Make Chiangmai Mail | your Homepage | Bookmark

Chiangmai 's First English Language Newspaper

Pattaya Blatt | Pattaya Mail |

 

Copyright 2019 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Update April 2019


Home
Thailand News
World News
World Sports
Arts - Entertainment - Lifestyles
Book Review
Health & Wellbeing
Odds & Ends
Science & Nature
Update by Natrakorn Paewsoongnern
 
 
 
Health & Wellbeing
 

FDA takes up decades-long debate over breast implant safety

This Dec. 11, 2006 file photo shows a silicone gel breast implant in Irving, Texas. U.S. health officials are taking another look at the safety of breast implants, the latest review in a decades-long debate. (AP Photo/Donna McWilliam, File)

Matthew Perrone

Washington (AP) - U.S. health officials are taking another look at the safety of breast implants, the latest review in a decades-long debate.

At a two-day meeting that started Monday, a panel of experts for the U.S. Food and Drug Administration heard from researchers, plastic surgeons and implant makers, as well as from women who believe their ailments were caused by the implants.

The panel will consider next steps, but for now, the FDA isn’t proposing any new restrictions or warnings. The agency’s longstanding position is that implants are essentially safe as long as women understand they can have complications, including scarring, pain, swelling and implant rupture.

But the FDA and other regulators around the world have been grappling with how to manage a recently confirmed link to a rare cancer and the thousands of unconfirmed complaints of other health problems.

In documents released before the meeting, FDA regulators said it is “impossible” for them to determine how frequently the cancer - a form of lymphoma - occurs because the U.S. does not track the total number of implants on the market. Estimates of the frequency of the disease range from 1 in 3,000 women to 1 in 30,000.

Most confirmed cases of the disease, known as breast implant-associated anaplastic large cell lymphoma, have involved a particular style of implants with a textured surface, designed to reduce scar tissue and slippage. But the FDA said it has also received reports of the disease in smooth implants - which account for most of the U.S. market - raising questions about whether the cancer is a risk with both implant types.

The disease is not breast cancer, but a form of cancer that attacks the immune system and usually forms in the scar tissue surrounding implants. It grows slowly and can usually be successfully treated by surgically removing the implants.

Thousands of women have also blamed their implants for a host of ailments, including rheumatoid arthritis, chronic fatigue and muscle pain. In the documents, the FDA reiterated its position that “there is not sufficient evidence” linking them to breast implants. The agency also sidestepped requests from patients to add a boxed warning - the agency’s most serious type - to breast implants and to require manufacturers to give women a checklist of potential harms and complications before surgery.

“I’m a little discouraged,” said Jamee Cook, one of more than 20 patients set to speak at the meeting, after reviewing the FDA materials. “But I guess I’m hoping that what we have to say will prompt discussion on those action points.”

A former paramedic, Cook said she had an array of health problems after getting implants in 1998, including exhaustion, migraines and an immune system disorder. She said her symptoms either resolved or improved after the implants were removed in 2015.

Breast augmentation is the most popular form of cosmetic surgery in the U.S., with roughly 300,000 women undergoing the procedure each year. Another 100,000 women receive implants for breast reconstruction after cancer surgery. Most women choose silicone gel-filled implants, which are considered more natural looking than saline implants.

Implants first went on sale in the mid-1960s. But they attracted little attention until the late 1980s, when a wave of lawsuits alleged serious harms and diseases linked to the devices. The FDA banned the silicone gel type in 1992 because of fears they might cause breast cancer, lupus and other disorders. But when studies seemed to rule out most of the disease concern, regulators returned the implants to the market in 2006 with the requirement that manufacturers track recipients to see how they fare long term.

Implant makers Allergan and Mentor - which is now part of Johnson & Johnson - enrolled nearly 100,000 women in a 10-year study. But more than half of the women dropped out within three years, leaving insufficient data to draw firm safety conclusions.

Last September, researchers at the University of Texas MD Anderson Cancer Center analyzed the company reports and found that women with silicone implants seemed to have greater rates of an immune system disorder called Sjogren syndrome, a connective tissue disorder called scleroderma and the skin cancer melanoma. But the authors acknowledged the limitations of the data, which often relied on incomplete, undiagnosed patient reports. FDA regulators said they “respectfully disagree” with the conclusions.

Last week, the FDA sent warning letters to Mentor and a smaller implant maker, Sientra, for failing to enroll or retain enough patients in their long-term studies. Allergan and the other U.S. manufacturer of breast implants - Ideal Implant - did not receive warnings.


Bingo and bongs: More seniors seek pot for age-related aches

In this Feb. 19, 2019 photo, a group of seniors from Laguna Woods Village consult with sales associates at Bud and Bloom cannabis dispensary in Santa Ana, Calif. The seniors boarded a bus for the pot shop and spent hours choosing from a variety of cannabis-infused products, including candies, drinks and weed. (AP Photo/Jae C. Hong)

John Rogers

Laguna Woods, Calif. (AP) - The group of white-haired folks - some pushing walkers, others using canes - arrive right on time at the gates of Laguna Woods Village, an upscale retirement community in the picturesque hills that frame this Southern California suburb a few miles from Disneyland.

There they board a bus for a quick trip to a building that, save for the green Red Cross-style sign in the window, resembles a trendy coffee bar. The people, mostly in their 70s and 80s, pass the next several hours enjoying a light lunch, playing a few games of bingo and selecting their next month’s supply of cannabis-infused products.

“It’s like the ultimate senior experience,” laughs 76-year-old retired beauty products distributor Ron Atkin as he sits down to watch the bingo at the back of the Bud and Bloom marijuana dispensary in Santa Ana.

Most states now have legal medical marijuana, and 10 of them, including California, allow anyone 21 or older to use pot recreationally. The federal government still outlaws the drug even as acceptance increases. The 2018 General Social Survey, an annual sampling of Americans’ views, found a record 61 percent back legalization, and those 65 and older are increasingly supportive.

Indeed, many industry officials say the fastest-growing segment of their customer base is people like Atkin - aging baby boomers or even those a little older who are seeking to treat the aches and sleeplessness and other maladies of old age with the same herb that many of them once passed around at parties.

“I would say the average age of our customers is around 60, maybe even a little older,” said Kelty Richardson, a registered nurse with the Halos Health clinic in Boulder, Colorado, which provides medical examinations and sells physician-recommended cannabis through its online store.

Its medical director, Dr. Joseph Cohen, conducts “Cannabis 101” seminars at the nearby Balfour Senior Living community for residents who want to know which strains are best for easing arthritic pain or improving sleep.

Relatively little scientific study has verified the benefits of marijuana for specific problems. There’s evidence pot can relieve chronic pain in adults, according to a 2017 report from the National Academies of Sciences, Engineering and Medicine, but the study also concluded that the lack of scientific information poses a risk to public health.

At Bud and Bloom, winners of the bingo games take home new vape pens, but Atkin isn’t really there for that. He’s been coming regularly for two years to buy cannabis-infused chocolate bars and sublingual drops to treat his painful spinal stenosis since the prescription opiates he had been taking quit working.

It was “desperation” that brought him here, he said, adding that his doctors didn’t suggest he try medical marijuana. But they didn’t discourage him either.

The dispensary is filled with the 50 people from the bus as they peruse counters and coolers containing everything from gel caps to drops to cannabis-infused drinks, not to mention plenty of old-fashioned weed.

Adele Frascella, leaning on her cane, purchases a package of gummy candies she says helps keep her arthritic pain at bay.

“I don’t like to take an opioid,” said Frascella, 70.

Fashionably dressed with sparkling silver earrings, Frascella confirms with a smile that she was a pot smoker in her younger days.

“I used to do it when I was like 18, 19, 20,” she said. “And then I had a baby, got married and stopped.”

She took it up again a few years ago, even investing in a “volcano,” a pricey, high-tech version of the old-fashioned bong that Gizmodo calls “the ultimate stoner gadget.” But these days, like many other seniors, she prefers edibles to smoking.

Renee Lee, another baby boomer who smoked as a youth, got back into it more than a dozen years ago after the clinical psychologist underwent brain surgery and other medical procedures that she said had her taking “10 meds a day, four times a day.”

“And I wasn’t getting any better,” she said, adding that she asked her doctors if she might try medical marijuana as a last resort. They said go ahead and she found it ended her pain.

In 2012 she founded the Rossmoor Medical Marijuana Club in her upscale San Francisco Bay Area retirement community.

“We started with 20 people, and we kept it really quiet for about a year and a half,” she said, noting that although California legalized medical cannabis in 1996, it was still seen in some quarters as an outlaw drug.

Her group has since grown to more than 1,000 members and puts on regular events, including lectures by pro-cannabis doctors and nurses.

People Lee’s age - 65 and over - are the fastest-growing segment of the marijuana-using population, said Dr. Gary Small, professor of psychiatry and aging at the University of California, Los Angeles.

He believes more studies on the drug’s effects on older people are needed. And while it may improve quality of life by relieving pain, anxiety and other problems, he said, careless, unsupervised use can cause trouble.

“We know that cannabis can cause side effects, particularly in older people,” he said. “They can get dizzy. It can even impair memory if the dose is too high or new ingredients are wrong. And dizziness can lead to falls, which can be quite serious.”

Richardson said Colorado saw an uptick in hospital visits by older users soon after the state legalized cannabis in 2012. The problem, he said, was often caused by novices downing too many edibles.

That’s a lesson Dick Watts, 75, learned the hard way. The retired New Jersey roofing contractor who keeps a winter home at Laguna Woods Village began having trouble sleeping through the night as he got into his 70s. He attended a seniors’ seminar where he learned marijuana might help, so he got a cannabis-infused candy bar. He immediately ate the whole thing.

“Man, that was nearly lethal,” recalled Watts, laughing.

Now when he has trouble sleeping he takes just a small sliver of candy before bed. He said he wakes up clear-headed and refreshed.

“And I have it up on a shelf so my grandkids can’t get to it,” Watts said.


US experts: Medicines for opioid addiction vastly underused

This July 23, 2018 file photo shows packets of buprenorphine, a drug which controls heroin and opioid cravings, in Greenfield, Mass. (AP Photo/Elise Amendola)

Matthew Perrone

Washington (AP) - Medicines proven to treat opioid addiction remain vastly underused in the U.S., the nation’s top medical advisers said.

Only a fraction of the estimated 2 million people addicted to opioids are getting the medications, according to a report by the National Academies of Sciences, Engineering and Medicine. The influential group, which advises the federal government, called for increased prescribing of the drugs and other changes to reduce barriers to their use.

In 2017, opioids were involved in nearly 48,000 deaths - a record. In recent years, there have been more deaths involving illicit opioids, including heroin and fentanyl, than the prescription forms of the drugs, which include oxycodone and codeine.

Government-approved medications, which include methadone, buprenorphine and naltrexone, help control cravings and withdrawal symptoms like nausea, muscle aches and pain. Their use is backed by most doctors and medical groups. Yet they still have skeptics, especially among supporters of 12-step programs that favor abstinence-only approaches.

The report concludes that patients taking the medicines fare better over the long term and are 50 percent less likely to die than if they weren’t on them. An “all hands on deck” response is needed - including doctors, law enforcement and family members - to expand access to treatment, it said.

The group’s conclusions echo similar reports from the U.S. Surgeon General and a presidential commission appointed to President Donald Trump to make recommendations for curbing the opioid epidemic.

The 14-member panel, which included addiction and rehabilitation specialists, summed up several reasons behind the low use:

Stigma

Stigma and misunderstanding about the nature of addiction remains one of the biggest barriers to treatment in part because two of the medications used to treat opioid addiction - methadone and buprenorphine - are themselves opioids. The panel said this contributes to the mistaken belief that it’s “just substituting one drug for another.”

Experts said the medications are given at doses big enough to fend off withdrawal, but too small to produce a euphoric high. Patients can drive, rebuild relationships and get back to work.

Rules

The medicines are subject to restrictions that limit their use. For example, methadone can only be given at government-regulated clinics, which can require patients to commute. Buprenorphine can only be prescribed by certified health professionals who must complete eight hours of training. Federal rules also cap the number of patients that these physicians can treat to 275.

The authors also note that medications are often not available to prison inmates. The report concludes there’s no scientific basis for such limitations.

Lack of training

Addiction treatment has long been separate from mainstream medical training, the report notes, which means many doctors, nurses and social workers don’t receive training on treating drug addiction. The report calls for combining addiction programs into standard medical education.


Monthly shots control HIV as well as pills in 2 big studies

This electron microscope image shows a human T cell, in blue, under attack by HIV, in yellow, the virus that causes AIDS. The virus specifically targets T cells, which play a critical role in the body’s immune response against invaders like bacteria and viruses. Colors were added by the source. (Seth Pincus, Elizabeth Fischer, Austin Athman/National Institute of Allergy and Infectious Diseases/NIH via AP)

Carla K. Johnson

Seattle (AP) — Monthly shots of HIV drugs worked as well as daily pills to control the virus that causes AIDS in two large international tests, researchers reported.

If approved by regulators in the United States and Europe, the shots would be a new option for people with HIV and could help some stay on treatment. Instead of having to remember to take pills, patients instead could get injections from a doctor or nurse each month.

“Some people will be thrilled” at the convenience, said Mitchell Warren, executive director of AVAC, an AIDS advocacy group.

Condoms remain the most widely available and inexpensive form of HIV prevention. Pills taken daily can keep HIV levels so low the virus is not transmittable to sex partners, but not everyone takes them as prescribed.

The shots could improve how well some people stick to treatment, perhaps helping those who have trouble remembering to take daily medicine to keep infection at bay.

There are other potential benefits. Getting shots at a clinic can lend more privacy to patients worried about the stigma of filling an HIV prescription at a pharmacy, said Dr. Susan Swindells of the University of Nebraska Medical Center in Omaha, who presented results Thursday at an HIV conference in Seattle.

Cost will be an issue “to make sure that everyone has access to this medication,” said Dr. Hyman Scott of the San Francisco Department of Public Health, who was not part of the study. It’s not clear how much the shots would cost. HIV pills can cost a patient up to thousands of dollars monthly, depending on the drug combination, insurance coverage, rebates and discounts.

And there will be concerns about patients missing a monthly shot, which could lead to drug-resistant strains of the virus. It will be “a good option for some people,” Scott said.

Whether monthly shots will also work to protect users’ sex partners hasn’t been studied yet, but there is reason to think they will, said experts at the conference.

The shots are a long-acting combo of two HIV drugs — rilpivirine, sold as Edurant by Johnson & Johnson’s Janssen, and ViiV Healthcare’s experimental drug known as cabotegravir.

ViiV Healthcare paid for the research. The drugmakers are seeking approval later this year in the United States and Europe.

One study included 616 people who were taking pills to treat their HIV infection. The other study enrolled 566 people who hadn’t yet started treatment, so they first got pills to get the virus under control.

In each of the studies, half the participants switched to the shots while the rest stayed on pills. After nearly a year, 1 to 2 percent of people in both groups had traces of virus in their blood, whether they got shots or pills. That shows the shots worked as well as the standard pill therapy. A few people withdrew from the studies because of pain after the injections.

The studies were done in Europe and North America and in nations including Argentina, Australia, Russia, South Africa, South Korea, Sweden, Japan and Mexico.

“We don’t have experience rolling out an injection in the real world,” said Warren, the AIDS advocate. He said the next challenges will be how to deliver the shots and whether patients will remember to come back monthly. “These are big questions.”

 


HEADLINES [click on headline to view story]

FDA takes up decades-long debate over breast implant safety


Bingo and bongs: More seniors seek pot for age-related aches


US experts: Medicines for opioid addiction vastly underused

Monthly shots control HIV as well as pills in 2 big studies