Category Archives: Obstetrics and Gynecology

Cancer Research and Care Embrace Technology

Oncology is about to take a huge step toward changing the way that cancer is understood and treated with the development of a breast cancer-specific prototype for a rapid learning system in cancer care. This system takes advantage of health IT advances (such as EHRs) in order to connect oncology practices, measure quality and performance, and provide physicians with decision support in real time.

The prototype is part of the American Society of Clinical Oncology’s (ASCO’s) vision for CancerLinQ  a “system that assembles and analyzes millions of unconnected medical records in a central knowledge base, which will grow ‘smarter’ over time,” according to the organization.

Illustration courtesy of the American Society of Clinical Oncology

As part of ASCO’s focus on quality improvement, the protoype will use clinical practice guidelines and measures of the Quality Oncology Practice Initiative to build quality measurement and clinical decision tools. Next, breast cancer patient records and data (stripped of identifying information) imported from the electronic health records (EHRs) of academic centers and oncology practices will be added.

As a proof of concept, ASCO says that the prototype will:

  • provide the foundational information and lessons learned to allow ASCO to move into a full-scale implementation;
  • provide real-time, standardized, clinical decision support integration within a demonstration EHR;
  • demonstrate a set of value-added tools; including a physician’s ability to measure their performance against a sub-set of QOPI measures in real-time;
  • demonstrate the ability to capture data from a variety of sources and aggregate the data using novel methodologies;
  • and create a demonstration which will allow exploration of data in unprecedented ways and generate hypotheses related to breast cancer.

Once the full technology platform is completed, CancerLinQ ultimately is expected to improve personalized treatment decisions by capturing patient information in real time at the point of care; provide decision support to cancer teams to adapt treatment plans to each patient and his or her cancer; and report on quality of care, compared with clinical guidelines and the outcomes of other patients. It’s also hoped that the system will help to “educate and empower patients by linking them to their cancer care teams and providing personalized treatment information at their fingertips.” Lastly, the system stands to be a powerful new data source for analysis of real-world quality and comparative effectiveness, as well as to generate new ideas for clinical research. It’s hoped that in time, this approach can be adapted to all types of cancer.

Kerri Wachter

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Counties Pursue Safer Drug Disposal

New programs to make it easier and safer for San Francisco Bay Area residents to get rid of unused medications are some of the first to try this on a large scale, and may serve as models for other cities and counties.

Since May 2012, a pilot program in San Francisco has allowed residents to drop off old medications at 13 pharmacies and 10 police stations (where controlled substances must be brought). San Francisco supervisors initially considered forcing drug companies to fund the program, and instead agreed to accept $110,000 from Genentech and the Pharmaceutical Research and Manufacturers of America to fund the program.

(Photo by J. Troha, courtesy of National Cancer Institute)

On July 24, supervisors in Alameda County (which includes East Bay cities such as Oakland and Berkeley) are likely to approve a Safe Drug Disposal Ordinance that would require drug companies to pay for disposal of their products or face fines of up to $1,000 per day, The Bay Citizen reports. Public agencies currently fund 25 drug disposal sites there, and the cash-strapped county wants the comparatively wealthy pharmaceutical industry to take more financial responsibility for the lifecycle of its products in order to reduce overdoses, accidental poisonings, and water pollution.

As we reported earlier this year, making prescription-drug “recycling” a cultural norm is one of five emerging public policies that could help the medical system keep opioids available while reducing the risk of addiction, abuse and accidental overdose, according to Keith N. Humphreys, Ph.D. Smaller versions have met with success, such as a drug take-back day organized by sheriffs in a small town in Arkansas (population 20,000) that brought in 25,000 pills, said Dr. Humphreys, acting director of the Center for Health Care Evaluation, Veterans Health Administration, Menlo Park, Calif., and a professor of psychiatry at Stanford University. He reports having no financial conflicts of interest on this issue.

Not everyone is happy with the idea. Trade associations for the pharmaceutical industry and biomedical companies argue that there’s no evidence that these programs will reduce poisonings, and they haven’t ruled out the possibility of suing to block the Alameda County ordinance, The Bay Citizen reports. The compromise that San Francisco reached for voluntary instead of mandatory funding from the pharmaceutical industry may be a middle ground.

In an era when government agencies have less and less money for public programs, it’s probably inevitable that they’ll pursue alternative financing for programs like this.

If your community has a drug disposal program, let us know how it’s working. Will these programs succeed, and will they reduce abuse, addiction, and accidental overdoses? We’ll keep an eye on this topic, and keep you posted.

–Sherry Boschert (@sherryboschert on Twitter)

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Can HPV Vaccination Be Simplified?

The human papillomavirus vaccine was recommended for routine use in 11-12 year old girls in 2007. But by 2010, the most recent year for which data are available, less than half had received one dose of the three-dose series and fewer than a third had received all three. The inconvenience of the need for three separate office visits along with the vaccine’s price – about $130 per Gardasil dose, as of July 2011 – have certainly contributed to the low uptake.

©BVDC/Fotolia.com

Now, some parts of the world – including Mexico, Switzerland, and parts of Canada have moved to either a two-dose schedule, or a so-called “extended dose” schedule, in which the third dose is delayed until 5 years after the second one. (In the current U.S. three-dose schedule, doses two and three are given at 2 and 6 months, respectively, after dose one.)

“There has been emerging interest in HPV vaccine schedules with fewer than three doses, for a variety of reasons. These schedules could facilitate implementation, they may be more convenient for providers, parents, and vaccinees, and of course they would be cost-saving,” said Dr. Lauri Markowitz, of the Centers for Disease Control and Prevention, at a recent meeting of the CDC’s Advisory Committee on Immunization Practices.

No data on the efficacy of fewer than three doses have been published by either Merck or GlaxoSmithKline from their pivotal trials of Gardasil and Cervarix, respectively. But some other data are available for both vaccines. A nonrandomized study in Costa Rica that included more than 1,100 women who had received just one or two doses of Cervarix suggested that two doses or maybe even just one – could be as protective as three doses against infection at 4 years.

And in an as-yet unpublished study done in Canada, immune responses against both HPV 16 and 18 at 3 years were similar between two doses of Gardasil given at age 9-13 years and three doses given at age 16-26 years. But, there are limited efficacy data and no long-term data, Dr. Markowitz said.

Electron micrograph of human papillomavirus (HPV) / Courtesy of the National Cancer Institute

In an e-mail, Deb Wambold of Merck Vaccines said that, while the company does support studies of alternative dosing schedules for HPV vaccination including two-dose regimens, so far those studies are “interesting preliminary explorations in select subpopulations of vaccinees,” and “It is important to note that there are no data on the clinical efficacy or durability of effectiveness with two doses of either of the HPV vaccines, as we have for the recommended three-dose vaccination regimen.”

Dr. Joseph A. Bocchini Jr., who chairs the ACIP HPV vaccine working group, concurred. In an interview at the ACIP meeting, he noted that the long-term efficacy of two doses is “worth looking at,” as is the varying of three-dose schedules. “But, at this point, there are too few data to apply this to recommendations in the United States.”

More data from ongoing trials will be available in the next few years, Dr. Markowitz said.

-Miriam E. Tucker (@MiriamETucker on Twitter)

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“Turning the Tide” on HIV/AIDS

In advance of the upcoming XIX International AIDS Conference, the International AIDS Society and the University of California, San Francisco, have issued the “Washington D.C. Declaration,” a nine-point action plan aimed at broadening global support for “Turning the Tide” of the AIDS epidemic.

Everyone is urged to sign the Declaration.

It calls for:

1) An increase in targeted new investments;
2) Evidence-based HIV prevention, treatment, and care in accord with the human rights of those at greatest risk and in greatest need;
3) An end to stigma, discrimination, legal sanctions, and human rights abuses against those living with and at risk for HIV;
4) Marked increases in HIV testing, counseling, and linkages to services;
5) Treatment for all pregnant and nursing women living with HIV and an end to perinatal transmission;
6) Expanded access to antiretroviral treatment for all in need;
7) Identification, diagnosis, and treatment of tuberculosis;
8) Accelerated research on new tools for HIV prevention, treatment, vaccines, and a cure;
9) Mobilization and meaningful involvement of affected communities.

Turning the Tide is the theme of this year’s biennial conference, which will take place July 22-27 in Washington.  It is expected to draw 25,000 attendees, including HIV professionals, activists, politicians, and celebrities. Sir Elton John will open the conference and Bill Clinton will close it. A large delegation of U.S. members of Congress will participate, and Bill Gates will moderate a session. An enormous “Global Village” outside the D.C. Convention Center will be open to the public. “If you haven’t been, it’s a conference like no other,” conference cochair Dr. Diane V. Havlir said at a press briefing.

The recent optimism regarding HIV/AIDS stems from major advances in knowledge regarding prevention of partner transmission with early patient treatment, pre-exposure prophylaxis, and male circumcision as HIV infection prevention (new data will be released at the meeting), all of which are viewed as breakthroughs  in the fight against HIV/AIDS. “So we have now in our hands the tools. The question is how do we combine those tools together, and how do we roll them out,” said Dr. Havlir, professor of medicine at the University of California, San Francisco, and chief of the HIV/AIDS division at San Francisco General Hospital.

Dr. Diane V. Havlir / Photo by Miriam E. Tucker

Monday’s plenary session will include an address from Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, on “Ending the HIV Epidemic: From Scientific Advances to Public Health Implementation.” Other plenary topics during the week will include viral eradication, vaccines, TB and HIV, and HIV/AIDS in specific populations including minorities, women, youth, and men who have sex with men. On Friday, there will be a plenary talk that may be of particular interest to the primary care community, “The Intersection of Noncommunicable Diseases and Aging in HIV.”

Plenaries and other conference sessions will be webcast at http://globalhealth.kff.org/aids2012.

-Miriam E. Tucker (@MiriamETucker on Twitter)

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Title IX Hits 40

Image courtesy of Sarah Jones via Wikimedia Commons (CC)

What does Title IX mean to you? Athletics is typically high up on the list for many people. Title IX has played an important role in getting girls and young women onto the field. On the 40th anniversary of the landmark gender equity in education legislation, U.S. Secretary of Education Arne Duncan noted in a speech, “when Title IX was enacted in 1972, less than 30,000 female students participated in sports and recreational programs at NCAA member institutions nationwide. Today, that number has increased nearly six-fold. And at the high school level, the number of girls participating in athletics has increased ten-fold since 1972, to three million girls today.”

In an era of nationwide public health concerns over childhood obesity, getting girls and young women involved in sports becomes even more important. However, Title IX’s expansion of school-based athletics programs has more far-reaching benefits as well. As Secretary Duncan pointed out, female athletes “are more likely to graduate from college than female students who don’t play sports.” Female athletes are also less likely to use drugs and become pregnant as teenagers.

Sports are only part of the Title IX picture though. In fact, neither the word “sports” nor “athletics” are used in the text of the legislation. The law has changed the academic landscape for female students.

U.S. Navy photo by Greg Vojtko (Public Domain)

Here’s a few things that you might not know:

  • 57% of students in postsecondary education in 2009-2010 were women; women also accounted for 62.6% of students receiving a master’s degree.
  • Since 1976, girls enrolled in gifted and talented education programs have outnumbered boys enrolled. In 2009, 8.1% of girls participated in gifted and talented education programs, compared to 7.4% of boys.
  • A greater percentage of the girls in 7th or 8th grade (20%) are taking Algebra I, compared with boys (18%).
  • Girls are evenly represented in biology and outnumber boys in chemistry, but are underrepresented in physics.

Welcome to middle age, Title IX. Let’s see what else you can do to get girls on the field and in the classroom.

Kerri Wachter

Data from the “Gender Equity in Education A Data Snapshot” by the U.S. Department of Education’s Civil Rights Data Collection.

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IUD Contraception Cost May Inhibit Use

A copper intrauterine device (IUD) retails for the equivalent of $20 in France. In the United States, it costs $860, Dr. Eve Espey says.

“This is highway robbery. It has to change,” she said during a talk on long-acting reversible contraception at the annual meeting of the American College of Obstetricians and Gynecologists (ACOG). “Honestly,” she sighed, “If you went to Home Depot and picked up the supplies to make yourself an IUD, what would it cost? Like, under $1.” (Not that she’s advocating that.)

Dr. Eve Espey (Sherry Boschert/IMNG Medical Media)

Strong words, and they’re not coming from just any frustrated physician. Dr. Espey is chair of ACOG’s Working Group on Long-Acting Reversible Contraception and a professor of ob.gyn. at the University of New Mexico, Albuquerque.

The high U.S. price may be one reason that only 6% of U.S. women using contraceptives choose an IUD, even though studies show it’s one of the most effective kinds of contraception, along with levonorgestrel intrauterine systems and contraceptive implants, the other two kinds of long-active reversible contraceptives.

Sure, the cost of a copper IUD may be somewhat less than $860 if the physician or patient has access to government prices or other discounts, but it still creates a financial burden for physicians to stock their shelves with IUDs, not to mention inadequate reimbursement from insurers, she said.

“I think that the emerging, biggest barrier to IUD and implant use in this country is price,” Dr. Espey said. “ACOG is really trying to work to make a dent in that, but I think that until we see a cheaper IUD, it’s going to be a barrier to increased usage.”

Dr. Espey reported having no financial disclosures.

There’s only one copper IUD approved for use in the United States, so I contacted the makers of the ParaGard IUD, Teva Women’s Health. The “typical cost” for one ParaGard is $754, according to the company’s vice president for corporate communications, Denise Bradley. She said that the ParaGard’s price is “below most other forms of female birth control,” that most insurance plans cover ParaGard, and that the company offers women whose insurers don’t cover the IUD the option of paying by monthly installments.

She didn’t respond directly to the question of whether ParaGard’s cost is a barrier to use, but said, “Teva Women’s Health believes that increased access to all forms of contraception is of critical importance to all women of reproductive age.” She declined to comment on price differences between copper IUDs in the United States and other countries.

Recent data show that when financial barriers are removed and women receive standardized information about contraceptive choices, many more choose long-acting reversible contraception. The Reproductive CHOICE Project recruited nearly 10,000 women in the St. Louis area who desired contraception, gave them standardized counseling, and provided contraceptives for free.

A copper IUD. (Photo courtesy flickr/+mara/Creative Commons)

Results from the first 4,167 women to complete a year of follow-up found that 71% chose a long-acting reversible contraceptive (45% the levonorgestrel intrauterine system, 13% the copper IUD, and 13% an implant), Dr. Espey said. Others chose contraceptive pills, vaginal rings, transdermal patches, or another method.

After 12 months of use, 80% of IUD users reported being somewhat or very satisfied, compared with 54% of pill, patch, or ring users, she said. Only 55% of pill, patch, or ring users were on the same choice of contraception after 1 year compared with 84% of IUD users, 83% of implant users, and 88% of women who got a levonorgestrel intrauterine system.

The investigators recently reported that there have been 334 unintended pregnancies in 7,486 participants. Those using the pill, patch or ring were 22 times more likely to experience contraceptive failure compared with participants on long-acting reversible contraceptives (N. Engl. J. Med. 2012:366:1998-2007).

Long-acting reversible contraception was equally effective in all age groups, but use of the pill, patch, or ring was strikingly less effective in participants younger than 21 years, who were nearly twice as likely to have an unintended pregnancy compared with older women using those same methods of birth control.

–Sherry Boschert (on Twitter @sherryboschert)

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Doctors Face Fallout from Adverse Events

When things go wrong medically or surgically – whether or not a mistake was made – two parties get hurt: the patient and the physician. It’s nice to see increasing attention on the effects of bad outcomes on physicians, as I reported in a previous post.

A new video helps ob.gyns. cope when things go wrong. (Sherry Boschert/IMNG Medical Media)

Here are the latest examples. The American College of Obstetricians and Gynecologists (ACOG) just released a new DVD that it is sending to all ob.gyn. residency program directors to view with their residents. Called “Healing Our Own: Adverse Events in Obstetrics and Gynecology,” the video features ob.gyns. describing the painful effects that adverse events have had on them, and how they recovered.

The video can be viewed in a members-only section of the ACOG website and it was shown in the Exhibit Hall during ACOG’s recent annual meeting.

Both members and non-members are welcome to join (for a fee) an ACOG-sponsored webinar on Adverse Events, Stress, and Litigation on July 10 at 1 p.m. Eastern Time. The webinar will address feelings of isolation, guilt, and shame that physicians commonly experience when bad things happen to their patients, feelings that only get exacerbated if the event leads to a lawsuit.

Ob.gyns. are the sixth most likely medical specialists to get sued regardless of whether a mistake was made, according to a 2011 report in the New England Journal of Medicine.

The stress created by adverse events is just a part of the higher than usual stress levels that physicians try to cope with every day. Tools like the American Medical Association’s A Physician’s Guide To Personal Health offer strategies for staying sane and healthy under stress. Non-profit groups like Medically Induced Trauma Support Services (MITSS) offer tools and templates for health care workers after adverse events, though they mainly focus on helping patients through the trauma. MITSS did post an extensive bibliography online for articles and resources related to the impact of adverse events on caregivers.

If you know of other medical specialty organizations like ACOG that are helping physicians cope with the fallout from adverse events, let us know and we’ll share the resources with our readers.

–Sherry Boschert (on Twitter @sherryboschert)

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Abortion Protests Absent at Ob.Gyn. Meeting

While covering the annual meeting of the American College of Obstetricians and Gynecologists, I noticed something similar to what I first reported in a blog post from ACOG’s 2010 meeting, when room numbers had been left out of the printed program intentionally – for security reasons – for sessions on abortion and even contraception.

There’s something very different about this year’s ACOG meeting, though. Anti-abortion and anti-contraception protesters who previously were camped outside with signs vilifying obstetricians for being “child haters” are nowhere to be seen this year. Is that a sign of the times? Or a difference between having the meeting in protest-crazy San Francisco in 2010 and this year’s meeting in more conservative San Diego?

Protesters outside ACOG’s annual meeting. (Sherry Boschert/IMNG Medical Media)

Don’t get me wrong. There still are protesters here calling obstetricians “sex criminals.” With anti-abortionists and anti-contraceptionists gone, all that were left were the anti-circumcisionists handing out cards with links to Web sites such as Doctors Opposing Circumcision (DOC).

That means there’s still a strong police presence at the doors to the convention center and workers diligently checking to see that people who come into the center are wearing registration badges.  I haven’t heard of any cases of anti-circumcisionists murdering ob.gyns. as some abortion opponents have done, though.

For the record, ACOG’s policy on circumcision is essentially the same as that of the American Academy of Pediatrics. They do not recommend routine circumcision for newborn males, but advise physicians to weigh the potential risks, benefits, and costs of circumcision with the newborn’s parents.

And looking at the ACOG program, I didn’t see “Room TBD” next to the two presentations on circumcision, one of which I’ll be reporting soon: “A Cost-effective Analysis of Male Circumcision for the Prevention of HIV in the United States.” The findings may surprise you. Stay tuned.

–Sherry Boschert

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The Trauma of Politics in Medicine

It’s been a quick reversal for the Susan G. Komen for the Cure Foundation, reinstating funding some 72 hours after cutting off Planned Parenthood because of new criteria barring grants to organizations under investigation, prompted in this case, by a Republican congressman.

“We will amend the criteria to make clear that disqualifying investigations must be criminal and conclusive in nature and not political,” Komen CEO and founder Nancy Brinker said in a statement issued Friday.

The uproar brought more than $3 million in donations to Planned Parenthood in just three days, but also highlights the volatile mixture of politics and medicine.

Dr. Richard Carmona recently observed that one of the most popular presentations he made during his tenure as the 17th Surgeon General of the United States did not address emerging infections, physical trauma, or national diasters, but rather the plague of politics in medicine.

“This traumatic plague of politics is more insidious and virulent than emerging infections; has potentially more morbidity and mortality than hemorrhagic shock or blunt or penetrating trauma; has virtually no diagnostic criteria; and is resistant to all therapy, especially voices of reason, substantive discussion or positions of compromise,” he said during a memorial lecture at the recent meeting of the Eastern Association for the Surgery of Trauma.

Dr. Richard Carmona Patrice Wendling/Elsevier Global Medical News

Dr. Carmona didn’t have far to look for examples to flesh out his diagnosis.

More than a century ago, public health officials’ efforts to control the bubonic plague outbreak of 1900 in San Francisco were nearly derailed by politicians who claimed that quarantine procedures, including closing the city’s harbor to incoming ships, were an over-reaction that would impede commerce and tourism, and result in the collapse of San Francisco, and possibly California. The Surgeon General who intervened based on the scientific evidence was labeled a heretic and asked to resign.

In the 1980s, similar calls were made after former Surgeon General Dr. C. Everett Koop refused to back down from statements that HIV could be prevented. At the time, Dr. Carmona reminded the audience, senior elected officials were telling the American public that HIV was God’s way of punishing homosexuals.

In the 1990s, the tenure of Surgeon General Dr. Joycelyn Elders  was cut short after controversy erupted over a 1994 speech at the United Nations World AIDS Day that included remarks that masturbation was a normal part of sexuality and that abstinence-only education was “child abuse.”

During his own term under President George W. Bush, Dr. Carmona said, abstinence-only became the mantra of the administration, “based solely on ideological and theological concepts, and not science.

“Science had really demonstrated that abstinence alone was a failed proposition,” Dr. Carmona said. “Ironic, that an administration that was repeatedly caught up in the issue of abortion did not see the connection that comprehensive sex education was the best method to prevent STDs, unwanted pregnancies, and therefore abortions. As Surgeon General, this is a science-based position I have always held.”

Dr. Carmona, the only Surgeon General to be unanimously confirmed to the position in over 200 years, said the trauma of politics and its preventable deleterious outcomes are owned equally by politicians on both sides of the aisle.

He pointed out that over-the-counter sales of Plan B stalled under the Bush administration before gaining limited approval in December 2006, but fared no better seven years later under the more liberal Obama administration. In December 2011, HSS Secretary and Democrat Kathleen Sebelius overruled the FDA’s decision to make the emergency contraceptive available, without prescription, to girls of all childbearing ages. While Sebelius cited a lack of conclusive data, Dr. Carmona said it was the administration’s desire to avoid a political battle in the face of an upcoming election.

“The immunization for preventing the continued viralness of political trauma is transparency, full disclosure, accountability for elected officials, a citizenry that is informed and participatory, coupled with civil discourse of complex issues,” he said.

–Patrice Wendling

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Stress in Early Pregnancy Linked to Fewer Baby Boys

Exposure to acute stress during early pregnancy could reduce a woman’s chances for delivering a baby boy and increase her risk for premature delivery.

Courtesy Flickr/paparutzi/Creative Commons License

Those are key findings from a study of how the 2005 Tarapaca earthquake in Chile– which was a magnitude 7.9 event – impacted pregnant women in the region. The findings, based on an analysis of birth certificates in Chile between 2004 and 2006, were reported online in the Dec. 7, 2011 issue of the journal Human Reproduction (Hum. Reprod. 2011 Dec. 7 [Epub doi: 10.1093/humrep/der390]).

“Generally, there are more male than female live births,” study coauthor Dr. Karine Kleinhaus, an assistant professor of psychiatry, obstetrics and gynecology, and environmental medicine at New York University, said in a statement. “The ratio of male to female births is approximately 51:49 — in other words, out of every 100 births, 51 will be boys. Our findings indicate a 5.8% decline in this proportion, which would translate into a ratio of 45 male births per 100 births, so that there are now more female than male births. This is a significant change for this type of measure.”

The finding supports previous research which found that male fetuses tend to grow larger than females and need more resources from the mother, and therefore are more likely to miscarry in times of stress. In addition, male fetuses may be less robust than females and may be less capable of adapting their development to a stressful environment in the womb.

”Our findings on a decreased sex ratio support this hypothesis and suggest that stress may affect the viability of male births,” said the study’s other coauthor, Florencia Torche, Ph.D, also of NYU. “In contrast, among female conceptions, stress exposure appears not to affect the viability of the conception but rather, the length of gestation.”

The study also revealed that women who experienced the earthquake during their second and third months of pregnancy had shorter pregnancies and were more likely to have premature babies.

— Doug Brunk

Image courtesy paparutzi’s photostream

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