Given a paragraph, generate a claim that is supported by the given paragraph. 1) The claim must contain information from within the paragraph. 2) A sentence within the paragraph can be used as a claim. 3) The claim should not have contradictions within the paragraph. 4) The claim should be at most one sentence long.

[Q]: The U.S. Food and Drug Administration questioned the differences in size and formulation of the patch used in trials and the to-be-marketed patch. The generic drugs maker, which received a “complete response letter” from the FDA, said it planned to work closely with the agency to address the questions. Such letters typically lay out FDA concerns that need to be addressed before a treatment is approved. Actavis’ contraceptive skin patch is designed to provide continuous delivery of the hormone norethindrone, a type of progestin, during a once-weekly, seven-day dosing regimen. Progestin, the synthetic form of female sex hormone progestogen, inhibits ovulation and thickens the layer of mucus at the cervix so sperm cannot enter the uterus. The treatment will compete with Johnson and Johnson’s Ortho Evra, an estrogen/progestin combination contraceptive patch. Estrogen is another female sex hormone. A progestin-only patch can be safer than combination patches as high levels of estrogen are often linked to blood clotting disorders and an increased risk of cancer. The company also filed on Tuesday an application to market the generic version of Merck & Co Inc’s NuvaRing, a estrogen/progestin combination hormonal contraceptive vaginal ring. Actavis said it may be the first applicant to file the application, which, if approved may entitle it to 180 days of generic market exclusivity. Shares of Dublin, Ireland-based Actavis were down 0.6 percent at $165.16 in early trading on the New York Stock Exchange on Tuesday.
[A]: FDA rejects Actavis' contraceptive patch, seeks more data.


[Q]: - Frustration over limited time spent with patients. - Inordinate amounts of time inputting required data. - Side effects including high levels of stress. The patient? Herself. The remedy? “I did the research and found direct primary care,” said Anderson-Elder of Windsor. And in June she joined Dr. Frank Morgan at Balance Health in Greeley, a direct primary care clinic he founded four years ago in Greeley. Leaving her family practice at UCHealth Medical Clinic in Windsor after seven years wasn’t an easy decision, she said, but it was the right decision for her. Many physicians — from all specialties — share Anderson-Elder’s frustration and levels of stress incurred while working in insurance-based health care systems. In the 2018 Medscape National Physician and Depression Report, 42 percent of family physicians admitted to having burnout or depression, listing “too many bureaucratic tasks (charting, paperwork)” and “too many hours at work” as the leading factors in burnout. Although direct primary care has been around for some time, it is just now gaining a toehold with both physicians contemplating the switch to a different way of providing care and patients willing to give it a shot, so to speak. In 2017, there were more than 600 direct primary care clinics in the U.S., 10 percent of those in Colorado, according to the Colorado Independent. Anderson-Elder said in her research she found 1,000 out of the 80,000 family doctors practicing in the U.S. have gone the direct primary care route. DIRECT PRIMARY CARE What is direct primary care? And why the interest? First and foremost, the major difference is that direct primary care does not accept insurance. Patients instead pay a monthly membership fee that includes unlimited visits, calls and emails, along with many routine services and access to prescriptions and lab work at a reduced cost. For the physician, it means quality time spent with patients and no more time filling out paperwork to satisfy health insurance company regulations. What the monthly fee is varies from clinic to clinic. At Balance Health, it is $99 for adults, $180 for couples and $30 for children. Those who sign up for direct primary care are asked to sign an annual contract but can be released from it with 30 days’ notice, Anderson-Elder said. “We want to be accessible to our patients. We don’t want them to go to urgent care or ER if they don’t have to,” she said. And yes, that includes calls at 3 a.m., but if it can wait till morning, the patient is worked into that day’s schedule. Anderson-Elder typically sees eight to 17 patients per day, depending on whether it’s cold and flu season. And she spends as much time as needed with them. At her previous practice, she was limited to spending 15 to 20 minutes per patient. “People service their cars,” she said. “They should do the same thing with their bodies. You should be looked at and tuned up.” While most people think of going to the doctor only when they don’t feel well or need a physical for work or school, Anderson-Elder said she likes to see patients even when they feel healthy so she can check in on their well-being and talk about proper nutrition. “Oftentimes patients think they’re healthy, but then we do an exam and sometimes find things,” she said. Direct primary care works best when combined with a high-deductible health plan, Anderson-Elder said, for those times when unexpected surgeries are scheduled and for patients who suffer from chronic illnesses. But she said about one-third of her patients have no health insurance at all. She also noted direct primary care should not be confused with concierge medicine, which also provides direct access to providers for a flat fee but still bills insurance companies for services provided. Another key distinction between the two is direct primary care is mentioned in the Affordable Care Act as an acceptable option for receiving medical care without insurance, while concierge medicine is not, according to the American Academy of Family Physicians. And last year, Colorado Gov. John Hickenlooper signed Colorado HB17-1115, which establishes that direct primary health care can operate without regulation of the division of insurance. Windsor Republican Rep. Perry Buck was a primary sponsor of the bill. Patients at Balance Health also can tap into other healthy-living services for additional fees. Dr. Dana Morgan, a family care physician, specializes in bioidentical hormone replacement therapy. Balance Health also has a small fitness gym replete with trainers and classes. Wellness coaching also is offered. Leaving her practice in Windsor, though a hard decision, has been the right prescription for her, she said. “I no longer take paperwork home,” she said. “I’m happier and less stressed.” ___ Information from: The Tribune of Greeley, Co, http://greeleytribune.com
[A]: Windsor doctor joining direct primary care movement.


[Q]: Inside, a basic clinic is crowded with young mothers and newborn babies, the latest additions to a population boom that has risen as relentlessly as the sea in a deeply Christian outpost where family planning is still viewed with skepticism. It is a boom that threatens to overwhelm the tiny atoll of South Tarawa as quickly as the rising seas. Some 50,000 people, about half of Kiribati’s total population, are already crammed onto a sand and coral strip measuring 16 sq km (6 sq miles). “Climate change is a definite long-term threat to Kiribati, there’s no doubt whatsoever about that,” says Simon Donner, a climate scientist at the University of British Columbia who has been visiting South Tarawa since 2005. “But that doesn’t mean it’s the biggest problem right now ... Any first-time visitor to Tarawa is not struck by the impacts of sea level rise, they’re struck by how crowded it is.”  Low-lying South Pacific island nations such as Kiribati (pronounced Kee-ree-bahs) and Tuvalu, about halfway between northeast Australia and Hawaii, have long been the cause célèbre for climate change and rising sea levels. Straddling the equator and spread over 3.5 million sq km (2 million sq miles) of otherwise empty ocean, Kiribati’s 32 atolls and one raised coral island have an average height above sea level of just two meters (6-1/2 feet). Studies show surrounding sea levels rising at about 2.9 mm a year, well above the global average of 1 - 2 mm a year. Kiribati President Anote Tong has grimly predicted his country will likely become uninhabitable in 30-60 years because of inundation and contamination of its fresh water supplies. While climate change poses a serious longer-term threat, many people, including Tong, recognize that breakneck population growth is a more immediate problem. South Tarawa’ population density of more than 3,000 per sq km is comparable to Los Angeles or parts of London - without the high rises. The government fears South Tarawa’s population could double to more than 100,000 by 2030 unless the birth rate and internal migration slows. Rudimentary huts of little more than timber sleeping platforms and palm thatch roofs line a single dusty road running the length of the atoll. Dotted among them are pig pens, chicken coops, overcrowded grave sites and the blasted relics from one of the bloodiest battles of World War Two. Bwabwa Oten, Kiribati’s director of hospital services, says current annual population growth in Kiribati is close to 6 percent, with overcrowding a major contributor to disease and an infant mortality rate among the highest in the region. The church plays an integral role in the South Pacific and efforts to limit birth rates have run into resistance. Large families are also traditional in the region, which has one of the world’s highest rates of teen pregnancy. Describing the population surge as “a menace”, Tong has called on churches to help curb growth by allowing their members to use birth control. “Religion is incredibly powerful in the Pacific and there is quite an overt suspicion that, when we are talking about family planning, it in fact means family stopping,” said Bronwyn Hale of New Zealand-based Family Planning International, which is working to promote sexual and reproductive health in Kiribati. Progress is being made, with clinic visitor numbers up and a growing acceptance of the threat of over-population. “Right now, population is the major issue, the number one issue we should face,” said Peter Itibita, a member of the Mormon Church in South Tarawa. Many health problems also stem from a lack of clean water as rising salinity and pollution affect underground water, with diarrhea outbreaks caused by contamination from human and animal waste and other pollutants. Nawerewere Hospital also has problems, with new mothers spilling from overcrowded wards onto verandas and into corridors. “Sometimes with the new babies, we don’t have the water to wash them,” says Rina Tabi, a maternity ward nurse. Plans are underway for solar-powered energy and desalination plants but the cost of building and maintaining them is a challenge for cash-strapped Kiribati, which relies on aid and royalties from foreign fishing fleets. The complexities of sea level change are becoming more apparent and there is little doubt that nations like Kiribati will be among the most affected. But it is equally clear that vulnerable states like Kiribati are responsible for less than 0.1 percent of global emissions of greenhouse gases from burning fossil fuels. According to the United Nations, population growth in the Pacific has consistently exceeded all other regions except Africa for the past 30 years and is likely to remain higher than the global average for the next 40-50 years, even though barely 10 million people are dotted across the world’s biggest ocean. There is also a history of concern about Pacific over-crowding, with dire predictions of population growth outstripping food production dating back to the 1960s. Barry Coates, executive director of Oxfam New Zealand, said populations of fragile atolls had long-developed resilience in dealing with resource shortages, cyclones and other periodic climatic events. “But what is happening now is that the pressures of population growth and climate change are overwhelming the traditional coping mechanisms,” Coates said. The Kiribati government has also been looking at radical options for feeding and housing its people, including negotiating to buy land on nearby Fiji. Larger Pacific neighbors New Zealand and Australia are likely to play a big role if large-scale migration is needed, and Western governments are under pressure to create a new refugee category for those fleeing the effects of climate change. A test case from Kiribati was rejected in New Zealand in 2012 and changes to international law will likely be needed.
[A]:
Tide of humanity, as well as rising seas, lap at Kiribati's future.