Scientists Clone Human Embryos To Make Stem Cells

Rob Stein and Michaeleen Doucleff

Scientists say they have, for the first time, cloned human embryos capable of producing embryonic stem cells.

The accomplishment is a long-sought step toward harnessing the potential power of embryonic stem cells to treat many human diseases. But the work also raises a host of ethical concerns.

“This is a huge scientific advance,” said , a Harvard stem cell scientist who wasn’t involved in the work. “But it’s going to, I think, raise the specter of controversy again.”

The controversy arises from several factors. The experiments involve creating and then destroying human embryos for research purposes, which some find morally repugnant. The scientists also used cloning techniques, which raise concerns that the research could lead to the cloning of people.

Ever since human embryonic stem cells were discovered, scientists have had high hopes for them because the cells can morph into any kind of cell in the body. That ability means, in theory, that they could be used eventually to treat all sorts of illnesses, including diabetes, Alzheimer’s, Parkinson’s and spinal cord injuries.

So for years, scientists have been trying to use cloning techniques to make embryonic stem cells that are essentially a genetic match for patients. The idea is that such a close match would prevent their bodies from rejecting the cells.

“It’s been a holy grail that we’ve been after for years,” says , a stem cell pioneer at the University of Pennsylvania.

But every previous attempt ended in failure or fraud, leading many scientists to wonder if the goal might be impossible to reach.

Making Personalized Stem Cells

Scientists report Wednesday that they have successfully cloned human embryos from a person’s skin cells. Here’s how they could eventually use the technology to create new therapies for a patient.

Making Personalized Stem Cells

However, of the Oregon Health & Science University and his colleagues never gave up. They succeeded in mice and monkeys. And in this week’s issue of the journal Cell, Mitalipov’s team they finally did it in humans.

“I’m very excited,” Mitalipov says. “It’s a very significant advance.”

The researchers first recruited women who were willing to provide eggs for the research. Next, they removed most of the DNA from each egg and replaced the genetic material with DNA from other peoples’ skin cells.

Then, after a long search, they finally found the best way to stimulate each egg so that it would develop into an embryo without the need to be fertilized with sperm. The key turned out to be a combination of chemicals and an electric pulse.

“We had to find the perfect combination,” Mitalipov says. As it turned out, that perfect combination included something surprising: caffeine.

“The Starbucks experiment, I guess,” quipped Daley. “This little change in the cocktail was what really allowed the experiment to really ultimately succeed.”

Shoukhrat Mitalipov, of Oregon Health & Science University, first cloned monkey embryos before trying his method on human eggs.

Shoukhrat Mitalipov, of Oregon Health & Science University, first cloned monkey embryos before trying his method on human eggs.

That ingredient, plus other tweaks in the process, including using fresh eggs and determining the optimal stage of each egg’s development, Mitalipov says.

The researchers showed that the resulting embryos could develop to a stage where they could produce healthy stem cells containing the genes from the skin cells. They even showed that the stem cells could be turned into other types of cells, including heart cells that in a laboratory dish could pulse like a beating heart.

The work drew immediate criticism because of ethical concerns.

First of all, the Oregon researchers compensated women financially to donate eggs for the experiments — something many in the field have considered ethically questionable.

But beyond that, the creation and destruction of a human embryo is morally repugnant to people who believe an embryo has the same moral standing as a human being.

“This is a case in which one is deliberately setting out to create a human being for the sole purpose of destroying that human being,” says , a professor of medicine and a bioethicist at the University of Chicago. “I’m of the school that thinks that that’s morally wrong no matter how much good could come of it.”

Moreover, Mitalipov used the same method that researchers used previously to clone . That approach raises the possibility that scientists could try to clone a human being.

“This raises serious problems because it is the first actual human cloning,” Sulmasy says. “We already know there are people out there who are itching to be able to be the first to bring a cloned human being to birth. And I think it’s going to happen.”

But Mitalipov dismisses those concerns. He says the embryos he created aren’t the equivalent of a human being because they weren’t fertilized naturally. And his experiments with monkeys indicate that it’s unlikely that they could ever develop into a healthy baby.

“The procedures we developed actually are very efficient to make stem cells, but it’s unlikely that this will be very useful for kind of reproductive cloning,” Mitalipov says.

Other researchers agree with him and argue that the possible benefits of the research outweigh the concerns. “Where you can improve [a patient's] quality of life tremendously through this kind of technology, I personally believe that it is ethical to use material like this,” Gearhart says.

The scientists acknowledge that it will be years before anyone knows whether this step will actually result in treatments that might help patients. In the meantime, it’s clear that the intense debate over embryonic stem cells is far from over.

http://www.npr.org/blogs/health/2013/05/15/183916891/scientists-clone-human-embryos-to-make-stem-cells

Angelina Jolie’s Double Mastectomy: What We Know About BRCA Mutations and Breast Cancer

She doesn’t have cancer yet, but like many women with breast cancer mutations, she had the radical surgery to lower her risk.

Describing her decision as “My Medical Choice,” the 37-year-old actress revealed in an op-ed in the New York Times that she carries the BRCA1 gene mutation, which gives her an 87% risk of developing breast cancer at some point in her life. The abnormal gene also increases her risk of getting ovarian cancer, a typically aggressive disease, by 50%. To counteract those odds, Jolie wrote that she decided to have both her breasts removed.

 

While radical, her decision to pre-empt any future cancer is a common one, and backed by studies. In 2010, Australian scientists found that women with the BRCA1 or BRCA2 mutations who chose to have preventive mastectomies did not develop breast cancer over the three-year follow-up. What’s more, since the genetic abnormalities increase the risk of ovarian cancer, women who had their ovaries and fallopian tubes removed also dramatically lowered their risk of developing ovarian or breast cancers. TIME’s story about the study explained:

 

They were 89% less likely to develop ovarian cancer and 61% less likely to develop breast cancer over three years than their counterparts who did not have prophylactic surgery. Among the 250 study participants who underwent preventive mastectomies, none developed breast cancer during the study follow-up. Additionally, a patient’s surgical choice affected overall mortality rates, both cancer related and not: only 3 percent of surgery participants died at the time of the study follow-up versus 10 percent of those who avoided the surgery.

 

 

And while the mutations are inherited – a mother with either aberration has a 50-50 chance of passing it on to her children – women who don’t get the mutation are not at increased risk of developing breast cancer, even if they belong to families with a history of the disease. Previous studies had suggested that women who did not have the mutations but had a mother or sister who did, could have up to a five times greater risk of developing different types of breast cancer, which led them to schedule frequent biopsies and even preventive mastectomies. The latest research, however, suggests that’s not necessarily the case. As I wrote in 2011:

 

But the new study counters those findings, concluding that the risk of breast cancer in women from BRCA families, who do not carry the mutations themselves, are no higher than that of women in families with other types of breast cancer. The study involved more than 3,000 families with breast cancer, including nearly 300 who had the BRCA1 or BRCA2 mutations.

 

The genetic test for the BRCA mutations isn’t done for every woman, or even for every woman who is at risk of developing breast cancer. Doctors recommend it for those who develop cancer at a young age, or have multiple family members with the disease. It’s expensive – up to $3000 – and insurers require that patients meet a threshold for needing the test before they cover its cost. Jolie is fortunate to be able to afford not just the test but the reconstructive surgery following the procedure as well. But she’s aware that not all women are even aware of the genetic screening and may not be able to afford the testing. She wrote that her goal in announcing her choice to remove her breasts prophylactically is to raise awareness of the test and the treatment options that women have if they are positive for the mutations.

Robert G. Edwards, 1925-2013: Changing Rules of Conception With the First ‘Test Tube Baby’

By  NY Times
Published: April 10, 2013
Robert G. Edwards, who opened a new era in medicine when he joined a colleague in developing in vitro fertilization, enabling millions of infertile couples to bring children into the world and women to have babies even in menopause, died on Wednesday at his home near Cambridge, England. Dr. Edwards, who was awarded the Nobel Prize for his breakthrough, was 87.

Robert G. Edwards with the world’s first “test tube baby,” Louise Brown, second from right, in 2008, just before her 30th birthday. With them are her mother, Lesley, and her son, Cameron…

http://www.nytimes.com/2013/04/11/us/robert-g-edwards-nobel-winner-for-in-vitro-fertilization-dies-at-87.html?hp

FDA Investigating Potential Problems with Popular Surgical Robot

By April 09, 2013

The biggest thing in operating rooms these days is a million-dollar, multi-armed robot named da Vinci, used in nearly 400,000 surgeries nationwide last year – triple the number just four years earlier.

But now the high-tech helper is under scrutiny over reports of problems, including several deaths that may be linked with it and the high cost of using the robotic system.

There also have been a few disturbing, freak incidents: a robotic hand that wouldn’t let go of tissue grasped during surgery and a robotic arm hitting a patient in the face as she lay on the operating table.

Is it time to curb the robot enthusiasm?

Some doctors say yes, concerned that the “wow” factor and heavy marketing have boosted use. They argue that there is not enough robust research showing that robotic surgery is at least as good or better than conventional surgeries.

Many U.S. hospitals promote robotic surgery in patient brochures, online and even on highway billboards. Their aim is partly to attract business that helps pay for the costly robot.

The da Vinci is used for operations that include removing prostates, gallbladders and wombs, repairing heart valves, shrinking stomachs and transplanting organs. Its use has increased worldwide, but the system is most popular in the United States.

SRM Applauds Court Decision Striking Down Age Restriction for Emergency Contraception

April 5 , 2013
by: ASRM Office of Public Affairs
Published in ASRM Press Release

Statement attributable to Linda C. Giudice, MD, PhD, President, American Society for Reproductive Medicine

Washington, DC —  ”We are pleased with Judge Korman’s decision ordering FDA to lift its restrictions on access to emergency contraceptives.  Restricting over-the-counter access by age has historically been a political decision. We agree with the court that these decisions need to be based on science, not politics.  In the field of reproductive medicine,  politicians too often seek to substitute their judgment for that of physicians and their patients or the scientific evidence. This results in bad medicine and bad policy. Today’s decision tells the Federal Government that science should guide policy, and we applaud that stance.”

Background:

U.S. District Court Judge Edward Korman has ordered the FDA to make levonorgestrel-based emergency contraception available over-the-counter without age or point of sale restriction.  U.S. Department of Health and Human Services Secretary Kathleen Sebelius had used her power as Secretary to overturn a recommendation from FDA to remove the age restriction.  The court’s decision can be read here: http://www.washingtonpost.com/blogs/wonkblog/files/2013/04/Tummino-SJ-memo.pdf.

The order was issued in response to a suit brought by the Center for Reproductive Rights.  See http://reproductiverights.org/en/press-room/federal-judge-orders-fda-to-broaden-access-to-emergency-contraception  for more information.

The American Society for Reproductive Medicine, founded in 1944, is an organization of more than 7,000 physicians, researchers, nurses, technicians and other professionals dedicated to advancing knowledge and expertise in reproductive biology.  Affiliated societies include the Society for Assisted Reproductive Technology, the Society for Male Reproduction and Urology, the Society for Reproductive Endocrinology and Infertility, the Society of Reproductive Surgeons and the Society of Reproductive Biologists and Technologists.

Court ruling lifts age limit on morning-after pill

By Monte Morin and Geoffrey Mohan, Los Angeles Times April 5, 2013

President Obama once fretted about the prospect that girls as young as 10 or 11 could walk into a drugstore and buy emergency contraception pills as easily as “bubble gum or batteries.”

With his blessing, the Department of Health and Human Services set aside the advice of medical experts and blocked efforts to allow girls younger than 17 to get the so-called morning-after pill without a prescription.

That age limit is poised to disappear now that a federal judge has cleared the way Friday for girls — and boys — of any age to purchase the medication without having to notify their parents or a doctor.

In a sharply worded ruling that called government regulators “politically motivated and scientifically unjustified,” U.S. District Judge Edward Korman ruled that levonorgestrel-based contraceptives such as Plan B One-Step and Next Choice One Dose should be available over the counter to all customers within 30 days.

“There is no serious health risk associated with use of Plan B as prescribed and intended, much less one that would make restrictions on distribution necessary for its safe use,” Korman wrote.

Unless successfully appealed by the U.S. Department of Justice, the ruling would make contraceptives as readily available to minors as Tylenol or Benadryl. The biggest barrier to access would be the pill’s hefty $50 price tag.

Reproductive rights advocates hailed Korman’s ruling as a victory of science over politics, and said the ruling was a long time in coming for the politically sensitive drug.

“A federal judge has accomplished what two administrations failed to do: make a decision about access to a drug based on medical evidence,” said Michael Halpern, program manager at the Center for Science and Democracy at the Union of Concerned Scientists.

The lawsuit that prompted the order was brought by the Center for Reproductive Rights. On Friday, the center’s president, Nancy Northup, released a statement calling the decision a blow to deep-seated discrimination.

“Women all over the country will no longer face arbitrary delays and barriers just to get emergency contraception,” she said.

Though the ruling noted that both the George W. Bush and Obama administrations had a hand in restricting access, Korman’s action placed reproductive rights groups in the odd position of siding with a Republican-appointed federal judge who had harshly critical words for a Democratic administration.

“This case is not about the potential misuse of Plan B by 11-year-olds,” the judge wrote. “These emergency contraceptives would be among the safest drugs sold over-the-counter,” he noted, and “the number of 11-year-olds using these drugs is likely to be minuscule.”

Justice Department spokeswoman Allison Price said the government was “reviewing the appellate options and expects to act promptly.”

Plan B was the first emergency contraceptive drug approved in the United States and required a prescription when it came on the market in 1999.

The drug, a synthetic hormone, prevents pregnancy by blocking ovulation and impeding the mobility of sperm. It does not cause an abortion in women who are already pregnant; nor does it harm a developing fetus.

In 2006, the Food and Drug Administration allowed adults to buy the drug over the counter but still required prescriptions for those younger than 18.

In late 2011, the FDA was ready to permit the nonprescription sale of the drug to people of all ages, but Health and Human Services Secretary Kathleen Sebelius overruled the agency and continued to require prescriptions for those 16 and younger. She cited concern that the drug had not been tested in girls as young as 11, even though 10% of them are “physically capable of bearing children.”

It was the first time that a Health and Human Services secretary had overruled an FDA decision.

To critics, it seemed that presidential politics was the real reason for Sebelius’ action. The 2012 election was less than a year away.

The Center for Reproductive Rights went to court and argued that the age and prescription requirements limited access to the drug for all women by creating confusion among pharmacists and clerks. Also, because pharmacists kept the drug behind the counter, it was not available outside regular 9-to-5 pharmacy hours.

http://www.latimes.com/news/science/la-sci-plan-b-20130406,0,5624429.story

Controversy Over Contraception Misses the Economic Point

By Bryce Covert (Forbes)

If someone asked you what the most controversial part of the Affordable Care Act is, what would you say? So-called “death panels”? The Medicaid expansion? Breast pumps?

If you guessed the requirement for insurance companies to cover contraception without co-payment, you’d win the jackpot. The Sunlight Foundation just analyzed public comments on federal regulations – the public’s most direct way to share input on a given bill or rule – and found that this mandate has by far received the most, clocking in at more than 147,000 comments. The runner up got a mere 4,600 in comparison. And while public comments can always be fan mail, in this case most of them opposed the contraception provision.

This news surfaces alongside some research on contraception that’s worth taking into consideration. It turns out that women’s access to contraception isn’t just about their desire to space or delay pregnancies. Contraception access has huge economic ramifications for their lives and for the rest of us. It’s something the haters might want to take into consideration.

The Guttmacher Institute just released a review of the research that’s been done on the impact of access to contraception on women’s lives. It’s not just a nice to have. It’s a need to have. That’s because the research confirms that women’s ability to control their fertility has huge educational and economic outcomes. Legal access to contraception is a significant factor in a larger number of women getting at least some college education and in more women pursing advanced degrees. Access to the pill has also been a “driving force behind significantly more women participating in the labor force, including jobs requiring advanced education and training,” Guttmacher reports. And it helps women stabilize their financial situations, increasing their earning power and decreasing the gender pay gap. On an emotional wellbeing level, it also helps them have more stable relationships with their partners and experience less depression and anxiety.

These are all incredibly important outcomes for the women themselves and our economy as a whole. More women in the workforce has increased GDP by 25 percent. On top of this, contraception also has an impact on women’s families. A new paper from the Brookings Institute finds that giving women access to contraception through federally financed family planning programs has big benefits for their children’s economic wellbeing. These programs lifted household income of the children born in communities that could access them by $1,146 a year in 1980 dollars. It also led to a big reduction in poverty: children living in these communities were 5 percent less likely to live in poverty and 15 percent less likely to live in a house that received welfare benefits. This is obviously incredibly important for the lives of these children. But we all see a benefit when fewer people grow up in poverty and fewer families have to turn to welfare to get by.

Women’s access to contraception isn’t a moral question. It’s an economic one. It’s something women need, and we all benefit when they’re able to access it without encountering financial barriers. The requirement that it be covered without a co-pay is a huge step forward for women and our economy. Too bad that’s not getting a fair hearing in the public comments.

http://www.forbes.com/sites/brycecovert/2013/03/25/controversy-over-contraception-misses-the-economic-point/

Medical groups file brief in Hobby Lobby case disputing claims on emergency contraceptives

By Brianna Bailey | Published: March 23, 2013 (The Oklahoman)
 
The American College of Obstetricians and Gynecologists and several other medical groups that support the use of emergency contraceptives have challenged Oklahoma City-based Hobby Lobby Store’s Inc.’s claim that the drugs are a form of abortion.

The groups moved Thursday to file a friend of the court brief in Hobby Lobby’s court battle over a portion of the Affordable Care Act that requires the company to cover the cost of emergency contraceptives for its workers through its employee health plan.

Hobby Lobby argues that the drugs are a type of abortion and that covering the cost of the drugs for its employees would violate the Christian religious beliefs of CEO David Green and his family.

The contraceptives Hobby Lobby takes issue with include Ella and Plan B, commonly known as the week-after and morning-after pills, as well as some types of IUDs.

The American College of Obstetricians and Gynecologists, a nonprofit that claims to represent about 90 percent of all board-certified obstetricians and gynecologists practicing in the United States, filed the brief along with seven other women’s health groups and three academics including James Trussell, senior fellow for the reproductive health advocacy group, the Guttmacher Institute.

The groups moved to get involved in Hobby Lobby’s lawsuit to dispel myths about emergency contraceptives, the brief said. Several anti-abortion and conservative groups have also filed friend of the court briefs in the case in support of the company’s position…

http://newsok.com/medical-groups-file-brief-in-hobby-lobby-case-disputing-claims-on-emergency-contraceptives/article/3770492

Herbal Medicines Pose Health Risk to Millions in Asia

March 20, 2013 (TIME Magazine)

A commonly used herbal remedy that is banned in the U.S. and many European countries may still be harming users in Asia.

Since researchers connected an epidemic of kidney disease among Belgium women in the early 1990s to herbal medicines from a weight loss clinic, scientists have monitored the remedy for other potential health risks.

During the initial outbreak, scientists traced the kidney problems to aristolochic acid (AA), which belongs to a group of plants known as birthwort or Dutchman’s pipe. The agent is used for weight loss and to treat asthma and arthritis. But since the epidemic, herbs with aristolochic acid have been banned for medicinal uses in many countries, including the U.S. Researchers at King’s College London, however, now report in the Annals of Internal Medicine that millions of people are still being exposed, especially in Asia.

The scientists, led by Graham Lord, the director of the National Institute for Health Research Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, found that herbal medicines containing the acid are still found in China and other Asian countries and can be purchased online. “The reason we wrote this paper is to provide a diagnostic classification for aristolochic acid nephropathy (AAN) [the type of kidney failure associated with the agent]. For countries that haven’t asked the question of whether this is present, here is diagnostic criteria. We just don’t know what the levels of exposure are throughout the world,” he says.

After reviewing 42 case studies and one trial related to caring for the disease, Lord and his colleagues came up with guidelines to help doctors to recognize cases of AAN, as well as treat the disease’s symptoms. They concluded that aristolochic acid could be linked to a variety of kidney diseases and urothelial cancer

http://healthland.time.com/2013/03/20/herbal-medicines-pose-health-risk-to-millions-in-asia/

Read more: http://healthland.time.com/2013/03/20/herbal-medicines-pose-health-risk-to-millions-in-asia/#ixzz2OAybh8ym

U.S. Catholics in Poll See a Church Out of Touch

and NY Times
March 5, 2013

Roman Catholics in the United States say that their church and bishops are out of touch, and that the next pope should lead the church in a more modern direction on issues like birth control and ordaining women and married men as priests, according to the latest New York Times/CBS News poll.

even out of 10 say Pope Benedict XVI and the Vaticanhave done a poor job of handling sexual abuse, a significant rise from three years ago. A majority said that the issue had led them to question the Vatican’s authority. The sexual abuse of children by priests is the largest problem facing the church, Catholics in the poll said.

Three-fourths of those polled said they thought it was a good idea for Benedict to resign. Most wanted the next pope to be “someone younger, with new ideas.” A majority said they wanted the next pope to make the church’s teachings more liberal.

With cardinals now in Rome preparing to elect Benedict’s successor, the poll indicated that the church’s hierarchy had lost the confidence and allegiance of many American Catholics, an intensification of a long-term trend. They like their priests and nuns, but many feel that the bishops and cardinals do not understand their lives.

“I don’t think they are in the trenches with people,” said Therese Spender, 51, a homemaker in Fort Wayne, Ind., who said she attended Mass once a week and agreed to answer further questions after the poll. “They go to a lot of meetings, but they are not out in the street.”

Even Catholics who frequently attend Mass said they were not following the bishops’ lead on issues that the church had recently invested much energy, money and credibility in fighting — artificial birth control and same-sex marriage

http://www.nytimes.com/2013/03/06/us/poll-shows-disconnect-between-us-catholics-and-church.html?hpw&_r=0

Availability of sugar influences rate of diabetes, study says

By Melissa Healy, Los Angeles Times February 27, 2013

In a finding certain to put new pressure on the purveyors of sugary foods and drinks, a worldwide analysis shows that regardless of its effect on obesity, the ebb and flow of sugar in a country’s diet strongly influences the diabetesrate there.

The new study provides compelling evidence that obesity isn’t driving the worldwide pandemic of Type 2 diabetes as much as the rising consumption of sugar — largely in the form of sweetened sodas, experts said.

Increases in sugar intake account for a third of new cases of diabetes in the United States and a quarter of cases worldwide, according to calculations published Wednesday in the journal PLOS ONE. In the 175 countries studied, a 150-calorie daily increase in the availability of sugar — about the equivalent of a can of Coke or Pepsi — raises the prevalence of Type 2 diabetes by 1.1%, a research team from Stanford University and UC San Francisco found.

Dr. Walter Willett, a nutritionist and epidemiologist at the Harvard School of Public Health, said the results almost certainly underestimated the role of added sugar in the development of diabetes, since the data didn’t distinguish between sugar that comes from fresh fruit and sugar that is concentrated in junk foods and sodas with no other nutrients.

The results make clear that sugar consumption “is fueling the global epidemic of diabetes,” and that reducing that consumption is an essential step in controlling the rise of the disorder, said Willett, who was not involved in the study.

Over the last half-century, the increasing availability of sugar has made 62 new calories available every day to each man, woman and child on Earth. Most of that extra sugar has been produced in the last decade, as the U.S., China and other countries have vastly expanded their production of sweetener for the world market.

The result has been a global rise in the number of people who are overweight or obese, with an estimated 1.4 billion adults over 20 falling into one of those categories, according to the World Health Organization. Type 2 diabetes was once a disease of affluence, but it now affects an estimated 312 million people in rich and poor countries alike; WHO estimates that diabetes deaths — largely due to cardiovascular disease — will increase by two-thirds to about 5.7 million by the year 2030…

http://www.latimes.com/health/la-sci-sugar-diabetes-20130228,0,373620.story

Morning-After Pills Don’t Cause Abortion, Studies Say

by  February 21, 2013 (NPR)

The most heated part of the fight between the Obama administration and religious groups over new rules that require most health plans to cover contraception actually has nothing to do with birth control. It has to do with abortion. Specifically, do emergency contraceptives interfere with a fertilized egg and cause what some consider to be abortion?

“The Health and Human Services preventive services mandate forces businesses to provide the morning-after and the week-after pills in our health insurance plans,” said David Green, founder and CEO of the arts and crafts chain Hobby Lobby, one of the firms suing over the requirements. “These abortion-causing drugs go against our faiths.” The morning-after pill he’s referring to is sold under the brand name Plan B. The week-after pill, which actually only works for five days after unprotected sex, is called ella.

Both are classified by the Food and Drug Administration as contraceptives. Neither is the same as the abortion drug RU486, or Mifeprex. That pill isn’t considered a contraceptive and isn’t covered by the new insurance requirements. The constant references to Plan B and ella as abortion-causing pills frustrates Susan Wood, a professor of health policy at George Washington University and a former assistant commissioner for women’s health at the FDA.

“It is not only factually incorrect, it is downright misleading. These products are not abortifacients,” she says. “And their only connection to abortion is that they can prevent the need for one.” That’s not a universal medical opinion, however.

“It would be my preference that none of these products had any potential to cause abortion or post-fertilization effects — that would be my preference — but we don’t know that,” says Gene Rudd, senior vice president of the Christian Medical and Dental Associations and a practicing OB-GYN in Bristol, Tenn. That’s not really the case anymore.

For years, scientists knew the pills, particularly Plan B, were highly effective in preventing pregnancy after unprotected sex but weren’t exactly sure how they managed that. “It wasn’t really clear whether it worked before ovulation or after ovulation,” says Wood.

Scientists did know the drug worked primarily by preventing ovulation. It stops an egg from being released from a woman’s ovary and thus prevents any chance of fertilization and pregnancy. But they also thought the drug might make it more difficult for a fertilized egg to implant in a woman’s uterus. Technically, that’s not an abortion, says Wood.

“We know that about half of fertilized eggs never stick around. They just pass out of the woman’s body,” she says. “An abortifacient is something that interrupts an established pregnancy.” But people like Rudd worry that even if what the drugs do is not technically abortion, it’s still objectionable if it happens after fertilization.

But it turns out, at least when it comes to Plan B, there is now fairly definitive research that shows the only way it works is by preventing ovulation, and therefore, fertilization. ”We’ve learned a lot about how these drugs work,” says Diana Blithe, a biochemist and contraceptive researcher at the National Institute of Child Health and Human Development. “I think it’s time to revise our speculations about how things might work in view of data that show how things do work.”

For example, says Blithe, a study published just last year led the International Federation of Gynecology and Obstetrics to declare that Plan B does not inhibit implantation. And some abortion opponents in the medical community are beginning to accept that conclusion. ”Up until recently I would not prescribe the Plan B product because we didn’t have enough science to say it doesn’t have a post-fertilization effect,” says Rudd. “Now, I’m becoming — sitting on the fence with that.”

Less, however, is known about ella, the other widely available emergency contraceptive. And that’s where the controversy continues to rage. ”It kills embryos. And it kills embryos before they implant, and it kills embryos after they implant,” says Donna Harrison, director of research and public policy for the American Association of Pro-Life Obstetricians and Gynecologists. Harrison says the biggest problem with ella is that it’s a chemical cousin of the abortion pill RU-486. “So at an equal dose of ella and RU-486, they cause equal actions,” she says.

But NIH’s Blithe, who worked to bring ella to market, says that’s wrong. First of all, she says, a woman would never take ella and RU-486 in similar doses “unless they were trying to harm themselves.” But more importantly, while the drugs may be related, ella works much differently. “It’s chemically similar [to RU-486], but it was designed to have stronger effects on the ovary and less effect on the endometrium,” she says. RU-486 works in part by changing the lining of the uterus — the endometrium — to make it impossible for an early pregnancy to be sustained.

Blithe says studies have also shown that ella, like Plan B, doesn’t prevent pregnancy if a woman has already ovulated. Women who took the drug after ovulation got pregnant at the same rate as those who took nothing at all. She says that strongly suggests it does not have any effect on blocking implantation. Ella opponents aren’t convinced. “To be as successful as they say it is, it would have to have post-fertilization effects,” says Rudd. But opposition seems to be waning in Europe.

Ella is now available in heavily Roman Catholic Italy, for example. And on Thursday, Germany’s conference of bishops said both drugs are acceptable to give to rape victims in Catholic hospitals.

Study Raises Doubts Over Robotic Surgery

By MELINDA BECK (Wall Street Journal)

The use of robotic surgery for hysterectomies has grown dramatically in recent years, even though it costs one-third more than other minimally invasive surgery and has little added benefit, a major study said Tuesday.

The findings, in the Journal of the American Medical Association, are likely to raise new questions about whether the fast-growing surgical technology brings value to patients along with higher costs. Since 2000, 1,370 U.S. hospitals have purchased at least one of the $1.5 million-to-$2.2 million robots, known as the da Vinci Surgical Systems, made by Intuitive Surgical Inc. ISRG -2.92% of Sunnyvale, Calif.

The only such system for general surgery, da Vinci robots are used for a growing array of procedures, including prostate, gallbladder, cardiovascular and gynecological surgery.

In robotically assisted surgery, the surgeon sits at a console and operates four robotic arms that manipulate miniaturized tools inserted into the patient’s body through small incisions. A tiny lighted camera displays the surgical field in 3-D on video screens.

Proponents say robotic surgery involves less scarring, less pain, less blood loss, fewer complications, shorter hospital stays and a faster recovery than traditional open surgery with a large incision that can take weeks to heal.

Critics say those advantages are due to the fact that it’s a minimally invasive procedure, not that it’s robotic: Conventional laparoscopic surgery, in which surgeons manipulate specialized tools and video camera by hand through small incisions, is also minimally invasive, at less cost.

For the new study, researchers at Columbia University examined the records of 264,758 women who had hysterectomies—removal of the uterus—for noncancerous conditions at 441 U.S. hospitals from 2007 to 2010. During that time, robotic surgery rose from 0.5% to nearly 10% of all the hysterectomies studied and 22% of those at hospitals where robotic surgery was offered. Laparoscopic procedures rose from 24% to 30%. Open surgeries dropped but were still the most common form of hysterectomy as of 2010. A fourth option, where the uterus is removed vaginally, remained about 20%.

About 25% of the women who had laparoscopic hysterectomies stayed in the hospital longer than two days, compared with 20% of those who had robotic procedures. But the overall complication rate was the same—5%—for both groups.

The average total cost to the hospital for the robotic hysterectomy was $8,868, compared with $6,679 for a laparoscopic procedure and $6,651 for the open surgery.

“There are so many options for hysterectomies now that patients should discuss the pros and cons of all of them with their doctors,” said the study’s lead author, Jason Wright, an associate professor of women’s health at Columbia University. The research was supported by a grant from the National Cancer Institute.

Myriam Curet, chief medical adviser for Intuitive Surgical, says robotic surgery should be compared with open, not laparoscopic, surgery: “We did not develop the robot to compete with laparoscopic surgery. We developed the robot to bring the benefits of minimally invasive surgery to more women.”

Why Pregnant Women Should Get Flu Shots

By Feb. 20, 2013 (TIME Magazine)

It’s not too late to get a flu shot – especially if you’re pregnant, say experts at the March of Dimes.

The US Centers for Disease Control and Prevention (CDC) is urging all Americans to get an influenza vaccine, and pregnant women should be at the front of that line. The flu vaccine is safe during pregnancy and can protect both mother and baby from the flu and its possible consequences.

Pregnant women are at higher risk of complications from flu because pregnancy takes a toll on their respiratory and immune systems. Pregnant women are more likely to be hospitalized with flu and influenza infections can increase their risk of preterm labor and delivery. Health complications from influenza, such as pneumonia, can be serious and even deadly.

Newborns are also at an increased risk of severe illness and even death from the flu.  Nationwide, 64 child deaths have been reported this flu season.

Newest Non-Invasive Option for Prenatal Testing for Patients at Risk for Aneuploidy

From the American College of OB/GYN

The current method of prenatal screening for fetal aneuploidy utilizes serum biochemical markers in combination with ultrasound measurement of the nuchal translucency based on maternal and gestational age related background risks. This screening results in a detection rate of 90-93% with a false positive rate of 2-3%.

It has been found that fetal and maternal cell-free DNA (cfDNA) circulate in maternal plasma. Fetal cfDNA is primarily derived from the placenta and is cleared from the maternal blood shortly after delivery. A higher than expected percentage of a chromosome, such as chromosome 21, may indicate a trisomy of that chromosome. This technique has been shown to detect trisomy 13, trisomy 18, and trisomy 21 as early as 10 weeks gestation. No prospective studies are available, but the use of cfDNA has demonstrated detection rates for trisomy 13, trisomy 18, and trisomy 21 of approximately 98-99% with false positive rates of less than 0.5%.

Noninvasive prenatal testing using cfDNA became commercially available in late 2011. Recent ACOG Committee Opinion from December 2012 suggested that cfDNA could be offered as a primary aneuploidy screening option for women at an increased risk of fetal aneuploidy. This includes women 35 years of age or older, and increased risk of aneuploidy by first trimester of second trimester screening test, fetus with ultrasound markers of aneuploidy, a previous child with a trisomy, or a parent who is a carrier of a balanced translocation with increased risk of a trisomy.

It is important to remember that cfDNA testing detects only trisomy 13, 18, and 21 and at present does not offer other genetic information as diagnostic tests such as amniocentesis and chorionic villus sampling do. The accuracy of cfDNA testing in twins and in the low risk population is not well established. Women with positive results on cfDNA testing should be offered confirmation with diagnostic testing. Prior to offering cfDNA testing, women should be counseled regarding limitations of the test and family history should be reviewed to determine if other screening or diagnostic options are more appropriate. Maternal serum alpha-fetoprotein screening should still be offered. Second trimester ultrasound should also be performed in high-risk pregnancies to evaluate closely for structural anomalies and to look for ultrasound markers of aneuploidy as a negative cfDNA test does not ensure an unaffected pregnancy.

Folic Acid For Pregnant Mothers Cuts Kids’ Autism Risk

February 12, 2013 (NPR)

A common vitamin supplement appears to dramatically reduce a woman’s risk of having a child with autism.

A study of more than 85,000 women in Norway found that those who started taking folic acid before getting pregnant were about 40 percent less likely to have a child who developed the disorder, researchers reported in the Journal of the American Medical Association.

“That’s a huge effect,” says Ian Lipkin, one of the study’s authors and a professor of epidemiology at Columbia University’s Mailman School of Public Health.

Folic acid is the synthetic version of a B vitamin called folate. It’s found naturally in foods such as spinach, black-eyed peas and rice. Public health officials recommend that women who may become pregnant take at least 400 micrograms of folic acid every day to reduce the chance of having a child with spina bifida.

The link between folic acid and autism risk is especially striking because the supplement is so cheap and easy to get, Lipkin says. “The notion that a very simple, nontoxic food supplement could reduce your risk is profound,” he says.

There are caveats, though. To get the full benefit, mothers had to start taking folic acid supplements four weeks before conceiving and keep taking them during the first eight weeks of pregnancy. Risk reduction was also limited to severe autism, not milder forms such as Asperger’s.

Despite public health campaigns urging women in the U.S. to take folic acid, many are still not taking the supplements when they become pregnant. That may be because spina bifida and related birth defects are quite rare.

“But when you start talking about autism, a disorder that has an incidence of 1 percent or higher, that really does bring it to home,” Lipkin says. “That is a substantial risk.”

In the U.S. some foods are fortified with folic acid. Yet women often do not get enough folate through diet alone, Lipkin says, even if they eat a lot of healthful foods.

“I have nothing at all against green vegetables and beans,” he says. “But you only absorb about half of the dietary folate that you take in.”

The study of Norwegian mothers is the biggest one so far to link folic acid to a reduced risk of autism, though smaller studies have reached a similar conclusion.

“This study is reassuring that folic acid supplementation not only is safe but actually decreases the rate of autism,” says Susan Hyman, a professor of pediatrics at the Golisano Children’s Hospital at the University of Rochester.

The study also offers a reminder that brain disorders are often linked to events that take place soon after conception. “Those very first weeks to months of brain development that can provide long-lasting differences in neurologic function,” she says

Previous studies have found that factors including obesity and diabetes can also influence a mother’s risk of having a child with autism, Hyman says.

Women who may become pregnant should eat a balanced diet, exercise, decrease stress and take supplements containing folic acid “so they can have the healthiest baby possible,” she says.

http://www.npr.org/blogs/health/2013/02/12/171828067/folic-acid-for-pregnant-mothers-cuts-kids-autism-risk

Vital statistics: Teen pregnancy fell to ‘historic low’ in 2011

Eryn Brown, February 11, 2013 (LA Times)

Births to women ages 15-19 and 20-24 in the U.S. declined to “historic lows” in 2011, declining to 31.3 births per 1,000 women, said researchers at the U.S. Centers for Disease Control‘s National Center for Health Statistics.

Writing in the journal Pediatrics on Monday, Brady E. Hamilton and colleagues summarized vital statistics from birth certificates and death records in all 50 U.S. states and the District of Columbia.  Overall, there were 3,953,593 births in the U.S. in 2011, 1% fewer than in 2010. The birth rate was 12.7 births per 1,000 total population, the lowest rate ever reported in the nation.

Breaking the data down by ages, birth rates fell for women ages 15-29 and rose for women 35-39 and 40-44.  Rates were unchanged for women 30-34 and 45-49.

Significantly, among teenagers 15-19 the birth rate fell 8%. The authors wrote that the overall teen birth rate fell 49% from 1991 through 2011, creating a “substantial” impact. If 1991 birth trends had persisted, they said, there would have been an additional 3.6 million births to 15- to 19-year-olds.

The analysis also included data on births broken down by marital status — in all, 40.7% babies were born to unmarried women in 2011, a slight decline from 2010 — and by race. The rate of Cesarean delivery was unchanged at 32.8%. The twin birth rate fell slightly, to 33.1 twins per 1,000 births, and triplet births also fell.

The report also summarized mortality data: overall, 2,513,171 people died in the U.S. in 2011, at a rate of 7.4 people per 1,000 — a record low. Among the deaths, 23,910 were in infants and 20,192 were in children 1 to 19 years old.  The leading cause of death in kids was accidents (35.6% of deaths) and the second leading cause was homicide (11.4% of deaths). The death rate for suicide increased, the team reported.

http://www.latimes.com/health/boostershots/la-heb-teen-pregnancy-historic-low-20130211,0,1142850.story

No, Please, not this Personhood Again!

Eli Reshef MD

 “Sell crazy someplace else- we’re all stocked up here!” (Jack Nicholson, As Good as it Gets, 1997)

“It has been said numerous times that the definition of insanity is to repeat the same actions over and over again expecting a different outcome. If that axiom is true, the pro-life movement may be standing at the precipice of a mental illness.”  This statement was recently made by Operation Rescue, one of the most vocal anti-abortion movements in U.S. history. It refers to its mission to halt abortion that was hijacked and mangled by extreme elements so much so that the last election and opinion polls have clearly shown diminished support for the movement by the American public.

Case in point: the Personhood movement. It is considered by many anti-abortion organizations as loose cannon that has undermined their message. Its aim is to stop all abortions, including in cases of rape and incest, by according any biological entity from a fertilized egg and beyond the legal status of a born person. Personhood amendments and ballot initiatives have been presented in state legislatures since 2008. Many of those were not supported by Pro-life movements because of their questionable constitutionality and broad unintended consequences. This is the third year in a row that Personhood has been forced on the Oklahoma legislature. In this upcoming 2013 legislative session, HB 1029 repeats almost verbatim a demand for Personhood seen in the past two sessions. All national and local Personhood initiatives so far have failed miserably, yet certain lawmakers persist to present them, dividing their own camp and creating ill will and rancor in the process.

Such disruption of the legislative process is unconscionable or even outright (see above) insane. In Oklahoma, we have more vital priorities than to debate a divisive, poorly constructed, unconstitutional issue that threatens, if passed, to drag us into the dark age of diminished reproductive choices and a downright embarrassment for our great state. Personhood legislation will eliminate in vitro fertilization as a vital treatment for infertility. Physicians like myself would be unwilling to handle fertilized eggs in the laboratory for fear of harming a “person.” Certain contraceptives, such as the “morning-after” pill, would be banned under the assumption that they prevent the implantation of a “person” into the uterus.

Last year, the Oklahoma House of Representatives was bitterly split by the Personhood debate. It was not a chasm across the partisan divide but Republicans vs. Republicans. Common sense finally prevailed after even the authors of the Personhood bill realized the host of unintended negative consequences to the health of Oklahomans if it passed. Concomitantly, the Oklahoma Supreme Court rejected a Personhood ballot initiative unanimously as unconstitutional.

So what part of “unconstitutional”, “senseless”, and “hopeless” do those legislators that still support Personhood not understand? I hope that the new Speaker of the House, who last year was so fed up with the tactics of the Personhood movement, sends the Personhood bill to the shredder where it belongs. We’re all stocked up here!

Dr. Reshef practices medicine in Oklahoma City.

A Message from ACOG President James T. Breeden, MD

A Message from ACOG President James T. Breeden, MD

January 23, 2013

Gun Safety Has To Start Somewhere
Did you know that American women who are killed by their intimate partners are more likely to be killed with guns than by all other methods combined? That a recent study shows that access to firearms increases the risk of intimate partner homicide more than five times compared to instances where there are no weapons? And that women are twice as likely to be shot and killed by intimate partners as they are to be murdered by strangers using any type of weapon?
Clearly, gun safety is an issue of great importance to our patients. It’s imperative that we talk to our patients about their safety and about gun ownership safety. And it’s imperative that we back reasonable action to help stem the tide of gun violence in America.
That is why ACOG is backing legislation introduced by Senator Dianne Feinstein (D-CA) to reinstate the assault weapons ban, the Assault Weapons Regulatory Act of 2013. This bill would ban the sale, transfer, importation, or manufacturing of assault weapons and large capacity magazines, while protecting legitimate hunters and the rights of existing gun owners and increasing safety requirements for gun ownership.
Will this legislation stop all gun violence in America? Of course not. But, especially after the Sandy Hook tragedy, I feel strongly, and maybe you do too, that we have to do what we can to protect our patients, our families, and innocent lives.
ACOG is joined by the American College of Surgeons, the American Academy of Pediatrics, and many other physician organizations in standing up for sensible steps to help ensure the safety of our communities, and to help make sure there are no more Sandy Hooks.

IVF on Steroids: The Dangerous Off-Label Use of ‘Dex’ During Pregnancy

By , The Atlantic, Jan 16, 2013

When Susan Manning, a 39-year-old woman just a few weeks into her first pregnancy, wrote to tell me she had been put on the steroid dexamethasone to prevent a miscarriage–and to ask whether she should be worried about taking this drug–at first I could not even process what she was saying. Dexamethasone is known to cross the placental barrier and impact fetal development, so the very idea of first trimester exposure sets off warning bells. Besides, dexamethasone is not known to help in preventing miscarriage. Susan’s story sounded too crazy to be true.

It also sounded too close to the history of DES (diethylstilbestrol). From the 1940s through the 1970s, some doctors gave pregnant women DES, a synthetic estrogen, to try to prevent miscarriage. In spite of clinical evidence that it didn’t work as intended, millions of fetuses were exposed in utero before doctors discovered that prenatal DES exposure could lead to infertility and deadly cancers. Just last week, Eli Lilly & Co. settled a suit brought by four sisters who believe their breast cancers were caused by prenatal DES exposure.

But as it turns out, Susan (a pseudonym) had it right. Women like her, pregnant by virtue of in vitro fertilization (IVF), are today routinely put on dexamethasone for miscarriage prevention at some IVF clinics. Susan is being treated abroad at a high-profile clinic, but some American infertility clinics also advertise this off-label use of dexamethasone as if it is the standard of care.

I inquired about this with Dr. Geoffrey Sher, Executive Medical Director of the Sher Institutes for Reproductive Medicine, a high-profile infertility practice with offices across the country. He confirmed in an email that, “We recommend 0.5 mg – 1.0 mg. [of dexamethasone] orally daily (dosage varies based upon individual patient needs) from the time of initiating the [IVF] cycle through to the tenth week of pregnancy.” He could not point to studies showing that dexamethasone helps prevent miscarriage, but argued, “Since there are so many other variables that are involved” in IVF pregnancies, studies “would virtually be impossible to do…”

http://www.theatlantic.com/health/archive/2013/01/ivf-on-steroids-the-dangerous-off-label-use-of-dex-during-pregnancy/267187/