Archive for the ‘Health & Medicine’ Category
Eisai’s RTP plant aims to supply the world
Sunday, May 1, 2011, 9:36 pm No Comments | Post a CommentEisai’s new production plant in Research Triangle Park is fully equipped to make Halaven, a new treatment for advanced breast cancer, but the 66,700-square-foot building is still empty of people except for the occasional employee mopping floors. It will stay that way until the Food and Drug Administration inspects the plant and clears it for production.
Stephen Errico
The FDA approval, which Stephen Errico, director of Eisai’s parenteral operations, expects in September, will usher in a new era for Eisai and its main U.S. manufacturing site in RTP.
The Japanese drugmaker is switching its attention to injectable drugs after focusing on pills for many years. Injectable cancer treatments such as Halaven are on top of Eisai’s priority list and no matter whether these cancer treatments will come out of Eisai’s own research and development labs or the labs of partners, the new RTP plant will make and package them and ship them, first to the U.S. market and later the rest of the world.
Plans to seek regulatory approval for the RTP plant to produce for the European market are next.
“This facility is very unique and important to Eisai,” Errico said during a recent tour of the plant.
For the past 13 years, Eisai has made and packaged pills in RTP – Aricept, the leading Alzheimer’s treatment, and Aciphex, an acid reflux treatment. Aricept, Eisai’s biggest seller, generated about $2 billion in annual sales in the U.S. But in November, Aricept lost patent protection and Eisai expects to lose about 60 percent of its blockbuster’s sales to cheaper generic competitors over the next two years. In March, Eisai cut 70 jobs at its RTP operations, all of them in the pill part of its business.
Future growth sees the company in the injectables and oncology market.
So do most pharmaceutical companies.
Cancer is the second most common cause of death in the U.S., according to the American Cancer Society. In 2010, more than 500,000 Americans died from the disease and more than 1.5 million Americans were newly diagnosed with cancer. With more than 200,000 new cases every year, breast cancer is the most common cancer in women.
The active ingredient in Havalen is eribulin mesylate, a synthetic version of a chemical made by a black sea sponge. It was first isolated in 1985 by a Japanese scientist and has shown to prevent cell division. Eisai found it screening chemicals made by plants and animals living under water and in the tropical rain forest.
Eisai's operations in RTP include a new plant to make injectable oncology drugs. The new plant, in the foreground, could be expanded where the parking lot is now.
Eisai makes the eribulin mesylate in Japan. The active ingredient arrives in RTP as a powder, is then mixed with alcohol and water, filled in vials, labeled and packaged. All of the employees who will work on the line making Havalen will have to wear special clothing – from scrubs, hairnet, booties and gloves to two layers including a whole-body suit – for protection and to ensure the liquid isn’t contaminated.
Havalen faces competition from two other recently approved treatments for advanced breast cancer, but Eisai projects Havalen will become a blockbuster seller, generating about $1 billion per year. Up to 40 production workers could crank out as many as 4 million vials of Havalen on the RTP plant’s commercial production line per shift, Errico said. A second shift could be added.
A second production line is reserved for smaller batches of injectables used in clinical trials.
Errico estimated that initial demand for Halaven will keep about 25 percent of a shift busy. About 30 people have been hired and trained to work in the new plant. Errico said Eisai is looking for contracts to make other injectible products. “Our goal is to be a multi-product facility,” he said.
A framed architectural drawing on the wall shows three production lines Eisai could add on the southside of the building. But those are long-term plans. “I’ll probably be retired before we fill that,”Errico said.
RTP oncology startup gears up to launch first product
Wednesday, April 20, 2011, 7:15 pm No Comments | Post a CommentEditor’s note: North Carolina’s Research Triangle is home to hundreds of young companies. Scientists and entrepreneurs started them to develop technologies and medicines for better detection and treatment of diseases. Some of the companies work on innovations that are the result of research done at one of the area’s universities. Others are outgrowths of established companies. CivaTech Oncology, a startup that’s been around since 2006, employs two full-time and three part-time and is about to launch its first product, is one of those young companies.
Much of the furniture in the about 2,500-square-feet that CivaTech occupies at Park Research Center, a 13-building complex in Research Triangle Park, is second-hand. As the company’s two full-time employees, Suzanne Troxler Babcock and Seth Hoedl have important-sounding titles – Babcock is executive chairwoman and Hoedl is chief science officer – but they rely on a team of part-time employees and consultants.
Suzanne Troxler Babcock
Like many startups, CivaTech operates on a tight budget. Since its inception, the company has raised about $2 million from private investors, most of them live in the RTP area.
But things are about to change, said Babcock.
“We think we’ll look quite different as an organization by the end of this year,” she said.
CivaTech is looking for a partner to start selling its first product, a next-generation alternative to radioactive seeds that have been used for about 20 years to help reduce tumors in the prostate, breast and cervix.
The Food and Drug Administration has already approved the product, called Civa-String, and Babcock said the first prostate cancer patient is expected to get a Civa-String implant this fall.
That would make the start-up a competitor in a growing market already occupied by some large, publicly traded companies.
Brachytherapy products, which is what the radioactive seeds are, generated $240 million in U.S. sales in 2008, according to a 2009 report by Bio-Tech Systems, a market research firm in the healthcare field. But by 2016, the market is projected to increase to about $2 billion in sales.
Radioactive seeds to treat prostate cancer accounted for about half of the 2008 sales, Bio-Tech Systems reported.
The biggest suppliers of the seeds are C.R. Bard, a New Jersey-based company that is publicly traded and reported $2.7 billion in sales last year; Oncura, a division of General Electric; and Theragenics, an Atlanta-based company with about $80 million in annual revenue.
The radioactive seeds are about the size of rice kernels – cylinders made of titanium and filled with radioactive material, iodine-125 or palladium-103. Worldwide, about 15,000 prostate cancer patients receive the seeds every year.
The radioactive seeds have side effects, frequent bathroom visits and sensitivity to many fruits and other foods. But the biggest problem with the seeds is that they can migrate, Hoedl said. About 120 seeds are implanted in a prostate for a therapeutic dose, he said. If one or two of them migrate, they can end up in the patient’s lung or kidney and do damage.
Civa-Strings shouldn’t migrate. They’re cheaper to make, because they require half the radioactive material to deliver the same therapeutic dose, Hoedl said. They dispense the radiation more uniformly and they’re made with palladium-103, an isotope that works more than three times faster than iodine-125.
A Civa-String, filled with palladium-103 and gold markers. The gold helps the doctor find the strip once it is implanted. Courtesy: CivaTech
The strings are flexible plastic tubes about the thickness of an angelhair spaghetti noodle that are loaded with palladium-103 and gold pellets. Depending on the dose prescribed for each patient, they come in lengths from less than an inch to about 2.5 inches. Radiation oncologists place the loaded strings with the same kind of 8-inch-long needle as the seeds.
Seth Hoedl
Instead of about 120 seeds, a prostate cancer patient would require only 20 to 25 of the strings, Hoedl said.
CivaTech worked with the N.C. State University’s nuclear engineering department to make sure the palladium-103 doesn’t leach out.
If the launch happens as planned, Babcock expected to hire four more full-time employees this year.
Meanwhile, development of the next product, a sheet with palladium-103 loaded strips, continues. The sheet is aimed at shrinking cancers in the lung, colon and esophagus. Last year, CivaTech received $200,000 from the National Institutes of Health to work on the sheet.
Proposed global health spending cuts raise concerns in Research Triangle
Wednesday, April 6, 2011, 10:45 pm No Comments | Post a CommentAt a global health conference in Chapel Hill, the tug-of-war over budget cuts on Capitol Hill landed smack-dab in North Carolina’s Research Triangle.
In 2010, foreign assistance accounted for 1 percent of all U.S. spending.
While Republicans and Democrats are negotiating about getting a handle on the federal deficit, concerns about proposed federal funding cuts are rising in states with global health research hubs, such as North Carolina, California and Washington.
House Republicans have proposed cutting international affairs and foreign assistance spending by a total of 44 percent over the next five years, including 29 percent in 2012. They’re also pushing for an 11 percent funding cut for global health programs during the remaining months of the current fiscal year, which would scale back malaria programs and reduce immunizations, the number of skilled birth attendants and other basic health services worldwide, Dr. Rajiv Shah, head of the U.S. Agency for International Development, told a House appropriations subcommittee.
At the conference, which took place April 1 at the University of North Carolina Friday Center in Chapel Hill, experts from USAID and the Center for Strategic and International Studies in Washington, D.C., and the Centers for Disease Control and Prevention in Atlanta addressed the future of global health and development.
Stephen Morrison
“We’re now in an era of austerity, uncertainty and flattening or declining budgets,” said Stephen Morrison, director of the CSIS Global Health Policy Center.
Morrison didn’t foresee a catastrophic collapse of global health budgets. But the days of double-digit annual increases are gone, he said.
From 1990 to 2010, international spending for global health rose from about $6 billion to an estimated $27 billion, according to a report by Chris Murray of the University of Washington Institute for Health Metrics and Evaluation. About one-third of last year’s funding came from the U.S.
U.S. spending on foreign aid and global health more than doubled in the past 10 years and the increase benefited Africa and parts of Asia.
The Bush administration started an initiative to battle HIV/AIDS in Africa, contributed to an International Monetary Fund effort aimed at boosting education, health status, nutrition and gender equality in poor countries and increased security-related assistance to Afghanistan and Pakistan.
Regional distribution of U.S. foreign aid in FY 2000 and FY2010
In fiscal year 2010, the U.S. spent $39.4 billion on foreign aid, according to a Congressional report. Nearly 90 percent of that money was funneled through USAID. Still, foreign aid accounted for only about 1 percent of all U.S. spending.
Domestically, the funding increases boosted grant revenue at research institutes and created jobs at universities.
In the Research Triangle, RTI International was one of the biggest beneficiaries. RTI increased funding from USAID from $165.9 million in 2006 to $265.4 million in 2010. Another local research institute that benefited was Family Health International. FHI’s annual revenue rose about 40 percent from $224 million in 2005 to $370 million in 2009. About 70 percent of the global health funding FHI secured in 2009 came from USAID.
The UNC Gillings School of Global Public Health and the Duke Global Health Institute trained the workforce needed to implement the new initiatives.
In 2009, a Duke University study determined that North Carolina’s global health sector supported more than 7,000 jobs and $508 million in annual salaries and wages. The sector’s impact on the state’s economy was nearly the same as the textile industry’s, according to the study.
Similar economic impact studies have been done in California, where global health supports about 350,000 jobs that generate $19.7 billion in annual salaries, wages and benefits, and in Washington state, where global health supports 13,700 jobs that generate $1.7 billion in annual salaries, wages and benefits.
At the conference, Morrison encouraged global health professionals in the audience to lobby their House representatives, but he was convinced that global health would take a disproportional hit no matter how the budget negotiations would turn out.
“This is a moment of wake-up for us,” he said.
Offering a hand-up to student entrepreneurs
Tuesday, April 5, 2011, 5:24 pm No Comments | Post a CommentScott Kelly followed a long tradition with Startup Madness, a showcase of entrepreneurship and innovation in North Carolina’s Research Triangle.
Scott Kelly
Kelly, an investment banker at KeySource Bank who has worked in Internet marketing and sales, recognized the enormous job creation potential of a three-county area dotted with universities – just like economic developers, academics and businessmen did in the 1950s when they established Research Triangle Park on wooded land that was flanked by Duke University in Durham, the University of North Carolina at Chapel Hill and N.C. State University in Raleigh.
Just like the RTP supporters, Kelly focused on Duke, UNC and NCSU students.
Startup Madness, which took place March 31 on the American Tobacco Campus in downtown Durham, introduced student entrepreneurs to the Research Triangle’s investor and business community. The goal, Kelly said, was to encourage innovative young minds to stay and to retain the startup businesses that are born here on university campuses.
“We have the universities. We have young talent, possibly more than anybody else,” Kelly said. “It would be a shame if they leave.”
Startup Madness was the third entrepreneurial showcase Kelly has organized in the past year. The first took place in May 2010, three months after the recession pushed North Carolina’s unemployment rate to 11.4 percent. In the Triangle, more than 8 percent of the labor force was out of work at the time.
Considering that about three-fourths of U.S. jobs tend to be in businesses with fewer than 100 employees, Kelly thought that helping student entrepreneurs start companies in the Triangle would be a good idea to address the unemployment rate.
At Startup Madness, three student entrepreneurs, one each from Duke, UNC and NCSU, pitched business ideas. The crowd picked the most popular idea. The winner, Kelly said, would get lunch with local business leaders and venture capital and angel investors.
The pitches were:
- An infrared glove that monitors blood glucose levels in children with Type 1 diabetes continuously. The glove is worn at night and replaces repeated finger pricks, said Kyle Foti, one of eight NCSU undergraduate students working on a prototype. Currently, children with Type 1 diabetes must be woken several times at night and tested to prevent hyperglycemia, which can damage the brain and organs. The glove is not only more accurate, but it would also wake parents and children only when there’s a problem.
- Unfiltered voice messages from professional athletes that fans can receive on their mobile phones. Gridiron Grunts plans to start with messages from NFL football players and then go on to NASCAR drivers, said Jeb Terry, a UNC business student who spent five years playing football professionally. Revenue would come from subscriptions, Terry said.
- Internet discounts on merchandise that local businesses offer college students. After its launch a few weeks ago Sidewalk already had 1,000 users across Internet platforms, said Brian Laker, a Duke business student. The merchants pay Sidewalk a fee for the services.
And the winner was: The infrared glove to prevent hyperglycemia, the first product being developed by Diagnostic Apparel.
Expanding the Hamner one institute at a time
Monday, March 21, 2011, 11:03 pm No Comments | Post a Comment
William Greenlee
William Greenlee is getting ready to build another institute on the 56-acre campus of the Hamner Institutes for Health Sciences in Research Triangle Park.
Construction of the Global Translational Research Institute, a 150,000 square-foot building projected to cost $70 million, could start as early as this fall, the Hamner chief executive told members of the Triangle Area Research Directors Council at their March 16 meeting.
The building is part of a $500 million expansion plan Greenlee unveiled in 2006. The plan envisions five buildings of labs and office space – a research hub focused on drug safety early in the development of new medicines.
Greenlee’s vision for the Hamner is inspired by biomedical research hot spots like the Salk Institute in San Diego, Calif., the Scripps Research Institute in La Jolla, Calif., and Jupiter, Fla., and the Broad Institute in Cambridge, Mass.
At the TARDC meeting, Greenlee showed a map of Cambridge, with the Broad Institute at the center of a triangle that had Harvard University, the Harvard Medical School and Massachusetts General Hospital as its corners. “This is an instructive model,” he said and pointed out that the Hamner sits in the middle of a similar node of knowledge with the University of North Carolina at Chapel Hill, Duke University and N.C. State University as the corners of the triangle.
“We don’t want to become Cambridge,” Greenlee said. “We want to create the energy of Cambridge.”
In the past five years, the Hamner has already made headway in pursuit of the ambitious expansion plan: A research partnership with UNC, research footholds in China and a collaboration with the Food and Drug Administration to reduce drug-induced liver injuries.
In June 2009, Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research, cut the ribbon at the opening of the Hamner’s Institute for Drug Safety Sciences, which built on the more than 30-year expertise the Hamner has with chemical toxins.
Gossiping on Facebook doesn’t make a social media whiz
Friday, March 18, 2011, 10:46 am No Comments | Post a CommentConsidering the popularity of Facebook – the social networking site has more than 600 million active users and an award-winning movie to its credit – you’d think every teen and college student is a social media whiz.
Think again, said Whitney Chrisco, a 23-year-old college graduate and herself a member of the Net generation.
Whitney Chrisco
Chrisco, who has a biology degree from N.C. State University and graduated from the N.C. School of Science and Mathematics in Durham, went back to her high school a few weeks ago to see how much juniors and seniors know about Twitter, Tumblr, Flickr, Second Life and LinkedIn, social media tools used by millions to distribute information and network on the Internet.
The dozen teens who signed up for Chrisco’s seven-day class were smart, tech-savvy kids interested in public health and innovative ways to improve it. The N.C. School of Science and Math is a high school focused on science, math and technology whose graduates have started several Internet-based companies.
“I was worried they would know more than me,” she said. But she discovered, “They really didn’t know much.”
But then, much of what Chrisco knows about social media she learned last summer during a fellowship program at the University of North Carolina Gillings School of Global Public Health.
It’s no coincidence that Chrisco developed a high school course called “Social media networking through a public health lens” from scratch in North Carolina’s Research Triangle.
The region is a biotech and medical research hub that is also rich in global public health expertise. (More on the Research Triangle’s influence on global health here and on the benefits North Carolina reaps here.)
With researchers and students spread across the world, often working on a community level to improve water sanitation, prevent insect-borne diseases or reduce infant mortality, public health lends itself to social networking on the Internet. Free digital tools can help collect and distribute information and bring together people from all walks of life who are driven by the same concerns and interests.
All of the students who signed up for Chrisco’s course had a Facebook page to keep in touch with friends. They used Web cams on their laptops and video conferencing software called ooVoo to chat. They texted on their mobile phones. But they knew little about building a professional network using other resources and tools readily available on the Internet. Only two or three of them had a Twitter account, Chrisco said.
One of the students, Jeremiah McLeod, realized at the beginning of the course how limited his knowledge about Internet networking was.
In a post on the blogging platform Tumblr, McLeod wrote, ”Teenagers, such as myself — no longer spend evenings yakking on the cell phone, but rather, do so while sending gossip through instant messages, blogs, or oovoo. Reading what I’ve just written, I find myself sounding like an old grandpa, and I thus realize the vast importance of connecting with people in this new age.”
The Tumblr blog was one of the hands-on exercises Chrisco developed. Also, the students took photos of public health scenarios, uploaded them onto Flickr and created a map of the photo shoots for a public health sticker campaign. They went on field trips to see how different social media tools are used to promote public health. And they commented on their experiences on Twitter.
One field trip took them into the virtual world of Second Life, where each student created an avatar to visit a three-dimensional AIDS quilt. Fashioned after the AIDS Memorial Quilt, the 3D version is laid out below an enormous tree that grows on a virtual island on Second Life. Instead of fabric pieces commemorating loved-ones who died of AIDS, the 3D AIDS quilt has rooms that were contributed by relatives and friends, but also institutions involved in public health such as UNC’s Center for AIDS Research and the Triangle Global Health Consortium. (More on the 3D AIDS quilt here.)
Chrisco’s students also met two of the creators of the virtual quilt, Jena Ball and Martin Keltz of Startled Cat studios. Here’s what Greeshma Somashekar wrote on her blog about the encounter: “I would love to see the concept expanded to encompass other diseases as well. Like I mentioned earlier, I definetely feel that people are more inclined to learn about something from afar than at a conference, lecture, or public health campaign. Virtual worlds are an invaluable resource, in my perspective. People at risk for other diseases such as Alzheimers, Sickle-Cell Anemia, Tay-Sachs, Cystic Fibrosis, etc may benefit from being able to learn before making tough decisions such as whether or not to be tested for the responsible gene.”
Other students were less enthusiastic about the tool.
Adams Ombonga blogged this: “While I do feel Jenna and Martin’s idea of a virtual world is a very innovative and creative way of reaching out to the public and talk about these public health issues, I felt as if it wouldn’t be widely spread because of the everyday busy lives that people lead. I also felt that with the growth popular social sites such as facebook and twitter Second Life might not be able to compete with them because in the end Second Life is a virtual world and just can’t compete with reality.”
The other field trips took the students to two different places, the Rogers-Eubanks neighborhood northeast of Chapel Hill and the N.C. Biotechnology Center in Research Triangle Park, where speakers nonetheless addressed similar public health issues.
The Rogers-Eubanks neighborhood is predominantly African-American and borders the Orange County landfill. Unable to tap into public water and sewer lines, the neighborhood relies on wells many of which do not comply with federal water quality standards. To bring about changes in their neighborhood, residents use a blog to get their message out.
Water supply was also a topic Fred Gould, an NCSU professor, talked about during the Triangle Global Health Consortium breakfast the students attended at the biotech center. Gould’s presentation was about insect-borne diseases such as malaria and dengue fever and the mosquitoes that spread them. In communities where few households have running water, families store water indoors in open containers. These containers are breeding grounds for the mosquitoes, Gould said.
Kinesha Harris blogged about the visit to Rogers-Eubanks: “This neighborhood which was no more than a 15 minute bus ride away does not have sewage or decent water. There are pipes that run directly under their houses or are near by their houses that the government will not allow them to connect to. Residents of the neighborhood have been fighting for nearly 40 years to be able to connect to the pipes. Some people would ask why they do not just move to a different neighborhood and our guide, who has lived in the neighborhood a majority of his life, says that they will not leave because it is apart of their family history and they do not want to lose that history.”
Kelly Bates wrote about one solution Gould discussed to counter malaria and dengue – genetically engineered mosquitos. The class also read an article about such mosquitoes being released.
“Yesterday’s breakfast at the Triangle Health Consortium was unique. I had never been to something like that before. It was a presentation and discussion about genetically engineered mosquitos being flown into third world countries in the hopes of reducing malaria or dengue. Personally, I had never known about the genetically engineered mosquitos before reading the article and attending the meeting yesterday. All of this was new to me, so it opened my eyes to the huge debate that’s occurring between the people who like this new approach and those who don’t.”
Here’s a picture of Chrisco’s class taken after the Triangle Global Health Consortium breakfast:
From left: Whitney Chrisco, Holly Modlin, Troy Royal, Jelicia Diggs, Greeshma Somashekar, Kinesha Harris, Fred Gould, Jordan Calvert, Kelley Bates, KeAira Roland, Naseer Ahmed, Jeremy Saxe, Adams Ombonga. Not pictured, Jeremiah McLeod.
RF radiation harmful to humans? Sent on my iPhone.
Saturday, March 12, 2011, 12:08 am 2 Comments | Post a Comment
A graphic depiction of radiofrequency (RF) radiation (picture via TopNews.in)
Cell phones continue to become more and more prevalent, but so does a debate in the scientific community as to whether they do more harm than good.
That’s why the National Toxicology Program (NTP), a subset of the National Institute of Environmental Health Sciences based in Research Triangle Park, is studying the effects of cell phone, or radiofrequency (RF), radiation on animals.
So far, there is no evidence to suggest any short- or long-term damage to humans, said Dr. Mike Wide, an NTP toxicologist involved in the study. There are two types of radiation, he said: ionizing and non-ionizing.
“Ionizing is what most people are familiar with,” Wide said. “Things like X-rays and nuclear bombs.” Ionizing radiation will strip electrons away from atoms and molecules and thus has the potential to cause ionic damage in tissue.
Meanwhile, non-ionizing radiation—which includes radiofrequencies—is much lower in intensity and does not endanger ions. It can heat things up, though.
“When the power level gets high enough, eventually the RF radiation energy starts to excite molecules and creates heat, like a microwave,” Wide said. “Increase someone’s body heat enough, and you’re eventually going to have a body of problems.”
This is called the thermal effect. Wide said although the potential for such damage exists, there is currently no reason to believe RF radiation could harm human tissue.
Not all his colleagues share this belief. Wide was part of a cell phone radiation expert panel that testified before Congress in 2009. Dr. Devra Davis of the Environmental Health Trust was another panelist.
Davis said the evidence clearly shows cell phones cause physiological harm in humans.
The thermal effect created by the phones can alter brain metabolism and glucose, she said. This could be especially detrimental to children, whose brains are still developing and who absorb twice as much radiation as adults.
There could be sexual side effects, too. Davis said there is a 50 percent reduction of sperm count in young men who keep cell phones in their pockets for four hours a day.
“Just by keeping it in your pocket, you exceed the FCC limit,” she said in reference to the Federal Communications Commission’s standard on cell phone radiation emission rates.
Currently, the maximum Specific Absorption Rate (SAR) for commercial cell phones is 1.6 megawatts per kilogram (MW/kg), a number developed in 1996 on recommendations by top scientific agencies like the EPA and the FDA. This rate measures the amount of radiation that is absorbed over one gram of tissue when the phone is using its maximum power, explained Wide.
Phones are rarely using their maximum power and this SAR ceiling is well below the threshold for actual bodily harm from radiation, said Bruce Romano, associate chief of the FCC’s office of engineering and technology.
“It’s a safety mark intentionally set that low,” Romano said. “Artificially low, even.”
The phones, he said, would have to emit much more than 1.6 MW/kg of RF radiation to cause any acute human damage, so everything below that level is safe. Some mistakenly assume a SAR of 1.2 is safer than a SAR of 1.4; however, as long as they’re below 1.6, all SARs are equally safe, he said.
“If you’re moving under a 12 foot bridge, what’s the difference between a nine and ten foot truck?” Romano said. “They both fit under.”
Davis argues the best way to reduce the risk of harmful radiation is to use a head-set or turn on the speakerphone. She helped found the Global Campaign for Safer Cell Phones, along with CNN medical commentator Dr. Sanjay Gupta.
The campaign advises against regular use and carry of cell phones and advocates safer model designs. Yet, Romano is not sure better designs are the answer.
“At this point, they’ve probably done everything they can do design-wise,” he said. “The next thing would be to lower the power, but then it doesn’t work as well or you need more base stations.”
What Wide points out is that the FCC’s standards are based on protection from acute injury. They are not designed to guard against long-term effects from repeated low-level exposure to thermal energy.
“That’s one of many reasons why we’re interested in this study,” Wide said, explaining that current regulations are not based in real life data, as far as the way people are using cell phones. He said 85 percent of Americans and four billion people worldwide use cell phones regularly.
“Even if there’s a small effect, with so many using them, it could affect a lot of people,” he said. “It will definitely remain an issue for several more years to come.”
Davis, on the other hand, said the time to act is now. Changes must be made to shield the younger generation from chronic exposure.
“We do not have the answers, but when should we have asked against tobacco or asbestos?” she said. “If we have to wait on proof for cell phones like with these, we’ll end up with dead bodies, of our children and grandchildren.”
Practice Makes Perfect: NC TraCS sponsors first-ever practice-based research conference in the state
Thursday, March 10, 2011, 1:49 am No Comments | Post a CommentImproving health is a scientific process. For physicians to improve the way they deliver health care – to truly understand what works and what doesn’t — they have to study it. This idea of medicine as a work-in-progress was a theme of the first North Carolina Conference on Practice-Based Research, held Friday, March 4, in Chapel Hill.
Co-sponsored by the North Carolina Network Consortium (NCNC) and the NC Translational and Clinical Sciences (NC TraCS) Institute, home of the Clinical and Translational Science Awards (CTSAs) at UNC, the conference brought together over 100 primary care providers, clinic staff and research coordinators from across the state to discuss the kind of studies practice-based research networks can conduct to improve health care.
“The new treatments that come out all the time from drug companies, device makers, or even things we do in clinic, require testing and evaluation prior to widespread adoption,” said Rowena Dolor, M.D., M.H.S., director of the Duke Primary Care Research Consortium, one of six practice-based research networks in the NCNC. “What we do know though is once a new drug or device is out on the market, there is widespread variation in how it is used in clinical care. And despite good intentions, not all treatments benefit patients. For example, we didn’t realize the COX2 inhibitors that were meant to relieve arthritis pain would also increase the risk of heart attack or stroke. That is why research is necessary.”
Read more…
RTP panels address rogues gallery of multidrug-resistant bacteria
Tuesday, March 1, 2011, 2:29 pm No Comments | Post a CommentHow to prevent bacterial infections associated with poor hygiene in hospitals, nursing homes and day care centers has become a necessary though rarely pleasant topic for healthcare providers.
Source: Centers for Disease Control and Prevention
Every year, an estimated 5 percent of all hospitalized Americans, or about 1.7 million, are treated for a healthcare-associated infection. About 90,000 of them die, according to numbers reported by the Centers for Disease Control and Prevention. The infections are caused by multiple bacteria that can be traced back to healthcare settings and 14 percent involve a superbug, methicillin-resistant staphylococcus aureus or MRSA.
After rising rapidly in the 1990s, the number of MRSA cases began to decrease in the past decade, but following in MRSA’s footsteps are superbug wannabes such as floroquinolone-resistant pseudomonas aeruginosa (FQRP), vancomycin-resistant enterococci (VRE) and clostridium difficile, a bacterium that wreaks havoc after antibiotics wipe out healthy gut flora.
Staphylococcus aureus
Efforts to reduce healthcare-associated infections received boosts in the past few years.
In 2008, the Centers for Medicare and Medicaid Services stopped paying hospitals for infections they considered “serious complications that should never occur in a hospital” and private health insurers began to follow suit. The following year, the federal stimulus bill provided states with about $50 million to establish surveillance and prevention programs.
North Carolina’s state plan to monitor and prevent healthcare-associated infections, which took effect in January and relies on voluntary reporting, is such a program.
Pseudomonas aeruginosa
“It’s not inevitable that you go into the [intensive care unit] and you get a [central line-associated] bloodstream infection,” said Dr. Megan Davies, chief of the N.C. Division of Public Health’s epidemiology section.
Davies was one of five infectious disease experts in the Research Triangle who addressed healthcare-associated infections and the rogues gallery of multi-drug resistant bacteria. The Feb. 22 panel discussion was put together by Duke University and Becton Dickinson, a New Jersey-based medical instruments company whose corporate innovation center is in Research Triangle Park.
Enterococci faecium
Healthcare-associated infections add an estimated $28 billion to $33 billion in national healthcare costs every year, according to a report the CDC published in 2009.
Avoidable infections can enter the body at a surgical site or through a catheter, a ventilator or a central line used to supply medication, blood and fluids directly into the bloodstream.
In North Carolina, large programs to collect infection data and improve infection control have existed since 1997: the Statewide Program for Infection Control and Epidemiology, or SPICE, at the University of North Carolina School of Medicine and the Duke Infection Control Outreach Network, or DICON, that linked the Duke University School of Medicine and 39 community hospitals.
Central line-associated bloodstream infections and cases involving MRSA have decreased in the past decade due to efforts by SPICE and DICON.
But direct costs from dealing with healthcare-associated infections statewide are estimated to still exceed $280 million per year, according to the N.C. Department of Health and Human Services.
Innovations to prevent these infections such as special cleaning and medical supplies exist, said William Rutala, director of SPICE and one of the five infectious disease experts on the panel. But better compliance with more basic prevention tools such a hand hygiene would be an important first step.
Only an average 40 percent of healthcare workers washed their hands in accordance with CDC guidelines, studies conducted in the 1990s showed. And other studies show that only about one-third of the surfaces at high risk of harboring infectious bacteria in hospital rooms were thoroughly cleaned before new patients came in, Rutala said.
Fewer and fewer new antibiotics to battle the multi-drug resistant bacteria is yet another problem, said Dr. David Weber, associate chief of staff at UNC Health Care who was another infectious disease expert on the panel.
Years of antibiotic overuse and patients cutting short antibiotic treatments are driving forces behind the rogues gallery – not only in healthcare settings but maybe also in livestock farming.
About two-thirds of the MRSA central-line bloodstream infections in hospitals involve bacteria that came from outside the hospital but whose origin isn’t clear, according to Dr. Vance Fowler, an infectious disease specialist at Duke University.
Antibiotics are used extensively to promote growth in livestock farming, said Jorge Ferreira, a graduate student at the N.C. state University College of Veterinary Medicine. Daily use of antibiotics is also normal in dairy cows.
Fowler and Ferreira are collaborating on research to find out more about MRSA and whether the superbug is transmitted from animals to humans. They presented some of their findings as part of a panel discussion at the N.C. Biotechnology Center in RTP, a few hours after the infectious disease panel met in Durham.
So far, Ferreira reported, MRSA strains have been found in pigs, cows, dogs, cats and even hamsters.
Test your flu preparedness
Wednesday, January 12, 2011, 12:35 am 2 Comments | Post a CommentThe H1N1 virus that fueled the 2009/2010 flu pandemic was less deadly than initially feared, but it carried enough punch to infect more than 1.4 million and kill about 25,000 worldwide.
Dr. Anne Schuchat
Also, five months after the World Health Organization declared the end of the pandemic, the virus lives on as part of the seasonal flu. In the United Kingdom, the season geared up with an outbreak caused by the H1N1 virus that emerged in 2009.
With the flu season upon the U.S., Duke University invited Dr. Anne Schuchat, U.S. assistant surgeon general, to talk about influenza preparedness at its winter forum. The two-day forum starts at the beginning of the semester and allows about 100 undergraduate students to work through a global issue and what people can do about it.
Schuchat, who kicked off the forum Sunday, spoke about the intense media attention during the pandemic and how vital information sharing and transparency was in the public health response. Her talk inspired these questions and answers to test your flu preparedness. Read more…
