A new study says that adding pertuzumab to a combination of trastuzumab and docetaxel chemotherapy extended progression-free survival by a median of 6.1 months in patients with metastatic HER2-positive breast cancer. This is much better when compared with patients who received the combination therapy with placebo in the study.
Researchers conducted an international phase 3, double-blind, randomized trial, known as CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab), in which they randomly assigned 808 patients to receive trastuzumab and docetaxel chemotherapy with pertuzumab or placebo. Progression-free survival (PFS) was 18.5 months for patients who received pertuzumab compared with 12.4 months for patients who received placebo - a 38 percent reduction in risk for progression.
The findings, reported at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium, held Dec. 6-10, 2011, represent a significant advance in the treatment of this advanced breast cancer, said senior researcher José Baselga, M.D., Ph.D., professor in the department of medicine at Harvard Medical School, associate director of the Massachusetts General Hospital Cancer Center and chief of hematology/oncology at Massachusetts General Hospital.
"This is huge. It is very uncommon to have a clinical trial show this level of improvement in PFS," said Baselga. "Most metastatic patients with HER2-positive breast cancer eventually stop responding to trastuzumab, so the fact that we now have an agent that can be added to current treatment to delay progression is very exciting. With the advent of trastuzumab and now pertuzumab, we have come a very long way in treating a type of breast cancer that once had a very poor prognosis."
Drugs -- anastrozole (Arimidex) and fulvestrant (Faslodex) -- are currently used to treat breast cancer but they have typically been administered separately, not together.
The results of the randomized, controlled SWOG trial showed that the two anti-estrogen drugs given together extended the median survival time by more than six months compared to standard treatment with anastrozole only.
The study began in 2004 and included 707 postmenopausal women with metastatic hormone receptor-positive breast cancer.
All the women took a daily oral dose of anastrozole, which works by reducing production of tumor-promoting estrogen.
About half of the women also got a 250 milligram injection of fulvestrant every 28 days. Fulvestrant works by interfering with the receptors that allow estrogen to signal cells to grow and reproduce.
Lead study coordinator Rita Mehta of the University of California, Irvine, Medical Center said the two drugs together showed an impressive impact on a subtype of breast cancer that accounts for more than half of all cases.
"If we take away estrogen and the estrogen receptor, the two together should be better than just doing one at a time," Mehta said.
"These patients have not had a new treatment that gave them an overall survival benefit in more than a decade."
Women in the trial who received just anastrozole survived a median of 41.3 months. Women who received the two in combination survived a median of 47.7 months.
Researchers said side effects were generally similar in both groups, though the most severe side effects, including one stroke and two pulmonary embolisms, were seen in the combination group.
"This most likely will change the standard of care for how we treat these patients," said study co-author Kathy Albain of Loyola University Medical Center.
Two drugs can delay by several months the time before advanced breast cancer worsens, potentially providing new options for women with that disease, researchers reported Wednesday.
Both drugs, pertuzumab from Genentech and everolimus from Novartis, also showed signs in clinical trials that they could prolong lives, though researchers said it was too early to say that definitively.
Results of the studies, which were sponsored by the companies, are being presented this week at the San Antonio Breast Cancer Symposium and were published online Wednesday in The New England Journal of Medicine.
Pertuzumab is designed to complement Genentech’s big-selling drug Herceptin for the roughly 20 percent of breast cancer patients whose tumors have elevated levels of a protein called Her2. Both pertuzumab and Herceptin block the action of the protein but in different ways.
In a large international study, an experimental drug from Genentech called pertuzumab held cancer at bay for a median of 18 months when given with standard treatment, versus 12 months for others given only the usual treatment. It also strongly appears to be improving survival, and follow-up is continuing to see if it does.
"You don't see that very often. ... It's a spectacular result," said one study leader, Dr. Sandra Swain, medical director of Washington Hospital Center's cancer institute.
In a second study, another drug long used in organ transplants but not tried against breast cancer -- everolimus, sold as Afinitor by Novartis AG -- kept cancer in check for a median of 7 months in women whose disease was worsening despite treatment with hormone-blocking drugs. A comparison group that received only hormonal medicine had just a 3-month delay in disease progression.
Afinitor works in a novel way, seems "unusually effective" and sets a new standard of care, said Dr. Peter Ravdin, breast cancer chief at the UT Health Science Center in San Antonio. He has no role in the work or ties to drugmakers. Most patients have tumors like those in this study -- their growth is fueled by estrogen.
Results were released Wednesday at the San Antonio Breast Cancer Symposium and some were published online by the New England Journal of Medicine. They come a few weeks after federal approval was revoked for another Genentech drug, Avastin, that did not meaningfully help breast cancer patients. It still is sold for other tumor types.
The new drugs are some of the first major developments since Herceptin came out in 1998. It has become standard treatment for a certain type of breast cancer.
"These are powerful advances ... an important step forward," said Dr. Paul Burstein, a breast expert at Dana-Farber Cancer Institute in Boston who had no role in the studies.
A reality check: The new drugs are likely to be very expensive -- up to $10,000 a month -- and so far have not proved to be cures. Doctors hope they might be when given to women with early-stage cancers when cure is possible, rather than the very advanced cases treated in these studies.
Even short of a cure, about 40,000 U.S. women each year have cancer that spreads beyond the breast, and treatment can make a big difference in their lives.
Rachel Midgett is an example. The 39-year-old Houston woman has breast cancer that spread to multiple parts of her liver, yet she ran a half-marathon in Las Vegas on Sunday. She has had three scans since starting on Afinitor nine months ago, and "every time, my liver lesions keep shrinking," she said.
"My quality of life has been wonderful. It's amazing. I have my hair. ... If you saw me you wouldn't even know I have cancer."
Genentech, part of the Switzerland-based Roche Group, applied Tuesday to the federal Food and Drug Administration for permission to sell pertuzumab (per-TOO-zoo-mab) as initial treatment for women like those in the study.
The drug targets cells that make too much of a protein called HER2 -- about one of every four or five breast cancer cases. Herceptin attacks the same target but in a different way, and the two medicines complement each other.
The study tested the combination in 808 women from Europe, North and South America and Asia and found a 6-month advantage in how long the cancer stayed stable. All women also received a chemotherapy drug, docetaxel.
"That's a huge improvement" in such advanced cases, said study leader Dr. Jose Baselga, associate director of the Massachusetts General Hospital Cancer Center. He is a paid consultant for Roche.
So far, 165 deaths have occurred -- 96 among the 406 women given Herceptin and chemo alone, and only 69 among the 402 women also given pertuzumab. Doctors won't know whether the drug affects survival until there are more deaths.
Tags: Breast cancer patients, Bone drug breast cancer,Breast cancer screening guide, Breast cancer, Breast cancer seminar, Komen donate $1.8 million, FDA Avastin breast, Avastin breast cancer, Women walk 60 mil breast cancer, No Breast Cancer Screening 40-49
More than one third of women taking a certain class of breast cancer drugs are so bothered by side effects that they stop taking the pills before their treatment is complete, according to a new study.
Doctors typically prescribe a five-year course of the drugs, called aromatase inhibitors, for post-menopausal women after breast cancer surgery, chemotherapy or radiation treatment. The drugs are widely perceived as powerful tools to prevent breast cancer from returning.
But according to a survey of nearly 700 women on the drugs, 36 percent of them stopped taking the pills after four years, citing a number of intolerable side effects; 10 percent quit after just two years on the drugs. The study, presented today at the San Antonio Breast Cancer Symposium, is the first to ask women who are actually taking the drugs about how the drugs affect their quality of life.
Patients reported that a number of intolerable side effects -- severe joint pain, hot flashes, decreased libido, weight gain -- made them stop taking the drug before their treatments were complete. The patients who were most likely to stop taking their pills were women who had previously undergone chemotherapy or radiation treatments, toxic therapies that cause an array of unpleasant side effects.
"If they had a rough time with chemo, if they're feeling beaten up by treatment and medications, or if they're the type of person who has difficulty tolerating side effects, then they're much more likely to quit the drugs early," said study author Lynne Wagner, an associate professor of medical social sciences at the Northwestern University Feinberg School of Medicine.
he longer women were being treated, the more reported side-effects.
Those at highest risk of stopping before the recommended five years were those still experiencing side-effects from chemo or radiotherapy.
As a result of the side effects, 10% of the women had stopped taking the drug within two years. A further 26% had stopped by four years.
The researchers say there is a big gap between what women tell their doctors about side-effects and what they actually experience.
Dr Lynne Wagner led the study, which is being presented to the Annual San Antonio Breast Cancer Symposium.
She said: "Clinicians consistently underestimate the side-effects associated with treatment.
"They give patients a drug they hope will help them, so they have a motivation to underrate the negative effects.
"Patients don't want to be complainers and don't want their doctor to discontinue treatment. So no-one knew how bad it really was for patients."
Dr Wagner added: "This is a wake-up call to physicians that says if your patient is feeling really beaten up by treatment, the risk of her quitting early is high.
"We need to be better at managing the symptoms of our patients to improve their quality of life."
Dr Susie Jennings, senior policy officer at Breakthrough Breast Cancer, said: "It is worrying if breast cancer patients are stopping lifesaving treatment early without consulting their doctor.
"We are aware some patients in the UK do stop treatments early and the reasons behind this need further investigation.
"The patient information leaflets do warn women of all the side effects, but it is important there is a continued discussion throughout treatment between patient and doctor.
"If any women are considering stopping treatment we would urge them to speak with their doctor."
Tags: 2 new breast cancer drugs, Bone drug breast cancer,Breast cancer screening guide, Breast cancer, Breast cancer seminar, Komen donate $1.8 million, FDA Avastin breast, Avastin breast cancer, Women walk 60 mil breast cancer, No Breast Cancer Screening 40-49
Women who go on a low carb diet just two days per week have a lower risk of developing breast cancer compared to those who follow a standard calorie-restricted diet every day of the week, in order to lose weight and lower their insulin blood levels. Long-term high blood insulin levels are known to raise cancer risk. These findings were presented by scientists from Genesis Prevention Center at University Hospital in South Manchester, England, at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium.
The researchers stressed that a larger, longer-term additional study is required.
Michelle Harvie, Ph.D., SRD, a research dietician at the Genesis Prevention Center, who presented the study said:
"Weight loss and reduced insulin levels are required for breast cancer prevention, but [these levels] are difficult to achieve and maintain with conventional dietary approaches."
Harvie and her team set out to compare three different 4-month-long diets to assess the effects on weight loss and blood markers of breast cancer risk in 115 women who had a family history of breast cancer. The researchers randomly assigned patients into three groups:
The low cal/carb group - they followed a calorie-restricted, low-carbohydrate diet
The part-time low-carb group - they followed an "ad lib" low-carbohydrate diet whereby patients were allowed to consume unlimited proteins and healthy fats, like lean meats, olives and nuts for 2 days per week.
"The benefit persists" long after treatment ends, said study leader Dr. Michael Gnant of Austria's Medical University of Vienna. He presented the research this week at the San Antonio Breast Cancer Symposium.
Zometa (zow-MAY-tuh) should now be offered to all patients like those in this study — younger women forced into early menopause by hormone-blocking cancer treatments, some specialists said.
"It's a new standard of care," said Dr. James Ingle, a Mayo Clinic breast specialist who had no role in the study.
Bone drugs called bisphosphonates — sold as Fosamax, Boniva and Actonel — have long been sold for treating osteoporosis. Those are daily pills. Zometa, made by the Swiss company Novartis AG, is given intravenously to treat cancer that has spread to the bone.
Hope that it could do more grew in 2008, when Gnant reported that it lowered the risk of a cancer recurrence in a study of 1,800 premenopausal women with early-stage breast cancer. All had surgery followed by hormone blockers, and half also received Zometa.
Now, with seven years of follow-up, researchers see that Zometa not only helped keep cancer from coming back, but also improved survival. There were 33 deaths among women given the bone drug and 49 among those not treated with it.
That magnitude of benefit is comparable to many chemotherapy treatments. Researchers think because Zometa strengthens bones, it's tougher for cancer to spread there and the drug may also have direct effects against circulating cancer cells or microscopic tumors.
Zometa's side effects were mostly fever and bone and joint pain, and doctors saw no cases of jawbone decay, a serious problem long linked to bisphosphonates. Zometa costs more than $1,000 in the U.S. and about half as much in Europe, though the price may drop when its U.S. patent expires in 2013. Novartis helped pay for the study and Gnant consults for the company.
The bone drug proved disappointing though in a large study last year in postmenopausal women, who account for three-fourths of all breast cancers. But there was a glimmer of hope in the oldest patients.
"They benefitted substantially as long as they were well past menopause," said Dr. Peter Ravdin, director of the breast cancer program at the UT Health Science Center in San Antonio, who also had no role in the research.
Tags: 2 new breast cancer drugs, Breast cancer patients, Breast cancer screening guide, Breast cancer, Breast cancer seminar, Komen donate $1.8 million, FDA Avastin breast, Avastin breast cancer, Women walk 60 mil breast cancer, No Breast Cancer Screening 40-49
Colorado, like the rest of the nation, is in the midst of an obesity epidemic. Consider the numbers. Just 15 years ago, the highest adult obesity rate in the U.S. — Mississippi's — was 19.4 percent. That's lean by today's standards. Today, Colorado "boasts" of the nation's lowest adult obesity rate — at 19.8 percent.
Childhood obesity has tripled in the past 30 years. More than one out of every three children and adolescents are overweight or obese. Overweight and obese youth are at substantially increased risk for serious health issues, including cardiovascular disease, diabetes, bone and joint problems and stroke, according to the Centers for Disease Control and Prevention.
Once again, research points clearly to policy and behavior changes. We know that diet and physical activity can make a real difference in reducing obesity and that, for young people, school-based interventions can be particularly effective.
Coloradans agree with the research. A statewide survey conducted by the national polling firm American Viewpoint revealed overwhelming support among Coloradans — regardless of political affiliation — for higher nutrition standards in our schools. Eighty-eight percent of Coloradans said it was "very or somewhat important" for schools in Colorado to limit the availability of high fat and high sugar foods; 94 percent would either strongly or somewhat support "an effort to increase nutritional standards for school lunches reducing high fat and high caloric foods in favor of more fresh fruits, fresh vegetables and other health choices."
It was in this environment — an obesity epidemic, a growing body of research about the solutions to obesity, and sky-high public support for a stronger response — that the U.S. Department of Agriculture (USDA) earlier this year prudently proposed reasonable, evidence-based changes to incorporate more fruits and green vegetables into the nation's $11 billion school lunch program. The proposed changes to the school meal programs are based on sound nutritional science and the Institute of Medicine's recommendations.
Yet it was in this same environment that an influential segment of the food industry that included Coca-Cola, Del Monte Foods and ConAgra was recently able to persuade Congress to block federal funding from being used by the USDA to implement those proposed rules. Their arguments against the rules devolved into the absurd — suggesting, for example, that 2 ounces of tomato paste on a piece of pizza should count as a vegetable serving.
The forces behind evidenced-based policies to reverse obesity trends in Colorado and nationally have powerful allies: the facts and a growing recognition of the enormous public health consequences of this epidemic.
Wilkinson lost 30 pounds in 40 days, grazing on fresh vegetables and a daily portion of meat no bigger than a bar of soap. In two rounds of the diet, she lost a total of 48 pounds.
Another believer, Lisa Kolodziej of Nashville, went on the diet in August and lost 35 pounds in 40 days.
“I never would have tried a 500-calorie diet,” Kolodziej said. “They say it’s not healthy to do that, but I was flabbergasted at how the weight was just coming off.”
Proponents say the hormone, used for years as a fertility treatment, spurs stored fat cells to release their energy, which curbs fatigue and hunger during the low-calorie diet.
A version of the HCG (human chorionic gonadotropin) diet has been around for at least four decades but started growing in popularity after TV Dr. Mehmet Oz devoted a show to it in February. The hormone, derived from the urine of pregnant women, is produced in the hypothalamus, the area of the brain that controls appetite.
HCG is the marker that pregnancy tests check for, but men also can produce it. Physicians check for elevated levels in men when diagnosing testicular cancer, although Dr. David Penson, a urologic oncologist with Vanderbilt University Medical Center, said HCG doesn’t cause that cancer.
The weight-loss boost from HCG is more psychological than pharmacological, according to Roger Cone, who is chairman of the molecular physiology and biophysics departments at Vanderbilt University.
“There is absolutely no scientific or medical evidence to believe that it works,” Cone said, and any weight loss users experience is due to the low-calorie plan.
'Easy' lures people
But many Americans can’t help themselves when it comes to popular diets, said Ellen Granberg, a Clemson University sociology professor who has studied people who shed pounds and kept them off. They told her it took time to develop the discipline, effort, organization and maturity to stop looking for easy fixes.
“We are taught to believe that it should be easy to sustain a normal weight and it should be easy to lose weight, so if it is difficult, then something must be wrong,” Granberg said. “The first thing we think is ‘Something is wrong with this diet.’ ”
So Americans keep looking for a low-calorie diet with “sort of a gimmick on top of it,” or some other quick fix, Granberg said. Those gimmicks have included the African herb hoodia, the Amazon River Valley fruit acai and even tapeworms.
“One of my favorites is obesity soap,” she said. “This was from the early 20th century. You could see advertisements marketing obesity soap that would wash the pounds away.”
She said the first “pregnant pee” diet became popular in the 1970s and is now back as HCG. The Atkins diet followed a similar cycle: Dr. Robert Atkins published his first book in the 1970s and updated it in 2002. The diet plan became an industry, with retailers specializing in trademarked foods popping up.
For the HCG plan, the biggest expense is prescription-strength dosages of the hormone, which typically cost $300 to $900 for a 40-day supply — a cost that sometimes includes the medical exam.
Over-the-counter, weaker versions of the hormone are available at retailers for around $20. They come in oral drops.
Just a starting point
Despite the diet’s detractors, Dr. Marshelya Wilson of Nashville says it’s less risky and expensive than bariatric surgeries, which do have the FDA’s approval in certain cases of obesity.
“People have got to find other options that are not as invasive,” said Wilson, the prescribing physician for BYou Weightloss and Wellness in Green Hills.
She emphasizes that the diet is intended to be a starting point, not a long-term solution.
“We recommend it for people who are already thinking about making a lifestyle change,” Wilson said. “It is like any other lifestyle change that people embark on.”
But Dr. Tim Dibble, an internal medicine specialist who just opened Nashville Medical Weight Loss, decided not to offer the hormone even though his patients are asking for it.
“I didn’t want to anything that had a faddish component to it whatsoever,” said Dibble, who offers no easy fixes or quick starts for weight loss.
His program is based on individualized diets and helping people make lifestyle changes — what most physicians and registered dietitians recommend.
The quick weight loss at the front end of HCG is an indicator it won’t last, said Sarah-Jane Bedwell of Nashville, a registered dietitian in private practice. She expects HCG to have a short shelf life in the American public.
The Milton Hershey School is responding to a discrimination suit filed by a 13-year-old boy who did not get into the school because he has HIV.
Milton Hershey School sees itself as a very unique school since it houses students full-time over night. A dilemma since one way HIV is spread is through sex.
But the lawsuit filed by the 13-year-old Delaware County boy says his denial to the school is a violation of the Americans with Disabities Act.
AIDS and HIV advocates agree. “People with AIDS are covered by the Act and discrimination of this type is not accepted,” stated an advocate.
"We acknowledge challenging the students application,” stated Vice President of Communications for Milton Hershey Connie McNamara. “We have 1850 students in our
care.”
School attorneys argue they are not obligated to admit the student if he poses a ‘direct threat’ to the health and safety of others that can’t be easily fixed by changes to school policies, programs and buildings.
The 13-year-old boy’s parents are being assisted by the AIDS Law Project of Pennsylvania, a group advocating equal treatment of HIV-infected people. The lawsuit is claiming that the private school violated the Americans with Disabilities Act by rejecting their son as a disadvantaged student.
“This young man is a motivated, intelligent kid who poses no health risk to other students but is being denied an educational opportunity because of ignorance and fear about HIV and AIDS,” said attorney Ronda Goldfein.
The Milton Hershey School, which services economically disadvantaged students in the Derry township area, said they were only trying to protect the 1,850 students already in attendance at the school.
“In order to protect our children in this unique environment, we cannot accommodate the needs of students with chronic communicable diseases that pose a direct threat to the health and safety of others,” the school said in a statement. “The reason is simple. We are serving children, and no child can be assumed to always make responsible decisions which protect the well-being of others.”
Pennsylvania’s Patriot-News reported that the school was acting on its own decision on not official policy. Although the boy met the school’s eligibility requirements, it determined that his needs were “beyond the scope” of what the school could provide.
Goldfein, however, said the boy “does not need any special accommodations, nor did he ask for any.”
The Milton Hershey School was founded before Hershey’s death and was originally intended to educate orphans. Now, it is run on the proceeds of a $7.5 billion trust fund and accepts students in disadvantaged circumstances.
The lawsuit was officially filed Wednesday.
An appeals court has ruled that people who donate bone marrow through a newer and less invasive technology can be paid for doing so, overturning a decades-old law that makes it a felony to pay donors for bone marrow and organs.
A three-judge panel of the 9th U.S. Circuit Court of Appeals in California ruled unanimously that because the process of donating bone marrow is now so similar to that of donating blood plasma -- which people are paid for -- bone marrow should no longer be considered an organ for which payment is illegal under the National Organ Transplant Act.
A newer method of marrow extraction called peripheral blood stem cell apheresis removes stem cells from a donor's bloodstream in a process similar to donating blood, except that patients must take medication to spur greater production of hematopoietic stem cells, the donation process takes several hours, and instead of collecting bags of blood, the hematopoietic stem cells from the donor's bloodstream are filtered out and collected.
The 1984 National Organ Transplant Act included bone marrow in its list of "organs and parts thereof" for which donors could face criminal charges and five years in prison for providing them in exchange for money or other "valuable consideration."
Though bone marrow is naturally replenishable, unlike livers, kidneys and other whole organs, its sale was barred because the extraction method used at the time the law was passed was painful and risky for the donor and authorities feared the poor would be induced to submit to the procedure to earn money.
In the last 20 years, though, medical advances have brought about a less intrusive method by which the life-saving marrow stem cells are harvested from a donor's bloodstream in much the same way as blood is drawn at a blood bank. The new process, known as apheresis, filters out excess marrow stem cells that circulate in the bloodstream, as opposed to the surgical extraction method, known as aspiration, which inserts a large needle into the hip bone and siphons out the cells.
A unanimous three-judge panel of the 9th U.S. Circuit Court of Appeals ruled that the marrow cells taken from a donor's blood were blood parts, not organ parts, and that a donor is therefore free to accept compensation for a donation.
"This is a fundamental change to how deadly blood diseases will be treated in the country," said Jeff Rowes, the Institute for Justice attorney who argued the case before the 9th Circuit panel in February. "Compensation will expand the donor pool by at least hundreds and potentially thousands each year."
More than 3,000 Americans die each year waiting for a suitable marrow donor, Rowes told the court, representing a group of cancer patients and their families, a Minnesota doctor specializing in bone marrow treatments and the California nonprofit MoreMarrowDonors.org.
The lead plaintiff in the case is Doreen Flynn of Lewiston, Maine, a single mother of five trying to ensure that a broader field of potential donors is available when her three daughters suffering from Fanconi anemia need marrow transplants after treatment for the potentially fatal genetic disorder.
"That is, like, the best Christmas news ever!" said a jubilant Flynn upon hearing that the 9th Circuit had ruled to exclude marrow from the compensation ban. Her 13-year-old daughter is already on medication to stave off the need for a marrow transplant while waiting for a well matched donor, and Flynn must decide soon whether to put one of her 7-year-old twins on the same medication, she said.
MoreMarrowDonors.org wanted the organ transplant law struck down or amended to allow the nonprofit to offer $3,000 scholarships or housing payments to attract new registrants to the National Marrow Donor Program. The registry has more than 7 million members, but many joined years ago during donor drives for friends or family members and are often reluctant to donate to a stranger.
Although the extraction procedure has been greatly simplified, it remains difficult to find the right genetic match between donor and recipient, the plaintiffs argued. Unlike blood, of which there are only four types, marrow comes in millions of types.
The plaintiffs sued U.S. Atty. Gen. Eric H. Holder Jr., alleging that the federal law treating bone marrow in the same way as organs that can't be regenerated violates the Equal Protection Clause of the Constitution. The appeals court panel ruled that the older extraction method directly drawing cells from the marrow was reasonably included in the ban on compensation but that the marrow cells filtered out of a donor's blood were blood parts, not marrow parts.
"We construe 'bone marrow' to mean the soft, fatty substance in bone cavities, as opposed to blood, which means the red liquid that flows through the blood vessels," said the opinion written by Judge Andrew J. Kleinfeld, an appointee of President George H.W. Bush. "The statute does not prohibit compensation for donations of blood and the substances in it, which include peripheral blood stem cells."
Justice Department spokesman Charles S. Miller said the government hasn't decided yet whether to appeal.
"We're going to have to review it to make a determination about what the government's next step will be," Miller said, declining to comment on the ruling.
The 9th Circuit interpretation applies to its nine-state jurisdiction, but because it is the only federal appeals court to have ruled on the question, its judgment could guide future decisions nationwide.
Formerly conjoined twins Maria and Teresa Tapia should return home to the Dominican Republic by Christmas, their doctors say. The toddlers are currently recovering from separation surgery in Virginia.
PICTURES - Conjoined twins Maria & Teresa Tapia: Before and after
For the nearly daylong surgery on Nov. 8, doctors at the Children's Hospital of Richmond at Virginia Commonwealth University divided the twins' liver, pancreas, and other shared organs, and reconstructed their abdominal walls.
How are the twins doing?
"They are enjoying life now that they're separated," their mother, Lisandra Sanatis, said. "They enjoy seeing themselves as individuals."
But they're still getting accustomed to exploring their surroundings separately, and stay near each other and hold hands when they walk.
Dr. David Lanning, a surgeon and head of the girls' medical team, says both children have been recovering well.
Maria, the smaller of the two, weighs about 19 pounds, and Teresa weighs about 26 pounds. The disparity in their weight, caused by the configuration of their small intestines and blood flow from the liver, will gradually even out, Lanning said.
Maria's pancreas is slow to produce digestive enzymes, so she is taking replacement enzymes. Teresa is undergoing treatment on the incision where the girls were separated.
After being in Richmond for several months now, Sanatis says she and her daughters are more than ready to leave the confines of the hospital and are anxious to return to their family in their native country. "We're missing our family, and the girls miss their little brother, Lisander," she said.
The family also hasn't acquired a taste for American food - including hospital meals - and they order takeout Dominican dishes, including traditional beans and rice.
They will be staying at the Hospitality House, which provides temporary lodging for patients and their families while in Richmond to get medical care, while continuing physical and occupational therapy and medical follow-up before going home to the Dominican Republic, possibly by Christmas.
"It's great to see the girls happy and out the door," said physician David Lanning, the lead surgeon on the operation that took months to coordinate and plan.
In all, more than 100 people — doctors, nurses, therapists and other staff — were involved in the care of the girls and their family, said Leslie Wyatt, executive director of the Children's Hospital.
Other partners include the Rotary Club of South Richmond, which helped cover the family's living expenses while in Richmond.
"This is a tremendous culmination of a lot of teamwork," Lanning said.
The girls are adjusting to life as separate people. Their birth in April 2010 as conjoined twins was a medical rarity, occurring in one in every 50,000 to 100,000 births worldwide.
"All cases of conjoined twins can be very different even though on the outside they appear similar," Lanning said.
"Because the girls had a lot of organs that were conjoined, it really required a prolonged, complex operation with a lot of reconstruction, lots of different teams involved. I think we're really delighted with how they've done and to leave the hospital doing so well," Lanning said.
The girls are on aspirin therapy, a recommendation from the liver specialists, Lanning said.
"The aspirin is a little bit of a blood thinner" to minimize any risk of clotting, Lanning explained. "Even though they didn't have any liver tissue removed, they split it in half." They will be on aspirin therapy for a year, he said.
Maria, the smaller twin whose reconstructive surgery was more complex, is also taking oral medication that helps with digestion. Lanning said tests show that Maria's pancreas, the organ that produces insulin and other hormones, is working fine but may not be producing enough of some digestive enzymes.
"We anticipate it will recover, but in the meantime we are just giving her supplements," Lanning said. "They are enzymes that help break down carbohydrates. We think that will eventually recover because she has an adequate amount of pancreatic tissue."
The oral medications are cheap and easily available and will not hurt her, Lanning said. If lab tests on stool samples show inadequate digestive enzymes, she may be on the medication for several months while her pancreas ramps up.
There may be one more medical procedure, a surgery to create cosmetic belly buttons for the girls, Lanning said. Originally, they had one that was underneath their conjoined belly.
"Dr. (Jennifer) Rhodes could do it as an outpatient procedure with a little sedation," Lanning said. "Their focus was to get the belly closed, and they've done that."
The weeks leading up to their discharge have been marked by incremental milestones — first sip of water, first bowel movement, first bite of solid food, first independent step.
Still ahead for the girls is learning to get around on their own.
Before the surgery, the girls toddled around easily, with each twin providing balance for the other.
After surgery, they have had to relearn many things — to sit up, to go from sitting to standing, to stand assisted, to walk assisted. The girls, once on their feet, are good at pushing around a stroller.
"Once they are standing and holding on to something, they will walk forward," said occupational therapist Audrey Kane.
"They need to be able to get up and down from standing, from the floor. That's one where they are still trying to figure out what to do. When they are sitting on the floor, they are not quite sure yet how to go about getting up," Kane said. Both girls made gains in that area this week, Kane said Tuesday.
The girls still turn to their mother and aunt with outstretched arms for help, which is still there but in measured doses.
On Friday, Sanatis thanked everyone who made the surgery possible and who supported them but added that she was looking forward to going home.
"It is sad for me. I fell in love with everyone here," she said while holding Teresa, who grabbed at the microphone and, when prodded, leaned over and gave Lanning a kiss on the cheek.
Lanning, who has taken care of other children while on World Pediatric Project missions to Caribbean countries, said there is satisfaction in caring for children who might not get needed medical care otherwise.
At the same time, what they learn from such cases allows them to help many others.
"We may not necessarily have another set of conjoined twins come along, but we certainly learned a lot from this operation to take care of other kids," Lanning said.
"Just a month or so ago I had a baby born here with … all the intestines outside the belly. I knew I could close it a certain way because of a baby I had taken care of in St. Vincent on one of my mission trips. … We learn a lot … when we do these complex, unusual operations."
A statement from Asheville's Mission Hospital on Saturday afternoon said Graham's pulmonologist reports he is maintaining the improvement he showed on Friday.
The 93-year-old evangelist will continue physical therapy to help his strength and mobility. Doctors said Graham stood and walked Friday during a physical therapy session.
Doctors at the hospital in Asheville said Graham was able to stand and walk Friday during a physical therapy session.
Dr. Mark Hellreich, a pulmonologist treating Graham, said he's making good clinical progress and looks better since treatment with antibiotics began.
Graham has suffered from several ailments in recent years. He was admitted to the hospital Wednesday night after suffering from congestion, a cough and a slight fever that was later diagnosed as pneumonia.
Graham was able to take meals on Friday sitting in a chair while talking with hospital staff. No discharge date has been set. .
Whether it is housework, cooking or childcare, women do about 10 hours more multitasking in the home each week -- 48.3 hours compared to 38.9 -- which researchers say constitutes an important source of gender inequality.
"When you look at men and women in similar kinds of work situations they look very similar," Barbara Schneider, a professor of sociology at Michigan State University and a co-author of the study, said in an interview.
"But when they come home it is very clear that women are shouldering much more of the responsibilities of housework and childcare."
Schneider and Shira Offer, an assistant professor at Bar-Ilan University in Israel, used data from the 500 Family Study, which looked at how families in eight U.S. urban and suburban communities balance work and family life.
Their research, which is published in the American Sociological Review journal, is based on responses from a subset of 368 mothers and 241 fathers in dual-income families, which they said reflects the most time-pressured segment of the population.
"This (the findings) suggests that working mothers are doing two activities at once more than two-fifths of the time they are awake, while working fathers are multitasking more than a third of their waking hours," Schneider said.
In addition to doing more, the jobs women perform at the same time in the home are more labor intensive,
such as housework and childcare, than what men tackle.
The study showed that 52.7 percent of all multitasking for working mothers involved housework, compared to 42.2 percent for fathers, and 35.5 percent was taken up with childcare, as opposed to 27.9 percent for men.
"Fathers, by contrast, tend to engage in other types of activities when they multitask at home, such as talking to a third person or engaging in self-care. These are less burdensome experiences," Schneider explained.
Multitasking may feel productive, but psychological research suggests our brains aren't at their best when divided between two or more tasks. One 2010 study published in the journal Science found that the brain can juggle two tasks at once, but adding a third is a recipe for disaster. Even practiced multitaskers struggle with the overload. According to research by Stanford University professor Clifford Nass, the people who multitask the most are the worst at it.
But for modern families, multitasking is a way of life. Schneider and her colleagues wanted to know how much time moms and dads spend doing two or more things at once, and just as important, how they felt about it.
As part of a large 1999-2000 study of mostly middle-class families called the 500 Family Survey, researchers asked parents to wear pre-programmed wristwatches that would beep eight times each day. When the participants heard the beep, they stopped everything to record in a diary what they were doing, whom they were with, and their emotions at the moment. This method, called "experience sampling," was developed by Hungarian psychologist Mihaly Csikszentmihalyi.
"What we're really learning is not only how people are spending their time, but how they're feeling about it at a very deep and personal level," Schneider said.
With a total sample of 16,878 diary entries of 368 moms and 9,482 entries of 241 dads, the researchers found that multitasking is very common. Fathers multitask for more than a third of their waking hours, while mothers multitask for two-fifths of their waking lives.
Paid work puts a lot of multitasking burden on both moms and dads, with work-related multitasking making up 36 percent of multitasking episodes for dads and 23.4 percent of multitasking episodes for moms. At home, however, mothers are more likely than fathers to engage in two housework activities or two child care-related activities at the same time, the study found. Housework and child care combos accounted for 10 percent of moms' multitasking time and only 4.4 percent for dads.
Modern family
Though moms piled on more multitasking at home than dads, they were also less cheery about it. They reported a lower sense of well-being when multitasking than did multitasking dads, Schneider said. Moms reported more negative emotions and more stress when they multitasked at home compared with when they did a single task, while fathers did not show this increase in negative emotions.
"Basically, that's telling you that when dads are at home and they multitask, they pretty much are thinking it's a good thing," Schneider said. "This is less so in the case of moms."
Some of the emotional discrepancy may have to do with who juggles what tasks. The study found that for working moms, 52.7 percent of multitasking episodes at home were housework-related, compared with 42.2 percent for working dads. Likewise, 35.5 percent of home multitasking for moms involves child care, compared with 27.9 percent for dads.
The results highlight the stress that middle-class families face in the modern work force, Schneider said.
