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April 14, 2016
It's official: Zika virus causes birth defects
There's no longer any doubt that the Zika virus causes birth defects, federal health officials said Wednesday. The evidence has been piling up and
there really had not been any doubt that Zika was causing horrific brain damage to unborn babies. But the Centers for Disease Control and
Prevention made it official Wednesday in a publication rushed into the New England Journal of Medicine.
"It is now clear … that Zika does cause microcephaly," CDC Director Dr. Tom Frieden told reporters in a briefing. "We believe the microcephaly is
likely to be part of a range of birth defects."
Zika's been spreading in Brazil and since last year officials there noted a startling increase in the number of cases of microcephaly, a birth defect
caused by an underdeveloped brain and marked by a notable small head.
There were doubts at first that Zika, once thought to be a pretty harmless virus, could actually be causing birth defects. Until Brazil started raising the
alarm, doctors didn't think it even made most people sick. Mosquito-borne viruses had never before been known to cause birth defects, although
other viruses, such as rubella, are notorious for causing them.
But study after study has shown the virus gets into the developing fetus's brain, killing brain cells, stopping it from growing and, often, killing the
fetus. And it seems to do so at all stages of pregnancy, not just in the first trimester, as most other viruses do.
Advice to pregnant women doesn't change. "Our previous recommendations regarding how to prevent and avoid Zika virus infection and
transmission remain in place," the American College of Obstetricians and Gynecologists said.
"Obstetrician-gynecologists should be prepared to counsel their patients regarding the importance of postponing travel to affected areas if they are
planning to become pregnant or if they are pregnant, as well as the potential need to delay pregnancy with appropriate use of contraception if
women live in affected areas or if travel to these areas cannot be avoided."
The CDC, the World Health Organization, the National Institutes of Health and other agencies have been sounding the alarm about Zika for months.
Not only is it spreading across Latin America and the Caribbean; it is being carried into the United States by travelers.
It can be spread sexually and in the summer, when mosquito season starts, it is likely to cause local outbreaks. It's already caused outbreaks in the
U.S. territories of Puerto Rico, the U.S. Virgin Islands and Samoa.
The Obama administration has asked Congress to appropriate $1.9 billion to fight Zika, but House Republicans say they don't want to spend any
new money until they are sure all other available funds are used. In an unusual retaliation, the White House has freed up officials such as Frieden
and the NIH's Dr. Tony Fauci to plead for the cash and to outline what other programs will be cut if they don't get it.
White House press secretary Josh Earnest released a new salvo Wednesday, saying a bill aimed at speeding up vaccine development wasn't
anywhere near enough to help.
"In some ways, it's akin to passing out umbrellas in advance of a hurricane," Earnest told the White House briefing.
Much more study is needed, as well as a vaccine to prevent Zika infection, drugs to treat it and better mosquito control measures, officials say.
"Never before have we seen an illness spread by mosquitoes leading to a birth defect," Frieden said.
And the CDC's Dr. Sonja Rasmussen says it's important to find out fast what else Zika might be doing. "This doesn't mean that we have all the
answers," she told reporters. Doctors still don't know how many pregnant women who get Zika will have babies with birth defects. They don't know
what all birth defects there will be, and whether some might show up in childhood or even adulthood. They don't even know if a woman has to have
symptoms of Zika infection for it to affect her baby.
And there's more evidence that Zika can be passed person to person, and not only through mosquito bites. The CDC's confirmed sexual
transmission of Zika and now tells pregnant women to use condoms when having sex if their partner has been to a Zika-affected area.
Zika's been found in saliva, and the team said people need to be warned that there's a possibility they could catch it that way, they said.
Visit NBC News for the story.
Prescription drug spending hits record $425 billion in U.S.
Spending on prescription drugs in the U.S. rose 12 percent to a record $425 billion before discounts last year, boosted in part by the introduction of
breakthrough medicines for cancer and the growing number of patients seeking treatment for hepatitis C.
While net growth slowed as pharmaceutical companies offered more rebates and patient assistance programs to help cover the costs, spending will
continue to rise at a steady mid-single-digit rate through 2020, when it’s expected to hit $610 million to $640 million, according to a report from the
IMS Institute for Healthcare Informatics.
Drugmakers have been criticized for surging costs, and concerns about exploiting the healthcare system have sparked congressional hearings and
an outcry on the campaign trails. While high-profile examples such as Martin Shkreli, a former industry executive who bought older medicines then
boosted their prices, and Valeant Pharmaceuticals International Inc. have dominated the debate, the reasons underlying last year’s overall gains
were more nuanced, said Murray Aitken, executive director of the IMS Institute, the research unit of information and technology firm IMS Health Inc.
“Drug spending growth remains at historically high levels, even as it’s moderated from 2014,” Aitken said. “A surge of new drugs being approved and
becoming available for patients is a driver of increased costs.”
More than half of the spending growth stemmed from medicines approved within the past two years. Specialty pharmaceuticals, including drugs to
treat hepatitis C, cancer and multiple sclerosis, generated invoices worth $151 billion, an increase of 20 percent from a year earlier.
Drugmakers, facing competition and under pressure from health plans and pharmacy benefit managers to reduce costs, gave back an increasing
amount of money in the form of price concession and rebates, according to the report. Those concessions reached $115.3 billion in 2015, more than
double the $52.4 billion offered in 2009.
The introduction of generic drugs, the low-cost rivals of medicines that have lost patent protection, didn’t put as much pressure on pricing as they did
during the patent cliff in 2012. Spending on brands facing new generic medicines fell $14.2 billion in 2015, versus a drop of $32.6 billion in 2012.
There also may be signs of slowing growth for novel hepatitis C therapies from Gilead Sciences Inc., AbbVie Inc. and Merck & Co. While 250,000
patients were treated in 2015, up from 170,000 a year earlier, the number of people beginning the therapy slowed as the year progressed,
suggesting many of those most in need of the medicines may have received them, according to the IMS Institute.
The number of prescriptions for pain-relieving narcotics, led by acetaminophen-hydrocodone, plunged 17 percent. Still, oxymorphone, another
controlled substance under brand names including Endo International Plc’s Opana ER, rose 5.3 percent.
Visit Bloomberg for the report.
HLAC raises concerns over improperly used exchange carts and unused HCTs
The Healthcare Laundry Accreditation Council (HLAC) is saying there is "legitimate and increasing concern" of a "widespread" and "unsafe" industry
practice regarding the back-and-forth on exchange carts of unused healthcare textiles (HCTs) between hospitals and laundries.
While authorities such as The Joint Commission provide direction on the safe transport of unused linens to the healthcare facility, HLAC says they
don't address the return of unused linen from the healthcare facility back to the healthcare laundry.
HLAC Board President John Scherberger said the nonprofit organization, which inspects and accredits laundries that process reusable healthcare
textiles, has begun a process for clarifying its standards regarding exchange cart systems.
"Mixing unused, unprocessed linens with clean linens and returning all of them to the hospital is a failure of functional separation as is defined in our
2016 Standards," Scherberger said. "However, with regard to exchange cart systems, there seems to be some confusion that we will address and
endeavor to clarify with the industry and with healthcare laundries."
Visit HLAC for the report.
Coordinated response could reduce spread of emerging superbug in health facilities by more than 75 percent, study suggests
A simulation of how the so-called "superbug" carbapenem-resistant Enterobacteriaceae (CRE) might spread among healthcare facilities found that
coordinated efforts prevented more than 75 percent of the often-severe infections that would have otherwise occurred over a five-year period.
The study was led by researchers at the Johns Hopkins Bloomberg School of Public Health and published last month in the American Journal of
Epidemiology.
Superbugs such as CRE are antibiotic-resistant bacteria for which there are limited or no treatments. CRE is most commonly found in healthcare
facilities and the CDC says the germ can kill up to half of those it infects. Patients in hospitals and nursing homes are thought to be more susceptible
to superbugs in general because of the potentially high rate of exposure among vulnerable patients, many of whom transfer from one facility to
another while infected, bringing the bugs with them.
Superbugs are considered a serious public health threat and the U.S. Centers for Disease Control and Prevention (CDC) has issued a "tool kit" to
assist healthcare facilities to create plans to stem their spread - a blue print that walks management through steps from persuading leadership to
measuring outcomes.
For their new analysis, the researchers simulated how CRE would spread across healthcare facilities in Orange County, CA, under three scenarios.
The first involved no extra interventions. The second involved interventions at individual facilities, including testing transfer patients for CRE upon
admission and, for patients who test positive, using contact precautions such as gloves and gowns.
The third scenario used those same two interventions but coordinate efforts among facilities when the number of CRE cases reached a certain
threshold. The researchers did not detail how facilities would communicate but assumed that an advance communications plan would be in place.
For their analysis, the researchers used the Regional Healthcare Ecosystem Analyst model, a platform the team developed to run numbers and
scenarios on regional healthcare systems. In this study, the researchers drew from patient data for the 28 acute care hospitals and 74 nursing
homes serving adult patients in Orange County and the patients moving among the facilities in 2011 and 2012.
Orange County was selected in part for its size--it's the sixth-largest county in the U.S.-- and its diversity. The county is also more enclosed than
many counties, meaning most residents both live and work there, which means the potential for an infectious disease to spread among facilities is in
theory less likely than a more porous region.
The research team found that a coordinated approach prevented 2,789, or 77 percent of total infections, by the fifth year, while moderate control
measures averted 408 transmissions, or 21.3 percent, after five years. Adding no new infection-control measures to the mix in the event of a CRE
outbreak--an unlikely scenario, but a possible outcome the researchers highlight--would result in CRE being present in nearly all Orange County
facilities within a decade.
While the findings may not be a total surprise, they underscore the importance of advance planning. They illustrate there are three main barriers to
health care facilities taking a coordinated approach to superbug infection control: culture, competition and practicality. Culturally, many facilities are
stretched thin keeping up with patient demands, so stepping back and focusing on something that may or may not unfold is not a priority.
From a competitive standpoint, a hospital or nursing home with even a single superbug case may not want to advertise it among its rivals, despite
the obvious public health benefits of sharing the information. Practically, facilities that may want to work together face structural and legal obstacles.
Visit Science Daily for the study.
Research unveils function of gene associated with higher risk of autoimmune attack
In type 1 diabetes, the immune system attacks the body’s own insulin-producing cells. Scientists understand reasonably well how this autoimmune
attack progresses, but they don’t understand what triggers the attack or how to stop it, says Stephan Kissler, Ph.D., Investigator in the Section on
Immunobiology at Joslin Diabetes Center and Assistant Professor of Medicine at Harvard Medical School.
Mutations in dozens of genes raise the risk of the disease by small but significant amounts, and researchers are painstakingly uncovering how each
gene might contribute. Now the Kissler lab has shown one way in which one such gene, called RGS1, may help to foster the autoimmune attack.
In the attack, immune cells called T cells infiltrate the pancreas and damage the insulin-producing beta cells. Another type of immune cells called B
cells produce antibodies and are also involved. In a mouse model of type 1 diabetes, RGS1 affects the population of one type of T cell called a “T
follicular helper cell” that is critical for B cells and antibody production, Dr. Kissler and his colleagues reported recently in Genes and Immunity.
“In a nutshell, what we found is that this gene has an effect on the frequency of these T follicular helper cells, which are important for the B cells and
seem to be important for the disease,” says Dr. Kissler.
The finding was particularly striking because clinical studies have found that the number of these cells in the blood is higher in people with type 1
diabetes.
However, Dr. Kissler’s group discovered that reducing levels of the RGS1 protein did not slow the progression of the disease in mouse models,
suggesting that it may not offer much potential for human treatment.
Mutations of RGS1 are associated with several autoimmune diseases, including multiple sclerosis, and a drug targeting cell migration has been
approved to treat multiple sclerosis, he notes.
While the scientists had speculated that inhibiting RGS1 would lower the migration of T cells into the pancreas, they didn’t find evidence for that
movement in their mouse models. They did discover that the inhibition changes the ways cells move within lymph nodes and the spleen, organs in
which T follicular helper cells interact with B cells to promote antibody production.
Several pieces of evidence suggest that B cells are major players in type 1 diabetes, Dr. Kissler says. Among them, certain antibodies that are linked
to autoimmune attack and produced by B cells are the best known indicators for risk of type 1 diabetes.
Lymph nodes and the spleen have “follicular” regions full of B cells, and other regions full of T cells. “The RGS1 gene is important to allow activated
T cells to move into the regions with all the B cells, where they help the B cells get activated and produce antibodies,” he explains. “These are the T
follicular helper cells. If you don’t have any of these cells, the antibody production doesn’t work anymore.”
Visit Joslin for the study.
ASTM symposium leads to new medical devices cleaning standard
A new ASTM International standard will help medical device manufacturers collect sufficient data to demonstrate that they consistently clean medical
devices to a safe and effective level.
The new standard (soon to be published as F3127, Guide for Validating Cleaning Lines for Medical Devices) is the result of a November 2011
symposium sponsored by ASTM on Cleaning Validation of Medical Devices. At the end of the symposium, organized by ASTM member Stephen
Spiegelberg, Cambridge Polymer Group, there was consensus among attendees that a strong need existed for a guide that validates a standardized
level of cleaning.
According to ASTM member Randall J. Thoma, principal consultant, VeeSquared Consulting Services, the new standard is relevant because,
“society expects medical devices to improve quality of life. If there is a negative impact on quality of life because a device is not cleaned
appropriately, then the patient is not helped.”
While medical device manufacturers will be the main users of the new standard, it could also be helpful to regulatory agencies as a guide for
expectations to which companies should be held. Laboratories and consultants could also use the standard as a way to support device
manufacturers. ASTM welcomes participation in the development of its standards. Become a member at www.astm.org/JOIN.
Former Martin Shkreli-led drug developer pledges responsible pricing for its products
A biotechnology company, previously led by controversial former drug executive Martin Shkreli, on Monday vowed not to engage in aggressive
pricing and to develop a transparent and 'responsible' pricing model for its products. KaloBios Pharmaceuticals Inc, which fired chief executive
Shkreli last December following his arrest on charges of securities fraud, filed for Chapter 11 bankruptcy later that month.
Shkreli, who sparked outrage last year as the head of Turing Pharmaceuticals when he raised the price of a drug to treat a parasitic infection to $750
from $13.50, was indicted in December and sued at the same time by the U.S. Securities and Exchange Commission.
KaloBios, which is developing drugs to treat Chagas disease and cancer, said on Monday that it intended to price its products at overall cost, plus a
'reasonable and transparent' profit margin, if and when they are ready for marketing.
KaloBios named Shkreli as its CEO on Nov. 20, after Shkreli and a consortium of investors bought about 70 percent of its shares. Over the course of
Shkreli's tenure with KaloBios, the company acquired the rights to an experimental Chagas disease drug.
At the time, Shkreli had said that existing data on the compound, benznidazole, was sufficient to submit a U.S. marketing application in 2016.
There exist no approved drugs for Chagas disease in the United States or Europe. However, benznidazole is cleared for use in Latin America, and is
considered the standard-of-care treatment in the region.
Chagas disease, which affects more than 300,000 people in the United States, spreads through the droppings of a small beetle known as the Kissing
Bug and primarily attacks the heart, ultimately causing heart failure and death.
Visit Medical Daily for the story.
FDA Recall: Fetch 2 Aspiration Catheter by Boston Scientific
Boston Scientific has initiated a global, voluntary recall of all models of its Fetch 2 Aspiration Catheter, a thrombectomy catheter used during
procedures to remove small blood clots from coronary arteries. The Fetch 2 catheters were recalled on March 22, 2016, due to complaints of shaft
breakage.
All reports of shaft breakage happened during the procedure, and the broken section was either removed while still partially attached to the catheter
shaft or retrieved with a snare, without further patient complications.
Because Boston Scientific acquired the Fetch 2 catheter product line from Bayer Medical Care Inc., all recalled inventory is packaged and labeled as
Bayer product. This device was manufactured between June 11, 2014 and February 19, 2016. There are currently 21,155 devices on the market
subject to this recall. Refer to the Recall Notice for Fetch 2 Catheter UPNs.
As part of the recall, all affected healthcare facilities were advised to discontinue use of all Fetch 2 catheters immediately and return unused product
to Boston Scientific.
Read the FDA MedWatch safety alert.