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Update October 2017


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Health & Wellbeing
 

Update Saturday, Oct. 21 - Oct. 27, 2017

FDA OKs Glaxo’s inhaler, first one to combine 3 medicines

The Food and Drug Administration approved GlaxoSmithKline PLC’s Trelegy Ellipta inhaler, the first to combine three medicines to ease breathing in patients with emphysema or chronic bronchitis. (GlaxoSmithKline PLC via AP)

Linda A. Johnson

Trenton, N.J. (AP) - The Food and Drug Administration has approved the first inhaler combining three medicines to ease breathing in patients with emphysema or chronic bronchitis.

The FDA late Monday approved sales of Trelegy Ellipta, developed jointly by GlaxoSmithKline PLC and Innoviva Inc. It contains three widely used types of medicine to prevent - rather than treat -flare-ups of the life-threatening breathing disorders.

Once daily, patients inhale the medicines through their mouth to open breathing passages and reduce inflammation that can make breathing difficult in people with chronic obstructive pulmonary disease, which includes emphysema and bronchitis.

The disorder worsens over time, requiring patients to add more medicines to prevent flare-ups that can land them in the emergency department - or worse. Many patients use two inhaler types plus other medicines.

An estimated 384 million people worldwide have chronic obstructive pulmonary disease, or COPD, which can make everyday activities such as walking up stairs difficult. It’s usually caused by cigarette smoking or exposure to secondhand smoke, chemical fumes or excess dust in the environment.

U.K.-based GlaxoSmithKline is launching Trelegy with a list price of $530 per month. That’s $146 a month cheaper than the combined prices of two GlaxoSmithKline inhalers that together contain the same three medicines: Incruse Ellipta and Breo Ellipta.

The medicines are an inflammation-reducing steroid called fluticasone furoate, and umeclidinium and vilanterol, drugs that widen narrowed airways and relax their muscles. Common side effects include headaches and other pain, diarrhea, nausea, stomach cramps and cough. Vilanterol and similar drugs carry an increased risk of asthma-related death. Trelegy also can worsen glaucoma and certain infections.

Insurers and prescription benefit managers likely will win significant discounts off the $530 retail price in exchange for covering Trelegy. However, those payers may pass all or much of the savings on to employers and other clients, rather than reducing patients’ out-of-pocket costs.

The product’s approval, the fourth for a Glaxo inhaler since 2013, should help the company rebuild its flagship respiratory medicine business. It was long a leader in the category, thanks to its widely used allergy drug Flonase and its Flovent and Advair inhalers. Flonase has generic competition now, and the drugmaker now sells a nonprescription version.

Flovent, launched in 1994, has seen sales cut by newer inhalers, including Glaxo’s products. Advair, which provided about one-third of Glaxo’s revenue for many years, also has seen increasing competition in recent years. Advair sales are down by more than half since their peak of $8.15 billion in 2011 and are expected to decline to just $1.43 billion by 2020.

The Incruse and Breo inhalers, both launched since 2014, and the Anoro inhaler launched in 2013 have barely made up for one-sixth of that lost revenue.


Treatment restores signs of awareness in brain-injured man

This image provided by the CNRS Marc Jeannerod Institute of Cognitive Science in Lyon, France, shows brain activity in a patient before, top row, and after vagus nerve stimulation. Warmer colors indicate an increase of connectivity. (CNRS Marc Jeannerod Institute of Cognitive Science, Lyon, France via AP)

New York (AP) - French researchers say they restored some signs of consciousness in a brain-injured man who hadn’t shown any awareness in 15 years.

During months of experimental treatment, his gaze could follow a moving object and he turned his head toward people speaking to him. He could also turn his head when asked to do so, and his eyes widened when a researcher suddenly came very close to his face, the researchers reported.

The treatment involved implanting a device in the man’s chest to electrically stimulate the vagus nerve, which extends into the brain. The technique is sometimes used for depression or to reduce the number of seizures in epilepsy. The vagus nerve, which also reaches down into the abdomen, plays many roles including slowing the heartbeat and controlling muscles of the small intestine.

During the treatment, the man also shed tears and smiled while listening to a favorite song by French singer Jean-Jacques Goldman. The tears might have been the result of the nerve stimulation, said Angela Sirigu of the Marc Jeannerod Institute of Cognitive Science in Lyon, France, which is affiliated with the National Center for Scientific Research. Because of brain damage, the man could not speak, she said.

Sirigu is an author of a study released Monday by the journal Current Biology.

The 35-year-old man, who was injured in a traffic accident, had spent 15 years in a so-called vegetative state, which the eyes are sometimes open but the patient shows no signs of awareness.

His behavioral improvements appeared about a month after the device was switched on and persisted for the remaining five months of stimulation, Sirigu said. Brain scans also showed better functioning.

The result “totally makes sense to me,” said Dr. Nicholas Schiff, a neuroscientist at Weill Cornell Medicine in New York City who did not participate in the research. While it’s the first success in a patient who’d spent 15 years in a vegetative state, it fits with other results that show even patients with long-standing, severe brain injury can be helped by treatment, he said. The challenge now is translating that science into better medical care, he said.

Most experimental treatments for the vegetative state have failed to show improvement, said Dr. James Bernat, emeritus professor of neurology and medicine at Dartmouth College in Hanover, New Hampshire. Like any report about a single patient, he said, the new one is “provocative but not definitive,” and further study is needed to see what kinds of patient it can help.

Sirigu said she’s planning a large study involving several medical centers.


Update Saturday October 14 - October 20, 2017

Age matters when it comes to screening for cervical cancer

Graphic shows rate of cervical cancer in the U.S.

Lauran Neergaard

Washington (AP) - Getting checked for cervical cancer isn’t one-size-fits-all: Millions of women may soon have to decide between a routine Pap or a newer test that detects if they have a cancer-causing virus.

Draft national guidelines released Tuesday for the first time say either option is reasonable for certain women - those ages 30 to 65.

Paps, a mainstay for women’s health for decades, can spot pre-cancerous abnormalities in time to prevent cancer. Newer HPV tests detect the virus that causes nearly all of that cancer, and while they’re widely used to confirm Pap results, most U.S. medical groups haven’t yet pushed them as a stand-alone alternative for screening.

Tuesday’s proposal doesn’t signal an imminent end to the Pap era. Paps, not HPV tests, still are recommended for screening women in their 20s, stressed the guidelines from the U.S. Preventive Services Task Force.

And don’t let the which-test debate blur the main message: “Screening for cervical cancer saves lives,” said Task Force member Dr. Carol Mangione of the University of California, Los Angeles.

Today, too many women still miss out. Some things to know:

Cervical Cancer
still a threat

Cervical cancer has dropped dramatically over the past half-century thanks to Pap testing. Still, this year an estimated 12,820 U.S. women will be diagnosed with cervical cancer, and about 4,200 will die. Most haven’t been screened, or have gone too long between checks.

Paps examine cells scraped from the cervix. HPV testing looks for high-risk strains of the human papillomavirus, the nation’s most common sexually transmitted infection. According to the Centers for Disease Control and Prevention, just about everyone will get at least one strain at some point in their lives. But only certain strains cause cervical cancer - and only if they linger long enough in the body.

Age matters for screening

Otherwise healthy women need a Pap every three years from age 21 to 29, agree most U.S. physician groups and the draft Task Force guidelines. Cervical cancer grows so slowly that regular Paps can find a problem early enough to treat.

While the Food and Drug Administration has approved an HPV test for women as young as 25, national guidelines have long recommended Pap screening for 20-somethings. That age group is most likely to get HPV - and the vast majority of the time their bodies clear the infection before it harms.

What changes
at age 30?

The older you get, the greater the chance that an HPV infection is the years long, harmful kind. To better catch those cases, today what’s called co-testing is increasingly common for women 30 and over - a Pap-plus-HPV test combination. If the results of both tests are negative, women can wait five years to test again.

But both Paps and HPV testing can trigger false alarms, prompting unneeded, and sometimes harmful, additional care to rule out cancer. New studies show co-testing leads to more false alarms than either test alone, without adding benefit.

That spurred Tuesday’s Task Force proposal to let women 30 and over choose an HPV test by itself every five years - or a Pap every three years instead. The proposal is open for public comment through Oct. 9, before it will be finalized.

Some countries already are moving to make HPV testing the chief screening tool, including the Netherlands and Australia.

“Most experts in this area are in agreement that HPV testing alone is the future of cervical screening,” said Debbie Saslow of the American Cancer Society, who wasn’t involved with Tuesday’s draft guidelines.

Weigh pros and cons

Women in their 30s and older need to discuss screening options with their health providers, said Dr. Jason Wright, gynecologic oncology chief at New York-Presbyterian/Columbia University Medical Center, who also wasn’t involved with the new guidelines.

An HPV test can cost twice as much as a $40 Pap, but doesn’t require screening as often. Some data suggest HPV testing leads to more diagnosis of risky pre-cancer - but even by itself, an HPV test can spark more false alarms than a Pap, Wright said.

Also, some follow-up tests can alter the cervix in ways that may affect future pregnancies, a consideration for women still interested in childbearing, added the Task Force’s Mangione.

Who can skip cervical cancer screening?

It’s not recommended for women younger than 21, or those who had a cervix-removing hysterectomy.

Women can stop screening after age 65 if proper checks until then show they’re healthy, current guidelines agree.

What if women received the HPV vaccine as an adolescent?

Keep getting screened, following recommendations for your age. The first HPV vaccine hit the market about 10 years ago, too soon to know if it’s safe for the now-grown first recipients to be screened less often, and newer vaccine versions protect against more strains, said Saslow, the cancer society’s senior director of HPV-related and women’s cancers.

Eventually, if enough young women grow up fully vaccinated, screening recommendations may change, she said.


Update Saturday October 7 - October 13, 2017

Study shows hormone pills don’t shorten older women’s lives

 

In this Dec. 12, 2002 file photo, Dr. JoAnn Manson poses with a printout from a study she directed on hormone replacement therapy for women at her office in Boston. In research results released on Tuesday, Sept. 12, 2017, Manson said hormones may be appropriate for some women when used short-term to relieve hot flashes and other bothersome menopause symptoms. (AP Photo/Elise Amendola)

Lindsey Tanner

Chicago (AP) - Taking hormone pills for several years after menopause didn’t shorten older women’s lifespans, according to the longest follow-up yet of landmark research that transformed thinking on risks and benefits of a once popular treatment.

That research was halted early when unexpected harms were found from using replacement hormones - estrogen alone or with progestin - versus dummy pills for five to seven years. More breast cancer, heart attacks and strokes occurred in women on combined pills, and those on estrogen pills had more strokes.

But about 18 years of follow-up show that despite those risks, women had similar rates of deaths from heart disease, breast cancer and all other causes as those who took dummy pills.

The new results are reassuring and support current advice: Hormones may be appropriate for some women when used short-term to relieve hot flashes and other bothersome menopause symptoms, said Dr. JoAnn Manson, preventive medicine chief at Boston’s Brigham and Women’s Hospital and lead author of the follow-up report.

“It’s the ultimate bottom line,” said Manson, who was also part of the original research. Women want to know “is this medication going to kill me” and the answer appears to be no, she said.

Results were published Tuesday in the Journal of the American Medical Association.

Hormones were once considered a fountain of youth for women entering menopause because of weak evidence suggesting a host of purported benefits including reducing heart disease and boosting memory. The landmark research, backed by the U.S. government, began in the early 1990s to rigorously test hormones’ effects in older women randomly assigned to take the pills or dummy treatment. Brands studied were Prempro estrogen-progestin pills and Premarin estrogen-only pills.

The results led to advice against taking hormones to prevent age-related diseases. When used for menopause symptoms, the lowest possible dose for the shortest possible time was recommended, then as now. For some women already facing health risks, hormones’ potential harms may outweigh any benefits, and discussions with a doctor about starting the treatment are advised.

Participants were aged 50 to 79 and past menopause, older than typical users, and took larger doses than currently recommended.

The follow-up involved most of the more than 27,000 women who were part of the original research. It included time using pills and about 10 or so years after stopping. Some earlier follow-ups suggested no increased risk of death in hormone users, but Manson said this is the first to focus only on deaths from various causes.

Overall, almost 7,500 women died - about 27 percent each in the hormone and dummy pill groups. Most deaths occurred after women stopped taking hormones. About 9 percent of women in both groups died from heart disease and about 8 percent from breast and other cancers.

Among the youngest women, there were fewer overall deaths early on among hormone users than dummy-pill users, but the rates evened out after women stopped using the pills.

Overall, death rates were similar among women on both types of hormone treatment versus dummy pills.

Prempro and Premarin are both approved to treat menopause symptoms and to prevent bone-thinning osteoporosis. Even so, many women and their doctors remain wary of hormone use. An editorial published with the follow-up study says the results “will hopefully alleviate concerns” about the long-term consequences.

More research is needed on risks and benefits of other types of hormones including patches, Manson said.
 


DAILY UPDATEE

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HEADLINES [click on headline to view story]

FDA OKs Glaxo’s inhaler, first one to combine 3 medicines

Treatment restores signs of awareness in brain-injured man


Age matters when it comes to screening for cervical cancer


Study shows hormone pills don’t shorten older women’s lives


 



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