WHO to recommend earlier HIV drugs

30 June 2013 Last updated at 00:03 ET

By Jane Dreaper Health correspondent, BBC News

HIV drugsPeople with HIV will be given medication much earlier

New guidelines for HIV treatment could see millions more people in developing countries getting life-saving medicine.

The World Health Organization (WHO) is recommending that patients start taking medication at a much earlier stage of the disease.

The WHO says the guidelines, which are being launched at an international Aids conference in Kuala Lumpur, could help avert an extra 3m Aids deaths by 2025.

The charity MSF welcomed the move – but said extra investment would be needed.

A single pill combining three drugs will be given to people who are HIV positive much earlier, while their immune systems are still strong. Algeria, Argentina and Brazil are already doing this.

Not everybody who needs the medicine currently receives it, although big strides have been made in recent years in widening access to HIV treatment.

The WHO says these guidelines represent a “major shift” in policy, and will result in the number of people in developing countries who are eligible for drug treatment rising from 16m to 26m, or 80% of the total who are thought to have HIV.

It is thought the guidelines will add 10% to the $23bn (£15bn) overall cost of treating HIV/AIDS in developing countries.

WHO believes global donors and the affected countries themselves will be convinced that the idea is cost-effective.

It agreed the policy after a year-long consultation, in which evidence about the role earlier treatment can play in reducing transmission of the virus was considered.

‘Safer, simpler medicines’

The WHO’s HIV/Aids director, Dr Gottfried Hirnschall, said: “It will be very difficult to end Aids without a vaccine – but these new guidelines will take us a long way in reducing deaths.

“We’re recommending earlier treatment – and also safer, simpler medicines that are already widely available.

“We also want to see better monitoring of patients, so they can see how well they’re doing on the treatment.

“This is not only about keeping people healthy and alive – the anti-retroviral drugs block transmission, so there is the potential for a major impact in preventing epidemics within different countries.”

Five companies make the daily combination pill, which can cost about $127 for a year’s individual treatment in countries where price reductions have been negotiated.

The WHO says there is an “encouraging trend” of countries using their own finances to fight the HIV/Aids epidemic such as Zimbabwe, which has successfully used a levy on mobile phones.

The new recommendations also include providing drugs to all children under five with the virus, all HIV-positive pregnant and breastfeeding women and to people whose partner is uninfected.

In all of these cases, treatment would start regardless of how far the condition has damaged their immune system.

Dr Hirnschall added: “We are still seeing young children lagging behind in terms of access to treatment. Two-thirds of adults that need anti-retroviral drugs get them, but only a third of young children.”

‘Ambitious but feasible’

The Global Fund – set up to fight Aids, tuberculosis and malaria – welcomed the guidelines as “very timely”.

Its executive director, Dr Mark Dybul, said: “This is an example of how the Global Fund and the WHO work together to support countries as we move towards removing HIV as a threat to public health.”

MSF (Medecins Sans Frontieres / Doctors Without Borders) warned extra political and financial support would be needed for implementing the recommendations, which it said were “ambitious but feasible”.

MSF medical co-ordinator in South Africa Dr Gilles van Cutsem said: “With these new guidelines our collective goal should now be to scale up without messing up: to reach more people, retain them on treatment, and with an undetectable viral load.

“There’s no greater motivating factor for people to stick to their HIV treatment than knowing the virus is ‘undetectable’ in their blood.”

Paul Ward, deputy chief executive at the UK’s Terrence Higgins Trust, said: “These guidelines have implications for the UK and would expand the number of people eligible for HIV treatment.

“Using treatment to reduce transmission is a key part of modern prevention efforts, including our own.

“In the UK, we have some of the best treatments in the world, and offering them earlier could be one way of slowing the spread of the epidemic. It could also improve the person’s own long-term health.”


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Release of Eliquis blood clot preventer story

The entrance of Pfizer World headquaters in New York City, August 31, 2003. ECONM REUTERS/Jeff Christensen

The entrance of Pfizer World headquaters in New York City, August 31, 2003. ECONM

Credit: Reuters/Jeff Christensen

By Bill Berkrot

Sun Jun 30, 2013 6:03am EDT

(Reuters) – The blood clot preventer Eliquis, sold by Pfizer Inc and Bristol-Myers Squibb Co, proved as effective as widely used warfarin in treating a dangerous condition known as venous thromboembolism and caused far less bleeding, according to data from a large clinical trial.

The Pfizer and Bristol-Myers pill met the main goal of the study by showing it worked just as well as conventional treatment with warfarin, a generic blood thinner, in reducing recurrence of the condition and related deaths.

Eliquis also led to a nearly 70 percent reduction in the risk of major bleeding and more than a 50 percent reduction in a category known as clinically relevant non-major bleeding. Bleeding is typically the most troubling side effect of extended use of blood thinning drugs.

Dr. Giancarlo Agnelli, the study’s lead investigator, called the bleeding results “a remarkable real advantage” for Eliquis.

“This is to me the most striking finding of this study in terms of potential changes to clinical practice,” Agnelli, who presented the data on Monday at the International Society on Thrombosis and Hemostasis (ISTH) meeting in Amsterdam, said in a telephone interview. The results were also published in the New England Journal of Medicine.

“This really makes apixaban a really safe compound,” he added, using the chemical name for Eliquis.

Venous thromboembolism (VTE) is a potentially fatal condition consisting of blood clots in the leg, known as deep vein thrombosis, and clots in the lungs, known as pulmonary embolism. About 900,000 Americans and 1 million patients in the European Union are diagnosed with the condition each year. The condition recurs in up to 10 percent of patients.

SLOW UPTAKE FOR SOME

Eliquis belongs to a new class of blood clot preventers meant to replace warfarin, which has been in use for decades and requires rigorous monitoring. It competes directly with Xarelto from Bayer AG and Johnson & Johnson, and Boehringer Ingelheim’s Pradaxa.

Some doctors have been reluctant to switch to the new medicines in part because their blood-thinning effect is not easily reversed in case emergency medical treatment, such as surgery, is needed. Companies are testing agents that could be used to reverse the blood thinning effect if necessary.

Eliquis is already approved to prevent strokes and blood clots in patients with a common, but dangerous irregular heartbeat known as atrial fibrillation – by far the largest market for the new blood thinners.

ISI Group analyst Mark Schoenebaum forecast eventual peak annual sales of $3 billion for the drug. If approved for venous thromboembolism, it would add an important, if smaller, use for the medicine.

While doctors are comfortable using warfarin, it requires careful patient monitoring of levels of the drug in the blood and dose adjustments, as well as patient dietary and lifestyle changes to prevent dangerous bleeding. Eliquis and its rivals are a fixed dose treatment with little or no patient monitoring required.

“Even if you show just non-inferiority, the advantage (of Eliquis) in terms of increased practicality is huge,” said Agnelli, the director of the Department of Internal and Cardiovascular Medicine and Stroke-Unit of University Hospital in Perugia, Italy.

The nearly 5,400-patient trial tested 10 milligrams of Eliquis given twice a day for seven days followed by 5 mg twice daily for six months against the conventional use of initial injections of Sanofi’s Lovenox (enoxaparin) followed by daily use of warfarin.

For the composite goal of recurrence of VTE and VTE-related death there were 59 cases for Eliquis, or 2.3 percent, versus 71 cases for warfarin, or 2.7 percent.

For the primary safety goal of the study, there were 15 reports of major bleeding among Eliquis patients, or 0.6 percent, compared with 49 major bleeds among warfarin patients, or 1.8 percent. The 69-percent reduced major bleeding risk was deemed to be highly statistically significant, researchers said.

There were 103 reported cases of clinically relevant non-major bleeding with the Pfizer and Bristol drug versus 215 cases in the warfarin group, or a risk reduction of 52 percent.

(Reporting by Bill Berkrot; Editing by Sandra Maler)

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Obamacare 1.0: States brace for Web barrage when reform goes live

U.S. President Barack Obama takes the stage to speak about the Affordable Care Act during a visit to San Jose, California June 7, 2013. REUTERS/Kevin Lamarque

U.S. President Barack Obama takes the stage to speak about the Affordable Care Act during a visit to San Jose, California June 7, 2013.

Credit: Reuters/Kevin Lamarque

By Sharon Begley

NEW YORK | Sun Jun 30, 2013 7:03am EDT

NEW YORK (Reuters) – About 550,000 people in Oregon do not have health insurance, and Aaron Karjala is confident the state’s new online insurance exchange will be able to accommodate them when enrollment under President Barack Obama’s healthcare reform begins on October 1.

What Karjala, the chief information officer at “Cover Oregon,” does worry about, however, is what will happen if the entire population of Oregon – 3.9 million – logs on that day “just to check it out,” he said. Or if millions of curious souls elsewhere, wondering if Oregon’s insurance offerings are better than their states’, log on, causing Cover Oregon to crash in a blur of spinning hourglasses and color wheels and an epidemic of frozen screens.

Multiply that by another 49 states and the District of Columbia, all of which will open health insurance exchanges under “Obamacare” that same day, and you get some idea of what could go publicly and disastrously wrong.

Obamacare, formally known as the Patient Protection and Affordable Care Act (ACA), could fail for many reasons, including participation by too few of the uninsured and a shortage of doctors to treat those who do sign up. But because its core is government-run marketplaces selling health insurance online, the likeliest reason for failure at the opening bell is information technology snafus, say experts who are helping with the rollout.

Although IT is the single most expensive ingredient of the exchanges, with eight-figure contracts to build them, experts expect bugs, errors and crashes. In April, Obama himself predicted “glitches and bumps” when the exchanges open for business.

“This is a 1.0 implementation,” said Dan Maynard, chief executive of Connecture, a software developer that is providing the shopping and enrollment functions for several states’ insurance exchanges. “From an IT perspective, 1.0’s come out with a lot of defects. Everyone is waiting for something to go wrong.”

Two states that intended to build their own exchanges, Idaho and New Mexico, announced this spring that because of the tight timeline and daunting challenges they would have the federal government operate their IT systems.

“Nothing like this in IT has ever been done to this complexity or scale, and with a timeline that put it behind schedule almost before the ink was dry,” said Rick Howard, research director at the technology advisory firm Gartner.

WHAT COLOR WAS YOUR VOLVO?

The potential for problems will begin as soon as would-be buyers log onto their state exchange. They’ll enter their name, birth date, address and other identifying information. Then comes the first IT handoff: Is this person who she says she is?

To check that, credit bureau Experian will check the answers against its voluminous external databases, which include information from utility companies and banks on people’s spending and other history, and generate questions. The customer will be asked which of several addresses he previously lived at, for example, whether his car has one of several proffered license plate numbers, and what color his old Volvo was.

It’s similar to the system that verifies identity for accessing personal Social Security information. If someone gets a question wrong, he will be referred to Experian’s help desk, and if that fails may be asked to submit documentation to prove he is who he claims to be.

The next step is determining if the customer is eligible for federal subsidies to pay for insurance. She is if she is a citizen and her income, which she will enter, is less than four times the federal poverty level. To verify this, the exchange pings the “federal data services hub,” which is being built by Quality Software Services Inc under a $58 million contract with the Centers for Medicare & Medicaid Services (CMS).

The query arrives at the hub, which does not actually store information, and is routed to online servers at the Internal Revenue Service for income verification and at the Department of Homeland Security for a citizenship check.

The answers must be returned in real time, before the would-be buyer loses patience and logs off. If the reported income doesn’t match the IRS’s records, the applicant may have to submit pay stubs.

These federal computer systems have never been connected before, so it’s anyone’s guess how well they’ll communicate.

“The challenge for states,” said Jinnifer Wattum, director of Eligibility and Exchange Solutions at Xerox’s government healthcare unit, is that they have to build “the interfaces needed with the federal data services hub without knowing what this system will look like.” That makes the task akin to making a key for a lock that doesn’t exist yet.

CMS’s contractors are working to finish the hub, but “much remains to be accomplished within a relatively short amount of time,” concluded a report from the Government Accountability Office (GAO), the investigative arm of Congress, in June. CMS spokesman Brian Cook said the hub would be ready by September, and that the beta version had been tested for its ability to interact with the exchanges Oregon and Maryland are building.

The federal hub has to verify even more arcane data, such as whether the insurance offered to a buyer through his job is unaffordable, in which case he may qualify for federal subsidies, and whether the buyer is in prison, in which case she is exempt from the mandate to purchase insurance.

If someone’s income qualifies him for Medicaid, or his children for the Children’s Health Insurance Program (CHIP), software has to divert him from the ACA exchange and into those systems. Many of the computers handling Medicaid and CHIP enrollment are, as IT people diplomatically put it, “legacy systems,” meaning old, even decades old.

Many are mainframes, lacking the connectivity of cloud computing. They typically process eligibility requests in days, not seconds.

The legacy systems “rely on daily or weekly batch files to pass information back and forth,” and often require follow-up phone calls, said Wattum of Xerox, which is working to configure Nevada’s exchange so it can interface with the federal hub.

‘NO WRONG DOOR’

A “we’ll call you” message is unacceptable under Obamacare, which has a “no wrong door” goal: A buyer must never come to a dead end. If she is diverted to Medicaid, for instance, she must not be required to resubmit information, let alone wait a week for an answer about whether she’s now enrolled.

State IT systems must therefore “be interoperable and integrated with an exchange, Medicaid, and CHIP to allow consumers to easily switch from private insurance to Medicaid and CHIP,” said an April report from the Government Accountability Office (GAO), the investigative arm of Congress.

To make all those systems communicate, the state exchanges must either develop entirely new systems or use application programming interfaces (APIs) that work with the legacy systems to exchange data in real time. APIs are programming instructions for accessing Web-based software applications.

GAO’s Stan Czerwinski compares the necessary connectivity to adapters that let American electronics work with European outlets.

State officials told the GAO that verifying eligibility, enrolling buyers and interfacing with legacy systems are the most “onerous” aspects of developing their exchanges, “given the age and limited functionality of current state systems.”

A key goal for exchange officials is keeping would-be buyers in the portal so they don’t give up and use a state’s ACA call center, which could quickly be swamped.

To avoid this, Oregon brought in potential users to test design prototypes, recorded what people did and where they had trouble, and tweaked the consumer interface to make it as user-friendly as possible, said Karjala.

“Even with that, if you have a family of four and you’re eligible for a tax credit to offset your premium,” he said, “you could be sitting at the computer for a long time.”

What everyone hopes to avoid is a repeat of the early days of the Medicare prescription-drug program in 2006. Some seniors who tried to sign up for a plan were mistakenly enrolled in several, while others had the wrong premium amounts deducted from their Social Security checks.

Another challenge is capacity. Websites regularly crash when too many people try to access them.

“I had no choice but to be extremely conservative” in estimates of how many simultaneous users Cover Oregon has to be prepared for, Karjala said. “Building capacity is the only way to avoid the spinning hourglass or the site freezing, so in our performance testing we’re seeing what happens if the whole U.S. population came to Cover Oregon to check it out.”

This summer, state exchanges will test their ability to communicate with the federal data hub, whose security frameworks and connectivity protocols are still works in progress. But whether Obamacare 1.0 flies won’t be known until the new health plans take effect on January 1. Robert Laszewski, president of Health Policy and Strategy Associates Inc, a consulting firm, said he wouldn’t be surprised if some patients showing up at doctors’ offices next year with Obamacare policies are told their insurers never heard of them.

(Additional reporting by Caroline Humer; Editing by Michele Gershberg and Prudence Crowther)

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U.S. sets birth control rule for employers with religious ties

WASHINGTON | Fri Jun 28, 2013 11:32am EDT

WASHINGTON (Reuters) – The Obama administration on Friday issued its final rule requiring health insurance coverage of contraceptives for the employees of faith-affiliated universities, hospitals and other institutions.

Officials said the rule does not differ substantially from a proposed version released earlier this year that sought to insulate employers that oppose birth control on religious grounds by providing the benefits to their workers without out-of-pocket costs through outside plans funded by insurers.


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Pennsylvania girl gets second lung transplant after first failed

By Francesca Trianni

NEW YORK | Fri Jun 28, 2013 5:36pm EDT

NEW YORK (Reuters) – A 10-year-old Pennsylvania girl who sparked a national debate about child access to organ donation took her first independent breath this week on a second set of donor lungs after her first transplant failed, the girl’s family said on Friday.

Sarah Murnaghan, who had cystic fibrosis and needed a lung transplant, had been kept off an adult organ transplant list due to an age restriction. She became eligible for an adult pair of lungs only after a judge’s order.

The girl received the first transplant on June 12 but had to be put back on a waiting list to receive another organ donation after complications arose.

The girl underwent a second surgery, her family said in a statement, performed by the same surgeon who did the first transplant, Dr. Thomas Spray, at Children’s Hospital of Philadelphia.

“The road to recovery is long and Sarah’s fight is not over,” parents Janet and Fran Murnaghan, who live in the Philadelphia suburb of Newtown Square, wrote on Facebook on Friday.

The girl’s family had sued to prevent the U.S. Department of Health and Human Services from enforcing a policy that prevents children under 12 from receiving adult lung transplants, even if they are extremely ill.

The girl was set to undergo another surgery on Monday to provide the lungs with greater volume for expansion and remove a tube, the family’s statement said.

(Reporting By Francesca Trianni; Editing by Daniel Trotta and Leslie Adler)

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Heart risk warning over painkiller

29 June 2013 Last updated at 00:08 ET

PillsDiclofenac is used for conditions such as headaches, back pain and arthritis

People with heart problems have been advised to stop using one of the most commonly prescribed anti-inflammatory drugs in the UK.

The medicines regulator said painkiller diclofenac could significantly increase the risk of a heart attack or stroke for some patients.

The advice has been updated after a European review of the risks.

Millions of people take diclofenac for a range of conditions including headaches, back pain and arthritis.

The Medicines and Healthcare Products Regulatory Agency (MHRA) said the drug should not be used by people with serious underlying heart conditions.

People who have suffered heart failure, heart disease or a stroke should stop using it completely.

Smokers and people with high blood pressure, raised cholesterol and diabetes have been advised to use the drug only after consulting their GP or pharmacist.

The MHRA said diclofenac would continue to provide safe and effective pain relief, apart from patients in certain “at risk” groups.

Dr Sarah Branch, deputy director of the MHRA’s vigilance and risk management of medicines division, said: “Whilst this is a known risk and warnings have been included in patient and healthcare information for some time, this advice is now being updated.”

Six million prescriptions were written for diclofenac last year and the drug is also available over the counter.


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One Year Later, Readers Reverse Course on ACA

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Practice Management

Published: Jun 28, 2013

By Chris Kaiser, Cardiology Editor, MedPage Today

What a difference a year makes! Last year, a majority of readers were in favor of the Affordable Care Act (ACA). This year, it’s a minority.

In June of 2012, MedPage Today asked readers if the Supreme Court did the right thing when it ruled the ACA, in particular its individual mandate, did not violate the Constitution, but effectively left the decision to expand Medicaid up to each state.

As part of our anniversary coverage of the Supreme Court’s vote, we asked the same question again.

The vote tallies are like peering through Alice’s looking glass: nearly an eerie mirror image of each other:

  • 2012 — 59% Yes, 41% No
  • 2013 — 40% Yes, 60% No

What happened?

A Step in the Right Direction for Some

In 2012, readers who were in favor of the ACA expressed an exhausted gratitude that it was a step in the right direction. It may not be perfect, they said, but it’s a start to fix a system that definitely needs fixing.

They said insuring everyone is the right thing to do. They were full of compassion for those less fortunate, but they also wondered if the ACA was workable.

In 2012, those who were not in favor of the court’s decision expressed themselves in many different shades of negativity.

Obamacare would ruin the country. Look at how other countries with socialized medicine can’t sustain that model. We might need healthcare reform but the ACA is not the answer. It will only enrich insurance and pharmaceutical companies.

The comments from this week’s survey from those that are in favor of the ACA reflect a measured, thoughtful attitude.

“Yes, the SCOTUS [Supreme Court of the U.S.] did the right thing. I would have preferred Medicare for all, but that would never have a chance of passing the insurance lobby and conservatives in Congress. So, what we got was as good a compromise as was possible today,” said a reader.

Someone else created a bulleted list to explain her support:

  • Requiring citizens to carry private medical insurance is the antithesis of socialized medicine
  • The American Medical Association supports the ACA
  • A tax is a tax is a tax and is constitutional whether or not one chooses to call it a tax
  • The mandate preserves capitalism while addressing a very real, long-term and class-pervasive healthcare crisis. Without the mandate, the only alternative IS socialized medicine

A few readers acknowledged they voted “No” only because “we have yet to learn exactly what is in the Act.”

Others in agreement with most of the court’s decision would have preferred a ruling in favor of the Medicaid expansion.

One reader admitted to being ashamed that the U.S. is the only “developed nation in which individuals die because they cannot afford medical care.”

He went on to say, “True American charity was demonstrated at the Republican debate in Texas. When a question was asked about a cancer patient without health insurance, the audience screamed, ‘Let him die.'”

This comment from a supporter of the ACA might give a hint about the tone of the comments from those who did not favor the Supreme Court’s decision.

“Oh, yawn,” he said. “The laundry list of Tea Party platitudes sounds so self-centered.”

He reminded readers that their “precious freedom was handed over to corporations and ‘the investor class’ some time ago.”

Naysayers See ACA as Harmful

Nevertheless, the naysayers voiced their strong opposition.

“This so-called Affordable Care Act is and should be called the Unaffordable Care Act. It is nothing more than socialized medicine, with the government now in control of one-sixth of the U.S. economy.”

“Remember ‘Do No Harm’? Remember subscribing to that? The ACA does harm. Irreparable, fatal harm, to our government, to our finances and financial institutions, to all insurance companies (they will be driven out of business when the government becomes the one-payer system, and tens of thousands of people will be thrown out of work), to research facilities, to pharmaceutical companies, to our hospitals and physicians, and to every patient in America, and to our country,” voiced a reader.

Here’s a comment you wouldn’t have seen last year: “With the government now tapping phone lines, looking in on emails, and checking on your so-called healthcare to make sure you obtain healthcare or pay a fine through the IRS, it is nothing more than tyranny or totalitarianism.”

“Just another opportunity to take from the many to give to the few,” was a sentiment reflected by many comments.

Several readers noted that Obama had a chance to create meaningful healthcare reform but missed it. Here’s one of those comments.

“He could have put everyone on a health savings account with a high deductible and had employers fund the difference with the money unspent coming back to the employee. This would have fixed the problem, as free market principles like supply and demand would have ruled the day. The elephant called healthcare would have been put on a serious diet.”

Several readers were frustrated at how the White House argued that the ACA’s penalty for not having insurance as not being the same as a tax, and then Supreme Court Chief Justice John Roberts declared it legal on the basis that it was a tax.

This reader reminded others where the bar is set in terms of the government running businesses.

“If you like the way that the government has run Amtrak and the U.S. Post Office, then you will love the way the U.S. Healthcare System will be run by the IRS, HHS, and other panels, boards, and committees that will be set up by the ACA.”

And, of course, there generally are a few comments that hint of a conspiracy.

“I think the Supreme Court decision might have been manipulated in the last few weeks leading up to it. Justice Roberts was clearly leaning in one direction then fairly suddenly changed his mind. Was he bribed or blackmailed? He may have a remote skeleton in his closet, or a friend or family member’s closet. With the NSA’s data mining, all skeletons will be revealed, and skeletons can be very useful for governments who are inclined to use such techniques.”


Chris has written and edited for medical publications for more than 15 years. As the news editor for a United Business Media journal, he was awarded Best News Section. He has a B.A. from La Salle University and an M.A. from Villanova University. Chris is based outside of Philadelphia and is also involved with the theater as a writer, director, and occasional actor.

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Bed rest after IVF doesn't help

By Kerry Grens

NEW YORK | Fri Jun 28, 2013 3:21pm EDT

NEW YORK (Reuters Health) – Bed rest immediately after an in vitro fertilization (IVF) procedure, despite being common practice, did not help women ultimately have a baby in a new study.

“The old wives’ tale of bed rest should be debunked once and for all, that you don’t need bed rest in any way, shape or form,” said Dr. Jani Jensen, a fertility expert at the Mayo Clinic, who was not part of the study.

The researchers found that women who continued to lie down for 10 minutes after embryos were transferred to their uterus were actually less likely to have a baby than women who got up and walked around right away.

“It demonstrates that there is no need to keep patients at bed rest after a transfer. They can immediately get up and leave,” said Dr. Richard Reindollar, the chair of the department of obstetrics and gynecology at Geisel School of Medicine at Dartmouth.

IVF involves inserting fertilized embryos into a woman’s uterus using a thin catheter.

Women lie down and prop their feet in footrests, and the procedure takes about five to 10 minutes, said Jensen.

Following the procedure, women are sometimes wheeled on a gurney to a recovery room, where they rest for several minutes up to several hours. Other times, women are asked to stand and walk out of the room on their own.

“In the past there were a number of people who felt strongly that patients have bed rest. Some had patients go to bed for five days,” said Reindollar, who did not participate in the study.

Some previous research has suggested that bed rest actually does no good, and could harm women’s chances for getting pregnant.

In the latest study, researchers in Spain, led by Dr. José Remohi at the Instituto Valenciano de Infertilidad, Valencia, and the Universidad de Valencia, randomly assigned patients to bed rest or to get up immediately following the procedure.

Half of the women in the study, 120 of them, stayed on the bed for 10 minutes after the embryos were transferred, while the other 120 women got up and walked out of the room.

Fifty women in the bed rest group went on to have babies, while 68 women in the other group delivered a baby.

“It’s not clear why,” said Jensen.

The pregnancy rates were similar in both groups, but miscarriage rates in the bed rest group were 27.5 percent compared to 18 percent in the other group. Statistically, though, that difference could have been due to chance, the researchers noted.

The authors point out that when a woman is standing, her uterus is in a horizontal position and speculate that may be better for successful embryo transfer.

They also propose that stress reduction from walking around after the procedure might play a role in the differing birth rates.

“We believe that encouraging patients to follow their daily routine immediately after (embryo transfer) may help them to cope with anxiety during treatment and thereafter to increase their skills in maintaining relaxation throughout the treatment, and this may be one possible reason behind our obtained results,” they write in the journal Fertility and Sterility.

Jensen agreed that stress reduction is important for would-be mothers.

“But I think that the intervention is too small to say that the 10 minutes of bed rest was detrimental,” said Jensen. “The better message is probably that you really don’t need any bed rest at all to still have good outcomes.”

Reindollar, who is also the president-elect of the American Society for Reproductive Medicine, said the study is important in developing a cache of evidence about the benefits and harms of bed rest

He said that with enough data the Society might consider issuing practice guidelines that recommend physicians discourage bed rest.

“This paper showed that it certainly does not hurt patients to get up and walk away, and it suggests that it might hurt to keep them there,” Reindollar told Reuters Health.

SOURCE: bit.ly/17kpqLI Fertility and Sterility, online June 10, 2013.

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Bed rest after IVF doesn’t help

By Kerry Grens

NEW YORK | Fri Jun 28, 2013 3:21pm EDT

NEW YORK (Reuters Health) – Bed rest immediately after an in vitro fertilization (IVF) procedure, despite being common practice, did not help women ultimately have a baby in a new study.

“The old wives’ tale of bed rest should be debunked once and for all, that you don’t need bed rest in any way, shape or form,” said Dr. Jani Jensen, a fertility expert at the Mayo Clinic, who was not part of the study.

The researchers found that women who continued to lie down for 10 minutes after embryos were transferred to their uterus were actually less likely to have a baby than women who got up and walked around right away.

“It demonstrates that there is no need to keep patients at bed rest after a transfer. They can immediately get up and leave,” said Dr. Richard Reindollar, the chair of the department of obstetrics and gynecology at Geisel School of Medicine at Dartmouth.

IVF involves inserting fertilized embryos into a woman’s uterus using a thin catheter.

Women lie down and prop their feet in footrests, and the procedure takes about five to 10 minutes, said Jensen.

Following the procedure, women are sometimes wheeled on a gurney to a recovery room, where they rest for several minutes up to several hours. Other times, women are asked to stand and walk out of the room on their own.

“In the past there were a number of people who felt strongly that patients have bed rest. Some had patients go to bed for five days,” said Reindollar, who did not participate in the study.

Some previous research has suggested that bed rest actually does no good, and could harm women’s chances for getting pregnant.

In the latest study, researchers in Spain, led by Dr. José Remohi at the Instituto Valenciano de Infertilidad, Valencia, and the Universidad de Valencia, randomly assigned patients to bed rest or to get up immediately following the procedure.

Half of the women in the study, 120 of them, stayed on the bed for 10 minutes after the embryos were transferred, while the other 120 women got up and walked out of the room.

Fifty women in the bed rest group went on to have babies, while 68 women in the other group delivered a baby.

“It’s not clear why,” said Jensen.

The pregnancy rates were similar in both groups, but miscarriage rates in the bed rest group were 27.5 percent compared to 18 percent in the other group. Statistically, though, that difference could have been due to chance, the researchers noted.

The authors point out that when a woman is standing, her uterus is in a horizontal position and speculate that may be better for successful embryo transfer.

They also propose that stress reduction from walking around after the procedure might play a role in the differing birth rates.

“We believe that encouraging patients to follow their daily routine immediately after (embryo transfer) may help them to cope with anxiety during treatment and thereafter to increase their skills in maintaining relaxation throughout the treatment, and this may be one possible reason behind our obtained results,” they write in the journal Fertility and Sterility.

Jensen agreed that stress reduction is important for would-be mothers.

“But I think that the intervention is too small to say that the 10 minutes of bed rest was detrimental,” said Jensen. “The better message is probably that you really don’t need any bed rest at all to still have good outcomes.”

Reindollar, who is also the president-elect of the American Society for Reproductive Medicine, said the study is important in developing a cache of evidence about the benefits and harms of bed rest

He said that with enough data the Society might consider issuing practice guidelines that recommend physicians discourage bed rest.

“This paper showed that it certainly does not hurt patients to get up and walk away, and it suggests that it might hurt to keep them there,” Reindollar told Reuters Health.

SOURCE: bit.ly/17kpqLI Fertility and Sterility, online June 10, 2013.

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UK government backs three-person IVF

27 June 2013 Last updated at 19:33 ET

By James Gallagher Health and science reporter, BBC News

BabyOpponents fear that other forms of genetic modifications could follow

The UK looks set to become the first country to allow the creation of babies using DNA from three people, after the government backed the IVF technique.

It will produce draft regulations later this year and the procedure could be offered within two years.

Experts say three-person IVF could eliminate debilitating and potentially fatal mitochondrial diseases that are passed on from mother to child.

Opponents say it is unethical and could set the UK on a “slippery slope”.

They also argue that affected couples could adopt or use egg donors instead.

Mitochondria are the tiny, biological “power stations” that give the body energy. They are passed from a mother, through the egg, to her child.

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The woman who lost all her children

Sharon Bernardi and her son Edward, who died last year aged 21

Every time Sharon Bernardi became pregnant, she hoped for a healthy child.

But all seven of her children died from a rare genetic disease that affects the central nervous system – three of them just hours after birth.

When her fourth child, Edward, was born, doctors discovered the disease was caused by a defect in Sharon’s mitochondria.

Edward was given drugs and blood transfusions to prevent the lactic acidosis (a kind of blood poisoning) that had killed his siblings.

Five weeks later Sharon and her husband, Neil, were allowed to take Edward to their home in Sunderland for Christmas – but his health slowly began to deteriorate.

Edward survived into adulthood, dying in 2011 at the age of 21.

Now Sharon is supporting medical research that would allow defective mitochondria to be replaced by DNA from another woman.

Defective mitochondria affect one in every 6,500 babies. It can leave them starved of energy, resulting in muscle weakness, blindness, heart failure and death in the most extreme cases.

Research suggests that using mitochondria from a donor egg can prevent the diseases.

It is envisaged that up to 10 couples a year would benefit from the treatment.

However, it would result in babies having DNA from two parents and a tiny amount from a third donor as the mitochondria themselves have their own DNA.

‘Clearly sensitive’

Earlier this year, a public consultation by the Human Fertilisation and Embryology Authority (HFEA) concluded there was “general support” for the idea and that there was no evidence that the advanced form of IVF was unsafe.

The chief medical officer for England, Prof Dame Sally Davies, said: “Scientists have developed ground-breaking new procedures which could stop these disease being passed on, bringing hope to many families seeking to prevent their future children inheriting them.

“It’s only right that we look to introduce this life-saving treatment as soon as we can.”

She said there were “clearly some sensitive issues here” but said she was “personally very comfortable” with altering mitochondria.

Scientists have devised two techniques that allow them to take the genetic information from the mother and place it into the egg of a donor with healthy mitochondria.

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Method one: Embryo repair1) Two eggs are fertilised with sperm, creating an embryo from the intended parents and another from the donors 2) The pronuclei, which contain genetic information, are removed from both embryos but only the parents’ is kept 3) A healthy embryo is created by adding the parents’ pronuclei to the donor embryo, which is finally implanted into the womb

Method two: Egg repair1) Eggs from a mother with damaged mitochondria and a donor with healthy mitochondria are collected 2) The majority of the genetic material is removed from both eggs 3) The mother’s genetic material is inserted into the donor egg, which can be fertilised by sperm.

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The result is a baby with genetic information from three people.

They would have more than 20,000 genes from their parents and 37 mitochondrial genes from a donor.

It is a change that would have ramifications through the generations as scientists would be altering human genetic inheritance.

Objections to the procedure have been raised ever since it was first mooted.

Dr David King, the director of Human Genetics Alert, said: “These techniques are unnecessary and unsafe and were in fact rejected by the majority of consultation responses.

‘Designer baby’

“It is a disaster that the decision to cross the line that will eventually lead to a eugenic designer baby market should be taken on the basis of an utterly biased and inadequate consultation.”

One of the main concerns raised in the HFEA’s public consultation was of a “slippery slope” which could lead to other forms of genetic modification.

Draft regulations will be produced this year with a final version expected to be debated and voted on in Parliament during 2014.

Newcastle University is pioneering one of the techniques that could be used for three-person IVF.

Prof Doug Turnbull, the director of the Wellcome Trust Centre for Mitochondrial Research at the university, said he was “delighted”.

A baby's hand

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He said: “This is excellent news for families with mitochondrial disease.

“This will give women who carry these diseased genes more reproductive choice and the opportunity to have children free of mitochondrial disease. I am very grateful to all those who have supported this work.”

The fine details of the regulations are still uncertain, yet it is expected to be for only the most severe cases.

It is also likely that children would have no right to know who the egg donor was and that any children resulting from the procedure would be monitored closely for the rest of their lives.

Sir John Tooke, the president of the Academy of Medical Sciences, said: “Introducing regulations now will ensure that there is no avoidable delay in these treatments reaching affected families once there is sufficient evidence of safety and efficacy.

“It is also a positive step towards ensuring the UK remains at the forefront of cutting-edge research in this area.”


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