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Zika Vaccine Enters Clinical Trials

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As the first local mosquito-borne transmissions of the Zika virus are being reported in the continental United States, an investigational vaccine developed by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) is entering phase 1 clinical trials.

 
Health Agencies Update |

Zika Vaccine Enters Clinical Trials FREE

Jennifer Abbasi
JAMA. 2016;316(12):1249. doi:10.1001/jama.2016.12760.
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As the first local mosquito-borne transmissions of the Zika virus are being reported in the continental United States, an investigational vaccine developed by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) is entering phase 1 clinical trials.

 
 

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An investigational Zika vaccine developed by NIAID and the NIH enters phase 1 clinical trials.

NIAID

At least 80 people between the ages of 18 and 35 years will be enrolled in the trial, which will take place at 3 study sites in the United States including the NIH Clinical Center in Bethesda, Maryland. The trial will test vaccine safety and immunogenicity.

Scientists at NIAID’s Vaccine Research Center developed the DNA vaccine, which does not contain Zika virus and therefore cannot cause an infection. The vaccine contains a genetically engineered plasmid—a small, circular piece of DNA—that encodes Zika virus proteins. These proteins assemble into viruslike particles that provoke an immune response against the virus. This response is composed of both neutralizing antibodies and T cells.

“NIAID worked expeditiously to ready a vaccine candidate, and results in animal testing have been very encouraging,” NIAID Director Anthony S. Fauci, MD, said in a statement (http://bit.ly/2bwrFDP). “Although it will take some time before a vaccine against Zika is commercially available, the launch of this study is an important step forward.”

Trial participants will be followed up for 2 years. A phase 2 trial in Zika-endemic countries is planned for early 2017, depending on the early results of the current trial.

NIAID is also supporting several other Zika vaccine candidates. NIAID will fund phase 1 trials of a whole-particle inactivated Zika virus vaccine developed at the Walter Reed Army Institute of Research, 2 of which will launch this fall and in early 2017.

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Scientists have finally figured out how cancer spreads through the bloodstream

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In what could be a major step forward in our understanding of how cancer moves around the body, researchers have observed the spread of cancer cells from the initial tumour to the bloodstream.

The findings suggest that secondary growths called metastases ‘punch’ their way through the walls of small blood vessels by targeting a molecule known as Death Receptor 6 (no, really, that’s what it’s called). This then sets off a self-destruct process in the blood vessels, allowing the cancer to spread

According to the team from Goethe University Frankfurt and the Max Planck Institute in Germany, disabling Death Receptor 6 (DR6) may effectively block the spread of cancerous cells – so long as there aren’t alternative ways for the cancer to access the bloodstream.

“This mechanism could be a promising starting point for treatments to prevent the formation of metastases,” said lead researcher Stefan Offermanns.

Catching these secondary growths is incredibly important, because most cancer deaths are caused not by the original tumour, but by the cancer spreading.

To break through the walls of blood vessels, cancer cells target the body’s endothelial cells, which line the interior surface of blood and lymphatic vessels. They do this via a process known as necroptosis – or ‘programmed cell death’ – which is prompted by cellular damage.

According to the researchers, this programmed death is triggered by the DR6 receptor molecule. Once the molecule is targeted, cancer cells can either travel through the gap in the vascular wall, or take advantage of weakening cells in the surrounding area.

cancer-2MPI for Heart and Lung Research

The team observed the same behaviour in both lab-grown cells and mice. In genetically modified mice where DR6 was disabled, less necroptosis and less metastasis was recorded.

The scientists have reported their findings in Nature.

The next step is to look for potential side effects caused by the disabling of DR6, and to figure out if the same benefits can be seen in humans. If so – and there’s no guarantee of that – this has the potential to be a seriously effective way of slowing down the spread of cancer. 

There are other hypotheses on how some metastases get around the body to cause secondary growths, though. Scientists at the University of California, Los Angeles (UCLA) are currently investigating the idea that tumour cells could also spread through the body outside blood vessels and the bloodstream.

The researchers suggest that a mechanism known as angiotropism could be used by some melanoma cancers to cling to the outside of blood vessels, rather than penetrating them. If this is confirmed, they would escape the effects of disabled DR6 and chemotherapy alike.

“If tumour cells can spread by continuous migration along the surfaces of blood vessels and other anatomical structures such as nerves, they now have an escape route outside the bloodstream,” explained researcher Laurent Bentolila from UCLA. 

The findings from that research, also conducted on mice, have been published in Nature Scientific Reports.

As the two studies show, not all cancers behave in the same way, which makes figuring out how they operate doubly difficult. But the more we come to appreciate how complex and varied this disease can be, the better chance we have of fighting it.

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India has a massive antibiotic resistance problem, and it’s up to the states to solve it

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India has a massive antibiotic resistance problem, and it's up to the states to solve it

On September 21, United Nations had a high-level meeting on antimicrobial resistance, which required commitments from heads of state to address the causes of antimicrobial resistance. The declaration resulted from the meeting also requires countries to come up with a two-year plan to curb the use of antibiotics in humans, animals and agriculture.

The pressure is on India, the world’s largest consumer of antibiotics and where carelessness in antibiotic use and environmental antibiotic pollution has been documented.

While the government drafted policy measures to tackle the problem, it has not been so forthcoming on the issue.

In 2010, when the Lancet published a study identifying an enzyme that rendered bacteria resistant to broad spectrum of antibiotics as New Delhi Metallo-beta-lactamase-1, it raised the hackles of the Indian government. The authors had said that they detected the bacteria in patients from the United Kingdom who had been to India and Pakistan for treatments. The health ministry described the report as “malicious propaganda” at the time.

The following year, though, the health ministry released a policy document, the National Policy for Containment of Antimicrobial Resistance. However, little was done to implement the policy.

In August 2012, all major medical societies of India got together in Chennai to formulate a roadmap to tackle the challenge of drug resistance in India. The stakeholders, including policy makers, adopted a document called Chennai Declaration.

Just a year before the Chennai Declaration was formulated, the medical community and other organisations were dragging their heels on antimicrobial resistance, said Dr Abdul Ghafur, who co-ordinated the historic Chennai meeting. “It was a topic of stigma for everyone,” he said. “But for me, and other clinicians, management of patients was becoming very difficult. I am an infection expert in a cancer centre. I see people die everyday because of drug resistance. They are the worst hit in this crisis.”

At the time, no politician or pharmaceutical company came forward to support the cause.

In the past few years, the government has taken some steps to tackle the problem. In February this year, Union Health Minister JP Nadda launched a multimedia campaign called “Medicines with the Red Line” to raise awareness on the rational use of medicines which carry a red line on their strip. This was the first mass campaign by the government that acknowledged the public health crisis and attempted to address the issue.

Advisory from the Ministry of Health and Family Welfare.
Advisory from the Ministry of Health and Family Welfare.

While there are some policy level changes, the government is not committing to implementing these policies at the international level.

“We have not made any promises,” said Dr Jagdish Prasad, director-general of health services, referring to the commitment made at the United Nations high-level meeting. “In such a big nation, we cannot promise anything. We have promised surveillance, which we will follow through.”

Hospital surveillance

Prasad was referring to surveillance of hospital acquired infections conducted in 10 hospitals across the country by both the health department and by the Indian Council for Medical Research.

Hospital acquired infections refer to infections that develop as a direct result of healthcare interventions such as medical or surgical treatment or from being in contact with a healthcare setting. Surveillance would include monitoring the infection levels, their impact, and the intervention at various healthcare facilities.

The initial results of the survey are not good, Prasad said. While not disclosing more details, he said that the surveillance showed the presence of several bacteria in hospitals there are resistant to drugs. The health department has released hospital infection control guidelines and standard treatment guidelines, which are available online. They are also holding workshops for doctors from secondary and tertiary level hospitals.

 

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“We will also start an awareness multimedia campaign for the public soon,” said Prasad.

In 2013, the Drugs and the Cosmetics Act has already introduced schedule H1 for third and fourth generation antibiotics for which the chemist has to maintain prescription records for a period of three years, which is open to inspection. There were already some drugs on schedule X that could only be stored in hospitals, and not be sold over the counter.

States not proactive

While the Centre can make policies and educate the states, it is finally up to the state administration to take up the cause. Health is on the state list and the final implementation of any policy is done by the states.

“We have put out guidelines for them,” said Prasad. “But implementation is very messy in this country. The state health secretaries keep changing.”

Whether it is the rational use of antibiotics, restriction of over-the-counter drug dispensation, self medication, or controlling the use of antibiotics to raise animals, the state has to take a stronger stand.

“With respect to state implementation, we see the maximum resistance,” said Ghafur. “If we go to the district level, there will be even amore resistance. We have to communicate with the grass root level people.”

The lack of medical education poses yet another problem. “You can pass a masters in medicine without answering a single question on antibiotics,” said Dr Chand Wattal, senior microbiologist with Sir Ganga Ram Hospital in Delhi. Wattal has conducted research in the area of drug resistance and was also part of the committee that drafted the 2011 policy.

There is some resistance from the unexpected quarters, like pharmacists. In Maharashtra, the pharmacists went on strike several times opposing the stringent implementation of antibiotic regulations, including that of the need for a pharmacist in each chemist shop.

Prasad said that formulating a law can also be completely useless in this respect. “We passed the Clinical Establishment Act in the Centre. Very few states have adopted it,” he said.

Kerala leads the way

The only way forward, Prasad observed, is to “educate, educate and educate.”

Some states though, have taken some initiative.

“Kerala came up with an antibiotic plan this year, Tamil Nadu is thinking of one, Sikkim knows that they have a hospital infection problem that politicians are very well aware of,” said Dr Ramanan Laxminarayan, Director of the Center for Disease Dynamics, Economics & Policy in Washington DC and Distinguished Professor at the Public Health Foundation of India, Delhi. “So we need to think of ways to bring this to the forefront, think of what the options are and act on them.”

Kerala seems ahead of others in this respect and has released a plan in January this year. For a few years now, Ghafur and Dr Sanjeev Singh, the medical superintendent of Amrita Medical Sciences in Kochi, have been lobbying with the government to take this issue seriously. The authorities have taken note.

“We have a five-pronged approach to tackle the problem,” said Singh. “We are training undergraduate, graduates, and postgraduates to understand the rational use of antibiotics and sensitising them about good practice. We are also training eight doctors in each district who in turn will train other doctors. We are also going to educate the patients and tell them that they do not need antibiotics for vomiting and diarrhoea.”

On September 23, 35 medical colleges changed their curriculum to include antibiotic stewardship, a programme that works for rational use of antibiotics.

For any policy against antibiotic resistance to work, there has to be multi-sectoral engagement of various departments including education, sanitation, animal husbandry, agriculture, and health among others. The key to tackling the issue head on is to engage politicians, feels Ghafur.

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This portable vaccine kit just needs added water

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Even when the right drugs are available, they can’t always get to the people who need them the most – but this new portable vaccine kit could help.

The pack works by holding freeze-dried pellets that form the basis of several vital medicines, but the real advantage is that no power or refrigeration is required. You just need to add water, and the drugs and vaccines are ready to be administered.

A team from the Wyss Institute at Harvard University has published a paper on their newly developed method, which they’ve called ‘portable biomolecular manufacturing’. The trick is not storing the drugs themselves, but storing their raw ingredients.

“The ability to synthesise and administer biomolecular compounds, anywhere, could undoubtedly shift the reach of medicine and science across the world,” said the study’s senior author, James Collins.

There are two parts to the kit: one holds pellets containing the chemical machinery that synthesises the end product, and the other holds pellets containing DNA instructions that tell the drug which compound to create.

Mix two parts together in a chosen combination, add water, and the treatment is ready.

All kinds of drugs could be created, said the team: tetanus and flu shots, vaccines against emerging outbreaks of disease, antimicrobial peptides to treat flesh wounds, and more.

drugs-2A mock-up kit created by the researchers. Credit: Wyss Institute

In the study itself, the researchers were able to synthesise a vaccine against diphtheria.

When you think about how hard it is to not only get access to, but keep fresh, these treatments far away from hospitals or even power sources (perhaps in the wake of a natural disaster), you can see how vital such a kit might be.

Medicines like this typically need an uninterrupted chain of cold refrigeration at every stage of the transport and storage process.

“This approach could – with very little training – put therapeutics and diagnostic tools in the hands of clinicians working in remote areas without power,” added one of the researchers, Keith Pardee, now at the University of Toronto.

The work builds on previous research by the same team that showed how this type of portable cell synthesising could happen outside of a living organism.

Not only are the pellets extremely stable and able to survive for at least a year at room temperature, they’re also very cheap to produce. A kit like the mock-up one produced by the Wyss Institute team could be distributed well in advance of any outbreak.

According to the World Health Organisation, more than half of the people sharing our planet live in rural areas. UNICEF statistics show that over 20 million infants didn’t get basic vaccination treatments for measles last year.

And it’s not just Earth where a kit like this could be useful – one day, it might even be used in space, say the researchers. If you ever get the chance to travel to Mars, look out for one in your astronaut pack.

The study has been published in Cell.

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No more misleading advertisements and telemarketting of AYUSH drugs

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The Union government is concerned over the misleading advertisements, tele-marketing, multi-level marketing, direct selling and e-tailing of Ayush drugs which are posing new challenges. The advertisements with tall claims are seen to lure desperate patients.

In this regard, Union Minister of State for Ayush Shripad Yesso Naik stated that efforts to amend the Drugs and Magic Remedies Act were underway. “The Law department has already approved it. Medicines sold through such advertisements while misguiding the public ought to be stopped,” the minister said during the recently concluded BRICS conference in Bengaluru.

Concurring with the minister was Maharashtra governor Vidyasagar Rao who expressed concern over the fact that many ayurvedic and traditional medicines were being sold in the market through commercial advertisements in media claiming to cure diseases like diabetes without scientific evidence or clinical trials to support the claims. He further appealed that the government must take strict action against such advertisers to protect public interests.

“Now the medical and scientific experts in the Aysuh sector  have the  responsibility to preserve legacy and ensure that its credibility is not compromised for cheap publicity or short term economic gains. In the long run such inept efforts are likely to bring disrepute to Indian traditions and knowledge heritage. The traditional knowledge systems like Ayurveda, Siddha and Unani are deeply rooted in Indian culture,” said Prof. Bhushan Patwardhan, Professor, Interdisciplinary School of Health Sciences and director, Center for Complementary and Integrative Health (CCIH), Savitribai Phule Pune University.

Now the government regulations and surveillance are required to ensure that gullible patients are not exploited. What is being sporadically done under the pretext of herbal drug development is certainly not in line with the basic principles, ethos and practice of Indian traditions. It is hoped that the new Consumer Protection Act 2015 Bill is cleared soon and the law will take strict course to put a stop to blatant cheating through misleading commercial advertisements claiming cure for many incurable diseases,” noted Prof. Patwardhan in the Journal of Ayurveda and Integrative Medicine 2016.

The country requires assured quality, safe, affordable and effective ASU drugs. Globally, there is increasing consensus among scientific community that mere pharmacological interventions with drugs are not sufficient for management of non communicable diseases (NCDs). The physiological interventions through lifestyle and behavioural modifications are gaining much more recognition. Health protection, disease prevention and simple yet effective medicines are the real strengths of Aysuh systems. The ASU community has unique leadership opportunity to offer novel healthcare models through yoga, meditation, panchakarma and principles of swasthavritta for safer and affordable public health to the Indian and global community, added Prof. Patwardhan.

Ayurveda has huge potential for natural product drug discovery of the new phyto-actives as novel chemical scaffolds. Admittedly, scientifically robust path of discovery and development of evidence based ASU drugs is not an easy task, he pointed out in his article on ‘Ayurvedic drugs in case: claims, evidence, regulations and ethics’ in JAIM.

There is need to opt for robust documentation of prevailing practices to show tangible benefits of ayurvedic drugs in clinical management of diseases. This approach should bring clinical experiences, case records, and textual information from classical traditional practice as an evidence of benefits. Such efforts could stall creation of misleading ads as Ayush drugs will be backed by evidence based systems which will be in place, said Prof. Patwardhan.

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