FDA takes steps to boost generic competition, limit prices
Wednesday, April 5, 2017, file photo, Dr. Scott Gottlieb, President
Donald Trump’s nominee to head the Food and Drug Administration, appears
at his confirmation hearing before the Senate Committee on Health,
Education, Labor, and Pensions, on Capitol Hill in Washington. (AP
Photo/J. Scott Applewhite)
Linda A. Johnson
The Food and Drug
Administration said it’s taking steps to boost the number of generic
prescription drugs on the market in an effort to make medicines more
affordable and to prevent price gouging.
generally have been much cheaper than original brand-name drugs. But
recent high-profile cases have shown how lack of competition and
medicine shortages allowed several drug companies to drastically
increase prices for generics and some older brand-name products such as
EpiPen emergency allergy injectors.
commissioner Dr. Scott Gottlieb made addressing prices a priority,
saying that agency can help by increasing market competition. While the
FDA reviews and approves medications, it doesn’t have the power to
“No patient should
be priced out of the medicines they need, and as an agency dedicated to
promoting public health, we must do our part to help patients get access
to the treatments they require,” Gottlieb said in a statement.
On Tuesday, the FDA
said it will now give priority reviews to new generic drugs until there
are at least three on the market. That’s the level at which prices tend
to drop sharply, up to 85 percent off the brand-name price.
The agency also
published its first list of brand-name drugs that no longer have a
patent’s protection but don’t yet have generic competition, a strategy
to entice generic drugmakers to develop copycats.
The list includes
an HIV medicine, a genetically engineered heart drug, prescription
multivitamins and IV salt and sugar solutions. Some have been in short
supply, sometimes for years, after quality problems shut down
manufacturing lines or companies stopped making them to pursue more
best-known cases of dramatic price hikes: Mylan’s fivefold increase for
EpiPen’s price and former pharmaceutical executive Martin Shkreli’s
Turing Pharmaceuticals raising the price of an old drug for a deadly
infection more than 5,000 percent, to $750 per pill.
Meanwhile, the FDA
has scheduled a July 18 meeting to discuss possible changes to its rules
for approving generics, which inadvertently have enabled some makers of
brand-name medicines to prevent or delay generic rivals. (AP)
Merck says new type of cholesterol drug worked in big study
Linda A. Johnson
(AP) - Merck & Co. said Tuesday that a new
type of cholesterol drug reduced heart attacks, deaths and other
complications of heart disease in a huge, late-stage study.
The positive result
was a welcome surprise because three previous experimental drugs of the
same type had failed.
anacetrapib, might eventually give high-risk heart patients a new option
to add to cholesterol treatments that have helped prevent millions of
heart attacks, strokes and deaths from heart disease. Cheap generics
don’t cut those risks enough for many people, while two new cholesterol
drugs cost $14,000 a year or more, so insurers have been restricting
The Merck drug
works by blocking a protein called CETP. That’s a different way to
control cholesterol than that of widely used, now-generic statins such
as Lipitor and Crestor, and the newer injected drugs, Repatha and
thought to benefit patients mainly by increasing HDL, or “good”
cholesterol. Over time, Merck found it also significantly lowered “bad”
cholesterol, or LDL, increasing the drug’s ability to prevent
artery-clogging buildups of fatty plaques that can trigger heart attacks
study included 30,000 people, who were followed for more than four
years. Half got the drug and the rest got dummy pills. Both groups also
took atorvastatin pills, or generic Lipitor.
The size and
duration of the study increased the chances that it would produce a
positive result. Still, that might be just a modest improvement,
Evercore ISI analyst Umer Raffat wrote to investors Tuesday.
Jersey-based Merck said it won’t release detailed study results until
Aug. 29, at a European conference of heart specialists. That’s standard
practice, but Merck raised questions about how well the medicine works
by noting the company will consult with outside experts before deciding
whether to seek regulatory approval to sell the drug.
testing shows a drug is effective and fairly safe, drugmakers rush to
apply for approval.
success with anacetrapib comes after three major rivals - Pfizer Inc.,
Eli Lilly and Co., and Roche Group - each saw drugs of the same type
fail because of lack of effectiveness or dangerous side effects. Roche
Group is starting a new test in heart patients with a particular genetic
variation, Raffat noted.
In its brief
statement, Merck said its initial analysis of study data found side
effects were about the same as in earlier, smaller studies, with the
most significant issue being that anacetrapib can accumulate and remain
in fatty tissue long after taking the drug. It’s unclear whether that is
Drug shows promise against vision-robbing disease in seniors
image provided by Roche, and manipulated by blurring the center of the
image by the source, to illustrate how vision is affected by the
so-called “dry” form of age-related macular degeneration. (Roche via AP)
Washington (AP) - An
experimental drug is showing promise against an untreatable eye disease
that blinds older adults - and intriguingly, it seems to work in
patients who carry a particular gene flaw that fuels the damage to their
image provided by the National Eye Institute shows a microscopic image
of a retina being damaged by the so-called “dry” form of age-related
macular degeneration. (National Eye Institute via AP)
Age-related macular degeneration,
or AMD, is the leading cause of vision loss among seniors, gradually
eroding crucial central vision. There are different forms but more than
5 million people worldwide, and a million in the U.S., have an advanced
type of so-called “dry” macular degeneration that has no treatment. At
first patients may notice blurriness when they look straight ahead.
Eventually many develop blank spots, becoming legally blind.
“These are seniors who are entering
their golden years and now they’ve lost the ability to read, watch
television, see their loved ones,” said Dr. Rahul Khurana, a retina
specialist and spokesman for the American Academy of Ophthalmology.
The experimental drug,
lampalizumab, aims to slow the destruction of light-sensing cells in the
retina, creeping lesions that characterize the stage of dry AMD called
“geographic atrophy.” When those cells die, they can’t grow back - the
vision loss is irreversible.
In an 18-month study of 129
patients, monthly eye injections of the drug modestly slowed worsening
of the disease when compared with patients given dummy shots. What’s
exciting for scientists came next, when researchers from drugmaker
Genentech Inc. took a closer look at exactly who was being helped.
It turns out that nearly 6 in 10 of
the study’s participants carry a gene variation that makes part of the
immune system go awry - a genetic flaw already known to increase the
risk of getting macular degeneration in the first place.
Those are the only patients who
appeared to benefit from the drug; they had 44 percent less eye damage
than the untreated patients, the Genentech team reported Wednesday in
the journal Science Translational Medicine. While the study is
too small to prove if lampalizumab really helps maintain vision, that’s
a bigger difference than the overall results suggested.
an immune-related gene affect aging eyes?
One arm of the immune system, the
complement pathway, helps fight infections by attracting immune cells to
Normally, there’s a barrier that
keeps such cells away from the retina. But that barrier can break down
with age, opening sensitive eye cells to harm from the spillover,
explained Genentech immunologist Menno van Lookeren Campagne.
Now for the gene connection:
Previous studies have linked macular degeneration to gene variations
that remove some of that pathway’s natural brakes, so it can become too
The hypothesis: Genentech’s drug,
lampalizumab, essentially offers a backup method for tamping down the
immune reaction. An antibody, it works by inhibiting a particular enzyme
named factor D that helps power the immune pathway.
“We try to reinsert the braking
ability,” said study lead author Brian Yaspan, a Genentech senior
Wednesday’s study detected no
safety concerns, clearing the way for Genentech and its parent company
Roche to open two large-scale studies that aim to prove if the drug
works. Results are expected later this year.
The current research sheds light on
how that long-suspected immune culprit might be working, and is “the
first suggestion that there may be a treatment for geographic atrophy
coming up in the future,” said National Eye Institute retina specialist
Dr. Wai Wong, who wasn’t involved in the study.
“It’s a very, very exciting study,”
said Khurana, the ophthalmologist association’s spokesman, who also
wasn’t part of the research. “From the basic science perspective, it
makes a lot of sense.”
advice for now
Macular degeneration tends to occur
after age 60, but it sometimes strikes earlier. According to the
National Eye Institute, it’s less common in people who exercise
regularly, avoid smoking, and eat a diet high in green leafy vegetables
Symptoms often aren’t noticeable
early on. But several eye tests can detect signs of macular
degeneration, including a dilated eye exam and a tool called an Amsler
grid with straight lines that may look wavy if the macula, the center of
the retina, is harmed.
Macular degeneration patients often
are advised to take certain vitamin combinations that may help stave off
advanced disease. And it’s important for patients to know what type they
have. While there’s no treatment for the advanced dry form, the “wet”
form occurs when leaky blood vessels grow under the retina - and there
are several therapies that can help those patients preserve vision.
FDA approves quicker-to-administer
drug for blood cancers
This photo provided by Genentech, the Roche
Group’s biologic drug unit, shows vials of Rituxan Hycela. On Thursday,
June 22, 2017, the Food and Drug Administration approved Rituxan Hycela,
a more convenient version of a blockbuster drug for treating three
common blood cancers. (Genentech via AP)
U.S. regulators have approved a more convenient version
of a blockbuster drug for treating three common blood cancers.
The Roche Group’s Rituxan, on the market for 20
years, is administered in a hospital or clinic through an intravenous
drip that can take several hours.
On Thursday, the Food and Drug Administration
approved the Swiss drugmaker’s new version, Rituxan Hycela (RIH’-tux-en
HEYE’-cell-uh). It’s injected in about six minutes, shortening clinic
It’s given every three weeks for six months to
treat diffuse large B-cell lymphoma, for a total cost of about $48,600
without insurance - the same as for Rituxan.
Rituxan Hycela also was approved for treating
follicular lymphoma and chronic lymphocytic leukemia.
Rituxan, which will still be available, is Roche’s
top seller. It had 2016 sales of $7.5 billion. (AP)
Hints of some steps that may boost brain health in old age
Washington (AP) - Are you seeking
steps to keep your brain healthy in old age?
There are no proven ways to stave
off mental decline or dementia, but a new report says there are hints
that exercise, controlling blood pressure and some forms of brain
training might offer help.
Without proof, the government
should not begin a public health campaign pushing strategies for aging
brain health, the National Academies of Sciences, Engineering and
Medicine said in a report released Thursday.
But the public should be told the
evidence is “encouraging,” though inconclusive, the report concluded.
That way, people can use the information in deciding whether to invest
time and money on different interventions.
The three highlighted strategies
“do no harm,” said neuroscientist Alan Leshner, chairman of the National
Academies committee. “At least two of them are really good for you” even
if the brain link doesn’t pan out.
Scientists know that risky changes
in the brain begin decades before symptoms of Alzheimer’s and other
dementias become apparent, suggesting there’s a window when people might
bolster their cognitive health. But the report says Americans face a
“bewildering” array of products and strategies promoted for brain health
despite little if any rigorous science to back them up.
The National Institute on Aging
asked the prestigious National Academies to review the field. The
committee said three interventions should be more closely studied to
prove if they really can help:
- Getting high blood pressure under
control, especially in middle age. People with hypertension need
treatment anyway to prevent heart disease and strokes.
- Increased physical activity.
Similar to the blood pressure advice, what’s good for the heart has long
been deemed good for the brain.
- Cognitive training, specific
techniques aimed at enhancing reasoning, problem solving, memory and
speed of mental processing. While immediate task performance may
improve, the committee said it’s not clear whether there’s lasting,
This is not merely “brain games” on
your computer, Leshner said. The committee isn’t backing those costly
computer-based programs. Indeed, the government fined one brain training
company last year for misleading consumers.
Instead, the best study to date
included training done in groups, providing social engagement too. And
cognitively stimulating activities include such things as learning a new
language, the report noted.
“Since generally keeping
intellectually active appears to be good for you, do that,” Leshner
advised, and if you’re considering a commercial program, ask the company
to see studies backing it.
The Alzheimer’s Association had
been awaiting the recommendations, and agreed that “more research is
needed to determine what the optimal interventions should be,” said
chief medical officer Maria Carrillo. “In the meantime, we recommend
that people challenge their brains to maintain brain health.”
Drones carrying defibrillators could aid heart emergencies
experimental study in Sweden suggests drones equipped with heart
defibrillators could help with response times for out-of-hospital
cardiac arrest. (AP Photo/Nati Harnik, File)
Chicago (AP) - It sounds
futuristic: drones carrying heart defibrillators swooping in to help
bystanders revive people stricken by cardiac arrest.
Researchers tested the idea and
found drones arrived at the scene of 18 cardiac arrests within about 5
minutes of launch. That was almost 17 minutes faster on average than
ambulances - a big deal for a condition where minutes mean life or
Drone-delivered devices weren’t
used on patients in the preliminary study, but the results are “pretty
remarkable” and proof that the idea is worth exploring, said Dr. Clyde
Yancy, a former American Heart Association president who was not
involved in the study.
Cardiac arrest is a leading cause
of death worldwide, killing more than 6 million people each year. Most
happen at home or in other nonmedical settings and most patients don’t
“Ninety percent of people who
collapse outside of a hospital don’t make it. This is a crisis and it’s
time we do something different to address it,” said Yancy, cardiology
chief at Northwestern University’s medical school in Chicago.
The researchers reached the same
conclusion after analyzing cardiac arrest data in Sweden, focusing on
towns near Stockholm that don’t have enough emergency medical resources
to serve summer vacationers. The analysis found an emergency response
time of almost 30 minutes and a survival rate of zero, said lead author
Andreas Claesson, a researcher at the Center for Resuscitation Science
at Karolinska Institute in Stockholm.
To see if care could be improved,
Claesson’s team turned to drones.
Drones are increasingly being
tested or used in a variety of settings, including to deliver retail
goods to consumers in remote areas, search for lost hikers and help
police monitor traffic or crowds. Using them to speed medical care
seemed like a logical next step, Claesson said.
The study was done last October and
was published Tuesday in the Journal of the American Medical
More than 350,000 Americans had a
cardiac arrest in a nonmedical setting last year, the American Heart
Association says. The condition is often confused with heart attacks but
Heart attacks occur when a clot or
other blockage stops blood flow to the heart. Cardiac arrest occurs when
electrical impulses controlling the heart’s rhythmic pumping action
suddenly malfunction. The heartbeat becomes very irregular or stops,
preventing blood from reaching vital organs. Death can occur within
minutes without treatment to restore a normal heartbeat, ideally CPR and
use of a defibrillator.
The researchers used a small heart
defibrillator weighing less than two pounds, featuring an electronic
voice that gives instructions on how to use the device. It was attached
to a small drone equipped with four small propeller-like rotors, a
global positioning device and camera.
They launched the drone from a fire
station within about 10 kilometers from homes where people had previous
In the study’s video footage
simulating a rescue, a drone soars over residential rooftops and then
lands gently in a backyard. A man dashes out of the house, grabs the
defibrillator and carries it inside.
There were no crashes or other
mishaps during the study, Claesson said. He plans a follow-up study to
test drone-delivered defibrillators for bystanders to use in real-life
The test results show “a great
potential for saving lives,” he said.
Obesity rising in nations rich and poor, especially in kids
New York (AP) - The global
obesity problem now affects 1 in 10 people in the world, it is rising in
countries rich and poor, and in many countries it is increasing faster in
children than adults, according to a new study.
The researchers estimated more than 107
million children and 603 million adults are obese.
The research found obesity has tripled
in children and young adults in countries like China, Brazil and Indonesia.
Those numbers are particularly troubling because it means more young people
are on track to become obese adults and develop problems like diabetes,
heart disease and a range of cancers, some experts said.
The study was led by a team at the
University of Washington in Seattle. It was published online by the New
England Journal of Medicine and presented at a food science and policy
meeting in Stockholm.
Researchers reported on 195 countries,
although data was incomplete or nonexistent for many of them. They made
assumptions and used mathematical modeling to fill in gaps.
Despite the limitations, “this is the
best picture that’s out there for global obesity,” said Edward Gregg, a
diabetes expert at the U.S. Centers for Disease Control and Prevention. He
wrote an editorial that accompanied the study.
Some of the findings:
- Obesity rates doubled in 73 countries
between 1980 and 2015. Countries where obesity did not increase
significantly included Afghanistan, Bulgaria, and the Democratic Republic of
- Worldwide, about 5 percent of
children and 12 percent of adults were obese in 2015. In the U.S. about 17
percent of children and 38 percent of adults are obese, according to earlier
- Among the 20 largest countries, the
United States had the highest level of obesity among children and young
adults. Bangladesh had the lowest.
- Egypt had the highest rate of obese
adults. Vietnam had the lowest.
- But the United States had the largest
number of obese adults in 2015, with 79 million. China came in second with
57 million obese adults - even though China has more than four times as many
people as the U.S.
- China had the largest number of obese
children, with 15 million. India had 14 million.
- Globally, about 4 million deaths were
attributed to being overweight or obese in 2014, from causes like heart
disease and diabetes.
Some good news is that improvements in
medications and other kinds of health-care seem to be helping people survive
longer even if they have weight-related health problems. Researchers did not
find an increase in weight-related rates of death and disability, Gregg
But with obesity levels rising, there
is a pressing need for better nutrition and other efforts to prevent
unhealthy weight gain, said Dr. Ashkan Afshin, the study’s lead author.
Unfortunately, “there is no single
simple solution for the problem of overweight and obesity,” he said.