If you have ever experienced severe abdominal pain, especially up high towards your right breast, and it was accompanied by nausea or vomiting (I have patients describe it as upper abdominal labor!) you probably ended up in your doctor’s office or the emergency room. The differential diagnosis (or DD as we doctors like to use in our alphabetical code) would be gallbladder disease due to gallstones, pacreatitis, food poisoning, ulcer, intestinal malfunction (inflammation, obstruction or just irritable) and let’s not forget, especially in women, heart attack! A work up would most likely include ultrasound and blood tests as well as cardiac testing. If gallstones were found and they were sizable, or the stones were causing enough pain to make you miserable (and your doctor worried) you would likely be referred to the nearest surgeon for removal of that stone ridden organ with a procedure called a cholecystectomy.

We are all at risk for gallstones; indeed this is the leading cause of gastrointestinal illness requiring hospital admission in western countries. There are more than 700,000 cholecystectomies performed every year in the United States. That’s the bad surgical news….the good news is that most of them can now be performed via laparoscopic surgery rather than the open incisions that were the norm (and the extended healing time) 2 decades ago.

Why do so many individuals produce and suffer the consequences of these stones? We synthesize cholesterol in our liver; some is excreted in the bile that is then collected in the gallbladder before it makes its way out to the intestine. Over 80% of gallstones are made of cholesterol. And the more cholesterol that is “sent out” though the bile duct, the more likely stones will be formed. Certain factors and conditions create an environment of supersaturated bile. These include age (the older we get the greater our propensity to synthesize cholesterols in our liver), female sex (sorry about this), obesity, high–fat and even high carbohydrate diets. Then we also find a predisposition to stone formation in women who take estrogen-containing birth control pills and postmenopausal estrogen therapy. The estrogen, especially if taken orally can cause higher bile cholesterol excretion.

So it would stand to reason that anything that lowered the cholesterol production in the liver and hence the concentration of this fatty substance in the bile would also help prevent gall bladder stone formation. A study just published in the Journal of the American Medical Association (JAMA) has partially substantiated this theory. The study showed that statins (which do lower cholesterol) help diminish the risk of gallstone disease if taken for more than a year.

The study was based on the UK General Practice Research Database. The authors analyzed records from 27,035 patients who underwent cholecystectomy between 1994 and 2008 and 106,531 matched controls that did not. (They tried to match each person who had the surgery with 4 controls who were matched for gender, age and were seen by general practitioners at approximately the same time.) Of these, 2396 gall bladder sufferers and 8868 controls were taking statins. The study population was comprised of 76% women and the mean age was 53.4 years. (Sorry to give you all these numbers, but these are what made the study relevant.) The statisticians also adjusted the findings so they would not be skewed by high body mass index (i.e. overweight, obese or really obese).

So here is the short analysis…The lowest odds ratio or chance of having gallstone disease followed by a cholecystectomy was in patients who used statins for at least 1 to 1.5 years or more. Their odds of the disorder and need for surgery was approximately 0.6 or 40% lower than “statinless folk” (my words). This low odds ratio also existed when long term statin users were compared to those who had used it for a short time (less than 1 to 1.5 years of treatment). That means that the statin’s affect on gallstone formation may have been somewhat independent of a recent presence of high cholesterol levels. (My interpretation of this last finding is that it may take a while to make gallstones.)

Considering the evidence that statins are protective against heart attack and stroke, even in high risk men AND women whose cholesterol values fall within the normal range, some cardiologists would like to have “statinization” of in our water supply (or at least those expensive but tasty vitamin drinks). But let’s remember that statins are prescription drugs with specific indications and yes, very infrequent but potentially serious side effects.

I have to admit that my cholesterol levels, albeit within normal range, started to rise a year ago. I thought I might just try statin therapy. Well, you doubtless have heard those incessant ads on TV… you know the ones that admonish you that if you have muscle pain or extreme fatigue you should consult your doctor immediately. Well I did (have the pain, so consulted myself). I stopped and brought my lipid levels down with diet and more exercise. I may try another statin in the future. I still don’t encourage the “everyone- should-be-on-a-statin” therapy. But for those who are taking it, or may need it….your gallbladder may appreciate the added benefit.

This will hit the headlines on Tuesday, so I thought I would share the opinions. At this point I will choose to follow the ACOG recommendations and continue to suggest mammograms for my patients between 40 and 50 as well as breast self exam (BSE).

Response of The American College of Obstetricians and Gynecologists to
New Breast Cancer Screening Recommendations
from the U.S. Preventive ervices Task Force*

In the November 17 issue of Annals of Internal Medicine, the U.S. Preventive Services Task Force (USPSTF) updates its recommendations on screening for breast cancer in the general population (see www.annals.org), including the following:

  • The USPSTF recommends against routine screening mammography in women aged 40 to 49 years. The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient's values regarding specific benefits and harms. (grade C recommendation)
  • The USPSTF recommends biennial screening mammography for women aged 50 to 74 years. (grade B recommendation) 
  • The USPSTF recommends against teaching breast self-examination (BSE). (grade D recommendation)

The American College of Obstetricians and Gynecologists, however, currently continues to recommend the following services:

  • Screening mammography every 1-2 years for women aged 40-49 years
  • Screening mammography every year for women age 50 or older 
  • BSE; BSE has the potential to detect palpable breast cancer and can be recommended.

The College is continuing to evaluate in detail the new USPSTF recommendations and the new evidence considered by the USPSTF. Any changes to College guidance will be published in its journal Obstetrics & Gynecology.

Why did the USPSTF recommendations change?

Mammography in Women Aged 40-49 Years

In 2002, the USPSTF recommended screening mammography, with or without clinical breast examination, every 1-2 years for women aged 40 and older (grade B recommendation). The new USPSTF recommendations are based on a systematic evidence review by Heidi D. Nelson, MD, MPH, and colleagues and a modeling study by Jeanne S. Mandelblatt, MD, MPH, and colleagues published in the same issue of Annals of Internal Medicine.

The 2009 USPSTF judged that, although women in their 40s and women in their 50s benefit equally from routine screening mammography, women in their 40s experience greater harms from screening than women in their 50s. The harms assessed by the USPSTF were radiation exposure, false-positive and false-negative results, overdiagnosis, pain during procedures, and anxiety, distress, and other psychologic responses. Therefore, the USPSTF recommended routine screening for women aged 50-74 but recommended against routine screening for women in their 40s.

Breast Self-Examination

In 2002, the USPSTF judged that evidence was inadequate to make a recommendation on teaching or performing BSE. The new USPSTF recommendations are based on a systematic evidence review by Heidi D. Nelson, MD, MPH, and colleagues published in the same issue of Annals of Internal Medicine. This systematic evidence review identified two studies published since the 2002 recommendations. These studies found that teaching BSE did not reduce breast cancer mortality but resulted in additional imaging procedures and biopsies. Therefore, the USPSTF recommended against teaching BSE on the grounds that it has no benefit for women but places them at risk of harm.

What Should Fellows Do?

At this time, The American College of Obstetricians and Gynecologists recommends that Fellows continue to follow current College guidelines for breast cancer screening. Evaluation of the new USPSTF recommendations is under way. Should the College update its guidelines in the future, Fellows would be alerted and such revised guidelines would be published in Obstetrics & Gynecology.

The College continues to recommend that Fellows advise mammography screening for their patients aged 40 and older and that they counsel their patients that BSE has the potential to detect palpable breast cancer and can be performed. Fellows should be aware that the new USPSTF recommendation against routine screening mammography for women aged 40-49 (a grade C recommendation) has implications for insurance coverage, as some insurers will cover only preventive services rated as an "A" or a "B" by the USPSTF. Fellows should counsel their patients that insurance coverage for "routine screening" mammography may become variable and that patients should address this question with their insurers. These recommendations do not apply to high-risk women or patients with clinical findings, and they should be managed accordingly.

Interpreting the U.S. Preventive Services Task Force Breast Cancer
Screening Recommendations for the General Population

What do the USPSTF letter grades mean?

The USPSTF's recommendations are based on its assessment of net benefit—identified benefits minus identified harms. The USPSTF will only make a recommendation if it judges the available evidence to be of high enough quality that it can have high or moderate certainty as to the magnitude of the net benefit.

Interventions that are deemed to have substantial net benefit receive an A grade; interventions with moderate to substantial net benefit receive a B grade; interventions with small net benefit receive a C grade; interventions that have no net benefit (have harms that exceed the benefits) receive a D grade. If the evidence does not meet USPSTF standards, an "I statement" is issued.

Each letter grade is accompanied by a suggestion for practice. For A and B recommendations, the suggestion is to "offer/provide this service." For C recommendations, the suggestion is to "offer/provide this service only if other considerations support offering or providing the service in an individual patient." For D recommendations, the suggestion is to "discourage the use of this service." For I statements, the suggestion is to "read the clinical considerations section of USPSTF Recommendation Statement. If the service is offered, patients should understand the uncertainty about the balance of benefits and harms."

Grade C recommendations highlight the need for individualized decision making that considers the patient's own assessment of benefits and harms. The American College of Obstetricians and Gynecologists strongly supports shared decision making, and in the case of screening for breast cancer it is essential. Surveys have shown that women are more concerned about their risk of breast cancer than heart disease, which is more common. Many women, after weighing the benefits and risks for their own particular situation, will choose to have screening mammography.

What is the College doing in response to the new recommendations?

The College, as a partner organization of the USPSTF, reviewed the draft recommendation statement and expressed concern regarding the implications of recommending against routine screening mammography for women in their 40s.
The College is continuing to evaluate in detail the new USPSTF recommendations and the new evidence considered by the USPSTF. The new recommendations and the evidence on which they were based will be reviewed by College committees that make recommendations on screening for breast cancer. Should the College update its guidelines in the future, Fellows would be alerted and such revised guidelines would be published in Obstetrics & Gynecology.

Why did the USPSTF recommend against routine mammography for women in their 40s?

The new USPSTF recommendations are based on a systematic evidence review by Heidi D. Nelson, MD, MPH, and colleagues and a modeling study by Jeanne S. Mandelblatt, MD, MPH, and colleagues that were published in the same issue of Annals of Internal Medicine as the recommendation statement. Based on these analyses, the 2009 USPSTF judged that although women in their 40s and women in their 50s benefit equally from routine screening mammography, women in their 40s experience greater harms from screening than do women in their 50s. Therefore, the USPSTF recommended routine screening for women aged 50-74 years but recommended against routine screening for women in their 40s.
The USPSTF's evaluation of the evidence found that the benefit to women in their 40s was virtually the same as the benefit to women in their 50s. The relative risk of breast cancer mortality for women randomly assigned to mammography screening was 0.85 in women aged 39-49 years and 0.86 in women aged 50-59.

Rather than benefit from screening, women without cancer who undergo mammography, additional imaging, and biopsies may incur harm. These outcomes were more common in women in their 40s (see Table). In addition, because the prevalence of breast cancer is higher in women in their 50s and because younger women are more likely to have dense breasts that may be difficult to assess on mammography, women in their 40s had more false-positive mammograms and underwent more additional imaging than women in their 50s.

Table. Age-Specific Screening Results from the Breast Cancer Surveillance Consortium

Age Group (Y) No. of procedures to diagnose one case of invasive breast cancer*
  Mammography Additional Imaging Biopsy
40-49 556 47 5
50-59 294 22 3

*Data are from a single screening round in regularly screened women. Because the Breast Cancer Surveillance Consortium incompletely captures additional imaging and biopsies, these rates may be underestimates.

Data from: Nelson HD, Tyne K, Naik A, Bougatsos C, Chan BK, Humphrey L. Screening for breast cancer: an update for the U.S. Preventive Services Task Force. Ann Intern Med 2009;151:727-37.

The number needed to invite for screening (over several rounds of screening and at least 11 years of follow-up) to prevent one breast cancer death in women aged 39-49 was 1,904, compared with 1,339 in women aged 50-59.
The USPSTF also considered pain and psychologic responses as harms. The USPSTF notes that "anxiety, distress, and other psychosocial effects. . . fortunately are usually transient, and some research suggests that these effects are not a barrier to screening. . . Other potential harms, such as pain caused by the procedure, exist but are thought to have little effect on mammography use."

The Mandelblatt modeling study assessed six separate models of the effects of screening mammography using the National Cancer Institute's Cancer Intervention and Surveillance Modeling Network (CISNET). It states: "If the goal of a national screening program is to reduce mortality in the most efficient manner, then programs that screen biennially from age 50 years to age 69, 74, or 79 years are among the most efficient on the basis of the ratio of benefits to the number of screening examinations. If the goal of a screening program is to efficiently maximize the number of life-years gained, then the preferred strategy would be to screen biennially starting at age 40 years."

How might women be affected by the new recommendations against routine screening mammography for women in their 40s?

U.S. Census data demonstrate that there were 22,327,592 women aged 40-49 years in the United States as of July 1, 2008. Based on Surveillance Epidemiology and End Results Program (SEER) data, breast cancer deaths expected over 10 years were estimated at 204 deaths per 100,000 women aged 40-49 years (including both screen-detected and nonscreen-detected breast cancer). This 10-year death rate leads to an estimate of 45,492 deaths of U.S. women aged 40-49 years from breast cancer over 10 years. With a relative risk of 0.85 for breast cancer mortality for women in their 40s screened by mammography, an estimated 38,668 deaths would occur in a screened population over 10 years, approximately 6,800 fewer deaths than expected with the 10-year death rate. The fewer deaths expected with screening compared to the predicted deaths demonstrates the significant benefit of screening on mortality in this age group.

Why did the USPSTF recommend against teaching BSE?

The new USPSTF recommendations are based on a systematic evidence review by Heidi D. Nelson, MD, MPH, and colleagues published in the same issue of Annals of Internal Medicine. This systematic evidence review identified two studies published since the 2002 recommendations. These studies found that teaching BSE did not reduce breast cancer mortality but resulted in additional imaging procedures and biopsies. Therefore, the USPSTF recommended against teaching BSE on the grounds that it has no benefit for women but places them at risk of harm.

Who uses the USPSTF recommendations?

The main audience for the USPSTF recommendations is the primary care clinician. The congressional mandate establishing the USPSTF charges it with reviewing "the scientific evidence related to the effectiveness, appropriateness, and cost-effectiveness of clinical preventive services for the purpose of developing recommendations for the health care community."

However, although the USPSTF recognizes that its recommendations also have relevance for and are widely used by policymakers, managed care organizations, public and private payers, quality improvement organizations, research institutions, and patients, it also recognizes that its recommendations are only part of what needs to be considered in setting health care policy. The disclaimer that accompanies these new recommendations reads: "The USPSTF recognizes that clinical or policy decisions involve more considerations than this body of evidence alone. Clinicians and policymakers should understand the evidence but individualize decision making to the specific patient or situation."

How will the USPSTF recommendations be used in health care reform?

Health care reform legislation being considered in the House and Senate seeks to ensure coverage of preventive services as part of a basic benefits package in all health insurance plans, as well as patient cost-sharing protections for these services. In determining which services should be covered, the bills rely heavily on the USPSTF recommendations. At a minimum, covered preventive services would be those that receive an A or B grade from the USPSTF.

It is vital that covered preventive services not be limited solely to USPSTF grade A and B recommendations. The USPSTF has not issued recommendations for many vital preventive services in women's health care, such as preconception care, family planning counseling and services, and bundled services such as the annual well-woman examination. The USPSTF only makes and updates a handful of recommendations each year, far too few to address clinically appropriate preventive services that ought to be covered by any plan.

My daughter is pregnant and she, like many pregnant women, has been offered the possibility of private umbilical cord blood banking. She might ask my opinion.

I get offers to put oodles of information and brochures in my waiting room for expectant parents (I don’t, since I no longer deliver babies). Absent information directly proffered by obstetricians, women are targeted by private cord banking companies through direct to pregnant –consumer advertising in prenatal magazines, web sited and the peer pressure established among pregnant women and their families as they traverse the studies, tests and tribulations of their gestation. So when that final push for a healthy baby is made by the Mom (or by the obstetrician if she has a C Section), should there be one more painless procedure performed? Should cord blood with its special stem cells be removed and sent for private storage for the next 20 years just in case it can be used as “biologic insurance” against a future disease of the child or a sibling?

A recent review that addressed cost-effectiveness of this procedure was published in the Journal of Obstetrics and Gynecology. They cited a survey by the American Society for Blood and Bone Marrow Transplantation of private umbilical cord blood banks; of approximately 460,000 private banked cord blood units, only 99 had been shipped for transplantation. Another survey of 93 pediatric specialists who perform the transplantations in the United States and Canada reported that only 49 transplants had been done in the donor child or its siblings; moreover in 36 of the instances, there was a known disease in a sibling and the blood had been collected preemptively.
There are several problems that may cause this minimal use: Some of the samples were contaminated by bacteria, others were improperly labeled. The literature indicates that 25% to 56% of cord blood specimens could not be used either because the stem cell count within the blood was too small or because of problems with the blood’s storage. Then there is the issue of whether the transplantation will help the disorder for which it is given. Currently the estimate of probability of future need for cord blood for treatment of the donor child is 1 in 2,500 or 0.04%. (It is currently used for bone marrow failure which can cause aplastic anemia or for blood malignancies such as leukemia as well as certain metabolic disorders.) However, if the donor child does develop leukemia there is concern about transplanting his or her own stem cells since they may have the propensity to become malignant. This would not be a problem if a sibling needs the stem cells obtained from the cord blood of a presumably healthy donor child. Hence the probability of using umbilical cord blood for a sibling is a little greater, but still rare, 1 in 1,425 or 0.07%.

The cost of private umbilical cord banking and storage for 20 years is high and according to Web sites ranges from $3,620 and $4,170.

The final assessment in what the statisticians call “base case analysis” (sorry but you might as well learn some new terms) is that private umbilical cord blood banking results in a lifetime gain of 0.0026 years. And if the cost is $3,620 (compared to $0 if not done) this amounts to an additional expenditure of $1,374,246 per life year saved.

The only way it might be “cost effective” (a term we will hear more and more as we strive to reduce the cost of health care) is if the likelihood of a child needing its own stem cell transplant was greater than 1 in 110 or of the likelihood of a sibling needing a stem cell transplant rose to 1 in 43…and/or the cost of umbilical cord blood banking was reduced to $262 (or less than 7% of what it is now).

The American College of Obstetricians and Gynecologists and The American Association of Pediatrics have already made statements recommending against private cord blood banking unless there is a family member with a known diagnosis that could be treated by umbilical cord blood. Despite this many patients still want to “play it safe” probably because they don’t understand the statistics and overestimate the probability of the need for its use. (And the data may not be appropriately explained.) Let’s also acknowledge the medical magic implied in the term “stem cells”. If we can get them for our progeny, it can’t be unnecessary or too expensive.  Obstetricians are placed in a difficult position and often have to accommodate their patient’s request. Dissuading is harder than accommodating.

The cost benefit for use of umbilical cord blood transplants would greatly benefit from a program of public cord banking. But alas this is not available in most areas of the United States.

Bottom line (and I’ll try to convince my daughter)…private umbilical cord blood banking is cost effective only for families with rare blood diseases in which a child has a very high risk of requiring a stem cell transplant. The for-profit private cord banking facilities are unlikely to stress these facts.

We could ask our kids (rarely works), speak to the school administrators (they are probably the last to know),  read Seventeen and Cosmo or just look with despair at the promiscuous styles offered to and requested by young girls (and boys).

In my perusal of journals, I found a fascinating study which addresses this question. It comes from the National Youth Risk Behavior Survey conducted from 1999 though 2007. (Remember it takes a year or two to collect, analyze and publish information of this sort, hence it did not include ‘08 and ‘09.) Researches analyzed data from this survey to determine age at first intercourse in 66,882 black, Latino and Latina, white and Asian students in grades 9 though 12. According to the students’ anonymous self reports, the probability for “coital debut” by their 17th birthday (I’m assuming they meant vaginal intercourse, the use of euphemisms in medical reportage is astounding!) was: 82% for black males, 74% for black females, 69% for Latinos, 59% for Latinas, 53% for white males, 58% for white females, 33% for Asian males and 28% for Asian females

Now before we take this report and approach our children or grandchildren with queries as to whether they fall into the above listed statistics (“did you or didn’t you?”), I should point out that the survey was based on self-reported data. Girls are more likely to underreport sexual activity, whereas boys tend to over report. The survey did not stratify the groups by parental income or educational level, nor did it differentiate between public or private school attendance. And the study did not include youths who had dropped out of school (who would, most likely, skew early coital debut to higher probability).

I realize that parents don’t always like to look at gross statistics when it comes to their own progeny. But this large study does show us that a majority of teens self report that they were sexually active before the age of 17. It’s way better than rumors… and should help parents decide when to make sure that their daughters have access to appropriate contraception. (This may have the appearance of a plug for Planned Parenthood and I should disclose that in the past I was on the board of the LA chapter of this organization). We know that timing is important for HPV vaccination. The best results will be achieved if the vaccine is given before a girl becomes sexually active. Hence most pediatricians now discuss this with parents at a time when they are not quite ready to consider that their “little girl” will engage in sexual activity. But they will… Finally this survey emphasizes what we already know; all young teens should be taught about STD’s and the need for protection before they have that first, often too early, sexual encounter.

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