Editing Emergency contraception (section)

==History==
In 1966, gynecologist [[John McLean Morris]] and biologist [[Gertrude Van Wagenen]] at the [[Yale School of Medicine]], reported the successful use of oral high-dose estrogen pills as post-coital contraceptives in women and [[rhesus macaque]] monkeys, respectively.<ref>{{cite news|url=http://www.time.com/time/magazine/article/0,9171,901858,00.html | archive-url=https://web.archive.org/web/20080408110025/http://www.time.com/time/magazine/article/0,9171,901858,00.html | url-status=dead | archive-date=April 8, 2008 | magazine=Time | title=Birth Control: The Morning-After Pill | date=1966-05-06 | access-date=2010-05-01}}</ref><!--
 --><ref>{{cite journal | vauthors =  | title = Postcoital contraception | journal = IPPF Medical Bulletin | volume = 1 | issue = 4 | pages = 3 | year = 1967 | pmid = 12254703 }}</ref> A few different drugs were studied, with a focus on high-dose estrogens, and it was originally hoped that postcoital contraception would prove viable as an ongoing contraceptive method.<!--
 --><ref name="The morning-after pill">{{cite journal | vauthors = Demers LM | title = The morning-after pill | journal = The New England Journal of Medicine | volume = 284 | issue = 18 | pages = 1034–1036 | date = May 1971 | pmid = 5553470 | doi = 10.1056/NEJM197105062841813 }}</ref>

The first widely used methods were five-day treatments with high-dose estrogens, using [[diethylstilbestrol]] (DES) in the US and ethinylestradiol in the Netherlands by Haspels.<ref>{{cite journal | vauthors =  | title = FDA considers DES safe as 'morning-after' pill | journal = JAMA | volume = 224 | issue = 12 | pages = 1581–1582 | date = June 1973 | pmid = 12257949 | doi = 10.1001/jama.1973.03220260003002 }}</ref><ref>{{cite journal | vauthors = Johnson JH | title = Contraception--the morning after | journal = Family Planning Perspectives | volume = 16 | issue = 6 | pages = 266–270 | year = 1984 | pmid = 6519238 | doi = 10.2307/2134916 | jstor = 2134916 }}</ref>

In the early 1970s, the Yuzpe regimen was developed by [[A. Albert Yuzpe]] in 1974;<!--
 --><ref>{{cite journal | vauthors = Yuzpe AA, Thurlow HJ, Ramzy I, Leyshon JI | title = Post coital contraception--A pilot study | journal = The Journal of Reproductive Medicine | volume = 13 | issue = 2 | pages = 53–58 | date = August 1974 | pmid = 4844513 }}</ref> progestin-only postcoital contraception was investigated (1975);<!--
 --><ref>{{cite journal | vauthors = Valle G | title = [The problem of postcoital contraception using oral progestins] | journal = Aggiornamenti in Ostetricia e Ginecologia | volume = 8 | issue = 3 | pages = 127–128 | year = 1975 | pmid = 12334868 }}</ref> and the copper IUD was first studied for use as emergency contraception (1975).<!--
 --><ref>{{cite journal | vauthors =  | title = Copper IUD, inserted after coitus averts pregnancy and provides continuing contraceptive protection | journal = International Family Planning Digest | volume = 1 | issue = 3 | pages = 11–12 | date = September 1975 | pmid = 12307393 | doi = 10.2307/2948217 | jstor = 2948217 }}</ref> [[Danazol]] was tested in the early 1980s in the hopes that it would have fewer side effects than Yuzpe, but was found to be ineffective.<ref>{{cite web|title=Danazol|publisher=Medscape|year=2002|access-date=2006-11-08|url=http://www.medscape.com/viewarticle/423473_8}}</ref>

The Yuzpe regimen became the standard course of treatment for postcoital contraception in many countries in the 1980s. The first prescription-only combined estrogen-progestin dedicated product, Schering PC4 (ethinylestradiol and norgestrel), was approved in the UK in January 1984 and first marketed in October 1984.<ref>{{cite web|title=Contraception: past, present and future|publisher=UK Family Planning Association|date=April 2006|access-date=2006-11-09|url=http://www.fpa.org.uk/about/info/contraceptionpastpresentandfuture.htm |archive-url=https://web.archive.org/web/20060928002621/http://www.fpa.org.uk/about/info/contraceptionpastpresentandfuture.htm <!-- Bot retrieved archive --> |archive-date = 2006-09-28}}</ref> Schering introduced a second prescription-only combined product, Tetragynon (ethinylestradiol and levonorgestrel) in Germany in 1985.<ref>{{cite journal | url=https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=3774816 | pmid=4816 | date=1975 | last1=Breese | first1=G. R. | last2=Smith | first2=R. D. | last3=Cooper | first3=B. R. | title=Effect of various 6-hydroxydopamine treatments during development on growth and ingestive behavior | journal=Pharmacology, Biochemistry, and Behavior | volume=3 | issue=6 | pages=1097–1106 | doi=10.1016/0091-3057(75)90023-4 | s2cid=20698213 }}</ref> By 1997, [[Schering AG]] dedicated prescription-only combined products had been approved in only 9 countries: the UK (Schering PC4), New Zealand (Schering PC4), South Africa (E-Gen-C), Germany (Tetragynon), Switzerland (Tetragynon), Denmark (Tetragynon), Norway (Tetragynon), Sweden (Tetragynon) and Finland (Neoprimavlar); and had been withdrawn from marketing in New Zealand in 1997 to prevent it being sold over-the-counter.<ref>{{Cite web|url=https://www.fda.gov/cder/foi/nda/99/21-045_Plan%20B_medr.pdf|title=Medical Officer Review of NDA 21,045: Levonorgestrel 0.75 mg tablets (2) for Emergency Contraception|website=[[Food and Drug Administration]] |archive-url=https://web.archive.org/web/20040227003954/https://www.fda.gov/cder/foi/nda/99/21-045_Plan%20B_medr.pdf |archive-date=2004-02-27 }}</ref><ref>{{Cite web|url=http://ec.princeton.edu/questions/dedicated.html |title=Emergency Contraception: Using emergency contraceptives worldwide|archive-url=https://web.archive.org/web/20070522214523/http://ec.princeton.edu/questions/dedicated.html |archive-date=2007-05-22 }}</ref> Regular combined oral contraceptive pills (which were less expensive and more widely available) were more commonly used for the Yuzpe regimen even in countries where dedicated products were available.<ref>{{cite journal |author=FDA |date=February 25, 1997 |title=Certain combined oral contraceptives for use as postcoital emergency contraception |journal=Fed Regist |volume=62 |issue=37 |pages=8610}} "Since the United Kingdom approved emergency contraceptive pills in 1984, more than 4 million prescriptions have been recorded. However, the actual use is much greater because providers have found it less expensive to provide tablets of identical drugs taken from products packaged as combined oral contraceptives."</ref>

Over time, interest in progestin-only treatments increased. The Special Program on Human Reproduction (HRP), an international organization whose members include the [[World Bank]] and [[World Health Organization]], "played a pioneering role in emergency contraception" by "confirming the effectiveness of levonorgestrel."<ref>{{cite web|title=Sponsors|publisher=Fertility|year=2002|access-date=2006-12-01|url=http://www.nature.com/fertility/sponsors/index.html}}</ref>  After the WHO conducted a large trial comparing Yuzpe and levonorgestrel in 1998,<ref name="WHO 1998" /><ref>{{cite journal | vauthors = Guillebaud J | title = Time for emergency contraception with levonorgestrel alone | journal = Lancet | volume = 352 | issue = 9126 | pages = 416–417 | date = August 1998 | pmid = 9708743 | doi = 10.1016/S0140-6736(98)22032-0 | s2cid = 43738693 | author-link = John Guillebaud }}</ref> combined estrogen-progestin products were gradually withdrawn from some markets (''Preven'' in the [[United States]] discontinued May 2004, ''Schering PC4'' in the UK discontinued October 2001, and ''Tetragynon'' in France) in favor of progestin-only EC, although prescription-only dedicated Yuzpe regimen products are still available in some countries.

In 2002, China became the first country in which mifepristone was registered for use as EC.

In 2020, Japan announced it would consider easing regulations on the sale of emergency contraceptive pills without a prescription.<ref>{{cite web |work=The Japan Times |date=Oct 9, 2020 |title=Japan considers making morning-after pill available without prescription |url=https://www.japantimes.co.jp/news/2020/10/09/national/morning-after-pill-without-prescription/ |access-date=2020-10-18}}</ref> Non-profit groups submitted a petition to the health ministry calling for prescription-free access to the pill. They had collected more than 100,000 signatures.<ref>{{cite web |author=NHK |date=December 26, 2020 |title=Calls rise for prescription-free morning-after pill |url=https://www3.nhk.or.jp/nhkworld/en/news/backstories/1437/ |access-date=2020-10-18}}</ref>

===Calculating effectiveness===
Early studies of emergency contraceptives did not attempt to calculate a failure rate; they simply reported the number of women who became pregnant after using an emergency contraceptive. Since 1980, clinical trials of emergency contraception have first calculated probable pregnancies in the study group if no treatment were given.  The effectiveness is calculated by dividing observed pregnancies by the estimated number of pregnancies without treatment.<ref>{{cite journal | vauthors = Dixon GW, Schlesselman JJ, Ory HW, Blye RP | title = Ethinyl estradiol and conjugated estrogens as postcoital contraceptives | journal = JAMA | volume = 244 | issue = 12 | pages = 1336–1339 | date = September 1980 | pmid = 6251288 | doi = 10.1001/jama.244.12.1336 }}</ref>

Placebo-controlled trials that could give a precise measure of the pregnancy rate without treatment would be unethical, so the effectiveness percentage is based on estimated pregnancy rates. These are currently estimated using variants of the [[calendar method]].<ref name="trussell 1996">{{cite journal | vauthors = Trussell J, Ellertson C, Stewart F | title = The effectiveness of the Yuzpe regimen of emergency contraception | journal = Family Planning Perspectives | volume = 28 | issue = 2 | pages = 58–64, 87 | year = 1996 | pmid = 8777940 | doi = 10.2307/2136125 | jstor = 2136125 }}</ref>
Women with irregular cycles for any reason (including recent hormone use such as oral contraceptives and [[breastfeeding]]) must be excluded from such calculations. Even for women included in the calculation, the limitations of calendar methods of fertility determination have [[Calendar-based methods#Failure rate|long been recognized]].  In their February 2014 emergency review article, Trussell and Raymond note:
{{blockquote|Calculation of effectiveness, and particularly the denominator of the fraction, involves many assumptions that are difficult to validate. The risk of pregnancy for women requesting ECPs appears to be lower than assumed in the estimates of ECP efficacy, which are consequently likely to be overestimates. Yet, precise estimates of efficacy may not be highly relevant to many women who have had unprotected intercourse, since ECPs are often the only available treatment.<ref name="Trussell 2014"/>}}

In 1999, hormonal assay was suggested as a more accurate method of estimating fertility for EC studies.<ref name="espinosa 1999">{{cite journal | vauthors = Espinós JJ, Rodríguez-Espinosa J, Senosiain R, Aura M, Vanrell C, Gispert M, Vega C, Calaf J | display-authors = 6 | title = The role of matching menstrual data with hormonal measurements in evaluating effectiveness of postcoital contraception | journal = Contraception | volume = 60 | issue = 4 | pages = 243–247 | date = October 1999 | pmid = 10640171 | doi = 10.1016/S0010-7824(99)00090-6 }}</ref>

===United States===

====DES====
* In 1971, a ''[[New England Journal of Medicine]]'' editorial calling attention to previously published studies on the use of [[Diethylstilbestrol|DES]] as a postcoital contraceptive at [[Yale University]], and a large study published in ''[[Journal of the American Medical Association|JAMA]]'' on the use of DES as a postcoital contraceptive at the [[University of Michigan]], led to off-label use of DES as a postcoital contraceptive becoming prevalent at many university health services.<ref name="The morning-after pill"/><ref>{{cite journal | vauthors = Kuchera LK | title = Postcoital contraception with diethylstilbestrol | journal = JAMA | volume = 218 | issue = 4 | pages = 562–563 | date = October 1971 | pmid = 5171004 | doi = 10.1001/jama.218.4.562 }}</ref>
* In May 1973, in an attempt to restrict off-label use of DES as a postcoital contraceptive to emergency situations such as [[rape]], a ''FDA Drug Bulletin'' was sent to all U.S. physicians and pharmacists that said the FDA had approved, under restricted conditions, postcoital contraceptive use of DES.<ref>{{cite journal | vauthors = FDA | title = Selected items from the FDA drug bulletin-may 1973 | journal = California Medicine | volume = 119 | issue = 2 | pages = 87–88 | date = August 1973 | pmid = 18730987 | pmc = 1455105 }}</ref> (In February 1975, the FDA Commissioner testified that the only error in the May 1973 ''FDA Drug Bulletin'' was that the FDA had '''not''' approved postcoital contraceptive use of DES).<ref name="Kennedy hearing">{{cite book |author=U.S. Senate |year=1975 |title=Regulation of diethylstilbestrol (DES), 1975: Joint Hearing before the Subcommittee on Health and the Subcommittee on Administrative Practice and Procedure, 94th Congress, 1st Session on S. 963, February 27, 1975 |location=Washington |publisher=U.S. Govt. Print. Off}}</ref>
* In September 1973, the FDA published a proposed rule specifying patient labeling and special packaging requirements for any manufacturer seeking FDA approval to market DES as a postcoital contraceptive, inviting manufacturers to submit abbreviated [[new drug application]]s (ANDAs) for that indication, and notifying manufacturers that the FDA intended to order the withdrawal of DES 25&nbsp;mg tablets (which were being used off-label as postcoital contraceptives).<ref name=proposed73>{{cite journal |author=FDA |date=September 26, 1973 |title=Diethylstilbestrol. Use as postcoital contraceptive; patient labeling |journal=Fed Regist |volume=38 |issue=186 |pages=26809–11}}</ref><ref name="deslabel1975"/><ref name="des25mg1973">{{cite journal |author=FDA |date=September 26, 1973 |title=Certain estrogens for oral use. Notice of withdrawal of approval of new drug applications |journal=Fed Regist |volume=38 |issue=186 |pages=26824–6}}</ref>
* In late 1973, [[Eli Lilly and Company|Eli Lilly]], the largest U.S. manufacturer of DES, discontinued its DES 25&nbsp;mg tablets and in March 1974 sent a letter to all U.S. physicians and pharmacists telling them it did not recommend use of DES as a postcoital contraceptive.<ref name="Kennedy hearing"/>
* Only one pharmaceutical company, Tablicaps, Inc., a small manufacturer of [[generic drug]]s, ever submitted (in January 1974) an ANDA for use of DES as an emergency postcoital contraceptive, and the FDA never approved it.<ref name="Kennedy hearing"/><ref name="dutton">{{cite book |author=Dutton, Diana B. |year=1988 |title=Worse than the disease: pitfalls of medical progress |location=Cambridge |publisher=Cambridge University Press |isbn=978-0-521-34023-6 |url-access=registration |url=https://archive.org/details/worsethandisease0000dutt }}</ref>
* In February 1975, the FDA said it had not yet approved DES as a postcoital contraceptive, but would after March 8, 1975, permit marketing of DES for that indication in emergency situations such as rape or incest ''if'' a manufacturer obtained an approved ANDA that provided patient labeling and special packaging as set out in a FDA final rule published in February 1975.<ref>{{cite journal |author=FDA |date=February 5, 1975 |title=Diethylstilbestrol as postcoital oral contraceptive; patient labeling |journal=Fed Regist |volume=40 |issue=25 |pages=5351–5}}</ref> To discourage off-label use of DES as a postcoital contraceptive, in February 1975 the FDA ordered DES 25&nbsp;mg (and higher) tablets removed from the market and ordered the labeling of lower doses (5&nbsp;mg and lower) of DES still approved for other indications be changed to state: "THIS DRUG PRODUCT SHOULD ''not'' BE USED AS A POSTCOITAL CONTRACEPTIVE" in block capital letters on the first line of the physician prescribing information package insert and in a prominent and conspicuous location of the container and carton label.<ref name="deslabel1975">{{cite journal |author=FDA |date=February 26, 1975 |title=Estrogens for oral or parenteral use. Drugs for human use; drug efficacy study; amended notice |journal=Fed Regist |volume=40 |issue=39 |pages=8242}}</ref><ref name="des25mg1975">{{cite journal |author=FDA |date=February 5, 1975 |title=Certain estrogens for oral use or parenteral use. Drugs for human use; drug efficacy study implementation; follow-up notice |journal=Fed Regist |volume=40 |issue=25 |pages=5384}}</ref>
* In March 1978, a ''FDA Drug Bulletin'' was sent to all U.S. physicians and pharmacists which said: "FDA has not yet given approval for any manufacturer to market DES as a postcoital contraceptive. The Agency, however, will approve this indication for emergency situations such as rape or incest if a manufacturer provides patient labeling and special packaging. To discourage 'morning after' use of DES without patient labeling, FDA has removed from the market the 25 mg tablets of DES, formerly used for this purpose."<ref>{{cite journal |author=FDA |date=March–April 1978 |title=DES and Breast Cancer |journal=FDA Drug Bull |volume=8 |issue=2 |pages=10}}</ref>
* In the 1980s, off-label use of the Yuzpe regimen superseded off-label use of DES for postcoital contraception.<ref name="dutton"/><ref>{{cite book |author1=Hatcher, Robert A. |author2=Stewart, Gary K. |author3=Stewart, Felicia |author4=Guest, Felicia |author5=Schwartz, David W. |author6=Jones, Stephanie A. |year=1980 |title=Contraceptive Technology 1980–1981 |edition  =10th |location=New York |publisher=Irvington Publishers |isbn=978-0-8290-0084-9 |pages=128–33}}</ref><ref>{{cite book |author1=Hatcher, Robert A. |author2=Stewart, Gary K. |author3=Stewart, Felicia |author4=Guest, Felicia |author5=Josephs, Nancy |author6=Dale, Janet |year=1982 |title=Contraceptive Technology 1982–1983 |edition=11th |location=New York |publisher=Irvington Publishers |isbn=978-0-8290-0705-3 |pages=[https://archive.org/details/contraceptivetec0000hatc/page/152 152–7] |url=https://archive.org/details/contraceptivetec0000hatc/page/152 }}</ref>
** DES is no longer commercially available in the U.S.; Eli Lilly, the last U.S. manufacturer, ceased production in spring 1997.<ref>{{cite book |author1=Ibarreta, Dolores |author2=Swain, Shanna H. |year=2001 |chapter=The DES story: long-term consequences of prenatal use |editor1=in Harremoës, Poul |editor2=Gee, David |editor3=Vaz, Sofia Guedes |title=Late lessons from early warnings: the precautionary principle 1896–2000 |location=Copenhagen |publisher=European Environmental Agency |isbn=978-92-9167-323-0 |pages=84–92 |chapter-url=http://reports.eea.europa.eu/environmental_issue_report_2001_22/en/issue-22-part-08.pdf |access-date=2006-12-07 |archive-date=2006-11-21 |archive-url=https://web.archive.org/web/20061121032157/http://reports.eea.europa.eu/environmental_issue_report_2001_22/en/issue-22-part-08.pdf |url-status=dead }}</ref>

====Preven====
* On February 25, 1997, the FDA posted a notice in the ''[[Federal Register]]'' saying it had concluded that the Yuzpe regimen was 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 (there are now 22) that could be used as ECPs.<ref name="fr 1997"/>
* On September 1, 1998, the FDA approved the prescription Yuzpe regimen Preven Emergency Contraception Kit (which contained a urine pregnancy test and 4 COCPs).<ref>{{cite web |author=FDA |date=September 1, 1998 |title=Preven approval package |website=[[Food and Drug Administration]] |url=https://www.fda.gov/cder/foi/nda/98/20946.pdf |access-date=2006-12-10 |archive-url=https://web.archive.org/web/20061011042637/https://www.fda.gov/cder/foi/nda/98/20946.pdf <!-- Bot retrieved archive --> |archive-date = 2006-10-11}}</ref> Preven was discontinued in May 2004.<ref>{{cite web |author=California Board of Pharmacy |date=December 22, 2004 |title=Pharmacists protocol for dispensing emergency contraception |url=http://www.pharmacy.ca.gov/licensing/ec_protocol.pdf |access-date=2006-12-10 |url-status=dead |archive-url=https://web.archive.org/web/20061211175253/http://www.pharmacy.ca.gov/licensing/ec_protocol.pdf |archive-date=December 11, 2006 }}</ref>

====Plan B====
* On July 28, 1999, the FDA approved the prescription progestin-only Plan B (two 750&nbsp;μg [[levonorgestrel]] pills) emergency contraceptive.<ref>{{cite web |author=FDA |date=July 28, 1999 |title=Plan B approval package |website=[[Food and Drug Administration]] |url=https://www.fda.gov/cder/foi/nda/99/21-045_PlanB.htm |access-date=2006-12-10 |archive-url=https://web.archive.org/web/20061011045016/https://www.fda.gov/cder/foi/nda/99/21-045_PlanB.htm <!-- Bot retrieved archive --> |archive-date = 2006-10-11}}</ref>
* On August 24, 2006, the FDA approved nonprescription behind-the-counter access to Plan B from pharmacies staffed by a licensed pharmacist for women 18 or older; a prescription-only form of Plan B was made available for younger females aged 17 and younger.<ref>{{cite web |author=FDA |date=August 24, 2006 |title=Plan B information page |website=[[Food and Drug Administration]] |url=https://www.fda.gov/cder/drug/infopage/planB/default.htm |access-date=2006-12-10}}</ref>
* On November 6, 2006, [[Barr Pharmaceuticals]] announced that its subsidiary, Duramed Pharmaceuticals, had initiated shipment of dual-label Plan B OTC/Rx and it would be available in pharmacies across the U.S. by mid-November 2006.<ref>{{cite web |author=Barr Pharmaceuticals |date=November 6, 2006 |title=Barr Launches Plan B OTC/Rx Dual-Label Product; Awarded 3 Years New Product Exclusivity |url=http://phx.corporate-ir.net/phoenix.zhtml?c=60908&p=irol-newsArticle&ID=926964 |access-date=2006-12-12 |archive-date=2018-11-03 |archive-url=https://web.archive.org/web/20181103012820/http://phx.corporate-ir.net/phoenix.zhtml?c=60908&p=irol-newsArticle&ID=926964 |url-status=dead }}</ref>
* On March 23, 2009, a US judge ordered the FDA to allow 17-year-olds to acquire Plan B without a prescription.<ref>{{cite news|title=F.D.A. Easing Access to 'Morning After' Pill| vauthors = Gardiner H |work=The New York Times|date=April 22, 2009|url=https://www.nytimes.com/2009/04/23/health/23fda.html}}</ref> This now changes the August 24, 2006, ruling and Plan B is now available "behind the counter" for men and women. There is a prescription method available for girls under 17.
* On April 30, 2013, the FDA approved (with three-year marketing exclusivity) [[Teva Pharmaceutical Industries]]' Plan B One-Step for sale without a prescription to anyone age 15 or over who can show proof of age such as a [[driver's license]], [[birth certificate]], or [[passport]] to a drug store [[retail clerk]].<ref name="FDA April 30, 2013">{{cite news| vauthors = Kliff S |date=May 1, 2013|title=Plan B will be available to 15-year-olds, but they might need a passport to get it|work=Wonkblog|url=https://www.washingtonpost.com/blogs/wonkblog/wp/2013/05/01/plan-b-will-be-available-to-15-year-olds-but-they-might-need-a-passport-to-get-it/|access-date=2013-05-02}}<br />{{cite web|date=April 30, 2013|title=FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older|location=Silver Spring, Md.|publisher=U.S. Food and Drug Administration|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350230.htm|access-date=2013-05-02}}</ref> [[Generic drug|Generic]] one-pill levonorgestrel emergency contraceptives and all two-pill levonorgestrel emergency contraceptives will remain restricted to sale from a [[pharmacist]]—without a prescription to anyone age 17 or over who can show proof of age.<ref name="FDA April 30, 2013"/>
* On June 10, 2013, the Obama administration ceased trying to block over-the-counter availability of the pill. With this reversal it means that any person will be able to purchase the Plan B One-Step without a prescription.<ref>{{cite news|title=U.S. Drops Bid to Limit Sales of Morning-After Pill|url=https://www.nytimes.com/2013/06/11/us/in-reversal-obama-to-end-effort-to-restrict-morning-after-pill.html|newspaper=The New York Times|date=10 June 2013 |access-date=11 June 2013| vauthors = Shear MD, Belluck P }}</ref>