JAMA

January 4, 2012
Robert Steinbrook, MD

On December 7, 2011, Health and Human Services Secretary Kathleen Sebelius overruled the US Food and Drug Administration’s (FDA’s) decision that levonorgestrel emergency contraception (sold under the brand name Plan B One-Step) was safe and effective for all women of childbearing potential, regardless of their age, and should be approved for sale as a nonprescription drug. Plan B One-Step is a single-dose 1.5-mg tablet of levonorgestrel that should be taken as soon as possible and within 72 hours after an episode of unprotected intercourse.

Emphasizing a concern about nonprescription use by the youngest girls of reproductive age, Sebelius wrote to Margaret Hamburg, MD, the FDA commissioner that the studies submitted to the agency “do not include data on all ages for which the drug would be approved and available over the counter” and “do not establish that prescription dispensing requirements should be eliminated for all ages.”^1​ Although the Health and Human Services (HHS) secretary has the legal authority under the Food, Drug, and Cosmetic Act to reverse an FDA decision, Sebelius was apparently the first to ever do so.

Plan B One-Step is manufactured by Teva Women’s Health and sells for about US $50. The FDA has approved the drug for use without a prescription in women aged 17 years or older and with a prescription for those who are younger. Most who use emergency contraception are 17 years or older. The pills are dispensed from behind the counter at pharmacies and clinics; they are more difficult to obtain than they would be if they were in the aisles of pharmacies, grocers, and other retailers, as are condoms and spermicides. A generic product that consists of two 0.75-mg pills of levonorgestrel (sold under the brand name Next Choice) is also approved under the same dual status.

Federal agencies know that decisions involving sexual matters are often controversial. But virtually no one foresaw the extraordinary reversal of an FDA decision about drug approval by a secretary in President Barack Obama’s cabinet, a decision the president said that he fully supported.

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Read the complete article and related information at Science, Politics, and Over-the-Counter Emergency Contraception

JAMA

January 4, 2012

To the Editor: In 2009, the US Food and Drug Administration facilitated access to emergency contraception among adolescents by making it available over-the-counter to individuals aged 17 years or older. A disproportionate number of teen pregnancies occur among adolescents from disadvantaged neighborhoods.^1​,2,3​ The availability and accessibility of emergency contraception in these neighborhoods relative to more affluent ones is unknown.

One possibility is that pharmacies in low-income communities are more likely to stock emergency contraception and are more versed in regulations regarding over-the-counter dispensing. Conversely, suboptimal access to many health services has been documented for low-income populations,^4,5​ and pharmacy staff could be less likely to convey accurate information. We sought to understand differences in availability of and access to emergency contraception across low- and non–low-income US neighborhoods.

From September to December 2010, female research assistants posing as adolescents who recently had unprotected intercourse were randomly assigned to call every commercial pharmacy in Nashville, Tennessee; Philadelphia, Pennsylvania; Cleveland, Ohio; Austin, Texas; and Portland, Oregon. We chose cities in geographically diverse states without pharmacy access laws that supersede uniform federal regulations. Lists of pharmacies were obtained from state boards of pharmacy. Calls were made weekdays between 9 AM and 5 PM, when pharmacies would presumably be fully staffed. Callers followed standardized scripts (Figure; details available on request) to simulate real-world calls and elicit specific information on emergency contraception availability and access. We examined same-day availability of emergency contraception, whether emergency contraception could be accessed by the caller, and whether the pharmacy communicated the correct age at which emergency contraception is accessible over-the-counter.

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Read the complete article and related information at Access to Emergency Contraception for Adolescents

The Intel Hub

A seismic shift is now occurring in the forces that will control health care in the United States and around the world. It is a shift in power away from the World Health Organization (WHO) and into a new alliance of wealthy governments (the G8), United Nations groups, and elite international non-governmental power brokers such as the Bill & Melinda Gates Foundation.

American taxpayers should be alarmed. This means that tens of billions of U.S. taxpayer dollars for “humanitarian” foreign aide is being spent on objectives never approved by Congress. Americans should pay attention when Bill Gates makes very public proclamations about the need to reduce the surplus population.

By Byron Richards
Wellness Resources
August 11, 2011

On July 29, 2011 the Department of Global Health and Population at the Harvard School of Public Health sounded the population alarm bell in the international science journal, Science, advocating for international contraception efforts to be funded by wealthy countries.

On August 1, 2011 the Obama administration announced its plan to force health insurers, beginning in 2013, to pay for “free” birth control for all U.S. women, including free birth control pills, morning after pills, sterilization, and any other “FDA-approved contraception methods and contraceptive counseling.”

Americans should understand that Food and Drug Administration (FDA) Commissioner Margaret Hamburg is well-versed in eugenics theory, as both of her elite psychiatrist parents have headed the American Eugenics Society.

We are rapidly moving toward the time when government bureaucrats issue regulations to determine which fetuses, at five weeks of age, are genetically fit enough to be born.

A Brief History of Eugenics

The goal of eugenics is to utilize science to improve the genetic composition of a population. The elite eugenics ruling class is terrified of rapid population growth in “undesirable genetic stock.”

Their efforts are focused on controlling rapid population growth in developing countries, such as African nations, and in minority groups in the United States and other developed countries.

The “scientific” theory of eugenics originated in the 19th century with the works of Charles Darwin and others. Its theory was adopted as a core principle of genetic research by The Rockefeller University, Carnegie Institution for Science, and others at the beginning of the 20th century.

It was openly promoted and discussed for the first four decades of the 20th century. It even gained a supportive Supreme Court ruling in 1927 which allowed for sterilization of mental health patients. Moreover, American eugenics-oriented psychiatrists continued to force sterilization on mental health patients into the 1970s.

Beginning in 1910 and ending in 1944, a massive database of genetic information on Americans and related eugenics articles were collected in a Rockefeller and Carnegie-funded data repository known as the Eugenics Record Office.

WWII sent the public face and target of eugenics to scurry for cover as Hitler applied the theory to the Jews, giving the eugenics movement a major black eye. However, behind the scenes, American psychiatrists, German psychiatrists, and the heads of Rockefeller maintained their close working relationships.

At the conclusion of WWII, the Rockefellers allotted land in New York City to house the United Nations (UN), an organization founded on the core beliefs of the elite eugenics thinkers.

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Read the complete article and related information at The Revitalized Eugenics Movement & the FDA’s Role

NEW YORK (Reuters Health) – More U.S. women seem to be using the “morning-after” pill now that the emergency contraceptive is available over-the-counter, a new study finds.

Researchers found that between 2006 and 2008, about twice as many women ages 15 to 44 said they had used emergency contraception, compared with four to six years earlier — when it was still restricted to prescription-only.

The emergency contraceptive Plan B has been available in the U.S. since 1999. The pills, which contain the hormone progestin, cut the risk of pregnancy after unprotected sex by stopping the ovaries from releasing an egg.

However, the contraceptive must be taken within 72 hours of having sex — and the sooner, the better. After the first 12 hours the risk of pregnancy increases by 50 percent.

So in 2006, after years of political controversy, the U.S. approved Plan B for “behind-the-counter” sales to adults — meaning they could get it from a pharmacy without waiting for a prescription. The age restriction was later lowered to 17 in 2009.

In the new study, researchers looked at data from a periodic government survey to see how national rates of emergency-contraception use may be changing.

They found that of more than 6,300 sexually active U.S. women surveyed between 2006 and 2008, nearly 10 percent said they had ever used emergency contraception.

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Read the complete article and related information at More U.S. women using “morning-after” pill: study

Pregnant women should be told that having an abortion is safer than having the baby, according to medical chiefs

The Telegraph

By Laura Donnelly, Health Correspondent 10:00PM GMT 26 Feb 2011

Never before has official advice to doctors and nurses in Britain instructed them to use such comparisons to help pregnant women decide whether to keep a child

Never before has official advice to doctors and nurses in Britain instructed them to use such comparisons to help pregnant women decide whether to keep a child.

Current guidance simply tells doctors and nurses that they should “be equipped” to provide accurate information about the relative dangers.

Josephine Quintavalle, of the Pro-Life Alliance accused the royal college of “manipulating the evidence” in order to promote a pro-choice message. She said: “I don’t believe that most women considering abortions are worried it will kill them or are worrying about dying in childbirth; this is a blatant attempt to force an absurdly liberal agenda on women when they are at their most vulnerable.”

Speaking in a personal capacity, Prof Patricia Casey, a consultant psychiatrist and fellow of the Royal College of Psychiatrists, said: “The message this sends out is very worrying. There are more than 30 studies showing an association between psychological trauma and abortion.”

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Read the complete article and related information at Abortion is safer than having a baby, doctors say

VirtualMedicalCentre.com

Australia

Let’s face it, unprotected sex does happen and sometimes, with a bit of bad luck, condoms can break and situations can arise where a woman may need emergency contraception. This kind of contraception is used after sex but before you are pregnant. If you are unsure about talking with the pharmacist or GP for any reason – don’t be. It’s nothing to get nervous about. In fact, 3 out of 4 unwanted pregnancies could be prevented if all women used emergency contraception after unprotected sex, and many abortions could also be avoided. The power is yours.

Eggs over easy: The right time to use it

Did you know there is a small time period after sex in which a woman is not yet pregnant? This happens for several reasons. An egg can only be fertilised when it leaves the ovaries and reaches the womb. So even though wily sperm can loiter around the womb, flowers in hand, for up to five days after unprotected sex, the egg still needs to show up for the date in order for conception to occur.

And even if an egg does become fertilised, it needs to become implanted into the womb wall, which only happens several days after the egg is fertilised. Many fertilised eggs do not implant in the womb, and when the egg does not implant within a seven-day timeframe, the woman does not become pregnant.

How do they work?

There are three types of emergency contraceptive, and they work in slightly different ways.

The morning after pill contains oestrogen and/or progesterone, the same hormones contained in the contraceptive pill or injection, just in a much greater dose. They work by preventing ovulation (meaning they prevent a woman’s egg from leaving her ovaries), so the egg cannot be fertilised and the sperm are jilted at the altar. However, it’s only effective in the first half of your menstrual cycle because you haven’t yet ovulated.

The intrauterine device is inserted inside a woman’s uterus or womb to cause the lining of the womb to change so that it is not receptive to a fertilised egg. If the egg can’t get comfortable in the womb, then you cannot get pregnant.

Mifepristone (also known as RU486) blocks the hormone progesterone. Without progesterone, an embryo cannot implant or stay implanted in the lining of the uterus.

Only the morning after pill and the IUD are available as emergency contraception in Australia. To receive a prescription for mifepristone, you must talk to your GP.

Read the complete article and related information at Morning after pill: Sisters are doing it for themselves

Care2

February 9, 2011
posted by: Cynthia Samuels

by Joanne Bamberger, PunditMom

What’s happened to the whole Republican “the economy and jobs are our first priority” mantra from the 2010 elections?  Eric Cantor can say it all he wants, but that isn’t making it true.  Instead of jobs, conservatives are once again focused on our lady parts.   While I am sort of  getting used to the new TSA pat downs,  I have to draw the line when it comes to the government getting its hands on my privates.

The GOP is focusing on the budget, but not for creating jobs — they are trying to impact substantive issues through bills that control spending, as they recently did in their (thankfully) failed attempt to redefine rape in the “No Taxpayer Funding for Abortion Act.” It initially called for limiting the availability of Medicaid funds for abortion only to women who had been “forcibly” raped.

Since the original passage of the Hyde Amendment in 1976, no federal taxpayer funds have been available to cover the cost of abortions through Medicaid except in instances of rape, incest or if the life of the mother is in danger. The forcible rape exception, introduced by Representative Chris Smith (R-N.J.), didn’t explicitly spell out in the bill what that meant, but a variety of organizations, including NOW and EMILY’s List, believed it would exclude victims of statutory rape, date rape, rape victims who initially said “no” but weren’t able to fend off their attackers, and women who feared for their lives unless they acquiesced to a rapist’s demands.

Often, Democrats are scarily silent in these debates.  Thankfully Democratic Senators Kirsten Gillibrand of New York and Richard Blumenthal of Connecticut led the charge that ended in having that exception pulled from the bill.  That’s good news as far as it goes.  Fortunately, they’re also spearheading a full court press to make voters aware of the mostly-Republican efforts to further chip away at women’s reproductive health rights.

Their full-court press includes a petition effort encouraging voters to contact their representatives if they disagree with the No Taxpayer Funding for Abortion Act.  And now several other Senators have joined with a fiery Gillibrand to protest not only this specific bill, but the GOP’s bait-and-switch agenda:

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Read the complete article and related information at GOP Budget Wars on Reproductive Health

RSC Advancing the Chemical Sciences

03 February 2011
Ben Merison

A particular crystal form of the female steroid hormone progesterone can no longer be made. UK chemists have analysed a fifty year old sample to find out why and say that it’s down to impurities. This takes researchers a step closer to understanding why certain pharmaceutical drugs lose their therapeutic effect.

Robert Lancaster from University College London, in collaboration with Pharmorphix, a company in Cambridge that carries out research for the pharmaceutical industry, analysed two crystal forms of progesterone, which has five known crystal forms, or polymorphs.

They discovered that impurities in the old sample – in this case, other steroids – that were added during the synthesis to induce crystal growth could account for the stability of form 2 over form 1. The researchers found 11 impurities in form 2 and only three in form 1. Unfortunately, they were unable to identify the exact structures of the impurities, making it practically impossible to reproduce the conditions to make the crystals again.

Studying polymorphism is important because many drugs receive regulatory approval for only a particular crystal form of a compound. But polymorphs can disappear – where it becomes difficult to continue growing a particular crystal form. New, more stable, forms are grown. This happened to a HIV drug called ritonavir. Over time, a second crystal form emerged, which was less soluble and so less effective as a drug. Ritonavir had to be pulled from the market while researchers worked to solve the problem.

To analyse the structure of the progesterone crystal, the group carried out a unique experiment in which they combined crystal structure prediction with other experimental methods, such as slow and rapid evaporative crystallisation. The result allows the identification of the most stable polymorph, which could then be used to develop a new pharmaceutical drug.

‘Pharmaceutical companies adopt a more rigorous approach to screening for polymorphs,’ explains Lancaster. ‘They try to find and develop the most stable polymorph but aggressive timescales associated with the development process may mean that nasty surprises can occur.’ Lancaster says his work aims to remove these surprises.

‘Future work will reveal more to explain what’s going on,’ predicts Nick Blagden, a polymorphism expert from the University of Bradford, UK, ‘and is linked to fundamental studies into nucleation and crystal growth, which are linked to crystal engineering.’

Lancaster is now looking at other polymorphic systems and carrying out new automated analytical and crystallisation methods to discover the most stable polymorphs.

Read the complete article and related information at The mystery of the disappearing crystals

Cafemomblog

Posted by Maressa Brown
December 13, 2010 at 12:55 PM

Ella is causing quite the controversy. No, she’s not a Victoria’s Secret model or co-starring opposite Johnny Depp in an upcoming blockbuster. Actually, it is a new birth control pill that can prevent pregnancy after an “oops!” moment, and it just became available by prescription. Like Plan B—which is most effective the “morning after” but far less effectual 72 hours later—Ella is emergency contraception.

But, unlike Plan B, Ella can cut the chances of becoming pregnant by about two-thirds for at least 120 hours after a condom fail or unprotected sex, studies have shown. That’s two days longer than Plan B.

Regardless of whether or not the drug fills a void in the contraception market, there are plenty of pro-life, hyper-reactionary opponents who want to see it done away with because they argue that Ella’s the same thing as an abortion. The thing is, it’s not.

How it works: Ella hinders progesterone and postpones the surge of hormones that tell the body it’s time to release a mature egg. With progesterone’s activity held at bay, the womb cannot be prepared to accept a fertilized egg and to care for a developing embryo.

The brouhaha: Ella is like a chemical cousin to the abortion pill RU-486, or mifepristone, which also blocks progesterone in an effort to prevent a fertilized egg from implanting; it also dislodges growing embryos. But evidence shows that Ella does not terminate already existing pregnancies.

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Read the complete article and related information at Reasons Why Ella Is NOT Abortion

National Review Online

October 5, 2010

This fall, Watson Pharmaceuticals will begin manufacturing a new drug called “ella.” Ella was approved by the Food and Drug Administration on August 13, and was categorized as an “emergency contraceptive.” That categorization is misleading: As the Family Research Council and several allied organizations have been explaining to pharmacists and the public at large, the drug has the potential to induce abortion.

Responding to this campaign, Watson Pharmaceuticals is claiming that ella is “not an abortifacient drug.” Yet the company did not address charges that the drug can abort an implanted baby. Nor did it dispute the FDA’s labeling information, which reads that “alterations to the endometrium [the inner membrane of the uterus] that may affect implantation may also contribute to the efficacy.”

Watson also failed to comment on the label statement that “pregnancy should be excluded before prescribing ella.” Why is ella “contraindicated” for pregnancy? Because, as the FDA notes, in studies of ella that were conducted on pregnant animals, all of the baby rats and half of the baby rabbits were aborted.

Watson made the obvious and uninformative statement that ella “is not RU-486,” yet did not address the key similarities between the two drugs. Ella and RU-486 have an almost identical chemical makeup and possess identical modes of action. (They are both selected progesterone receptor modulators.) By contrast, Plan B, currently the most widely used form of emergency contraception in the U.S., is a completely different class of drug and does not impact an already implanted pregnancy.

Ella and RU-486 both block the production of progesterone in a woman, which a fetus needs to develop and survive during its first ten weeks. In blocking progesterone, both RU-486 and ella can disrupt already-implanted embryos. In at least one study comparing the drugs at the same dose, ella was more potent in aborting animals than RU-486. Unfortunately, rather than address these scientific and ethical concerns, Watson simply labeled them “varying opinions.”

This dismissive response may mean that Watson does not fully understand the ramifications of marketing and disseminating ella. Until now, no major pharmaceutical company in the U.S. has ever willingly linked itself to abortion. When the Population Council assumed the U.S. rights to RU-486, Danco Labs was created (and chartered in the Cayman Islands) solely to sell the drug.

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Read the complete article and related information at Ella and Abortion