NIH Officially Lifts Ban on Research Studying Germs with Pandemic Potential


PANDEMIC POTENTIAL

The National Institutes of Health (NIH) has lifted a three-year freeze in federal funding for research projects pertaining to germs that can cause pandemics. The Department of Health and Human Services (HHS) released a new framework dictating how research that could create newer and deadlier germs with pandemic potential is funded.

“We have a responsibility to ensure that research with infectious agents is conducted responsibly, and that we consider the potential biosafety and biosecurity risks associated with such research,” wrote NIH director Francis S. Collins in a statement published on the organization’s website. “I am confident that the thoughtful review process laid out by the HHS P3CO Framework will help to facilitate the safe, secure, and responsible conduct of this type of research in a manner that maximizes the benefits to public health.

Pandemics are disease epidemics that occur worldwide and affect a large number of people, like the Spanish Flu in 1918 that killed nearly 50 million people. Typically, scientists manipulate existing pathogens – making them deadlier or easier to pass on – to better understand them and develop countermeasures against those that may threaten public health.

But the funding ban was put in place after a string of incidents involving avian flu and anthrax that raised concerns about the consequences of an accident occurring in a lab. Any research involving influenza, severe acute respiratory syndrome (SARS), or Middle East Respiratory Syndrome (MERS) viruses was blocked.

The issue has become a point of contention among members of the scientific community. While some argue that this work is an essential component of preparing for future pandemics, others maintain that the risks are too great.

“The public and regulators are looking for science-based advice, but, in this case, there is still considerable disagreement within the scientific community,” explained Daniel Rozell, a research assistant professor in the department of technology and society at Stony Brook University, in an email correspondence with Futurism.

“Furthermore, there is some unavoidable bias in the advice. Some of the virologists most acquainted with the specifics of the research have careers that depend on its continuance,” he said. “While they may have the best of intentions, there is still a tendency to underestimate familiar risks and to be partial towards one’s own efforts.”

RISK AND REWARD

When funding was paused in 2014, the NIH Office of Science Policy was tasked with carrying out a “comprehensive, sound, and credible” risk-benefit analysis to inform how the situation should be handled. Even this analysis proved contentious. However, risk assessments don’t just serve to determine whether or not the research can be carried out safely – they can establish best practices for doing so.

“A risk-benefit assessment is still a useful exercise because it can be used for risk exploration,” said Rozell. “When researchers are cognizant of the most likely hazards arising from a line of research, they can take steps to redesign the research to achieve the same outcome without the potential for unintended consequences.”

Research into pandemic pathogens could play a vital role in ensuring that we can respond appropriately to an outbreak – but it’s crucial that such research is carried out in such a way that it doesn’t end up causing the very situation it’s meant to address.

WHAT YOU NEED TO KNOW ABOUT EXTENSIVELY DRUG-RESISTANT TUBERCULOSIS


A woman with extensively drug-resistant tuberculosis (XDR TB) is currently being treated at the National Institute of Health as officials race to find anyone she might have exposed to the dangerous bacteria.

The patient has been in the U.S. for approximately six to seven weeks, traveling through three states – Illinois, Missouri and Tennessee – before being diagnosed, according to the U.S.Centers for Disease Control and Prevention.

The woman reportedly sought treatment for TB several times in India, but did not complete her treatment regimen, which can last months.

ABC News Chief Health and Medical Editor Dr. Richard Besser said not finishing a course of treatment is a common way this dangerous kind of TB can develop.

“This is a big deal and it’s not because this type of TB is more contagious but if you get this, 70 percent of the time it is fatal,” said Besser.

Extensively drug-resistant tuberculosis is a condition where TB bacteria have changed enough to circumvent the two most potent antibiotic medicines, as well as most others, according to the NIH website.

Once this form of TB develops, doctors are left with fewer treatment options to battle the disease.

The unnamed patient is currently being treated by Dr. Steven Holland, the chief of the National Institute of Allergy and Infectious Diseases, according to a statement from the NIH.

“The patient will likely receive drugs with activity against TB that he/she has not previously received,” NIH officials said in a statement. “We will confer with other XDR-TB experts, including those at CDC, to determine an optimal regimen.”

Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical School, said the arrival of XDR TB is “serious business.”

“We have to use combinations of drugs that are used less frequently, they may have more side effects and their effectiveness against TB bacteria is not quite as good or less certain,” Schaffner said of treating patients with this rarer form of TB.

This extreme form of TB is not more contagious but can be spread through prolonged close contact. Schaffner explained that a person can be more or less infectious depending on how the disease symptoms present.

“If the edges of your vocal chords are infected with TB you really aerosolize lots of TB bacteria,” said Schaffner, who said that happened in rare circumstances.

Tuberculosis can spread through coughs, sneezes, shouts or even singing, according to the CDC. Because it takes time for the bacteria to grow in the blood, health officials may test people multiple times to determine if they have developed the disease.

While there is a TB vaccine, it is not generally used in the U.S. due to its “limited effectiveness for preventing the most common forms of TB and in preventing TB in adults,” according to the CDC.

“The CDC will be figuring out who all those exposed people are,” said Schaffner. “And put them on a spectrum of likelihood of risk from trivial to much more serious.”

Cases of XDR TB are extremely rare in the U.S. and the NIH has admitted just about 20 patients with severe or resistant TB in the last 20 years.

Symptoms of the disease include weakness, weight loss, fever and night sweats. As the bacteria affect the lung patients may cough, have chest pain or cough up blood.

How Microbes in the Gut Influence Anxiety and Depression


We may not give much thought to the 100 trillion microbes living within our guts, but new discoveries within psychiatry have found that these organisms can profoundly affect our moods. In fact, psychiatrists are now exploring the possibility of manipulating these microscopic populations with the goal of treating clinical depression and anxiety — all without resorting to potentially harmful pharmaceutical drugs.

How Microbes in the Gut Influence Anxiety Depression 300x233 How Microbes in the Gut Influence Anxiety and Depression

The Mind-Gut Connection

The bidirectional link between the emotions and the gut is nothing new. Scientists have long known that the enteric nervous system (ENS) found within the gut is connected to the brain via the vagus nerve, and is so influential that it’s often referred to as the “second brain.” When we experience sadness, fear or another emotional state, the gut is affected. And yet, the reverse is also true. When imbalances within the gut are present, such as inflammation or an infection, our emotional state suffers as well.

Researchers have taken these findings a step further by examining how actual microbes within the gut alter behavior and mood. Premysl Bercik, an associate professor of gastroenterology at McMaster University, is one of the first scientists who made the leap from how microbiota impact gut function to how they shape emotions. Bercik realized that a significant portion of his patients were not only suffering from gastrointestinal maladies, but also substantial depression and anxiety.

Digging deeper, Bercik and his team discovered “mild gut inflammation caused by chronic parasitic infection… induces anxiety-like behavior in mice”. The following year (in 2011) the team published research that demonstrated how gut microbes influence behavior in mice. According to the AltNet piece, “How the Microbes Living in Your Gut Might Be Making You Anxious or Depressed”:

One study compared conventional and germ-free mice, finding behavioral and brain chemistry differences between the two groups.

They began with two different types of mice, Balb/c and NIH Swiss. Balb/c mice are traditionally timid and exhibit anxiety-like behavior, whereas NIH Swiss mice are known for being daring and adventurous. In addition to differing in behavior, these types of mice also differ in the composition of their gut microbes.

The scientists raised control mice of each type as well as germ-free mice of each type. When the mice reached adulthood, they colonized some of the Balb/c germ-free mice with normal Balb/c mouse gut microbes and they colonized another group with typical NIH Swiss mouse gut microbes. They did the same with the germ-free NIH Swiss mice.”

When “we colonized [them] with their own microbiota,” explains Bercik, they “basically reproduced the same behavior in the normal conventional mice.” Balb/c mice remained timid, and NIH Swiss mice remained daring “with a high exploratory drive”.

But when they colonized the Balb/c mice with NIH Swiss microbes, “they became more daring, their exploratory behavior increased. And the opposite happened with the other”. NIH Swiss mice colonized with Balb/c mouse microbes became more timid and anxious, “which would suggest that gut microbiota modulates or has an effect on behavior”.

Although still in its infancy, many in the psychiatric profession are taking this line of study to heart. Emily Deans, M.D., a psychiatrist in Massachusetts, reminds us that gut bacteria Lactobacillus and Bifidobacterium produce the chill-out neurotransmitter known as GABA, while Bacillus and Serratia produce dopamine — a neurotransmitter that activates the reward and pleasure centers of the brain. She admits that there is still much we don’t know about how microorganisms in the gut influence emotion and moods. Even so, there is enough solid evidence to support a daily habit of consuming probiotic-rich foods such as yogurt, kefir, kombucha and fermented vegetables — or a probiotic supplement — to encourage balanced moods and a bright outlook.

Sources for this article include:

U.S. government tried to cover up pandemic that killed 50 million


Have you noticed that, in the past few weeks, the mainstream media has stopped reporting on suspected cases of Ebola in the United States? That’s because they’ve been asked not to do so — at least until those suspected of having the virus test positive for it with a lab test. The implication is that the mainstream media — The Associated Press in particular — was asked to refrain from reporting on the suspected cases by the Obama Administration.

If so, that is far from the only example of federal government duplicity in dealing with pandemics and potential pandemics. As Washington’s Blog notes, citing a National Institutes of Health (NIH) report from 2005 called, “The Threat of Pandemic Influenza: Are We Ready?,” the 1918 Spanish Flu outbreak that killed 50 million people worldwide was mishandled badly by our government, and governments around the world.

The context of the outbreak is very noteworthy. The year, 1918, was the final year of World War I, a near-global conflict concentrated largely in Europe and the Near East which decimated entire populations and after which 37 million were dead, wounded or missing (not including civilian deaths). Entire cities laid in ruin; local and national economies were in a shambles.

‘The first casualty is truth’

According to the NIH report:

In the United States, national and local government and public health authorities badly mishandled the [1918 Spanish Flu] epidemic [which killed up to 50 million people worldwide], offering a useful case study. …

Every country engaged in World War I tried to control public perception. To avoid hurting morale, even in the nonlethal first wave the press in countries fighting in the war did not mention the outbreak. (But Spain was not at war and its press wrote about it, so the pandemic became known as the Spanish flu).

The United States was no different. In 1917, California Senator Hiram Johnson, an isolationist Progressive-Party-member-turned-Republican, stated: “The first casualty when war comes is truth.” At the time, Congress passed a measure, signed into law by President Woodrow Wilson, that made it punishable by up to 20 years in prison to “utter, print, write or publish any disloyal, profane, scurrilous, or abusive language about the government of the United States” — a blatant violation of the First Amendment’s free speech protections.

“One could go to jail for cursing or criticizing the government, even if what one said was true,” the NIH report said, noting that even a U.S. congressman was eventually put in jail for violating the law.

At the same time, the federal government launched a huge propaganda effort, which prompted one of the architects of it to remark, “Truth and falsehood are arbitrary terms…. There is nothing in experience to tell us that one is always preferable to the other…. The force of an idea lies in its inspirational value. It matters very little if it is true or false.”

As reported by Washington’s Blog, the NIH report further stated:

The combination of rigid control and disregard for truth had dangerous consequences. Focusing on the shortest term, local officials almost universally told half-truths or outright lies to avoid damaging morale and the war effort. They were assisted–not challenged–by the press, which although not censored in a technical sense cooperated fully with the government’s propaganda machine.

(Much like the press does today.)

Pattern was repeated in city after city

The result was that, as the Spanish Flu approached a city or town — “one could watch it march from place to place” — local officials initially advised the public not to be concerned, because public health officials would ensure that the town was protected from the virus.

When influenza appeared, officials almost always insisted it was the regular flu, not the feared and deadly Spanish Flu. And as the outbreak worsened, officials would advise the public, nearly every day, that the worst of it was past.

That pattern was repeated over and over again. Chicago is a case in point; the city’s public health commissioner said he would do “nothing to interfere with the morale of the community…. It is our duty to keep the people from fear. Worry kills more people than the epidemic.”

And that notion (“Fear kills more than the disease”) became the national mantra, in city after city.

Is the same pattern still being repeated, this time with the Ebola virus?

Learn all these details and more at the FREE online Pandemic Preparedness course at www.BioDefense.com

Sources:

http://www.washingtonsblog.com

http://www.nap.edu

http://www.poynter.org

http://www.washingtonsblog.com

http://science.naturalnews.com

Learn more: http://www.naturalnews.com/047560_pandemic_US_government_cover-up.html#ixzz3IUL32Wv0

Human trial of experimental Ebola vaccine begins this week


A highly anticipated test of an experimental Ebola vaccine will begin this week at the National Institutes of Health, amid mounting anxiety about the spread of the deadly virus in West Africa.

After an expedited review by the U.S. Food and Drug Administration, researchers were given the green light to begin what’s called a human safety trial, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

It will be the first test of this type of Ebola vaccine in humans.

The experimental vaccine, developed by the pharmaceutical company GlaxoSmithKline and the NIAID, will first be given to three healthy human volunteers to see if they suffer any adverse effects. If deemed safe, it will then be given to another small group of volunteers, aged 18 to 50, to see if it produces a strong immune response to the virus. All will be monitored closely for side effects.

The vaccine will be administered to volunteers by an injection in the deltoid muscle of their arm, first in a lower dose, then later in a higher dose after the safety of the vaccine has been determined.

Some of the preclinical studies that are normally done on these types of vaccines were waived by the FDA during the expedited review, Fauci said, so “we want to take extra special care that we go slowly with the dosing.”

The vaccine did extremely well in earlier trials with chimpanzees, Fauci said. He noted that the method being used to prompt an immune response to Ebola cannot cause a healthy individual to become infected with the virus.

Still, he said, “I have been fooled enough in my many years of experience… you really can’t predict what you will see (in humans).”

According to the NIH, the vaccine will also be tested on healthy volunteers in the United Kingdom, Gambia and Mali, once details are finalized with health officials in those countries.

CDC director raises Ebola alarm

Trials cannot currently be done in the four countries affected by the recent outbreak — Guinea, Sierra Leone, Liberia and Nigeria — because the existing health care infrastructure wouldn’t support them, Fauci said. Gambia and Mali were selected because the NIH has “long-standing collaborative relationships” with researchers in those countries.

According to the NIH, officials from the Centers for Disease Control and Prevention are also in talks with health officials from Nigeria about conducting part of the safety trial there.

Funding from an international consortium formed to fight Ebola will enable GlaxoSmithKline to begin manufacturing up to 10,000 additional doses of the vaccine while clinical trials are ongoing, the pharmaceutical company said in a statement. These doses would be made available if the World Health Organization decides to allow emergency immunizations in high-risk communities.

The GSK/NIAID vaccine is one of two leading candidate vaccines. The other was developed by the Public Health Agency of Canada and licensed this month to NewLink Genetics, a company based in Iowa.

According to the NIH, safety trials of that vaccine will start this fall.

Earlier this month, the Canadian government shipped what it said was “800 to 1,000” doses of that vaccine to Liberia, at the government’s request. It’s not clear whether it has been given to health workers or anyone else there.

Worth noting: In 2009, an earlier version of the vaccine was given to a lab worker in Germany after he thought he had pricked himself with a needle tainted with Ebola. He did not develop the disease.

While there currently is no proven treatment for Ebola beyond supportive care, government agencies and small biotech firms have been scrambling to speed up development of several potential therapies and vaccines.

A third vaccine, also developed by the NIH, was recently tested in primates and found to protect them from infection; it was given in combination with Depovax, an adjuvant that has been used with other vaccines and cancer therapies to boost the body’s immune response.

While vaccines might be given to prevent infection among health workers or other people thought to be at high risk, development has also been speeded up on drugs that might potentially be given to patients who already have the disease.

The drug that’s received the most attention is ZMapp, which has been given to at least seven individuals in the current outbreak, including two American missionary medical workers, Nancy Writebol and Dr. Kent Brantly.

The drug has never been formally tested in humans, and while the results in human patients are encouraging — five of the seven known to have received it are still alive — experts say there is too little data to say whether it played a role in their recoveries.

Are myths making the Ebola outbreak worse?

Earlier versions of ZMapp, which received backing from the U.S. and Canadian governments as well as from biotech firms, have shown some ability to protect rhesus macaque monkeys more than two days after they were infected with the virus.

Another drug, TKM-Ebola, has been tested for safety in a small number of humans. That trial was put on hold in January, after one volunteer developed moderate gastrointestinal side effects after receiving a high dose of the medication.

Last month, the FDA modified the hold to a “partial clinical hold.” In effect, this means that Tekmira could potentially be allowed to give the drug to doctors or hospitals who request it, on an emergency basis. There’s no indication that the company has received any such requests.

The vaccine going into trials this week is based on an adenovirus — a type of cold virus — that’s found in chimpanzees. The virus delivers genetic material derived from two species of Ebola virus, including the Zaire strain that’s responsible for the current outbreak. Those genes are meant to trigger the development of antibodies in the person who receives the vaccine, antibodies that can specifically defend against Ebola.

Another trial, using a version of the GSK/NIAID vaccine that uses only the Zaire strain of Ebola, will be launched in October, according to the NIH.

All participants in the trial will be evaluated nine times over a 48-week period. NIH expects to reveal the results of the trial by the end of the year.

If it’s approved for widespread use, the first priority will be to give the vaccine to health care workers or lab workers who are fighting the spread of the virus, Fauci said. It will then be considered for people in the communities where outbreaks occur.

NIH to Launch Human Safety Study of Ebola Vaccine Candidate.


Initial human testing of an investigational vaccine to prevent Ebola virus disease will begin next week by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The early-stage trial will begin initial human testing of a vaccine co-developed by NIAID and GlaxoSmithKline (GSK) and will evaluate the experimental vaccine’s safety and ability to generate an immune system response in healthy adults. Testing will take place at the NIH Clinical Center in Bethesda, Maryland.

The study is the first of several Phase 1 clinical trials that will examine the investigational NIAID/GSK Ebola vaccine and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. The others are to launch in the fall. These trials are conducted in healthy adults who are not infected with Ebola virus to determine if the vaccine is safe and induces an adequate immune response.

In parallel, NIH has partnered with a British-based international consortium that includes the Wellcome Trust and Britain’s Medical Research Council and Department for International Development to test the NIAID/GSK vaccine candidate among healthy volunteers in the United Kingdom and in the West African countries of Gambia (after approval from the relevant authorities) and Mali.

Additionally, the U.S. Centers for Disease Control and Prevention has initiated discussions with Ministry of Health officials in Nigeria about the prospects for conducting a Phase 1 safety study of the vaccine among healthy adults in that country.

The pace of human safety testing for experimental Ebola vaccines has been expedited in response to the ongoing Ebola virus outbreak in West Africa. According to the World Health Organization (WHO), more than 1,400 suspected and confirmed deaths from Ebola infection have been reported in Guinea, Liberia, Nigeria, and Sierra Leone since the outbreak was first reported in March 2014.

“There is an urgent need for a protective Ebola vaccine, and it is important to establish that a vaccine is safe and spurs the immune system to react in a way necessary to protect against infection,” said NIAID Director Anthony S. Fauci, M.D. “The NIH is playing a key role in accelerating the development and testing of investigational Ebola vaccines.”

“Today we know the best way to prevent the spread of Ebola infection is through public health measures, including good infection control practices, isolation, contact tracing, quarantine, and provision of personal protective equipment,” added Dr. Fauci. “However, a vaccine will ultimately be an important tool in the prevention effort. The launch of Phase 1 Ebola vaccine studies is the first step in a long process.”

“Tried and true public health interventions, strong supportive medical care and the rapid testing of Ebola vaccines and antiviral treatments can help to reduce suffering now and in the future,” said CDC Director Thomas R. Frieden, M.D., M.P.H.

The investigational vaccine now entering Phase 1 trials was designed by Nancy J. Sullivan, Ph.D., chief of the Biodefense Research Section in NIAID’s Vaccine Research Center (VRC). She worked in collaboration with researchers at the VRC, the U.S. Army Medical Research Institute of Infectious Diseases, and Okairos, a Swiss-Italian biotechnology company acquired by GSK in 2013.

Phase 1 clinical trials are the first step in what is typically a multi-stage clinical trials process). During Phase 1 studies, researchers test an investigational vaccine in a small group of people to evaluate its safety and the immune response it provokes. Phase 2 clinical trials of investigational vaccines are designed to further assess safety and immune response in larger numbers of volunteers. Under certain circumstances, the vaccine’s ability to prevent infection or disease (called efficacy) can be determined in a Phase 2 trial. Phase 3 clinical trials are directed predominantly at determining efficacy.

The NIAID/GSK Ebola vaccine candidate is based on a type of chimpanzee cold virus, called chimp adenovirus type 3 (ChAd3). The adenovirus is used as a carrier, or vector, to deliver segments of genetic material derived from two Ebola virus species: Zaire Ebola and Sudan Ebola. Hence, this vaccine is referred to as a bivalent vaccine. The Zaire species of the virus is responsible for the current Ebola outbreak in West Africa.

The vaccine candidate delivers one part of Ebola’s genetic material to human cells, but the adenovirus vector does not replicate. Rather, the Ebola gene that it carries allows the cells of the vaccine recipient to express a single Ebola protein, and that protein prompts an immune response in the individual. It is important to know that the Ebola genetic material contained in the investigational vaccine cannot cause a vaccinated individual to become infected with Ebola.

“The experimental NIAID/GSK vaccine performed extremely well in protecting nonhuman primates from Ebola infection,” Dr. Fauci noted.

The candidate vaccine builds upon three earlier NIAID-developed investigational Ebola vaccines that began Phase 1 clinical trial testing in 2003.

“The knowledge gained from each of those trials has contributed to the development of the candidate vaccine we are now studying, as well as our improved understanding of human immune responses to investigational Ebola vaccines,” said John R. Mascola, M.D., director of NIAID’s Vaccine Research Center.

The Phase 1 clinical trial, called VRC 207, will be led by principal investigator Julie E. Ledgerwood, D.O., chief of the VRC’s clinical trials program, and will be conducted among 20 healthy adults ages 18 to 50 years. Participants will be divided into two groups of 10 participants each. One group will receive an intramuscular injection of the NIAID/GSK experimental vaccine. The second group will receive a single injection of the same vaccine but at a higher dose.

A number of safety features are built into the study’s design, including daily and weekly reviews of patient data by clinical staff and the study protocol team. Additionally, the trial features a staged enrollment plan that requires interim safety reviews after three participants have been vaccinated and have undergone three days of follow up before enrolling additional study participants into the group. Participants in both groups will be seen and evaluated by clinical staff nine times over a 48-week period.

Additional Phase 1 Tests of the NIAID/GSK Vaccine

As part of the VRC 207 trial, NIAID will also test a version of the NIAID/GSK vaccine that contains genetic material from only the Zaire Ebola species. Hence, this vaccine is referred to as a monovalent vaccine. This portion of the Phase 1 safety study, which will also involve 20 healthy adults, is expected to begin in October at the NIH Clinical Center and potentially another U.S. location. Dr. Ledgerwood will also lead that effort. The VRC 207 clinical trial is being conducted based on expedited review and approval by the U.S. Food and Drug Administration.

In parallel, NIH has partnered with an international consortium that includes the British-based Wellcome Trust, as well as Britain’s Medical Research Council and Department for International Development to test the same NIAID/GSK monovalent vaccine candidate. The vaccine candidate will be tested among 60 healthy volunteers at the University of Oxford in England and among 40 healthy volunteers in Mali by the University of Maryland School of Medicine Center for Vaccine Development and its Center for Vaccine Development in Mali (a joint enterprise of the University of Maryland School of Medicine and the Ministry of Health of Mali). Additionally, the vaccine candidate is expected to be tested among 40 healthy volunteers in Gambia after approval from the relevant authorities.

The Oxford trial is expected to launch in mid-September pending ethical and regulatory approval.

“Today’s announcement shows how private and public partners can pull together to quickly respond to this critical public health emergency. Developing a new vaccine is complex with no guarantees of success, and we are still in the early days for our Ebola vaccine candidate. But we are encouraged by progress so far and will do the best we can, along with WHO and our partners, to speed up development and explore ways in which the vaccine could contribute to this or future Ebola outbreaks,” said Dr. Moncef Slaoui, chairman of Global R&D and Vaccines at GSK.

Initial safety and immunogenicity data from the Phase 1 trials of the NIAID/GSK investigational Ebola vaccine are expected in late 2014.

Vesicular Stomatitis Virus (VSV) Ebola Vaccine Testing

The NIH will also collaborate with the U.S. Department of Defense in support of efforts by NewLink Genetics Corp., a biopharmaceutical company in Ames, Iowa, to conduct Phase 1 safety studies of the investigational recombinant vesicular stomatitis virus Ebola vaccine (called VSV-EBOV) developed by and licensed from the Public Health Agency of Canada. Those clinical trials are expected to begin in the fall at the Clinical Trials Center of Walter Reed Army Institute of Research in Silver Spring, Maryland.

For more information about these early-stage Ebola vaccine clinical trials, see Questions and Answers: Phase 1 Clinical Trials of NIAID/GSK Investigational Ebola Vaccine.

NIH study finds regular aspirin use may reduce ovarian cancer risk.


Women who take aspirin daily may reduce their risk of ovarian cancer by 20 percent, according to a study by scientists at the National Cancer Institute (NCI), part of the National Institutes of Health. However, further research is needed before clinical recommendations can be made. The study was published Feb. 6, 2014, in the Journal of the National Cancer Institute.

It is estimated that over 20,000 women in the United States will be diagnosed with ovarian cancer in 2014, and more than 14,000 will die from the disease. Early stage ovarian cancer may be successfully treated. However, symptoms associated with this disease can mimic more common conditions, such as digestive and bladder disorders, so for this reason and others, it is often not diagnosed until it has reached advanced stages. Late stage ovarian cancer leaves women with limited treatment options and poor prognoses, making preventive strategies potentially important for controlling this disease.

Chronic or persistent inflammation has been shown to increase the risk of cancer and other diseases. Previous studies have suggested that the anti-inflammatory properties of aspirin and non-aspirin NSAIDs (non-steroidal anti-inflammatory drugs), may reduce cancer risk overall. However, studies examining whether use of these agents may influence ovarian cancer risk have been largely inconclusive. This is the largest study to date to assess the relationship between these drugs and ovarian cancer risk.

Britton Trabert, Ph.D., and Nicolas Wentzensen, M.D., Ph.D., of NCI’s Division of Cancer Epidemiology and Genetics, and their colleagues, analyzed data pooled from 12 large epidemiological studies to investigate whether women who used aspirin, non-aspirin NSAIDs, or acetaminophen have a lower risk of ovarian cancer. These 12 studies (nine from the United States) were part of the Ovarian Cancer Association Consortium. The scientists evaluated the benefit of these drugs in nearly 8,000 women with ovarian cancer and close to 12,000 women who did not have the disease.

Among study participants who reported whether or not they used aspirin regularly: 18 percent used aspirin, 24 percent used non-aspirin NSAIDs, and 16 percent used acetaminophen. The researchers determined that participants who reported daily aspirin use had a 20 percent lower risk of ovarian cancer than those who used aspirin less than once per week. For non-aspirin NSAIDs, which include a wide variety of drugs, the picture was less clear: the scientists observed a 10 percent lower ovarian cancer risk among women who used NSAIDs at least once per week compared with those who used NSAIDs less frequently. However, this finding did not fall in a range that was significant statistically. In contrast to the findings for aspirin and NSAIDs, use of acetaminophen, which is not an anti-inflammatory agent, was not associated with reduced ovarian cancer risk.

This study adds to a growing list of malignancies, such as colorectal and other cancers, that appear to be potentially preventable by aspirin usage. “Our study suggests that aspirin regimens, proven to protect against heart attack, may reduce the risk of ovarian cancer as well. However intriguing our results are, they should not influence current clinical practice. Additional studies are needed to explore the delicate balance of risk-benefit for this potential chemopreventive agent, as well as studies to identify the mechanism by which aspirin may reduce ovarian cancer risk,” said Trabert.

Adverse side effects of daily aspirin use include upper gastrointestinal bleeding and hemorrhagic stroke. Therefore, a daily aspirin regimen should only be undertaken with a doctor’s approval, caution the scientists.

Metreleptin improved metabolic parameters in children with lipodystrophy .


Positive results from an NIH-supported analysis indicate an investigational recombinant analogue of human leptin has potential as a therapy for pediatric lipodystrophy, according to data presented at the 2013 Pediatric Academic Societies Annual Meeting.

The literature has established that lipodystrophy is known to cause metabolic abnormalities (ie, hypertriglyceridemia, insulin resistance, diabetes andsteatohepatitis), which tend to become severe through childhood and adolescence, and may be resistant to current treatment options.

Rebecca Brown, MD, assistant clinical investigator of the diabetes, endocrinology and obesity branch at the National Institute of Diabetes and Digestive and Kidney Diseases, and colleagues included pediatric patients in an ongoing, open-label study at the NIH (2000 to present).

According to abstract data, patients included in the study (n=39; nine male and 30 female; mean age, 11.9 years) had four subtypes of the disease: congenital generalized lipodystrophy (n=26, 67%), acquired generalized lipodystrophy (n=9, 23%), familial partial lipodystrophy (n=2, 5%), and acquired partial lipodystrophy (n=2, 5%).

On average, the researchers administered metreleptin 4.4 mg (Bristol-Myers Squibb and AstraZeneca) subcutaneously once or twice daily for a mean duration of 3.9 years.

Data indicate that baseline HbA1c (9.8%) decreased significantly to 7.7% after 12 months (–2.3; 95% CI, –3.2 to –1.4) in adolescent patients aged 12 to 18 years.

Triglycerides were notably high in the same group at baseline (1,378 mg/dL), but improved significantly to 385 mg/dL after 12 months (–44; 95% CI, –73 to –15), according to data.

Both age groups displayed significantly elevated mean alanine aminotransferase (ALT; ≤12 years: 193 U/L; adolescents: 105 U/L) and aspartate aminotransferase (AST; ≤12 years: 119 U/L; adolescents: 87 U/L) at baseline. However, ALT (≤12 years: 155 U/L; adolescents: 59 U/L) and AST (≤12 years: 90 U/L; adolescents: 57 U/L) decreased after metreleptin therapy, according to data.

“Metabolic disorders resulting from lipodystrophy can develop in childhood and adolescence and are exacerbated over time,” Brown said in a press release. “This new analysis supports the continued study of investigational metreleptin as a potential treatment option for pediatric patients with lipodystrophy.”

Overall, metreleptin was well tolerated, and the most common adverse events reported were decreased weight (n=3, 7.7%) and hypoglycemia (n=3, 7.7%), followed by fatigue (n=2, 5.1%) and nausea (n=2, 5.1%), the researchers wrote.

According to the press release, metreleptin has acquired orphan designation from the FDA, and the European Medicines Agency is evaluating the agent.

  • o    Source: Endocrine Today

 

Metreleptin improved metabolic parameters in children with lipodystrophy.


Positive results from an NIH-supported analysis indicate an investigational recombinant analogue of human leptin has potential as a therapy for pediatric lipodystrophy, according to data presented at the 2013 Pediatric Academic Societies Annual Meeting.

The literature has established that lipodystrophy is known to cause metabolic abnormalities (ie, hypertriglyceridemia, insulin resistance, diabetes andsteatohepatitis), which tend to become severe through childhood and adolescence, and may be resistant to current treatment options.

Rebecca Brown, MD, assistant clinical investigator of the diabetes, endocrinology and obesity branch at the National Institute of Diabetes and Digestive and Kidney Diseases, and colleagues included pediatric patients in an ongoing, open-label study at the NIH (2000 to present).

According to abstract data, patients included in the study (n=39; nine male and 30 female; mean age, 11.9 years) had four subtypes of the disease: congenital generalized lipodystrophy (n=26, 67%), acquired generalized lipodystrophy (n=9, 23%), familial partial lipodystrophy (n=2, 5%), and acquired partial lipodystrophy (n=2, 5%).

On average, the researchers administered metreleptin 4.4 mg (Bristol-Myers Squibb and AstraZeneca) subcutaneously once or twice daily for a mean duration of 3.9 years.

Data indicate that baseline HbA1c (9.8%) decreased significantly to 7.7% after 12 months (–2.3; 95% CI, –3.2 to –1.4) in adolescent patients aged 12 to 18 years.

Triglycerides were notably high in the same group at baseline (1,378 mg/dL), but improved significantly to 385 mg/dL after 12 months (–44; 95% CI, –73 to –15), according to data.

Both age groups displayed significantly elevated mean alanine aminotransferase (ALT; ≤12 years: 193 U/L; adolescents: 105 U/L) and aspartate aminotransferase (AST; ≤12 years: 119 U/L; adolescents: 87 U/L) at baseline. However, ALT (≤12 years: 155 U/L; adolescents: 59 U/L) and AST (≤12 years: 90 U/L; adolescents: 57 U/L) decreased after metreleptin therapy, according to data.

“Metabolic disorders resulting from lipodystrophy can develop in childhood and adolescence and are exacerbated over time,” Brown said in a press release. “This new analysis supports the continued study of investigational metreleptin as a potential treatment option for pediatric patients with lipodystrophy.”

Overall, metreleptin was well tolerated, and the most common adverse events reported were decreased weight (n=3, 7.7%) and hypoglycemia (n=3, 7.7%), followed by fatigue (n=2, 5.1%) and nausea (n=2, 5.1%), the researchers wrote.

According to the press release, metreleptin has acquired orphan designation from the FDA, and the European Medicines Agency is evaluating the agent.

For more information:

Brown R. #3490.3. Presented at: Pediatric Academic Societies Annual Meeting; May 4-7, 2013; Washington.

Source: Endocrine today