Category Archives: FDA

16Nov / 2016

Antimicrobial resistance: What is it? Why is it a problem? What is being done to stop it?

Antimicrobial resistance: What is it? Why is it a problem? What is being done to stop it? | www.APHLblog.org

By Kelly Wroblewski, director, infectious diseases, APHL

Antimicrobial resistance is arguably the most significant public health threat facing the world today. As resistance builds, the threat of severe illness or death from common infections becomes an increasing possibility for everyone.

What is antimicrobial resistance?

Antimicrobial resistance occurs when microbes, including bacteria, viruses, fungi and parasites, evolve or adapt to survive exposure to drugs or other treatments designed to kill them. Once the microbes have developed resistance, treatments used against them are rendered useless.

While all types of antimicrobial resistance are extremely concerning, antibiotic resistance – when bacteria become resistant to antibiotics – is often seen as posing the most serious health threat. Why is this?

Compared to other microbes, more bacteria are becoming increasingly resistant to treatment, and resistant bacteria can cause more adverse health outcomes in infected people. Antibiotics are also more commonly used than antiviral, antifungal or antiparasitic drugs.

How did antibiotic resistance become such a big problem?

While many complex issues have led to this urgent situation, three factors stand out:

1. The overuse and misuse of antibiotics in healthcare, agriculture and other aspects of day-to-day life is a significant contributor to antibiotic resistance. Simply stated, every time we use antibiotics inappropriately, we’re helping bacteria figure out how to outsmart and outperform them – to resist Inappropriate use includes taking antibiotics to treat viral infections, starting a course of antibiotics and not completing it, using antibiotics in agriculture to improve livestock survival and crop yields, and the liberal use of over-the-counter antibacterial soaps and ointments.

2. Development of new antibiotics and diagnostic tools to detect resistance has suffered due to a lack of investment. As bacteria develop resistance to existing drugs, scientists must work to develop new antibiotics to treat infections. However, for the past 30 years, antibiotic drug development has been stagnant and the prospects are not promising.

Prior to the drug development phase (bringing drugs to market) is drug discovery, the process of identifying candidate medications and active ingredients. This is a challenging and therefore incredibly expensive endeavor with few economic incentives. For companies that make it to the drug development phase, creating drugs that kill bad bacteria without killing good cells (including the host) is extremely difficult.

3. It is difficult to systemically detect, track and respond to new resistant pathogens and outbreaks without a comprehensive global surveillance system. To slow the spread of resistance, we have to know where to find it and have a plan to stop its spread. Though the United States has acted to counter resistant forms of diseases like TB and gonorrhea, it hasn’t taken a public health approach to diseases commonly found in health care settings like the superbug CRE. Failure to detect and stop the spread of these infections at the community level contributes to increased numbers of resistant infections, poor patient outcomes and increased healthcare costs. What’s more, aggressive detection and response efforts are needed to prevent local outbreaks from becoming pandemics.

What’s being done to slow or stop antimicrobial resistance?

The past few years have brought much needed progress. Finally, the US public health and health care systems have a comprehensive plan to combat this problem and resources to make it happen.

In 2014, the White House released the National Strategy on Combating Antibiotic-Resistant Bacteria and President Obama signed an Executive Order directing key federal agencies to take action to combat the rise of antibiotic resistant bacteria. In December 2015, Congress passed a budget providing $375 million to implement this strategy with $161 million going to CDC.

Since then, significant steps have been taken to move the dial in the right direction.

  • CDC has distributed approximately $67 million to local and state governments to improve their ability to detect and respond to existing and emerging resistance as well as implement strategies to improve antibiotic stewardship.
  • CDC has established the Antimicrobial Resistance Laboratory Network (ARLN) which will provide infrastructure and capacity for seven regional public health laboratories across the country to better identify and characterize some of the most significant antimicrobial resistance threats. In addition, the ARLN will provide resources to all state and several large local public health jurisdictions to improve their CRE surveillance capacity.
  • CDC, FDA and NIH have launched a comprehensive campaign aimed at improving antimicrobial stewardship in healthcare and reducing the frequency of antibiotic use in agriculture.
  • NIH and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) launched the Antimicrobial Resistance Diagnostic Challenge, a $20 million prize competition that to stimulate innovation in the development of new, faster diagnostic tools.
  • CDC and FDA have collaborated to establish the Antimicrobial Resistance Isolate Bank, a repository of resistant pathogens that will be made available to companies developing new antibiotics and diagnostics.

These are significant and valuable steps forward. As these and future efforts get underway, collaboration across sectors will be critical to success. APHL is committed to supporting members and working closely with partners in the battle against antimicrobial resistance.

Read more:

The post Antimicrobial resistance: What is it? Why is it a problem? What is being done to stop it? appeared first on APHL Lab Blog.

Posted by in All Posts, antibiotic resistance, Antibiotics, antimicrobial resistance, CDC, FDA, get smart, Infectious Diseases, NIH

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20Sep / 2016

Random dog food sample proved critical in solving human illness outbreak

Random dog food sample proved critical in solving human illness outbreak | www.APHLblog.org

As part of Michigan’s routine pet food surveillance program, microbiologists in the Michigan Department of Agriculture and Rural Development (MDARD) Laboratory Division were used to testing random samples of dog food. While they rarely found anything unusual or harmful, they continued this testing. On April 2, 2012 the importance of their work was made abundantly clear.

In the MDARD microbiology lab, the unopened bag of dry dog food which was selected at random from a store shelf, looked like so many others. Such samples usually tested negative for contaminants and foodborne pathogens, but this one tested positive for Salmonella Infantis. The MDARD team recovered an isolate from the sample and sent it to the state’s PulseNet lab at the Michigan Department of Health and Human Services (MDHHS), Bureau of Laboratories.

There, scientists performed pulsed-field gel electrophoresis (PFGE) testing on the sample and promptly uploaded their findings to the PulseNet database. Once the data was entered on April 10, lab scientists noticed that the PFGE pattern from the contaminated dog food matched PFGE patterns from human illnesses in the US and Canada. These human cases were previously unsolved; the random sample of contaminated dog food was the smoking gun in over 50 human cases. They forwarded the information to state epidemiologists who promptly initiated an investigation.

Human illness from pet food isn’t uncommon. No, it doesn’t mean someone ate dog food. When humans handle pet food, any contaminants can be left on their hands. From there it’s easy to spread those potentially-harmful pathogens to other surfaces or unwittingly ingest it. It’s important to wash hands after handling pet food and thoroughly clean any surfaces where the food may have been.

In response to the discovery that previously unsolved human cases of Salmonella may be linked to the contaminated pet food, every key player was contacted. MDHHS reached out to MDARD’s Rapid Response Team, the Food and Drug Administration’s (FDA) Detroit District Office, the Public Health Agency of Canada, and notified PETNet, the FDA’s pet-food tracking system. The dog food manufacturer was also contacted to inform them of the findings. Because the manufacturing facility listed on the bag was said to be in Missouri, the Missouri Department of Agriculture was also contacted. It was later discovered that the factory where this food was made was in Gaston, South Carolina, so the South Carolina Department of Agriculture was eventually contacted as well.

As the scope of the investigation widened, state agriculture laboratories, public health teams, and CDC and FDA scientists joined Michigan’s epidemiologists and laboratory scientists in responding to the outbreak. They collaborated closely to conduct trace-back investigations of the implicated products, implement recalls and limit additional exposures by informing the public of the health risks associated with the products.

On April 20, scientists at the Ohio Department of Agriculture isolated the outbreak strain from an opened bag of dog food collected from the home of a case-patient. And on April 30, MDARD and FDA scientists isolated the outbreak strain from dog food samples collected from the SC facility.

With a clear link between the contaminated food and human illnesses established, the pet food company issued a national recall of the implicated brand of dog food. As the Departments of Agriculture in South Carolina and Ohio identified other contaminated pet foods manufactured by the firm, this recall was expanded eight times to include 17 brands representing approximately 30,000 tons of dry dog and cat food, all produced at the South Carolina facility.

Ultimately 53 human illnesses in 21 states and two Canadian provinces were connected to the outbreak. Ten of these cases required hospitalization. In addition, 37 animals were sickened, and there were numerous complaints of illnesses that met the case definition.

However, the effects could have been far worse as 30,000 tons of contaminated pet chow could have caused innumerable cases of human and pet illness if distributed. But thanks to Michigan’s routine pet food sampling program, clear PFGE data entered into PulseNet and strong collaboration among public health partners, the spread of disease was halted.

More on this outbreak: Notes from the Field: Human Salmonella Infantis Infections Linked to Dry Dog Food — United States and Canada, 2012

Posted by in agriculture, FDA, food safety, Michigan, missouri, ohio, pet food, PulseNet, Salmonella, South Carolina

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25Feb / 2016

14 Things that Cost the Same as a Gene Therapy Clinical Trial

imgres-150x150Several of the families I write about say that it takes about $3-5 million to fund a phase 1 clinical trial for a handful of patients to test a gene transfer protocol. A phase 1 trial

Posted by in clinical trial, FDA, featured, medical journalism, Rare Disease Day

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13Apr / 2015

5 Things You Didn’t Know (but Need to Know) about Listeria

By Michelle Forman, senior specialist, media, APHL

Listeria has reared its ugly head (and tail – flagella, technically speaking) seemingly quite a bit recently. According to FDA, there have been 14 recalls due to possible Listeria contamination so far this year. (Five of those were linked to the same spinach supplier.) And USDA’s list shows another three. While most of these recalls have not been linked to illnesses*, Listeria is extremely serious and considered a high-priority within the US food safety system. What is this nasty bacteria and why is it so serious? Here are five things that you didn’t know (but need to know) about Listeria.

5 Things You Didn’t Know (but Need to Know) about Listeria | www.APHLblog.org1. 90% of people who get listeriosis (the infection caused by Listeria monocytogenes) are part of a high-risk group such as pregnant women, adults over 65 years and people with weakened immune systems. In fact, pregnant women are about 10-20 times (depending on the source) more likely and the elderly are four times more likely to get listeriosis than the general population. If you’re part of one of these groups, take Listeria risk very seriously.

2. Listeria has a very high mortality rate. CDC estimates that there are about 1,600 cases each year and 260 die (approximately 16%). By comparison, CDC estimates 19,000 Salmonella cases each year and 380 die (approximately 2%).

5 Things You Didn’t Know (but Need to Know) about Listeria | www.APHLblog.org 3. Listeria is unlike many other foodborne pathogens because it can grow even in the cold temperature of the refrigerator making it extra important to avoid cross contamination from uncooked meat, fish or other high risk foods. Like other foodborne pathogens, proper cooking is the most effective way to kill Listeria that is lurking on your food.

4. The incubation period for Listeria is 3-70 days. That means it could be up to 70 days after Listeria entered your body before you get sick. Many people who get foodborne illness often point to the last thing they ate as the culprit, but that’s often not the case especially with Listeria. For the purposes of an outbreak investigation, epidemiologists will look back even further – as much as 120 days prior to when a person became ill – to be sure they are really looking at every possible suspect. Can you remember what you ate 70 days ago? Or even 120 days ago?

5 Things You Didn’t Know (but Need to Know) about Listeria | www.APHLblog.org

5. The US food safety system takes Listeria extremely seriously. There is an enhanced surveillance system led by CDC called the Listeria Initiative which requires health care providers to report listeriosis cases; requires public health officials to promptly interview anyone with listeriosis to gather information that could help identify the source of infection; and requires clinical labs to send positive samples to public health laboratories for subtyping using PFGE (DNA fingerprinting). The DNA fingerprints are uploaded to PulseNet, the national network of public health and food regulatory agency laboratories that connect foodborne illness cases together to detect clusters of bacteria that make people sick. All of this helps accelerate outbreak detection and surveillance, and decreases the amount of time it takes to stop an outbreak from progressing.

* While there have been 17 recalls due to possible Listeria contamination, most have not been linked to illness. Five national PulseNet clusters of illness have been detected and reported to epidemiologists this year. Four of those clusters have led to epidemiologic investigations. As of now, three of those investigations are still open and active. One of those investigations has led to a confirmed source and is still considered active.

Posted by in CDC, FDA, food safety, foodborne illness, listeria, listeria initiative, pregnancy, pregnant women, recall, USDA

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03Apr / 2015

More herbal supplement regulation? Plus scientific April Foolery

REGULATION OF HERBAL SUPPLEMENTS IS A SCAM. BUT YOU KNEW THAT. Steven Novella reports at Neurologica on a nice piece of investigative science journalism about government (non)regulation of the supplement industry at the Canadian Broadcasting Corporation. CBC researchers created a … Continue reading »

The post More herbal supplement regulation? Plus scientific April Foolery appeared first on PLOS Blogs Network.

Posted by in April Fool, DNA barcoding, FDA, GNC, herbal supplements, homeopathic, homeopathy, New York State, regulation, Science Journalism, Target

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12Mar / 2015

University of Oregon outbreak highlights collaboration between public health and clinical care

By Michelle Forman, senior specialist, media, APHL

University of Oregon outbreak highlights collaboration between public health and clinical care | www.APHLblog.org

In mid-January, a University of Oregon student was diagnosed with Neisseria meningitidis serogroup B, a rare but serious disease. Within one month, three additional students were diagnosed with the same disease, one of whom died. “I was the first assistant on that autopsy,” said Patrick F. Luedtke MD, MPH, senior public health officer and medical director of the Lane County Department of Health & Human Services Community & Behavioral Health clinics. (He’s also a past APHL president.) “The bacteria were everywhere. Neisseria meningitidis takes over the body and wins every battle.”

College campuses like the University of Oregon are perfect breeding grounds for meningococcal disease. Young adults ages 16-21 have higher rates than others, and it is transmitted through close or lengthy contact such as living in close quarters or kissing. So, yeah… meningococcal disease can make its way across a college campus if it isn’t stopped quickly. In fact, there were similar outbreaks at Princeton University and at University of California, Santa Barbara in 2013.

Meningococcal disease is rare, but if a person gets it they are likely to become very sick. Once it is suspected, clinical laboratories can do a test to confirm meningococcal disease and doctors can quickly begin antibiotic treatment. (Oftentimes prophylactic antibiotic treatment is given anyone who had close contact with the sick individual.) But even with quick and proper treatment, approximately 20% of people will have long-term disabilities and 10-15% of people die. The best way to prevent severe illness is to prevent illness all together – decrease the number of people who can get meningococcal disease in the first place – with vaccines. Here’s the kicker, though… Kids in the US receive a quadrivalent meningococcal vaccine at age 11. However, that vaccine only protects kids from serogroup A, C, Y or W-135. What about B, the serogroup found at the University of Oregon?

In October 2014, the FDA approved the first ever N. meningitidis serogroup B vaccine for use in people 10-25 years of age as a three-dose series. In January 2015, the FDA approved another N. meningitidis serogroup B vaccine for use in the same age group as a two-dose series. Neither vaccine has been recommended for routine use yet, but it has been recommended for controlling outbreaks like the one at the University of Oregon. In order to implement a massive campaign to vaccinate all 22,000 students, CDC needed to know that there had been at least three confirmed serogroup B cases within a three month period. The clinical test that confirmed meningococcal disease in each of the four patients wasn’t enough, though. Not only are clinical laboratories often without the capabilities to serotype meningococcal disease, the serogroup doesn’t affect clinical care. Whether the meningococcal disease was serogroup A, B, C, Y or W-135 didn’t change how they cared for the sick individuals. Further testing was needed to show that all four cases had the exact same strain of serogroup B meningococcal disease.

That was a task for the Oregon State Public Health Laboratory; in an outbreak, it is the public health laboratory’s role to show cases are truly linked. As each case was determined to be meningococcal disease, the public health laboratory was contacted and serotyping began. While the public health lab’s confirmation that the patients were sick with group B meningococcal disease was enough information for CDC to green-light the vaccination effort, the Oregon State Public Health Laboratory dug even deeper. With Neisseria meningitidis cases such as the ones at the university, the Oregon state lab routinely uses pulsed-field gel electrophoresis (PFGE) to isolate the DNA fingerprint of each strain to show that everyone got the disease from the same source. That information could help epidemiologists identify the index case. “Using PFGE to fingerprint meningococcus is considered very risky, and it is very expensive, so many laboratories don’t do it,” explained Robert Vega, general microbiology manager at the Oregon state lab. “The risk associated with this is very real to us. Our staff is vaccinated against groups A, B, C, Y and W-135; we are well equipped and I have highly proficient staff.”

Once it was confirmed that the cases were group B meningococcal disease, CDC approved the Lane County Health Department and the University of Oregon to implement a massive effort to quickly vaccinate 22,000 students. The vaccination effort began on March 2 and within one week over 10,000 students had received the first dose of the vaccination. “We still have more students to reach, but we are working hard to make sure everyone is vaccinated,” said Dr. Luedtke. Quick treatment from clinical care providers and fast, accurate testing by the public health lab will hopefully mean that this is the beginning of the end of this outbreak.

Posted by in CDC, FDA, Infectious Diseases, meningococcal disease, meningococcus, Neisseria meningitidis, Oregon, Public health laboratory, university of oregon, Vaccination, vaccine

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23Feb / 2015

The dangers of doing nothing: What pregnant women need to know about clinical trials

Please welcome a guest post by Kaitlin Bell Barnett, who writes about health and medicine for various print and online outlets. She’s at work on a book about medications and medical care in pregnancy. Her first child is due in July. … Continue reading »

The post The dangers of doing nothing: What pregnant women need to know about clinical trials appeared first on PLOS Blogs Network.

Posted by in FDA, medicine, nnt, pregnancy, risks

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06Jan / 2015

At Year’s End: Staff Editors’ Favorite PLOS ONE Articles of 2014

2014 has been an exciting year for PLOS ONE. We saw the journal reach a milestone, publishing its 100,000th article. PLOS ONE also published thousands of new research articles this year, including some ground-breaking discoveries, as well as some unexpected … Continue reading »

The post At Year’s End: Staff Editors’ Favorite PLOS ONE Articles of 2014 appeared first on PLOS Blogs Network.

Posted by in 2014, Aesop's fable paradigm, Aggregators, anesthesia, animal welfare, antibacterial, anticancer, antifungal, antiparasitic, article-level metrics, bioactivity, chickens walking like dinosaurs, clinical trial, dinosaur locomotion, dna, Drosophila, Editor, Events, FDA, Featured Image, fMRI, foldscope, fruit flies, fun, General, Genome, glial cells, H4, histone, Images, Internet/Blogging, ISWI, media, microscope, mitochondria, New Caledonian crow, nucleosome, origami, plant xylem, PLOS One, safe2013, sapwood, schizophrenia, sexual harassment, Sloth, Social Media, theropod, water filtration, women in science, world's oldest people, Yeast, zebrafish

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17Oct / 2014

Out in the cold: Freezing feces and human eggs. Also, scientific easter eggs

  More germ warfare, this time about fecal microbiota transplants Despite their mind-boggling track record, fecal transplants as  effective treatments for intestinal disorders (and possibly those elsewhere in the body) have encountered PR problems–what Loom blogger Carl Zimmer calls the … Continue reading »

The post Out in the cold: Freezing feces and human eggs. Also, scientific easter eggs appeared first on PLOS Blogs Network.

Posted by in Avogadro's Number, C. diff, Down syndrome, easter eggs, eggs, FDA, fecal microbiota transplant, fecal transplant, feces, FMT, monosomy, ova, pregnancy, trisomy, women

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09Oct / 2014

FDA Proposes Oversight of Laboratory Developed Tests: Is This Good for Public Health?

By Celia Hagan, MPH, Senior Specialist, Public Policy, APHL

It finally happened.

After an extended silence and lack of significant action since their 2010 public meeting on the oversight of laboratory developed tests (LDTs), the Food and Drug Administration (FDA) released their long awaited draft regulatory framework for LDTs. While the official comment period was announced in the Federal Register on October 3, 2014, this isn’t the first time that we’ve seen the outlined framework.

FDA Proposes Oversight of Laboratory Developed Tests: Is This Good for Public Health? | www.aphlblog.org

Just this past July, FDA released a Notice to Congress indicating their intent to move forward with regulation. At the same time, they provided public access to the draft oversight framework. During the 60-day period between July and October, APHL has been hard at work analyzing and interpreting the framework to assess and understand the impact on public health laboratories.

The proposed framework will regulate LDTs in a risk based approach, similar to the way medical devices are currently regulated. Due to growing concerns about the lack of clinical validity, FDA is proposing premarket review requirements to establish these characteristics in LDTs and the establishment of a quality system to assure the finished device will be safe and effective. Laboratories that manufacture or utilize LDTs will be required to notify FDA of their LDT inventory six months after the date of the published final rule. This will allow FDA to classify LDTs into risk categories. The requirement to establish the test’s clinical validity through premarket review will depend on how LDTs fall into these risk categories. While every laboratory will be required to comply with notification and medical adverse reporting no matter what the risk, high risk and moderate risk LDTs will be subject to premarket review requirements. Low risk LDTs will be allowed enforcement discretion with respect to premarket review.  (FDA will classify LDTs into risk classes at a later date.)

FDA is also allowing some enforcement discretion with respect to premarket review for:

APHL strongly supports accurate and quality testing. Public health laboratories exist because they are nimble, prepared, responsive and adaptive; therefore, as FDA gathers feedback on its proposed LDT regulation, APHL will advocate for a framework which will not inhibit the critical services provided by public health laboratories. The innovation and evolution, not to mention the daily activities, of the public health laboratory system relies on an LDT regulatory framework that is not so burdensome that it unintentionally eliminates testing that provides important public health benefits. APHL has engaged FDA’s leadership to communicate the necessity of continuing the services provided by public health laboratories within any LDT regulatory framework. In addition, APHL has educated congressional staff on the critical role of public health laboratories within the public health system.

As the 120-day comment period comes to an end on February 2, 2015, APHL will submit a thoroughly considered and carefully crafted comment to ensure that services provided by public health laboratories continue to improve the public’s health. We encourage others who support public health to voice their interest in maintaining this valuable work.

FDA will host an informational webinar on October 23, 2014, at 2:00 pm EDT. More details can be found on FDA’s website. In addition to the submission of formal comments to regulations.gov, APHL will present at FDA’s public comment meeting in January 2015 (details to be announced at a later date). See you there!

 

Posted by in FDA, laboratory developed tests, ldt, policy, Public Policy, regulations

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