghmour EA. Early compared with late neuraxial analgesia in nulliparous labor induction: a randomized controlled trial. Obstet Gynecol. 2009;113(5):1066–1074.  

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

“OOPHORECTOMY OR SALPINGECTOMY—WHICH MAKES MORE SENSE?”
William H. Parker, MD (March 2014)

Estrogen does not cause breast cancer
Excellent article by Dr. Parker, with one exception—he continues to promulgate the erroneous misconception that estrogen is what causes breast cancer. He repeats the inaccurate early conclusion of the Women’s Health Initiative (WHI) in 2002 that reported an increased risk of breast cancer. Yet review of that early data suggested that progestin was responsible for the increase, because patients taking estrogen alone had a lower breast cancer risk. Indeed, final and comprehensive review of the WHI studies in 2011 indicates that the estrogen-only arm of the study demonstrated lower breast cancer risks than the placebo group; that distinction continued in the post-intervention period as well.

We need to stop perpetuating the misconception that estrogen causes breast cancer, as the idea continues to be a major deterrent for patients to take estrogen during menopause, to the detriment of their health.

Rafael Haciski, MD
Naples, Florida

‡‡Dr. Parker responds:
Dr. Haciski is absolutely right about the fact that the estrogen-only arm of the WHI found a lower risk of breast cancer. The point I was trying to make, perhaps unsuccessfully, was that, in response to the 2002 WHI publication findings of an increased risk of breast cancer after estrogen and progesterone administration, the rate of oophorectomy declined. One interpretation of this trend toward ovarian conservation is that it reflected women deciding to keep their own ovarian hormones, rather than take exogenous hormones associated with health-related risks. While the 2004 WHI estrogen-only publication found a trend toward lower breast cancer risk, this association was not fully confirmed until 2012.¹ Even now, many women find the WHI estrogen-progestin and the estrogen-only publications confusing. It was not my intention to add to that confusion.

Reference

1. Anderson GL, Chlebowski RT, Aragaki AK, et al. Conjugated equine oestrogen and breast cancer incidence and mortality in postmenopausal women with hysterectomy: extended follow-up of the Women’s Health Initiative randomised placebo-controlled trial. Lancet Oncol. 2012;13(5):476–486.

“UPDATE ON MINIMALLY INVASIVE GYNECOLOGY”
Amy Garcia, MD (April 2014) 

Terminology is important: A cesarean scar pregnancy is not an ectopic pregnancy
I read with great interest the excellent “Update on minimally invasive gynecology,” by Amy Garcia, MD, co-member of OBG Management’s Board of Editors. In it she gives an excellent definition and discussion of an increase in the epidemic of cesarean scar defects (CSD). Her update focuses on intermenstrual bleeding when the menstrual blood presumably collects in the defect and comes out externally, and unpredictably, as old dark blood. I strongly agree with how she managed her clinical case, as I too have had success in such cases using the lowest dosed birth control pills.

My concern, however, is for a potentially fatal outcome because of our use of the term “cesarean scar ectopic pregnancy,” which she mentions as being an additional clinical outcome as described in the review article by Tower and colleagues.¹ The strictest definition of ectopic pregnancy is “a pregnancy that occurs outside the uterus.” Many clinicians, however, refer to any pregnancy outside the normal endometrial cavity as being “ectopic.” Regardless of the definition used, I am aware of cases when this nomenclature has been responsible (at least in part) for maternal mortality.

Here is a scenario: A clinician gets an imaging report that there is a cesarean scar ectopic pregnancy. The patient is then treated with a methotrexate protocol² for the ectopic pregnancy, even though the sac size is small and there is no embryo or cardiac activity.

This patient did not actually have a cesarean scar ectopic pregnancy. Ninety-eight percent of ectopic pregnancies are tubal and these are the ones in which methotrexate has been studied adequately and used. Cesarean scar pregnancies (and, in my opinion, cervical pregnancies as well as cornual pregnancies) are very different from “garden variety” tubal ectopic pregnancies, and should not automatically be plugged into existing methotrexate protocols. In my experience, the existing methotrexate protocols do not work for cesarean scar pregnancies, and place these women at risk for potential harm, such as severe hemorrhage.

We should be meticulous in referring to these as cesarean scar pregnancies—not cesarean scar ectopic pregnancies—to help keep well-meaning clinicians from being misled.

Steven R. Goldstein, MD
Professor, Department of Obstetrics and Gynecology
New York University School of Medicine, New York, New York

References

1. Tower AM, Frishman GN. Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications.
J Minim Invasive Gynecol. 2013;20(5):562–572.

2. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 94: Medical management of ectopic pregnancy. Obstet Gynecol. 2008;111(6):1479–1485.

‡‡Dr. Garcia responds:
While I can appreciate the comments from my co-editor, Dr. Goldstein, I believe he is defocusing the real issue regarding pregnancies occurring in scar defects caused by previous cesarean section. Rather than creating an issue with the semantics of “ectopic,” I would have preferred to read that Dr. Goldstein was emphasizing the potentially significant, if not fatal, complications and management of cesarean scar pregnancies as he did with co-authors Dr. Timor-Trisch and Dr. Monteagudo in a recent OBG Management article.¹

To clarify the terminology, I used “cesarean scar ectopic pregnancy” as it was quoted from the work of Tower and colleagues.² This terminology adequately describes the location of the pregnancy, as many cesarean scar defects are not just located in the isthmus of the uterus but in the cervix itself.³ And by all accounts a pregnancy at this location would be considered to be a cervical pregnancy, which ACOG defines as ectopic. The following definition of ectopic pregnancy is taken from Dr. Goldstein’s reference to ACOG Practice Bulletin #94: “Nearly all ectopic pregnancies (97%) are implanted within the fallopian tube, although implantation can occur within the abdomen, cervix, ovary, or uterine cornua.”⁴ Indeed if ACOG uses “ectopic” to describe a pregnancy within the cervix, then “cesarean scar ectopic pregnancy” should be adequate to describe the location of a potentially dangerous pregnancy.

Dr. Goldstein is concerned that our colleagues may become confused by the terminology “cesarean scar ectopic pregnancy” because the word “ectopic” might denote a less clinically significant scenario. Yet I say that anyone confused by the location of the pregnancy has not understood the part of the descriptive term that is “cesarean scar” regardless of the use of “ectopic.” Any clinician treating a patient with a cesarean scar pregnancy would benefit from Dr. ­Goldstein and his colleagues’ article for diagnosis and management of this critical and potentially life-threatening scenario.

References

1. Timor-Trisch IE, Monteagudo A, Goldstein SR. How to identify and manage cesarean scar pregnancy. OBG Manag. 2014;26(6):19–27. 

2. Tower AM, Frishman GN. Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications. J Minim Invasive Gynecol. 2013;20(5):562–572.

3. Garcia A. Update on minimally invasive gynecology. OBG Manag. 2014;26(4):18–32.

4. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 94: Medical management of ectopic pregnancy. Obstet Gynecol.  2008;111(6):1479–1485.

Totally painless birth: A new concept in obstetrical anesthesia and labor management

A recent review on epidural anesthesia for pain management during labor, which was published in the New England Journal of Medicine,¹ starts with the following case presentation: “A 30-year-old nulliparous woman at 39 weeks gestation is undergoing induction of labor for premature rupture of membranes. She is currently receiving an oxytocin infusion, and her cervical dilatation is 1 cm. Her obstetrician has ordered intermittent intravenous administration of Fentanyl for pain relief, but she feels nauseated, has been unable to rest, and describes her pain as 9 on scale of 10.”

The case we present in this letter sounds totally different: A 26-year-old multiparous woman at 39 weeks’ gestation is scheduled for induction of labor because of a decreased amount of amniotic fluid detected on prenatal ultrasonography. On admission, her cervix is 1-cm dilated and 60% effaced. She has no uterine contractions, and she describes her pain as 0 on the scale of 10. Anticipating a long induction and unwilling to experience any pain, the patient requests and is offered epidural anesthesia prior to oxytocin administration. Labor takes longer than expected but ultimately results in the birth of a healthy child. At no time during the course of labor and delivery does the mother experience any pain or discomfort, and she reports an extremely satisfying experience.

Traditionally, epidural anesthesia is administered upon maternal request when labor pain becomes difficult or intolerable. Many obstetricians discourage the use of epidural anesthesia prior to the onset of the active stage of labor, where the cervix is 4- to 6-cm dilated and the patient is in a great deal of pain.

This concept of administering an analgesic after the onset of pain is very different from the one where anesthesia is provided to patients prior to surgical procedures. No physician would begin a scheduled surgical procedure before confirming administration of adequate anesthesia. Why should labor be any different?

The pain of labor caused by uterine contractions and cervical dilatation is transmitted through visceral afferent nerves entering the spinal cord from T10 through L1. Perineal stretching transmits pain through the pudendal and sacral nerves. Epidural analgesia for labor and delivery involves injection of a local anesthetic agent and an opioid analgesic into the lumbar epidural space. The injected agents gradually diffuse across the dura into the subarachnoid cavity. In spinal analgesia, which is often combined with epidural analgesia, the medication is injected directly into the subarachnoid cavity, resulting in a more rapid effect.²

The American Society of Anesthesiologists and the American College of Obstetrics and Gynecology jointly state, “Labor causes severe pain for many women. There is no other circumstance where it is considered acceptable for an individual to experience severe pain, untreated. In the absence of medical contraindications, maternal request is a sufficient medical indication for pain relief during labor.”³

We decided to stretch this concept by allowing epidural anesthesia to be administered upon maternal consent in anticipation of pain, prior to onset. Our extensive literature search failed to find any comprehensive studies on the use of epidural anesthesia in anticipation of labor pain.

In theory, neuraxial local anesthetic in clinically relevant doses affect only skeletal muscles, not smooth muscles; therefore, this agent should not significantly decrease the amplitude or frequency of contractions in the myometrium.⁴ Randomized controlled trials of the effects of analgesia during labor do not exist since it is impossible to randomly assign women to a placebo group (no pain relief). Most trials have compared the use of epidural analgesia with that of systemic narcotics. In one large trial, 992 multiparous women were randomly assigned to either epidural analgesia or midwifery support supplemented by intramuscular narcotic injections. When pain was rated on a scale of 0–100 (100 is high), the median score before the study interventions was 80 in the group of patients who did not receive an epidural analgesia. With the administration of epidural analgesia, the median score was 27.⁵

Clinicians and patients also have been concerned about whether the use of epidural analgesia increases the risk of cesarean delivery. The results of three randomized controlled trials demonstrated that early administration of epidural analgesia does not increase the rate of cesarean delivery among women with spontaneous or induced labor as compared with early initiation of opioids.^6–8 The fact that early epidural placement does not appear to increase the incidence of cesarean delivery is encouraging for our ongoing study but doesn’t necessarily mean that epidural analgesia prior to the onset of pain (preventive epidural) will have the same outcome. More research is needed.

Boris M. Petrikovsky, MD, PhD; Elya Kozlov, MD; Matthew Ackert, MD; Ralph Ruggiero, MD; and Crystal Behofsits, DO
Wyckoff Heights Medical Center, Brooklyn NY

References

1. Haukins GL. Epidural analgesia for labor and delivery. N Engl J Med. 2010;362(16):1502–1510.

2. Catterall WA, Mackie K. Local anesthetics. In: Brunton LL, Lazo JS, Parker KL, eds. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 11th ed. New York, New York: McGraw-Hill; 2005;369–386.

3. American College of Obstetricians and Gynecologists. ACOG Committee Opinion #295: pain relief during labor. Obstet Gynecol. 2004;104(1):213.

4. Fanning RA, Campion DP, Collins CB, et al. A comparison of the inhibitory effects of bupivacaine and levobupivacaine on isolated human pregnant myometrium contractility. Anesth Analg. 2008;107(4):1303–1307.

5. Dickinson JE, Paech MJ, McDonald SJ, Evans SF. Maternal satisfaction with childbirth and intrapartum analgesia in nulliparous labor. Aust N Z J Obstet Gynecol. 2003;43(6):463–468.

6. Wong CA, Scavone BM, Peaceman AM, et al. The risk of cesarean delivery with neuraxial analgesia in labor. N Engl J Med. 2005;352(7):655–665.

7. Ohel G, Gonen R, Vaida S, Barak S, Gaitini L. Early versus late initiation of epidural analgesia in labor: does it increase the risk of cesarean section? A randomized trial. Am J Obstet Gynecol. 2006:194(3):600–605.

8. Wong CA, McCarthy RJ, Sullivan JT, Scavone BM, Gerber SE, Yaghmour EA. Early compared with late neuraxial analgesia in nulliparous labor induction: a randomized controlled trial. Obstet Gynecol. 2009;113(5):1066–1074.  

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.