Medicine Swings Like A Pendulum Do

In 2002, the NIH Stopped the Women's Health Initiative (WHI) Study of the use of estrogen and progestin in postmenopausal women because of a small increase in breast cancer incidence and a lack of overall benefit. The study's findings were thought controversial at the time for many reasons, among them being the use of a study group comprised mostly of older women who wouldn't have benefited from hormones anyway. Moreover, this group did not reflect the standard of care at the time.

Today, we learn the results of an updated WHI analysis. Its conclusion -

Thousands of postmenopausal women have died prematurely over the past decade because they avoided estrogen therapy after hysterectomy, a new analysis of a landmark study showed.

The most conservative estimates placed the total number of deaths at 18,601, and the toll could be as high 91,610.

What happened here? This new analysis was limited to the use of estrogen only in younger women who had undergone hysterectomy.

The updated analysis was limited to younger women (50 to 59) who had undergone hysterectomy. In that subgroup of patients, unopposed estrogen significantly reduced the mortality risk, Philip Sarrel, MD, of Yale University, and co-authors reported online in the American Journal of Public Health.

"The finding is so dramatic -- reporting thousands of women dying every year -- if this gets the attention that it deserves, we hope it will change clinical practice," co-author David Katz, MD, the Yale-Griffin Research Center, said in an interview. "We hope that clinicians will start routinely talking to their patients who have had a hysterectomy and bringing up the issue that taking estrogen may save your life. We have data to show that it can save your life.

"Frankly, our paper should do that. It's not every paper that has the potential to change clinical practice. This one should. It occurs in the context of a growing awareness of the damage we have done by talking women out of all forms of hormone replacement."

Props to the researchers for going back and re-evaluating the data, bucking the tide of conventional wisdom. This happens more than people realize in medicine. It's called the Sleeper Effect, after an early scene in the Woody Allen film Sleeper.

Medicine Swings Like A Pendulum Do.

Winning the #WarOnVaccines

ABC's The View tabbed Jenny McCarthy to replace Elizabeth Hasselbeck. Yes, Jenny McCarthy whose claim to notoriety has been the debunked notion that vaccines are causally linked to autism. In fact, the most damning paper by Wakefield et al, published in 1998, was retracted by The Lancet in 2010. Undeterred, Ms. McCarthy has soldiered on, backed by such scientific luminaries as Oprah Winfrey.

The problem is not one of facts or science. Medicine has that in spades. The problem is audience. Jenny McCarthy, last seen on ABC's New Year's Rockin' Eve, and her junk science now has exposure to a large segment of the American people on The View. When was the last time anyone saw the AMA President on TV? And can anyone name the AMA President? (Dr. Ardis Hoven)

Ms. McCarthy's exposure goes way past television. Jenny McCarthy has over 900K followers on Twitter. To put things in perspective, the owner of the most followed medical blog on the net, KevinMD.Com, Dr. Kevin Pho has 50K followers. See the problem?

There is one solution. There is one physician with a larger presence than Jenny McCarthy. That physician is none other than cardiac surgeon Mehmet Oz, MD. With over 2M Twitter followers and a large national audience on The Doctor Oz Show, @DrOz has the juice, the voice and the following to get the word out there. Make no mistake - this is a war. Our children's lives are at stake. Old childhood diseases are coming back. Dr. Oz, the time is now. How about it?

Cover Your Assets

A CT Gyn has had his personal assets seized to satisfy a plaintiff's verdict of $5 million which exceeded his liability insurance policy limit of $1 million. 

... An even more important lesson may be that a $1 million malpractice insurance policy limit may be inadequate for some specialties.

Regardless of the facts of the case, there is something terribly wrong here. And they wonder why defensive medicine exists.

Prenatal Sonograms and Autism

An article in The Daily Beast wondered about a connection between the more frequently used prenatal ultrasound examinations and autism. Dr. Roy Benaroch's post in Dr. Kevin Pho's widely read medical blog tries to shine some light to an evironoment filled with entirely too much heat.

... This is what’s actually reported in the article, in order of appearance:

1. References to a study showing that among low-risk pregnancies, routine ultrasounds don’t improve outcomes. This is true. It’s irrelevant to the title or thesis of the article, but it’s true. Media lesson #1: if you don’t have a study to prove your point, talk about a different study that says something else entirely.
2. Ultrasounds drive up the cost of care. Again, correct. Again, irrelevant. See point #1.
3. Women who undergo frequent ultrasounds are more likely to have a pregnancy where the baby is found to have growth restriction. Well, this is true. It’s also true that if you look outside you’re more likely to know if it is raining. Fetal growth restriction is diagnosed by ultrasound. If you don’t look, you don’t know it’s happened. But looking outside doesn’t make it rain; and looking at an unborn baby with an ultrasound doesn’t cause the baby to be small. And, in any case, this is again irrelevant to autism. See point #1.
4. The author of the article has written a book in part about her assertion that ultrasounds are to blame for what she calls “an astronomic rise in neurological disorders among America’s children.”
5. The mice studies I referenced before—those come up now, several paragraphs in, the first even remotely relevant material. The lesson here: if you are a mouse, do not get seven hours of ultrasounds a day.
6. A neurologist named Manuel Casanova shares the author’s concerns, and says he and colleagues have been testing the ultrasound-autism hypothesis for three years. However, and this is important: after several technical paragraphs about his ideas, he’s uncovered zero evidence to support this claim. What he’s saying are generalities about brain development that are true, and he’s juxtaposing this against information about ultrasounds and information about autism, but he doesn’t in any way refer to any of his or anyone else’s actual research establishing a connection. These are ideas. Ideas are not evidence.

That’s it. The whole article.

Obstetrician Dr. Jacques Abramowicz has also looked at this issue, concluding in the Journal of Ultrasound in Medicine:

...analysis of in utero exposure (to prenatal diagnostic ultrasound) in humans has failed to show harmful effects in neonates or children, particularly in school performance, attention disorders, and behavioral changes. There is no independently confirmed peer-reviewed published evidence that a cause-effect relationship exists between in utero exposure to clinical ultrasound and development of ASDs in childhood. 

Personally, after being bombarded nightly by various cable news pontificators, I'd suggest that the proliferation of cable news might be associated with autism. Of course, that's just my opinion. I could be wrong.

Blaming The Obstetrician

The Maryland Court of Special Appeals overturned a multimillion-dollar judgment against Johns Hopkins Hospital  in a case that accused its doctors of causing severe and irreversible brain damage to a baby born at the hospital. 

The judges ordered the case sent back to a lower court for retrial. They ruled that Hopkins should have been allowed to give more testimony about the role a midwife might have played in the baby's injuries.

Dr. Amy Tuteur has already posted on the rest of the story.

Enzo’s case was detailed in the suspension order issued by the Maryland Board of Nursing:

On or about April 14,2010, the Board received a complaint from … Director of Labor and Delivery and … Director of Gynecology and Obstetrics, at Hospital B. According to the complaint, between March 25th and 26th, 2010, Respondent failed to follow the standard of care in her management of an attempted home birth by:

I. Utilizing Intramuscular Oxytocin to stimulate labor in a term pregnancy;
II. Using fundal pressure in the second stage of labor to attempt to cause descent of
the fetus;
III. Using vaginal chlorhexadrine, rather than intravenous penicillin, in labor to treata known group B beta hemolytic strep vaginal carrier to prevent early onset GBS neonatal sepsis;
IV. Misdiagnosing fetal station resulting in an unnecessary episiotomy. The physical exam on admission to Hospital B was a fetus impacted in the vagina at + 1 station which was incompatible with the report that the fetus had been crowning when the episiotomy was performed…

… Patient B delivered a male infant (“Baby B”) by LSTCS, with a vertex fetal presentation and occiput posterior (“OP”) position at birth. The APGAR scores were 1 at 1 minute and 5 at 5 minutes and cord/Initial blood gas was ph 7.1; pC02 63; p02 10; BE -13. Baby B was limp and cyanotic on delivery with nuchal cord x 1, required PPV for 3 minutes before being transitioned to CPAP. Baby B was transported to the NICU on CPAP with diagnoses of Hypoxic Ischemic Encephalopathy and Seizure disorder.

Baby B was transferred to a pediatric rehabilitation hospital on April 21, 2010.

In other words, Muhlhan was horribly negligent in caring for this women and the hospital saved Enzo’s life. Enzo’s parents know this and do not dispute it. They insist that the hospital didn’t save Enzo’s life fast enough, contending that there was a delay in performing the necessary C-section.

How did the jury decide that it was a purported delay at the hospital that resulted in Enzo’s injury and not the egregious malpractice of Evelyn Muhlhan? It was easy. Enzo’s parents’ lawyers successfully argued to disallow any evidence of Muhlhan’s negligence.

As the court records show:

Plt [Plaintiff's] motion in limine to preclude any refence [sic], testimony or argument that ceritified nurse-midwife Evelyn Muhlhan Deviated from the standard of care and to preclude Loraal Patchen, CNM and Carolyn Gegor CNM from testifying is hereby heard and granted.

Clearly, the Hospital was sued as the one with "deep pockets." But is this right?
The Maryland Court of Special Appeals' decision seems a step in the right direction in righting a wrong. Justice should be about the truth, the whole truth, and nothing but the truth. But as Oliver Wendell Holmes famously observed, "This is a court of law... not a court of justice."

Further, the case speaks volumes about how we deal with the future care of neurologically impaired infants and their parents' facing serious financial strain. The Tort System isn't geared toward care, merely at judging fault. Some get compensation, others get nothing. This needs to change. It's way past time to have that adult conversation.

It's A Jungle Out There

Thinking of consulting Dr. Google? Best heed the advice of Dr. Kenneth Lin.

A recent survey found that 60 percent of adults have gone online at least once in the past year to look up health information. Unfortunately, finding high-quality health websites is a challenge. Several years ago, a review of 79 studies published in the Journal of the American Medical Associationconcluded that online health information for consumers is frequently flawed, inaccurate, or biased. Based on my experience, the situation isn’t any better today.

Why do some health websites contain misleading information? One reason is that the group or organization running the site may have a hidden agenda. Drug companies often create consumer demand for expensive new drugs by financing groups that promote awareness of a previously unrecognized health condition, a sales tactic known as “disease mongering.” (For example, Dartmouth Medical School researchers have argued that restless leg syndrome became a disease only when a drug was developed to treat it.) Unfortunately, a study published in 2011 in the American Journal of Public Health found that most health advocacy groups that receive drug-company funding don’t disclose that on their websites.

Another reason that websites may contain misinformation is that some groups willfully disregard scientific evidence to promote certain health beliefs. For example, even though the U.S. Institute of Medicine found in 2004, after an exhaustive review of the medical literature, that there is no relationship between childhood vaccines and autism, it’s easy to find websites that claim otherwise. Similarly, although most researchers have concluded that Morgellons disease—a bizarre skin condition that sufferers believe to be caused by an undiagnosed parasitic infestation—is likely to be a psychiatric delusional disorder, you wouldn’t know it by simply Googling “Morgellons.”

Read the whole thing. It's a jungle out there.

Law of Unintended Consequences

In 1984, Libby Zion died following an emergency admission to a New York hospital. Concluding that her death was the result of a medical error by exhausted housestaff, her well-connected father launched a crusade which ultimately led to resident work hour restrictions prescribed by the ACGME.

Now, we learn that restricting work hours for PGY 1 housestaff to 16 hours leads to a significant decline in surgical experience.

... Compared with the four academic years before the change, the year immediately following the restriction saw significant declines in total operative cases (by 25.8%), major cases (by 31.8%), and first-assistant cases (by 46.3%) performed by the interns (P≤0.008 for all), according to Christian de Virgilio, MD, of Harbor-University of California Los Angeles Medical Center, and colleagues.

The drops were seen across most types of surgery, the researchers reported online in JAMA Surgery.

"If the 16-hour shift were to be extended to all postgraduate year levels, one can anticipate that additional years of training will be needed to maintain the same operative volume," they wrote, noting that the reduced experience of interns entering postgraduate year two "may have a domino effect on subsequent competence."

While errors caused by sleep deprivation must be kept at an irreducible minimum, we must acknowledge the threat of unacceptable errors caused by inexperienced doctors. Perhaps, before instituting guidelines, august bodies should base their decisions on evidence, not eminence. 

Of course that's just my opinion. I could be wrong.