The American Dream

Is it time to re-think owning an illiquid, very large, concentrated, leveraged asset?

Religion and Healthcare Do not Mix, Part 1 Million

What could be more healthcare-y than depriving patients of medical information and treatment in the name of religious doctrine?

A dispute over condoms and Catholic values has left Greenwich Village without an urgent care clinic six months after St. Vincent's Hospital closed its doors in bankruptcy.

North Shore/Long Island Jewish Medical Center received a $9 million grant from the state to open a clinic in the West Village - likely in the now-abandoned St. Vincent's emergency room.

But sources familiar with negotiations say St. Vincent's leaders have insisted that the new facility abide by Catholic directives - including an agreement not to counsel patients about birth control.

Terry Lynam, a spokesman for North Shore/LIJ, would not confirm that birth control was the holdup, but said, "The terms presented to us pose some significant problems."

He said negotiations are continuing.

Mummified Remains of Babies Linked [Not!] to 'Peter Pan' Author James M. Barrie

Ah, the good old NY Daily News still trying valiantly to get the hang of this "reporting" thing. From an article headlined Mummified remains of babies linked to 'Peter Pan' author James M. Barrie (emphasis mine):

LOS ANGELES - Cops are following clues that suggest a link between the author of "Peter Pan" and the mummified remains of two babies found in a Los Angeles basement.

"Whether there's a link to the author, whether these are relatives or whether it's a freak coincidence, we don't know," Lt. Joe Losorelli told the Daily News Thursday.

...

The macabre mystery began late Tuesday when two women cleaning a building's storage area discovered the tiny skeletal remains shrouded in 1930s newspapers.

They were tucked into black leather satchels and locked in a steamer trunk emblazoned with the initials JMB.

...

Investigators quickly noticed the apparent owner of the trunk shared initials and a last name with James M. Barrie, the Scottish author of the famous "Peter Pan" series, who died in 1937 at age 77.

"We're not prepared to say there's any link," Losorelli said. "We're going to figure it out."

ellaOne: Matthew Perrone and The AP Should Be Ashamed of Themselves

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First, go wrap your head in a couple of towels. Then, and only then, go read this AP article on ellaOne and do your best to keep the head-hitting-desk at a minimum.

How is it possible for what should be a simple article about the approval of the new emergency contraceptive pill (ECP) ellaOne to contain such a massive amount of misinformation? Words fail me. Fortunately, my fingers still work so here we go:

Get everything wrong from the start

WASHINGTON – Federal health officials on Friday approved a new type of morning-after contraceptive that works longer than the current leading drug on the market.


The pill ella from HRA Pharma reduces the chance of pregnancy up to five days after sex. Plan B, the most widely used emergency contraceptive pill, begins losing its ability to prevent pregnancy within three days of sex.

Two paragraphs in and everything is wrong. (Is this some kind of record?)

First, Plan B is not the current leading ECP drug on the market seeing how, you know, it's been withdrawn and replaced with Plan B One-Step for quite some time now.

Second, the terminology morning-after contraceptive is wrong, wrong, wrong. It's either post-coital contraceptive (the class), or the ECP (a group in the class). You can use "morning-after" pill only if you make it clear it's an incorrect common usage. Otherwise you risk confusing your readers with the implication that the morning-after time period has any particular significance for the ECP dosage regimen. Which, of course, it doesn't.

You take the ECP as soon as possible after the act of unprotected intercourse -- an hour, 12 hours, two days, etc., up to five days.

Third, ellaOne, and pay attention AP reporters because this is important, as well as all the other available ECPs -- Plan B One-Step, Next Choice, iPill / Nextime, Levonelle One Step -- reduce the chance of pregnancy up to five days after sex.

But wait, there's more! All ECP brands, past and present, including Plan B and ellaOne begin losing their ability to prevent pregnancy the longer you wait to take them. For example, take ellaOne within 0 to 72 hrs after unprotected intercourse and it's 85% effective (pdf). Take it between 48 and 120 hrs (5 days) and it's only 61% effective.

Read the offending paragraph again:

The pill ella from HRA Pharma reduces the chance of pregnancy up to five days after sex. Plan B, the most widely used emergency contraceptive pill, begins losing its ability to prevent pregnancy within three days of sex.

To imply that one brand of ECP is more effective than another when you don't have the evidence for that is bad enough (more on that in a bit). To then mislead your readers about the effectiveness of ECP over time is inexcusable.

The effectiveness of ECPs is time-dependent; the sooner you take the pill, the better it works. This is crucial information about ECP regimens and failure to communicate it clearly and correctly can lull people into a false sense of security causing them to use ECPs incorrectly.

Get the studies wrong

The Food and Drug Administration approved the drug Friday as a prescription-only birth control option. The ruling clears the way for U.S. sales of the drug, which is already approved in Europe.


Morristown, N.J.-based Watson Pharmaceuticals will market the drug in the U.S. under an agreement with HRA. Watson said it will launch the pill in the fourth quarter.


Studies of ella by its manufacturer showed the drug prevented pregnancies longer and more consistently than Plan B.


In a head-to-head trial between the two drugs, women who took ella had a 1.8 percent chance of becoming pregnant, while women who took Plan B had a 2.6 percent chance. Experts tracked nearly 1,700 women who randomly received one of the two pills within three to five days of having unprotected sex.

More paragraphs, more major mistakes.

First, the trial did not compare ellaOne to Plan B. Rather, ellaOne was compared with NotPlan B.

Second, the Lancet study did not show that ellaOne prevents pregnancies longer and more consistently than Plan B NotPlan B. All it did show was that ellaOne is no worse than NotPlan B. As I mentioned in the linked post:

This may seem like a distinction without a difference, but it's not.

It's quite likely that ellaOne is more effective than the levonorgestrel brands when taken 3 to 5 days after unprotected intercourse but that hasn't been established yet and you should know that when deciding if ellaOne is the best emergency contraceptive option for you.

Sure, we all wish ellaOne turns out to be a better drug than the available alternatives. But until the evidence is in it is highly irresponsible to mislead your readers about the drug's effectiveness over time.

Be unclear on what's in ellaOne

Plan B is made by Teva Pharmaceuticals and is also marketed in several generic versions. Unlike ella, Plan B and other generic versions are available without a prescription for women 17 years and older.


HRA Pharma did not request over-the-counter status for its drug.


Ella uses the hormone progesterone to delay ovulation, a key step in the fertilization process.

Quick, when you read Ella uses the hormone progesterone to delay ovulation, what do you understand that to mean, A or B:

A) ellaOne contains progesterone and uses it to delay ovulation?

B) ellaOne contains ulipristal acetate (UA), a second generation progesterone receptor modulator (PRM), basically a progesterone antagonist. So, by blocking progesterone's action and modifying its activity ellaOne uses progesterone to delay ovulation? 

I would really like to believe that Matthew Perrone knows that ellaOne contains UA and he's just not very good at conveying that information but I doubt it. And here's why (emphasis mine):

Ella uses the hormone progesterone to delay ovulation, a key step in the fertilization process.

Despite this, the drug has drawn criticism from...groups who say it is closer to [another] pill....

Groups...argue the drug is chemically similar to the...drug mifeprestone....

I've truncated the paragraphs because I don't want you to get distracted by all the other misinformation that needs to be corrected. I'll do that in a moment. For now just focus on whether Matthew Perrone knows that ellaOne contains UA or not.

So, according to Perrone, despite the fact that Ella uses the hormone progesterone groups argue that ellaOne is chemically similar to mifepristone. [Incidentally, notice the caliber of reporting here. Who cares what the drug's actual composition is? Perrone reports on all the competing arguments from assorted groups and then you get to decide. "Professional" reporting at its best!]

Since both UA and mifepristone are PRMs, it looks to me that Perrone has no clue that ellaOne contains UA. In which case, both Perrone and the AP should be very ashamed for unleashing this level of misinformation on their readers.

Moving on.

When ignorance isn't enough, it's propaganda to the rescue

Despite this, the drug has drawn criticism from anti-abortion groups who say it is closer to an abortion pill than an emergency contraception pill.


Groups including the Family Research Council argue the drug is chemically similar to the abortion drug mifeprestone, which can be taken to end a pregnancy up to 50 days into the gestation period. That drug has been associated with severe infections and bleeding after abortion. However, FDA reviewers reported no life-threatening medical side effects with ella.

Incorrect information on top of incorrect information.

Before I go on, a quick note about the brand names. Notice the use of ellaOne and mifepristone in the paragraph above. That is incorrect. You don't mix brand names and compound names. So, the correct way is either ellaOne and Mifeprex (brand names) or ulipristal acetate (UA) (ellaOne) and mifepristone (Mifeprex). Moving on.

First, if you hope to maintain any credibility as a journalist you don't allow groups like the Family Research Council to use you as their propaganda mule.

"ellaOne and mifepristone are chemically similar so, um, OMG...abortion!!!Eleventyone!!111" has no place in a fact-based article.

Both ellaOne and Mifeprex are PRMs. Neither is a magic pill, nor, for that matter, an abortion pill. Depending on dosage and regimen, PRMs have different mechanisms of action. In particular, mifepristone can work on ovulation to prevent pregnancy (birth control) or the uterus to terminate a pregnancy (abortifacient). The specific doses/regimens are not interchangeable. The fact that mifepristone is a PRM and the fact that it can be part of a regimen which can be taken to end a pregnancy up to 50 days are totally irrelevant to emergency contraception and ellaOne.

As to ellaOne, it is a second generation, selective PRM, the first molecule to have been specifically designed and developed for use as an oral emergency contraceptive. (pdf)

Second, "mifepristone is Satan's drug but don't worry nobody's dropped dead yet from ellaOne" also not appropriate for a reality-based article.

In general, the side effects associated with an abortifacient regimen that contains mifepristone (or any other drugs for that matter) are totally irrelevant to an UA emergency contraceptive regimen. That's because, once a pregnancy is established, the anatomy and physiology change. For example, the delayed or prolonged bleeding/spotting caused by manipulating hormones with ECPs is not comparable with, say, the bleeding some women may experience after a termination, or even a term delivery, from retained POCs.

In particular, mifepristone has not been associated with severe infections after abortion. I know I just mentioned that mifepristone's side effects are irrelevant, but this "associated with severe infections" myth needs to die already so let me spend just a moment debunking it.

Briefly, there have been no severe infection cases in patients using the FDA-approved regimen of 600 mg mifepristone po, followed by 400 mcg of misoprostol po. There have been several fatal infection cases in patients using the off-label regimen of 200 mg mifepristone po, followed by 800 mcg of misoprostol PV. No association has been found between mifepristone and misoprostol, regardless of regimen, and the severe infection cases. (More on this here, here, and here.)

Back to the ellaOne/mifepristone paragraph, the best thing to do is to ignore it altogether. There's just too much misinformation, and the spectacle of a reporter being taken for a ride is unseemly. Which brings me to the bottom line on this entire article.

The AP throws a mishmash of confusing, incorrect, and irrelevant information at you and expects you to, somehow, make sense of it all, from extracting what few factual bits there are to identifying and ignoring the misinformation.

What kind of bizarro reporting is this?

Chinese Hospitals: “Everyone participate in the sorting out of the law and order problem!”

A very interesting article about Chinese hospitals, the quality of care, and violence against doctors.

Domestic Terrorism For Thee, But Not For Dr. Tiller's Assassin

Why is throwing two ground burst simulators (practice grenades) into a crowd of strangers in a parking lot considered domestic terrorism, but shooting someone in the head, someone you've explicitly targeted for terrorism, not so much?

I thought maybe it's because soldiers are held to a higher standard of conduct than civilians but, since the charges were brought by civilian authorities, I don't see how you can make an argument that some people deserve to be held to a different standard under the law just because of their chosen profession. Very odd, indeed.


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The Benefits of Invading Mexico

Photo by Gnarls Monkey

Everybody knows that if you live in Mexico there are advantages to invading the U.S. But what about the reverse? If you live in the States, are there any benefits to crossing the border into Mexico?

The answer is yes, you can benefit from, you know, invading Mexico, if you happen to be a low-income woman on the Pill that is.

Researches wanted to test the hypothesis that making access to the Pill more convenient -- by 1)removing the prescription requirement, and 2) providing users with more Pill packs -- could increase Pill use and continuation.

They recruited 1046 current Pill users living in El Paso, TX, a setting where low-income women can obtain the Pill without a prescription by crossing the border into Mexico and buying the Pill OTC from a Ciudad Juarez pharmacy. [532 women received Pill packs with a prescription from an El Paso clinic and 514 women purchased the Pill OTC from a Ciudad Juarez pharmacy.]

The study found that discontinuation was significantly lower for women who used the pharmacy to buy the Pill than for clinic users. When the number of Pill packs was taken into account, discontinuation rates were higher...for clinic users who received one to five pill packs. Only clinic users receiving 6+ pill packs had continuation close to pharmacy users.

So, convenience matters and can increase continuation. Which is all and good if you live near the border and have access to a pharmacy where the Pill is sold OTC. If you don't, unfortunately your options are limited. That's because most health plans limit the Rx filled at a pharmacy to a 30-day supply and [s]tate Medicaid polices vary across the country, but no more than a 100-day supply is dispensed at any one time.

One way to get around the 1 pack limit is to ask for same sample packs from your Ob/Gyn and check to see if your insurance plan has a mail-order pharmacy program which usually ships a 3-months supply of meds.

"Txt Now 2 Decrease Pregnancies L8r"

If you take the Pill, do you think receiving a daily text message reminder would help you use the Pill consistently and long-term?

If you answered yes, you're in agreement with the results of a study that sought to determine if daily educational text messages affect Pill continuation at 6 months.

Women ages 13 to 24 years electing to use the Pill at an urban family planning clinic were randomized to routine care or routine care and 180 daily educational text messages (the intervention group). There were 968 participants and 6-month continuation data was obtained on 682 (70%):

At 6 months, 54% of intervention participants were taking OC compared to 45% of the routine care group (p<.01). Similarly, 70% of intervention participants were taking OC the last time they had sexual intercourse compared to 61% of the routine care group (p=.03). The intervention group was less likely to report interrupted OC use than the control group (35% vs. 45%, p=.02) and more likely to report consistent OC use (40% vs. 29%, p=.002). The text message group started and finished more packs of OC than the routine care group (p<.05). Women in the intervention group received and read most of the text messages and were satisfied with the number, length and content of the messages.

Overall, the study found that, for the study population (young urban women), the effect of daily educational text message reminders on Pill continuation at 6 months was an improvement of 9% to 11% over the group receiving routine care alone.

On a practical note, I wish there was a Pill app I could recommend so that you could run your own experiment to see if a daily reminder would be helpful to you. I'm aware of a couple (The Pill and iPilule) but, unfortunately, based on anecdotal reports, neither seems ready for prime time yet.

Maybe I should look into developing an iPill app, no? In the meantime, if you know of a good Pill reminder app let me know.