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Revision as of 00:25, 17 December 2006

Please stay calm and civil while commenting or presenting evidence, and do not make personal attacks. Be patient when approaching solutions to any issues. If consensus is not reached, other solutions exist to draw attention and ensure that more editors mediate or comment on the dispute.

EC annual effectiveness

This sentence: The annual failure rate of EC is estimated at 19-38%, which means that over the course of a year, EC averages to less effective than it does for a single use implies both the 19% and 38% numbers are for levonorgestrel EC (perfect and typical use?), when actually the 38% number is for Yuzpe. I will speculate that the 19% figure is the effectiveness of Postinor? Not Postinor-2, marketed as EC, but the original Postinor, marketed as an ongoing postcoital contraceptive. Which is somewhat problematic in estimating the annual effectiveness of EC, because Postinor is only approved for use four times a month. Although, the PubMed-listed studies of Postinor imply failure rates lower than 19% (PMID 6362451, PMID 12334868).

So, I'm not sure we should leave those annual numbers in (they are of suspect validity - though further research might be able to resolve that issue). If they are left in, I think we should specify which number is levo and which is Yuzpe, and that they are for perfect use (not typical use). Also, "less effective than for a single dose" doesn't appear to be true - levo 75% reduction in pregnancies single dose, annual (100-19=) 81% prevention of pregnancy - Yuzpe 57% reduction in pregnancy single dose, annual (100-38=) 62% prevention of pregnancy. So technically more effective annually (though I think that's a result of inaccuracies in the estimates) - or can we even compare "reduction in pregnancy" numbers with "annual pregnancy rate" statistics? I think the data does not support the "less effective..." statement and it should go. However, looking for other opinions before I go a-editing. Lyrl _Contribs 04:48, 2 December 2006 (UTC)

I was just looking at the same sentence. The reference is a BMJ "rapid response" and doesn't actually cite the numbers in question, just says it's "no more effective" than withdrawal. Since the BMJ letter referenced Trussell, I found this on the Princeton/Trussell EC website, which cites a 20% annual failure rate for progestin-only and 40% for combined (close enough to 19-38%). But I think the main issue is that those estimates (19-38%) are for annual use of EC as the sole means of contraception. As Lyrl points out, this is problematic - EC is clearly not intended for use as a sole means of contraception, so the numbers seem a little meaningless. I rewrote the sentence, leaving in the numbers, but emphasized that those numbers are estimated failure rates for EC as sole means of contraception, which absolutely no one is advocating. I also moved it below the numbers on single-use effectiveness in the emergency setting, since this is the more meaningful real-world context. MastCell 22:14, 2 December 2006 (UTC)

Postinor (the original) is still sold, so obviously someone is advocating EC as sole means of contraception (however, only for women having intercourse four or fewer times per month). Reviewing the article, there is actually a section on EC as an ongoing birth control method. I'm going to move the discussion of annual failure rates to that section and make some related changes. Lyrl _Contribs 23:15, 2 December 2006 (UTC)

Effectiveness of ECPs, again

I've been reading more about the effectiveness after the recent anonymous edits pointing out the support of major organizations (AFP, FDA) for higher failure rates than currently listed in this article (75% for Yuzpe, 89% for levonorgestrel). Although, there does seem to be some acknowledgement of uncertainty - the Princeton website says The exact effectiveness of emergency contraceptive pills is difficult to measure and some researchers believe the effectiveness may be lower than that reported on package labels. I'm thinking of rearranging by:

• shortening the initial effectiveness discussion to simply state the officially supported numbers ("so and so says such and such effectiveness") - no discussion, no history, and shorten the quote by excluding text before "these numbers do not translate..."
• moving the last paragraph ("Because women in clinical trials...") to the "Controversy" section
• renaming the "Controversy" section "Uncertainties in calculation" (or something similar? Suggestions welcome) as there doesn't really seem to be a controversy (definition) - the general public is not involved, and there do not seem to be high feelings amoung the researchers - just a calm, evolving exchange of opinions and research on which methods of calculating effectiveness are most accurate and useful.
• giving ranges of effectiveness rates found by different studies in the renamed section, to supplement official numbers given at beginning of "Effectiveness" section
• summarizing the other information in the renamed section - mention sources of uncertainty, provide references for readers interested in more information, done. (Working in this wikilink could significantly reduce the need for a lot of text explaining the uncertainties of calendar methods).

Lyrl _Contribs 01:22, 3 December 2006 (UTC)

I agree with pretty much all of those suggestions - specifically, I agree with a leaner approach to citing the published efficacy data in the effectiveness section (along with attribution of which sources these numbers come from). I think a "Controversy" section is appropriate for dealing with issues of pro-life objections, conscience clauses, WalMart, politics of OTC approval in the US, etc - but agree that methodologic issues re: efficacy stats could be moved out of "Controversy" to reflect that it's more of an area of ongoing research than controversy per se. MastCell 08:49, 3 December 2006 (UTC)

FDA has not approved Ovrette® as EC

The Aug 15, 2004 AFP Emergency Contraception review article is a WP:RS, but its statement: "The FDA has cleared 13 brands of oral contraceptives for safety and efficacy when used for emergency contraception (Table 2)" listing 12 combined oral contraceptive pills and the progestin-only oral contraceptive Ovrette® is not correct.

On Feb 25, 1997, the FDA posted a notice in the Federal Register (Certain combined oral contraceptives for use as postcoital emergency contraception. Fed Regist 62(37):8610-2) which said the FDA Commissioner had concluded that certain COCPs (containing ethinylestradiol and norgestrel/levonorgestrel, i.e. the Yuzpe regimen) were safe and effective for off-label use as postcoital EC, was prepared to accept NDAs for COCPs labeled as ECPs, and listed 6 then available COCPs that could be used as ECPs (Ovral®, Lo/Ovral®, Nordette®, Levlen®, Triphasil®, Tri-Levlen®).

On Sep 2, 1998, the FDA approved the prescription Yuzpe regimen Preven® Emergency Contraception Kit (which contained a urine pregnancy test and 4 COCPs equivalent to 4 Ovral® pills).

On Jul 28, 1999, the FDA approved the prescription progestin-only Plan B® (two 750 µg levonorgestrel pills) emergency contraceptive.

The FDA never approved the use of 40 regular progestin-only Ovrette® (75 µg norgestrel) POPs as safe and effective for use as EC.

Since the 1997 FDA notice almost 10 years ago that the COCP Yuzpe regimen for EC was safe and effective, 16 additional COCPs containing ethinylestradiol and norgestrel/levonorgestrel have been marketed in the U.S. that contain doses equivalent to the 6 COCPs listed in the 1997 FDA notice.

Forty Ovrette® pills containing 3 mg of norgestrel is equivalent to the 1.5 mg of levonorgestrel in two Plan B® pills and would work as EC, but is much less convenient and the likelihood of already having (or being able to purchase) over a month's supply of one brand of regular POPs is much lower than the likelihood of finding 4 to 10 pills of one of the 22 available brands of COCPs usable for the Yuzpe regimen.

References:

• Oct 20, 2006 - Planned Parenthood - Emergency Contraception
• Nov 29, 2006 - Emergency contraception: Pill brands, doses, and instructions

68.255.31.5 07:28, 5 December 2006 (UTC)

Proposed rewrite of "Contraindications" et. al. sections

Adverse effects

Plan B and Yuzpe should not be used by women who are already pregnant, because they are not effective after implantation.

Because they contain estrogen, combined estrogen-progestin emergency contraception (Yuzpe regimen) pills should not be used by women with a history of heart attack, stroke, blood clots, or patients with severe liver disease or the very rare condition of porphyria.

If pregnancy occurs despite use of ECPs, the women is at slightly increased risk of ectopic pregnancy. A history of ectopic pregnancy is not a contraindication to use of ECPs, but consumers and health providers should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking levonorgestrel EC. Ectopic pregnancy is a medical emergency which can be fatal.

The herbal preparation of St John's wort and some enzyme-inducing drugs (e.g. anticonvulsants or rifampicin) may reduce the effectiveness of ECP, and a larger dose may be required. (Levonorgestrel 1500mcg initial dose and an extra 750 mcg after 12 hours).

Three cases of convulsions have been reported following use of levonorgestrel ECPs. Two cases occured in women with epilepsy, and are surmised to be caused by interaction of contraceptive hormones with antiepileptic drugs.

Ten cases of hypersensitivity (allergic) reaction, seven of which were considered life-threatening, have been reported following use of levonorgestrel ECPs.

Breast cancer cells are often hormone-sensitive, therefore hormonal birth control methods (including ECPs) are not recommended for women who have, have had, or suspect they have breast cancer. Laboratory studies have suggested levonorgestrel might have an effect on breast cancer. Human studies to date have been too small to draw definite conclusions about breast cancer risk of ongoing progesterone-only contraception, though it is known that ongoing use of combined hormonal contraceptives slightly increases breast cancer risk.

Side effects

The most common side effect of emergency contraception pills is nausea (50% of users of combined pills, 23% of progestin-only users), and a significant number of users vomit. Estrogen in combined ECPs is responsible for the increased incidence of nausea and vomiting. Antiemetics may be prescribed for both methods. Consider antiemetics 1 hour before each ECP dose. If vomiting occurs within an hour after taking ECPs, it may be necessary to repeat the dose.

Other common side effects are abdominal pain, fatigue, headache, dizziness, breast tenderness. These side effects normally resolve within 24 hours.

Temporary disruption of the menstrual cycle is also common and may manifest as early or late periods, spotting or breakthrough bleeding, and (less commonly) missed periods. The primary mechanism of EC is delaying ovulation. Menstruation occurs, on average, 14 days after ovulation, so delayed ovulation results in delayed menstruation. Suppression of ovulation may cause anovulatory bleeding, which could manifest as an early period.

This would combine seven sections of heavily related topics into one section (though I'm not sure 'adverse effects' is the best title for the new section). I believe combining them improves readibility in general (many short sections in a row are difficult to read), makes the related nature of the effects more understandable (for example, by putting the discussion of women taking antiepileptics needing a higher dose next to reports of epileptics having seizures associated with ECPs), and helps the table of contents look less unbalanced with so many negative headings.

This edit would also put discussion of the menstrual disruption side effect directly above the section discussion when pregnancy testing is appropriate, which I think would be a helpful tie-in. Comments and suggestions? Lyrl _Contribs 02:47, 8 December 2006 (UTC)

I like this a lot. Good work. I agree that combining sections, and making things more concise is better (and do we really need a new section header for one sentence paragraphs?)--Andrew c 04:02, 8 December 2006 (UTC)

I think it's a good idea, and the proposed wording is a good start. MastCell 05:27, 8 December 2006 (UTC)

France & ECs

I'm confused as to what is meant by the sentence "...parochial high school nurses were allowed to dispense Norlevo in schools." I checked the link, but it seems to say the same exact thing with no explanation. Is it saying that nurses at french parochial schools can dispense ECs whether the school allows it or not if they so choose, or are they forced to do it? I think that this section needs a little clarification even though it is just a minor detail. Is there any way we can actually find a copy of whatever law approved this? Chooserr 04:52, 10 December 2006 (UTC)

I don't think France (or any European country) has had the conscience refusals so publicized in the U.S. So I would assume French school nurses would have no objection to dispensing ECPs. The law would seem to say that schools were required to allow nurses to dispense ECPs upon request. Does that help any? Lyrl _Contribs 14:03, 10 December 2006 (UTC)

Yes, but I'm talking about catholic schools. In which case you wonder is the law forcing the nurses to dispense ECs, or saying that they can dispense ECs, if they want, regardless of the opinions of those who own and run the school. Allow seems to me to be the wrong word here, and it'd be better if we can link to and quote from the actual law. Chooserr 01:43, 11 December 2006 (UTC)

I also found this. Not sure if you will have access or not, but it says similar things that the AGI article, but in different words. Same with this and "Without Fanfare, Morning-After Pill Gets a Closer Look", GINA KOLATA October 8, 2000, NYT. It seems like they were 'granted the right' to dispense, not necessarily required to. Maybe a French speaker with access to French sources could help out, but I agree with Lyrl that refusal probably isn't as big of an issue in France as it may be in other places. Regardless our sources support our wording. Just because we don't have all the answers to your questions doesn't mean we need a fact tag.--Andrew c 03:12, 15 December 2006 (UTC)

Andrew C, I don't think that it is good enough just because our source claims it, especially since they probably don't follow the NPOV rules that wikipedians should hold in mind while writing articles. I don't think that quoting some external source just makes it POV. These cases should be looked into, for I am certain that this isn't the only one. And if it can't be verified it should be removed or reworded or something. Chooserr 03:34, 15 December 2006 (UTC)

I don't understand what isn't verifiable. We have the New York Times, the Guttmacher Institute, and two employees of HRA Pharma Laboratoire in Paris writing to a peer-reviewed, scholarly journal. Can you please explain to me what your objection is? A law was passed in France on a national level in late 2000 that gave permission (authorization, allowed, etc) to school nurses to give out EC in schools. This is verifiable by all of these sources, right? And this is basically what our text says, right? So what is the problem? I apologize for my confusion.-Andrew c 04:58, 15 December 2006 (UTC)

Maybe I wasn't saying what I meant properly, or maybe you just misunderstood, but while this may be verifiable it is still in my opinion vague. I don't know the implications. Would this force a school nurse, even those at catholic schools, to dispense ECs inspite of their opinions, or allow them to distribute them regardless of the opinions of those who own and run the schools if they so choose? Those are my two questions. Chooserr 05:18, 15 December 2006 (UTC)

I agree that we do not have every fine detail included in the article (and maybe that section could use expansion). But I feel that this issue is independent of verification and citation claims. I'll look further into this. If that section needs a tag, I feel an Template:Expand-section tag would work better. And yes, I was a little confused and I'll take the blame for the misunderstanding. Hopefully we can get more detail, but I personally think the current state of that section isn't terrible or anything. You wouldn't happen to know French, would you?-Andrew c 06:03, 15 December 2006 (UTC)

Ok, I found this. It is "Bulletin Officiel du ministère de l'Education Nationale et du ministère de la Recherche" or Official Bulletin for the Ministry of National Education and for the Ministry of Research. Scroll down to "Application de la loi n° 2000-1209 du 13 décembre 2000 relative à la contraception d'urgence" or Application of the law # 2000-1209, Dec. 12, 2000 regarding emergency contraception. And in the "Annexe" for that section is PROTOCOLE NATIONAL SUR LA CONTRACEPTION D'URGENCE EN MILIEU SCOLAIRE or National Protocol on Emergency Contraception in Scholastic Environments. And there list what I believe to be the text of the law. And from what I can gather, your concerns are not addressed in the text of the law. Therefore, you are asking sticky legal questions that can only be answered by French courts. Have these questions been asked? Maybe we should look into that, but further speculation seems like OR without sourcing. Feel free to use google or babblefish to translate the text and see if I missed anything (or if you know French, ignore that last part). Hope this helps.-Andrew c 06:38, 15 December 2006 (UTC)

I know a little bit of french so I may check this out, especially your link. Thanks, by the way. Chooserr 07:31, 15 December 2006 (UTC)

Scratch that my french is no where near standing up to this document, but it seems like there is a lot of information if we can just get someone to read it. It talks about the situations and the "right" so it's gotta be there. Chooserr 07:34, 15 December 2006 (UTC)

From what I can gather from babelfish, wiktionary, and my year and a half living in Montréal, it describes the following: The law deals with the methods of administering EC without a perscription in secondary schools. Each school is responsible for making sure the following provisions are respected and enacted. 1. To be able to administer EC, the nurses associated with the school should have a private room for confidentiality. 2. Regardless of the student's age (minor or not) before EC is dispensed, there must be a discussion. This gives the nurse time to assess if the situation meets both the criteria of article L. 5134-1 of the code of the public health and the drug infosheet. The nurse then must tell the student that EC is not a regular method of BC, that it is not always effective. If the student doesn't meet the criteria for the drug, they shall be directed to a family planning center, hospital, OBGYN, or other doctor. 3. Describes the situations for minors and those 18 and over. For minors, the nurse describes the usual routes for obtaining EC, and recommends going to a doctor. Parental/guardian involvment is encouraged, but not required. If the student is distressed and cannot obtain EC in the normal means, then the nurse can dispense the drugs in exceptional circumstances. For those 18 and over, it is basically the same. 4. The nurse must keep a record of dispensing EC in a "cahier de l'infirmière" or similar log book. Statistics must be compiled at the end of the year. 5. The nurse should set up a follow-up appointment for the student with a medical professional, where pregnancy tests, STD preventions, and regular method of contraception can be discussed. That's all I could get from there. Nothing seems to suggest anything about refusal clauses or anything. I'm fine with how the article is, and I think I'm going to give up on researching more. If you find anything else, or have more concerns, please voice them (and if you are so inclined, you could contact Misplaced Pages:Reference desk/Language or Misplaced Pages:Translation or Misplaced Pages:Translation into English. Good luck.--Andrew c 19:23, 15 December 2006 (UTC)

St. Croix

I removed the International Availability entry for the United States Virgin Islands (population 112,000 in 2005) that stated:

The Yuzpe regimen and diethylstilbestrol are used on the island of St. Croix.

citing, on the Women's Coalition of St. Croix website (last updated May 24, 2005), a webpage of information on what to do:

• If You've Been Sexually Assaulted, listing under:
  • Choices You Need To Make
    • In order to prevent pregnancy from the assailant, there is the option of taking the "Morning After Pill." Up to 72 hours following your assault, and preferably less than 24, you may choose to take the Morning After Pill. The Morning After Pill treatment actually consists of four pills, two taken initially and two more taken twelve hours after the initial dosage. This is not a form of contraception. Each of the pills contains a high dosage of the synthetic hormones estrogen and/or progesterone. The pills prevent implantation of a fertilized egg in the uterus. Some women may experience side effects including headache, nausea and vomiting. More serious side effects may occur, and those women who are advised against using birth control pills are advised not to use the morning after pill.
    • Some physicians recommend a drug called Diethylstilbestrol (DES), or another pregnancy preventing drug. This drug prevents pregnancy if you begin taking it within 48 hours after the rape and continue the medication for the next 5 days. DES has potential side effects, the most common being cramps and vomiting. Ask the doctor what you can expect when taking the drug, so you can decide if it makes sense to you.

Although I'm sure the Women's Coalition of St. Croix is a wonderful organization, they are not a WP:RS on the medication currently prescribed by U.S. physicians on St. Croix for emergency contraception.

Why would U.S. physicians on St. Croix (population 52,324 in 2000) still use DES, a medication that the FDA ordered labeled "THIS DRUG PRODUCT SHOULD NOT BE USED AS A POSTCOITAL CONTRACEPTIVE" over three decades ago, was superseded by the Yuzpe regimen two decades ago, and has not been commercially available in the U.S. for a decade, OR the Yuzpe regimen, still be used an emergency contraceptive INSTEAD OF Plan B, which is more effective, has fewer side effects, and has been FDA-approved over six years ago for emergency contraception??

As stated in WP:RS: Exceptional claims require exceptional evidence. Not a webpage containing some information that appears to have not been updated for two decades or more.

FP101 23:31, 10 December 2006 (UTC)

Planned Parenthood "controversy"

In reading the recent edits by FP101, I couldn't find the information about $25 million in EC sales, and 3% of the annual budget, in the cited source. Perhaps I'm not looking in the right place - are those figures given in the PP annual report? MastCell 18:20, 15 December 2006 (UTC)

PPFA Annual Report 2004-2005, p. 5, Affiliate Service Summary:

EC kits distributed in 2004 = 983,537

STOPP (Stop Planned Parenthood) survey:

average Plan B price at Planned Parenthood clinics = $25

$25 Plan B price x 983,537 EC kits distributed in 2004 = $25 million Plan B revenue

PPFA Annual Report 2004-2005, p. 22, Combined Statement of Revenue, Expenses & Changes in Net Assets:

total revenue in 2004 = $882.0 million

$25 million / $882 million = 3% of total revenue from Plan B in 2004

I actually don't think this is a real "ethical and legal controversy" and don't think it should not be in an encyclopedia article on emergency contraception. What is the "ethical and legal controversy" here?

The United States legal and ethical controversies section lists three real ethical and legal controversies:

1. the FDA Plan B OTC approval process (and OTC age restrictions)
2. legal and ethical issues in requiring Catholic hospitals to provide EC as an option for rape survivors
3. legal and ethical issues in the refusal of pharmacies to carry and/or pharmacists to dispense EC

and two phony "ethical and legal controversies" that are neither:

1. Planned Parenthood's financial "conflict of interest"
2. A 2002 letter from the FDA to W.C.C. (which formerly distributed and marketed Plan B) objecting to the exact wording used in one radio ad and one newspaper ad placed to inform women in Washington State about a pilot program there to allow pharmacy access to Plan B. What is the legal and ethical controversy here?

FP101 23:44, 15 December 2006 (UTC)

I've said this in the past, (and it was controversial to the other party involved back then, sorry Cindery), but I really think that doing math like this is Original Research. The 2004 number from PP is a reliable source. The price, put out by an anti-PP organization is not a RS. Furthermore, we are not sure if PP gave out any free or discounted doses, or did anything to help low income clients. Also, is this net or gross revenue? Is it taking into consideration the actual cost of the medication? etc. We cannot say that PP for sure makes $3 million off of EC each year. This is simply speculation, and in this case I believe 'doing math' is original research. I think the point can be made without giving specific figures that are not derived from PP financial documents.--Andrew c 00:07, 16 December 2006 (UTC)

If I'm understanding FP101's position correctly, that the last two "controversies" in the list should not be in the article, then I agree with that position. I would support wholesale removal of those entire discussions. Lyrl _Contribs 03:15, 16 December 2006 (UTC)

That is my main point. I included the additional information for context to make the point that the Planned Parenthood "financial conflict of interest controversy" is not a real financial conflict of interest and not a real controvery and should not be in the article.

FP101 05:17, 16 December 2006 (UTC)

I agree with Andrew c that combining figures from diverse sources to make a unified mathematical argument (like the % of PP's budget accounted for by EC's) is original research, and that the point can be made without going down that particular road. On the other hand, I agree with both FP101 and Lyrl that the Planned Parenthood "controversy" could be removed - it seems the sources alleging a conflict of interest are predominantly ones whose entire reason for being is to stop PP, and its relevance to the EC article (as opposed to, say, the Planned Parenthood article) is questionable. That said, although we are all in agreement here, Cindery's opinion should be sought and will need to be taken into account, although I believe she's currently on a Wikibreak. MastCell 00:25, 17 December 2006 (UTC)

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   Basu A, Candalier C (2005). "Ectopic pregnancy with postcoital contraception--a case report". 10 (1)page=6-8). PMID 16036291. {{cite journal}}: Cite journal requires |journal= (help)
   {{cite web}title=Morning after pill to carry new warning on ectopic pregnancy|publisher=bmj.com|date=January 30, 2003|accessdate=2006-11-09|url=http://www.bmj.com/uknews/news20030130.shtml#2}}
4. For women who are using liver enzyme inducing drugs, what dose of progestogen-only emergency contraception is advised? PDF members response 916 Faculty of Family Planning and Reproductive Health Care - Clinical Effectiveness Unit
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7. "Mirena (levonorgestrel-releasing intrauterine system). Product information" (PDF). Berlex. 2004. Retrieved 2006-07-26.
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11. Kumle M; et al. "Use of oral contraceptives and breast cancer risk: the Norwegian-Swedish Women's Lifestyle and Health Cohort Study". Cancer Epidemiol Biomarkers Prev. 11 (1375): 81. PMID 12433714. {{cite journal}}: Explicit use of et al. in: |author= (help)