Flies found by
FDA threaten Indian town built on generics
Americaâ€™s $93 billion pipeline of generic pharmaceuticals often starts in
places like Toansa, a village in northern India where a drug-making facility
rises up beside mustard fields and manure-flecked ox-cart tracks. Toansaâ€™s
factory complex, owned by Ranbaxy Laboratories Ltd. one of Indiaâ€™s largest
drugmakers, has for years produced ingredients for dozens of pharmaceuticals
sold to Americans, including AstraZeneca Plcâ€™s top-selling heartburn
medication Nexium, as well as its own generic copies of drugs including
Pfizer Inc.â€™s Lipitor.
Ranbaxy and its Toansa factory are in the crosshairs of the U.S. Food and
Drug Administration, which has recently taken a tougher stance on the
quality of generic drugs originating in India amid complaints by doctors and
others. The agency said last month that it has begun a $20 million program
to test generic drugs.
In January, FDA inspectors paid a surprise visit to the facility in Toansa,
in a rural area north of New Delhi, and found broken equipment, windows
stuck open and flies â€śtoo numerous to count,â€ť according to the FDAâ€™s report
of its inspection. Workers ran quality tests over and over until they got
the results they wanted, the FDA noted.
Shortly after, the FDA banned the import of drug components made at the
Ranbaxy voluntarily suspended all shipments of active pharmaceutical
ingredients, or APIs, from Toansa and a second Indian plant, Dewas, after
the FDA ban, Ranbaxyâ€™s parent company, Tokyo-based Daiichi Sankyo Co., said
in a Feb. 25 statement. Ranbaxy is continuing to make drugs for non-U.S.
markets using API inventory from Toansa and Dewas and from external sources,
Yasuki Minobe, a Daiichi spokesman, said by telephone March 4.
A recent visit to Toansa found a town deeply dependent on the fortunes of
Ranbaxy. While consumers in rich nations have learned about the workers who
make their T-shirts and tennis shoes, less light has been shed on those who
make medications that save and extend lives. The happenings in Toansa help
illuminate working conditions in Indiaâ€™s pharmaceuticals industry, which has
grown as wealthy governments seek to reduce the costs of medical treatments.
The FDAâ€™s Toansa ban completed a grim sweep: Ranbaxy, based in Gurgaon in
northern India, once had four Indian facilities registered with the FDA to
send drugs and drug components to America. Toansa was the last of the four
to have its products suspended from U.S. sale for failing to meet the FDAâ€™s
so-called current Good Manufacturing Practices.
Those last two suspensions came after Ranbaxy agreed last year to pay a $500
million settlement in the U.S., in which it admitted it sold batches of
drugs that were improperly manufactured, stored and tested. It also pleaded
guilty to four felony counts of knowingly making false statements to the
Several makers of generic drugs in India and elsewhere have maintained
strong track records. â€śUnfortunately, the many Indian companies that
understand good manufacturing and quality processes have been overshadowed
by recent lapses in quality at a handful of pharmaceutical firms,â€ť FDA
Commissioner Margaret Hamburg said in a blog post while on a trip to India
last month, during which she said the FDA would step up inspections of
plants in India.
Pharmaceutical production in India has boomed in recent years. Indian
companies sold about $5 billion worth of generics to the U.S. in the year
that ended March 2013, according to an estimate from Hitesh Mahida, an
analyst at KR Choksey Shares & Securities Pvt. in Mumbai.
While Indian producers accounted for 6 percent of the dollar value of all
generic drugs sold in the U.S., they accounted for one-quarter of generics
sold by volume, according to Standard Chartered, which analyzed data from
Indiaâ€™s pharmaceuticals boom has created more than 4 million jobs, according
to the Organisation of Pharmaceutical Producers of India, which includes
positions in thousands of factories producing for domestic and international
markets. The country has more than 500 factories registered with the FDA.
Drug manufacturing in India costs about half as much as in Western
industrialized countries, according to PricewaterhouseCoopers. Indiaâ€™s wage
costs are one-fifth of the level in the U.S. and 30 percent of those in
Europe, PwC said.
Much of Indiaâ€™s pharmaceuticals industry is located in rural and small
regional centers, according to the International Labour Organization, where
there are parcels of land large enough for the factories. State governments
have sought to benefit by wooing industries that promise to alleviate high
Toansaâ€™s fortunes shifted on Jan. 5 when a minivan arrived bearing an FDA
inspector, five villagers recounted. The factoryâ€™s planning department had
counted on an audit in February, a plant technician said. At the time of the
snap visit, construction was underway in the quality-control lab, another
worker said. Managers were preparing to fix a broken piece of equipment in a
different lab by February, he said.
In its week-long inspection, the FDA found the quality control and
microbiology labs were in â€śsignificant disrepair,â€ť according to the
inspection report filed by the FDA that detailed eight possible violations
of the Food Drug and Cosmetic Act. On Jan. 23, the FDA blocked exports to
the U.S. from the Toansa factory of all ingredients.
In a statement Jan. 24, Ranbaxy said it had suspended U.S. - bound shipments
of API from Toansa once it received the FDAâ€™s inspection results. It
expressed disappointment at the ban, apologizing to stakeholders â€śfor the
inconvenience caused by the suspension of shipment.â€ť
Among those affected by the Toansa suspension was AstraZeneca, which has
sourced esomeprazole magnesium, used in Nexium sold in the U.S., from
facilities in France and in Toansa, said spokeswoman Vanessa Rhodes.
AstraZeneca is now getting the ingredient from its French source, she said,
adding that it has found no problems with the quality of its products
already on the market.
Locals still prefer to work at the factory than in the fields, said Krishan
Kumar, chief of Toansaâ€™s village council."You couldnâ€™t find a single man
whoâ€™s unemployed in this village because of this factory,â€ť Kumar said in an
interview. â€śEven people whoâ€™ve only passed fifth grade, they got jobs.â€ť
Visit Bloomberg for the article.
emergency department first to test Google Glass on medical conditions
PROVIDENCE â€” Beginning Friday, Rhode Island Hospitalâ€™s emergency department
will become the first in the nation, officials say, to use Google Glass
technology to stream live images of a patientâ€™s medical condition to a
consulting specialist located elsewhere.
If an ensuing six-month feasibility study is successful, project coordinator
Dr. Paul Porter envisions an ambulance crew someday responding to a stroke
victim, using the eyeglass technology to provide real-time video and audio
to a neurologist back at the hospital who could then order a clot-busting,
brain-saving drug immediately.
For now the hospital will test the technology only with emergency room
patients suffering skin rashes or other dermatological afflictions and who
volunteer to be part of the study.
The reason, says Porter, is because the standard of care now for such
problems is a simple visual inspection and asking patients questions, such
as, â€śDoes it itch?â€ť This way if any kinks in the technology develop â€” a lost
video or audio feed, for example â€” patient care wonâ€™t be compromised.
Porter was the force behind the hospital soliciting Google to see if its
latest Glass technology could be used in what the doctor calls â€śtele-medicine.â€ť
Google Glass is a special pair of glasses equipped with smartphone
components and a tiny transparent screen that appears on the right lens. It
allows the wearer, largely through voice commands, to link to the Internet,
access GPS and to send live audio or visual images of what the wearer is
seeing at that moment.
Porter has been interested in telemedicine since 2011 when, as an Army
reservist, he ran an emergency room in Baghdad. Because of the dangers of
moving soldiers around, Porter often emailed images of soldiersâ€™ wounds to
Walter Reed National Military Medical Center, in Bethesda, MD, where
specialists could evaluate the injuries and suggest treatment.
Then last December, Porter was on a plane, reading about Google Glass, when
he realized the opportunity he was looking for. With the help of two Rhode
Island Hospital residents, Peter Chai and Roger Wu, the team prepared a
research proposal, received approval from hospital officials and began
working with experts at Pristine, a Texas startup company, which last year
developed the only form of Google Glass that meets strict federal patient
In essence, Pristine produced a stripped-down version of Glass. It canâ€™t
link to the Internet or store video or audio. It offers only live and
encrypted video and audio. The consulting specialist, using a small tablet,
can see and hear exactly what the emergency room doctor is seeing and
hearing, as well as speak to the patient. The special Glass version doesnâ€™t
store photos, video or audio, since Porter saw those capabilities as an
unnecessary risk to patient confidentiality. â€śBut it streams it in an
encrypted way to our remote dermatology physicians,â€ť he said.
Porter says not only will the technology provide better medical care but it
will likely save patients the cost of a second or follow-up visit, since the
specialist they would normally be referred to participates in the initial
emergency room visit.
Hospital spokeswoman Ellen Slingsby says the emergency room sees about 100
patients a month with skin afflictions who require a dermatological consult.
That should be a sufficient pool of prospective volunteers, Porter says, to
adequately test Glass in the next six months. The hospital purchased two
sets of Glass eyeglasses, tablets and software for about $2,400 each.
While other hospitals and healthcare companies are experimenting with Google
Glass â€” educating a classroom of residents, for example, who can watch a
surgeon work from the doctorâ€™s perspective â€” Porter says this is the first
initiative where Glass is being used for real-time emergency room care.
Visit Providence Journal for the story.
Hospital group to
post how quickly newborn screens are sent to lab
MADISON â€” Expectant parents in Wisconsin will soon be able to see if the
hospital where their baby will be born promptly sends newborn screening
samples to the state lab, where they are tested for rare yet deadly
disorders. Beginning in April, the Wisconsin Hospital Association will post
performance metrics for each hospital on CheckPoint, its website that lists
quality and performance data for state hospitals.
The hospital association announced the decision Friday at a meeting in
Madison designed to review quality improvement and assurance measures for
Wisconsin's newborn screening program.
Newborn screening has been under review by public health officials since a
Milwaukee Journal Sentinel investigation in November found that
thousands of hospitals throughout the country send babies' blood samples
late to the state labs that perform the lifesaving tests.
The state lab initially refused to release performance data from specific
hospitals to the Journal Sentinel. Lab director Charles Brokopp said
doing so would be "adversarial" to the hospitals. The data was eventually
provided to the Journal Sentinel and showed that dozens of hospitals
weren't quickly sending newborn screening samples to the state lab for
The Journal Sentinel began its investigation after learning that a
baby nearly died from an easily treatable condition when the New London
hospital where he was born delayed sending his blood test to the lab.
About one in every 800 babies is born with a potentially severe or deadly
condition that can be treated and managed if the child is properly tested.
These babies often appear healthy at birth but can become extremely sick
Nearly every baby in the country has blood collected within 24 to 48 hours
of birth for the screening. The baby's heel is pricked, and blood is
collected on a card. The card is supposed to be sent within 24 hours to the
lab for testing.
A Journal Sentinel analysis of nearly 3 million newborn screening
tests found that at least 160,000 blood samples from newborns arrived late
at labs throughout the country last year â€” a conservative calculation, as
the newspaper used five or more days as a standard for lateness; federally
backed guidelines recommend blood samples take no more than three days to
arrive at labs for testing.
In Wisconsin, an analysis of one year of data showed that 2.9% of samples â€”
or 1,769 â€” were delayed five or more days. Statewide, 87% of newborn
screening samples arrived at the lab within three days of collection. That
means about 7,700 blood samples from hospitals did not arrive within the
period recommended by federal advisory groups.
Data published to the hospital association's CheckPoint will gauge how many
samples are received at the state lab within four days of collection.
Kelly Court, chief quality officer for the hospital association, said
hospitals are pleased to have the data to improve their programs.
In Wisconsin, the Department of Health Services technically oversees newborn
screening, but all testing is handled by the state lab, which is part of the
University of Wisconsin System.
The Department of Health Services is now overseeing a quality improvement
initiative for newborn screening and is working with the state's newborn
screening advisory group, which is made up of more than a dozen people,
including state health and laboratory officials, medical experts, members of
advocacy groups and the state's hospital association.
State lab officials said they are also continuing to review how hospitals
get blood samples to the state lab. A state-financed courier service
collects blood samples from many hospitals, yet others use United Parcel
Service or the U.S. Postal Service, as the courier is unavailable or
untimely in some areas.
Read more from Journal Sentinel.
safety measures reduce risk of contaminated hospital food
A new study found more than 80 percent of raw chicken used in hospitals in
food for patients and staff was contaminated with a form of antibiotic
resistant bacteria called extended-spectrum beta-lactamase producing E.
coli. While sufficient preparation eliminated the presence of bacteria,
poultry meat delivered to hospital kitchens remains a potential point of
entry for these dangerous bacteria into the hospital.
The study was published in the April issue of Infection Control and
Hospital Epidemiology, the journal of the Society for Healthcare
Epidemiology of America.
"While a high proportion of chicken contaminated by antibiotic resistant
E.coli is a significant concern, robust food safety measures taken by
hospital kitchen staff are able to prevent the spread of these pathogens and
minimize risk to food handlers, staff and patients," said Andrew Stewardson,
MD, the lead author of the study.
Researchers from the University Hospital of Geneva in Switzerland
collaborated with the Food Control Authority of Geneva to test raw chicken
delivered to the central hospital kitchen that prepares more than 8,000
meals daily. They compared the hospital samples to food in local
supermarkets for the presence of ESBLs finding that most (86%) chicken meat
samples were positive. E. coli is a normal part of healthy human gut
flora but can also cause urinary tract infections and occasionally more
serious invasive infections.
The researchers also looked at how food, as a potential source of
multi-resistant bacteria, impacts the health of food handlers, healthcare
workers and patients. They found six of 93 food handlers were ESBL carriers,
but overall were no more likely to be colonized by ESBL-producing bacteria
than the Swiss population.
The authors concluded that industrial risk management strategies in the
hospital kitchen appear sufficient to minimize risk to food handlers,
hospital staff and patients. However they caution that this conclusion may
not apply to household kitchens, where food safety precautions are less
Visit SHEA for the report.
upgrades to Masimo SET pulse oximetry for improved patient outcomes
Masimo announced that Flagler Hospital in St. Augustine, FL, ranked among
the top 5% of all hospitals in the nation for both clinical excellence and
patient safety for the past eight consecutive years -- has upgraded
system-wide to Masimo SET pulse oximetry.
Flagler Hospital joins a growing and distinguished roster of health
organizations using Masimo SET pulse oximetry, clinically shown to virtually
eliminate false alarms and help clinicians detect life-threatening events.
Flagler Hospital standardized to Masimo SET pulse oximetry.
The performance of Masimo SETpulse oximetry is proven by more than 100
independent and objective studies and thousands of clinical evaluations.
Compared to other pulse oximeters, during patient motion and low perfusion,
Masimo SET provides measurements when other pulse oximeters cannot,
dramatically reduces false alarms (specificity), and accurately detects true
alarms (sensitivity) that can indicate a deteriorating patient.
Most important, Masimo SET pulse oximetry has been shown to improve patient
outcomes by helping clinicians reduce retinopathy of prematurity in
neonates, screen newborns for critical congenital heart disease reduce
ventilator weaning time and arterial blood gas measurements in the ICU, and
save lives and costs while reducing rapid response activations and intensive
care unit transfers on the general floor.
Visit Masimo for the release.
A powerful new
way to edit DNA
In the late 1980s, scientists at Osaka University in Japan noticed unusual
repeated DNA sequences next to a gene they were studying in a common
bacterium. They mentioned them in the final paragraph of a paper: â€śThe
biological significance of these sequences is not known.â€ť Now their
significance is known, and it has set off a scientific frenzy.
The sequences, it turns out, are part of a sophisticated immune system that
bacteria use to fight viruses. And that system, whose very existence was
unknown until about seven years ago, may provide scientists with
unprecedented power to rewrite the code of life. In the past year or so,
researchers have discovered that the bacterial system can be harnessed to
make precise changes to the DNA of humans, as well as other animals and
This means a genome can be edited, much as a writer might change words or
fix spelling errors. It allows â€ścustomizing the genome of any cell or any
species at will,â€ť said Charles Gersbach, an assistant professor of
biomedical engineering at Duke University.
Already the molecular system, known as Crispr, is being used to make
genetically engineered laboratory animals more easily than could be done
before, with changes in multiple genes. Scientists in China recently made
monkeys with changes in two genes.
Scientists hope Crispr might also be used for genomic surgery, as it were,
to correct errant genes that cause disease. Working in a laboratory, not, as
yet, in actual humans, researchers at the Hubrecht Institute in the
Netherlands showed they could fix a mutation that causes cystic fibrosis.
But even as it is stirring excitement, Crispr is raising profound questions.
Like other technologies that once wowed scientists â€” like gene therapy, stem
cells and RNA interference â€” it will undoubtedly encounter setbacks before
it can be used to help patients.
It is already known, for instance, that Crispr can sometimes change genes
other than the intended ones. That could lead to unwanted side effects. The
technique is also raising ethical issues. The ease of creating genetically
altered monkeys and rodents could lead to more animal experimentation. And
the technique of altering genes in their embryos could conceivably work with
human embryos as well, raising the specter of so-called designer babies.
Still, Crispr is moving toward commercial use. Five academic experts
recently raised $43 million to start Editas Medicine, a company in
Cambridge, MA, that aims to treat inherited disease. Other start-ups include
Crispr Therapeutics, which is being formed in London, and Caribou
Biosciences in Berkeley, CA.
Agricultural companies might use Crispr to change existing genes in crops to
create new traits. That might sidestep the regulations and controversy
surrounding genetically engineered crops, which generally have foreign DNA
The development of the new tool is an example of the unanticipated benefits
of basic research. About 15 years ago, after it became possible to sequence
the entire genomes of bacteria, scientists noticed that many species had
those repeated DNA sequences that were first noticed a decade earlier in
Osaka. They were called â€śclustered regularly interspaced short palindromic
repeatsâ€ť â€” Crispr for short.
But what was their purpose? In 2007, researchers at Danisco, a company that
supplies bacterial cultures used in making cheese and yogurt, confirmed
hypotheses that Crispr protects bacteria from viruses. It is part of an
adaptive immune system â€” one that remembers a pathogen so it is ready the
next time that same invader appears. The human adaptive immune system is why
people get measles only once and why vaccines work. But it was not imagined
that single-cell organisms like bacteria had such systems.
Cheese and yogurt companies can examine Crispr regions to see if their
bacterial cultures are immunized against particular viruses that could slow
production. â€śNow you can extend the shelf life of that great strain,â€ť said
Rodolphe Barrangou of North Carolina State University, who previously worked
at Danisco and was the lead author on the 2007 paper.
The real frenzy, however, started in 2012, when a team led by Emmanuelle
Charpentier, then at Umea University in Sweden, and Jennifer A. Doudna of
the University of California, Berkeley, demonstrated a way for researchers
to use Crispr to slice up any DNA sequence they choose.
In the past, making an animal with multiple genetic changes usually required
creating separate animals with single changes and then crossbreeding them to
produce offspring with multiple changes. With Crispr, multiple genetic
changes can be made in one step, by putting multiple guide RNAs into the
For some diseases, it may be possible to extract blood stem cells from the
body, alter them using Crispr, and put them back. If that is not possible,
the DNA needed to make Cas9, the guide RNA and the corrective patch might be
put into a disabled virus. This technique is used for gene therapy, but does
not always work well. It is likely to be a few years before Crispr is tested
in people. For now, there is a lot more to learn about it.
Visit the New York Times for the article.
births increasing in popularity in the U.S.
Giving birth outside the hospital setting has increased over the past
decade, the Centers for Disease Control and Prevention reported. The CDC
wrote in a National Center for Health Statistics data brief on March 4 that
after slight declines through the 1990s, out-of-hospital births have
increased since 2004. The rate significantly jumped from 1.26 percent in
2011 to 1.36 percent in 2012.
While the majority of births in the 1900s occurred outside a hospital, the
practice had dropped to 44 percent by 1940. The rates further declined to 1
percent by 1969, and hovered around that number throughout the 1980s.
"If this increase continues, it has the potential to affect patterns of
facility usage, clinician training, and resource allocation, as well as
healthcare costs," the CDC commented on its website.
Out-of-hospital births are births outside a hospital setting, including
births in a home, a birthing center, a clinic, a doctor's office or another
location. The CDC said the number of U.S. non-hospital birthing centers
increased from 170 in 2004 to 248 in January 2013. Still, 13 states did not
have a birthing center as of the latest count.
The American Academy of Pediatrics (AAP) issued a statement in April 2013
urging doctors to listen to women who may want to give birth at home. It did
not advise against home births, but said if it was done, there should be
arrangements with a local medical facility in case of an emergency.
Of the out-of-hospital births that occurred in 2012, 66 percent happened at
home and 29 percent happened at a freestanding birthing center. Five percent
of babies were delivered in a clinic, doctor's office or other location.
Though home births only increased 0.05 percent between 2011 and 2012, it is
notable since the rate has steadily gone up a little less than 1 percent
Alaska, Montana, Oregon, Washington, Idaho and Pennsylvania led the nation
in out-of-hospital births in 2012. Forty-five percent of states had
significant increases between 2004 and 2012, with 27 states reporting 50
percent or more out-of-hospital births that previously recorded.
Interestingly, women who gave birth in a non-hospital setting tended to have
fewer risks than those who opted for the hospital. "Compared with hospital
births, home and birthing center births tended to have lower risk profiles,
with fewer births to teen mothers and fewer preterm, low birthweight, and
multiple births," the CDC noted.
However, 19 percent of out-of-hospital births were among mothers over 35,
which is considered to be a higher risk pregnancy. Only 14.9 percent of
hospital births were moms in this age group.
Visit CBS News for the study.
possibly 'cured' of HIV
The first time, it happened almost by accident. Just hours after delivery, a
baby born with HIV in Mississippi was given high doses of three
antiretroviral drugs. More than three years later, doctors say the little
girl has no evidence of the life-threatening disease in her blood, despite
being off medication for nearly two years.
Now doctors say another child born with the virus appears to be free of HIV
after receiving similar treatment. The case report was presented at the
annual Conference on Retroviruses and Opportunistic Infections in Boston
this week. The girl was delivered at Miller Children's Hospital in Long
Beach, CA, last summer to a mother with AIDS.
Doctors gave the baby high doses of antiretroviral drugs -- AZT, 3TC and
Nevirapine -- four hours after birth. Eleven days later, the virus was
undetectable in her body and remained undetectable nine months later. The
California baby is still on antiretroviral treatment, so it's too soon to
tell if the child is actually in remission.
While doctors around the world are trying to duplicate the Mississippi case,
more research needs to be done before new standards are implemented for
treating babies born with HIV. The child in Mississippi was born to a mother
who received no prenatal care and was not diagnosed as HIV-positive herself
until just before delivery, according to a case report published in October
in the New England Journal of Medicine.
Researchers have long known that treating HIV-positive mothers early on is
important, because they pass antibodies on to their babies. All HIV-positive
moms will pass on those antibodies, but only 30% will transmit the actual
virus, said Dr. Katherine Luzuriaga, an immunologist at the University of
Massachusetts. And HIV-positive mothers who are given appropriate treatment
pass on the virus in less than 2% of cases.
Newborns are considered high-risk if their mothers' HIV infections are not
under control or if the mothers are found to be HIV-positive when they're
close to delivering. Usually, these infants would get antiviral drugs at
preventive doses for six weeks to prevent infection, then start
antiretroviral therapy, or ART, if HIV is diagnosed. ART is a combination of
at least three drugs used to suppress the virus and stop the progression of
the disease. But they do not kill the virus.
Tests showed the virus in the Mississippi baby's blood continued to decrease
and reached undetectable levels within 29 days of the initial treatment.
Visit CNN for the story.