Sunday, August 13, 2006

Journalism: What the NY Post Can't Tell Us

When you write an op-ed titled 'PLAN B': What Science Can't Tell Us, you better make sure you know the basic facts about Plan B. That goes double if you use scare quotes for scientific (what does that even mean?) and you end your article with a nebulous statement. But I'm getting ahead of myself.

This is what the author, Abby Wisse Schachter, tells us about Plan B:

...Plan B - the "morning-after pill."... Plan B is basically a double dose of the regular birth-control pill.


First, Plan B is the "emergency contraception pill[s]", or the "postcoital pill[s]", not the "morning-after pill":

The terms "morning after pill" or "72 hour pill" are misleading because emergency contraception (EC) can be used before the morning after -- but also up to five days after sex. It is most effective when it is taken in the first 12 hours after intercourse. But it can still significantly reduce pregnancy risk if it is taken up to 120 hours after intercourse.


Second, Plan B is not a pill, it's two pills. Two 0.75 mg levonorgestrel pills, to be exact.

An actual emergency contraceptive pill, like Levonelle, is one 1.5 mg levonorgestrel pill. This is important information because the current recommendation is to take one 1.5 mg dose (TWO Plan B pills, ONE Levonelle pill) as soon as possible after unprotected intercourse.

Last, but not least, Plan B is not basically a double dose of the regular birth-control pill.

The author doesn't define regular birth control pill, a fundamental omission, but no matter; there are only two possibilities. This regular birth control pill is either a combination (COC) pill [two hormones, estrogen + progestin], or a progestin-only (POP) one [one hormone, a progestin].

A bit of background:

Most combination pill brands have the same type of estrogen, called ethinyl estradiol (EE). The amount of estrogen in each pill is very small--it's usually measured in micrograms (mcg). Different pill brands have different EE amounts--from a high of 50 mcg in the older brands (mostly manufactured and used before 1975), to a low of 15 mcg in newer ones. Brands with 35 mcg EE and less (low dose and very low dose) are most common today. The other estrogen used in combination pills is mestranol.

In contrast to estrogen, the progestins in combination pills are of many types. These progestins are sometimes referred to as first- and second-generation (the older ones) and third-generation (the newer ones). The amount of progestin in each pill is also very small, and it's usually measured in milligrams (mg).

...

Because different pill brands have different types of progestins, you can't directly compare the strength of the brands. In other words, if two brands have the same dose but different progestin types, the potency can vary widely For example, 0.5 mg of levonorgestrel is equivalent to 1 mg of norgestrel.


So, we have COCs, POPs, and the assertion that Plan B is, more or less, a double dose of either one (?or both) of them. Not even close.

Plan B is a POP; it does not contain any estrogen. So that rules out COCs.

And just in case Ms. Wisse Schachter is confused by the fact that some COC brands, which contain the progestin levonorgestrel, may be used as EC--that still doesn't magically transform Plan B into a COC. [Nor does it mean that it's the OTC sale of COCs, rather then that of Plan B, that's under discussion.] A full dose (two pills) of Plan B is 1.5 mg of levonorgestrel. That's ten pills of Alesse (0.02 mg EE + 0.10 mg levonorgestrel), or eight pills of Levora (0.03 mg EE + 0.15 mg of levonorgestrel), or four pills of Ovral (0.05 mg EE + 0.5 mg norgestrel), etc. [More brands here.]

Plan B is also not basically a double dose of a regular POP, like Ovrette (0.075 mg norgestrel). It's actually forty Ovrette tablets.

So, we know that Plan B is a 1.5 mg dose, progestin-only, emergency contraceptive. We also know what the side effects associated with Plan B use are: nausea and vomiting, bleeding pattern changes, headache, dizziness, fatigue, abdominal pain, and breast tenderness. Unfortunately, this basic knowledge has yet to reach the NY Post and its columnists:

Of course, some of the risks are mild, such as dizziness, weight gain and irregular periods. But others are more serious, if rare - cardiovascular disease, high blood pressure, blood clots, heart attack and strokes.


This is so inaccurate, it's bordering on farcical.

Short version:

Plan B is not associated with cardiovascular disease, high blood pressure, blood clots, heart attack and strokes. Ms. Wisse Schachter is either ignorant, or making stuff up.

Longer version:

Plan B (progestin-only) is not a COC (estrogen + progestin). When estrogen and progestin are used together, like in COCs, their overall effect can be quite different from the individual side effects. Last, but not least, even if you're a confused journalist who doesn't realize the difference between Plan B's side effects, and those of COC EC regimens, and who, for some reason, wants to list the side effects of COC EC regimens when discussing Plan B, you still need to be accurate.

COC EC regimens have not been associated with cardiovascular disease, high blood pressure, blood clots, heart attack and strokes:

No deaths or serious complications have been causally linked to emergency contraception. According to the latest World Health Organization (WHO) medical eligibility criteria, there are no situations in which the risks of using ECPs outweigh the benefits. WHO notes specifically that women with previous ectopic pregnancy, cardiovascular disease, migraines, and liver disease and women who are breastfeeding may use ECPs. Given the very short duration of exposure and low total hormone content, combined ECP treatment can be considered safe for women who would ordinarily be cautioned against use of combined oral contraceptives for ongoing contraception.*


But wait! There's more. Getting back to Plan B (you know, the topic of the article) and those alleged more serious, if rare side effects. Not only are those side effects not associated with Plan B use, quite the opposite. Plan B is the preferred EC method for patients with a history of blood clots or stroke.

Finally, we have this parting paragraph from our intrepid opiner:

Maybe there's no "scientific" reason not to allow over-the-counter Plan B sales. But that doesn't mean that selling it in every Rite-Aid and CVS won't have serious, even disturbing, repercussions. And it's not just pro-lifers who are nervous.


Pardonne moi? Either she's not sure that there's no reason not to allow Plan B to be sold OTC [in which case she needs to reread her own article; in particular this The FDA's scientists went through the normal process, and found Plan B safe for over-the-counter sales.], or she's not clear on the meaning of the word scientific [in which case, among other things, she needs to review the concept of reality].

Here's the thing, the fact that selling Plan B OTC has been found safe means exactly that making it available in every Rite-Aid and CVS will not have serious, even disturbing [mwahahaaa], repercussions. Pity the same can't be said about the repercussions reading this op-ed has inflicted on my neurons.



*Emergency Contraception: A Cost-Effective Approach to Preventing Unintended Pregnancy. James Trussell, PhD, Felicia Stewart, MD, Elizabeth G. Raymond, MD, MPH. July 2006

5 Comments:

At 2:53 AM, Anonymous Anonymous said...

Excellent shredding...
Well done...

 
At 9:15 AM, Anonymous Anonymous said...

Please say you've forwarded at least some of this to Abby Schachter, the NY Post, or both.

 
At 9:24 AM, Blogger Sockatume said...

For the sake of clarity, I took the liberty of editing out all the sections of the article which you show she got wrong, or did not justify with evidence:

Hillary Clinton says the federal Food and Drug Administration is being politicized, and she'll hold up the confirmation of its new commissioner until it stops. President Bush nominated acting FDA chief Andrew von Eschenbach for the permanent job; at a Senate hearing last week, Clinton told him he'll have to wait. She told von Eschenbach: "This is not just about Plan B. Once we start politicizing the FDA there is no stopping. It is essential that we draw a line and we are drawing it right here."

But it plainly is all about Plan B - the "morning-after pill." Barr Pharmaceuticals has been trying to get it cleared for over-the-counter sale - no prescription needed. Last year, Clinton held up the confirmation of the last FDA nominee, Lester Crawford, until he promised a quick decision on the issue. But, in office, Crawford delayed, citing "technical reasons." Now Clinton wants the approval before confirmation.

Taken within 72 hours of unprotected sex, it effectively prevents pregnancy. But pro-lifers say it can function as an abortifacient, and pro-choicers like Sen. Clinton believe that's why approval's been stalled.

Yet the pro-Plan B side hasn't been entirely honest, either: It claims over-the-counter Plan B could mean avoiding as many as 1.5 million unwanted pregnancies and 600,000 abortions prevented - but those numbers don't hold up.

So says Kirsten Moore, president and CEO of Reproductive Health Technologies Project - a staunchly pro-choice and pro-Plan B outfit. Last December, she told the National Press Club that two separate studies show that access to emergency contraception like Plan B has not reduced unwanted pregnancies or abortions: "I think it's an honest question, the experts had estimated that we would see a drop by up to half in the rates of unintended pregnancy and the rates of abortion. And in fact in the real world we're not seeing that."

Still, Clinton has a point: The FDA's scientists went through the normal process, and found Plan B safe for over-the-counter sales. Why not approve it?

Well, approval raises a host of troubling questions.

Medical professionals have doubts. Dr. Vivian Roston, an OB-GYN at St. Luke's Roosevelt Hospital, worries that over-the-counter access to emergency contraception means she won't have the chance to educate her patients. "I wouldn't want someone not to have access [to emergency contraception]," she told me. "But then again, you lose the opportunity to present all the medical issues associated with taking a high-dose hormonal drug" if a woman doesn't have to see a doctor to get it.

And it's not just pro-lifers who are nervous.

 
At 2:45 PM, Blogger Kaethe said...

Let's reduce the article further:

She told von Eschenbach: "This is not just about Plan B. Once we start politicizing the FDA there is no stopping. It is essential that we draw a line and we are drawing it right here."

No other drug that was recommended for OTC status has been held up for years because of purely political reasons.

Last year, Clinton held up the confirmation of the last FDA nominee, Lester Crawford, until he promised a quick decision on the issue.

Because the decision had already been put off, for not good reason, for three years.

But, in office, Crawford delayed, citing "technical reasons."

Despite Crawford's promise, he did not approve Plan B, offered no valid reasons why not, and quit the job. As have others.

But pro-lifers say it can function as an abortifacient

Not only is Plan B proven not to abort an established pregnancy, but all evidence suggests that it would increase the liklihood of implantation of a fetilized egg. There is no evidence to support the pro-life baseless and bizarre assertion that it is an abortifacient.

So says Kirsten Moore, president and CEO of Reproductive Health Technologies Project - a staunchly pro-choice and pro-Plan B outfit. Last December, she told the National Press Club that two separate studies show that access to emergency contraception like Plan B has not reduced unwanted pregnancies or abortions: "I think it's an honest question, the experts had estimated that we would see a drop by up to half in the rates of unintended pregnancy and the rates of abortion. And in fact in the real world we're not seeing that."

The key point here would be access. Most women do not know about Plan B, not how it works or where to get it; many doctors, pharmacies, and hospitals will not prescribe or provide it. If by real world, however, one means countries that do make Plan B readily available, there it is proving most useful.

Well, approval raises a host of troubling questions.

Nope. Approval hasn't raised any scientific doubts at all. It has produced a lot of political/religious hand-waving, though.

Medical professionals have doubts. Dr. Vivian Roston, an OB-GYN at St. Luke's Roosevelt Hospital, worries that over-the-counter access to emergency contraception means she won't have the chance to educate her patients. "I wouldn't want someone not to have access [to emergency contraception]," she told me. "But then again, you lose the opportunity to present all the medical issues associated with taking a high-dose hormonal drug" if a woman doesn't have to see a doctor to get it.

Oddly enough, doctors around the world have concluded more than a decade ago, that there aren't any issues associated with taking Plan B that need to be discussed with patients.

And it's not just pro-lifers who are nervous.

It's also people who are ignorant about the science and medicine of Plan B, the role of the FDA, and those who read articles like this one.

 
At 6:53 PM, Blogger Jene said...

good lord i loved reading this post.

 

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