| Health & Wellbeing
FDA takes up decades-long debate over breast implant safety
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)
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
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)
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
“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
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
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
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
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
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)
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
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 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.
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
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,
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
“Some people will be thrilled” at the
convenience, said Mitchell Warren, executive director of AVAC, an AIDS
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
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.”