TOP CRO in India
2020 has not been a good year for mental health. The emergence of a global pandemic has left many people fearing for their lives, stressing over their finances, panicking over the news, and yearning for their loved ones.
While we’re still not sure what the mental health toll will be, the World Health Organisation expects levels of loneliness, depression, harmful alcohol and drug use, and self-harm or suicidal behaviour to rise.
Of all the nations in the world, New Zealand took some of the fastest and most drastic measures to COVID-19. And while this ‘go early, go hard’ strategy saved many lives and ultimately eliminated the virus, the successful measures also came with their costs – not just to the economy but also to public wellbeing.
Roughly halfway through New Zealand’s toughest stage of lockdown, which lasted for 33 days, a public survey saw levels of stress, anxiety, and depression rise higher than normal, especially among younger people.
Among the 2,010 respondents, nearly a third scored above the cut-off for moderate to severe psychological distress, and almost 40 percent said their level of wellbeing was low.
It’s worth noting the study couldn’t distinguish whether it was the lockdown itself that was causing the mental health effects or the broader threat of the pandemic, but it still shows a worrying trend.
“New Zealand’s lockdown successfully eliminated COVID-19 from the community, but our results show this achievement brought a significant psychological toll,” says psychologist Susanna Every-Palmer from the University of Otago, Canada.
“Substantially increased rates of distress were seen among those who reported having lost their jobs or experienced a reduction in work as a result of the pandemic, those who had potential vulnerabilities to COVID-19, or identified their health status as poor, and those who had a past diagnosis of a mental illness.”
On the whole, it was younger people, between the ages of 18 and 24, who appeared to have the toughest time, with almost half receiving a score well above the threshold for moderate psychological distress.
Older folks, on the other hand, seemed to weather the storm much easier, despite being more at risk from the virus and despite being less connected online as a group.
“This is not to say older people were unscathed,” the authors explain.
“In our survey, psychological distress was more prevalent among people of all age groups when compared with prevalence in the same age bracket in the NZ Health Survey.”
But younger age groups appear particularly vulnerable. This could be because lockdown coincided with fewer daily disruptions and economic impacts for different age groups.
When over 90 percent of the world’s students have been impacted by pandemic closures, it makes sense that young people seem to be suffering the most in initial psychological research.
New Zealand’s strictest lockdown only lasted for 33 days, with all schools and non-essential businesses shut down and people told to stay at home. That’s a very different scenario to what’s happening in the US and many other parts of the world, with lockdowns stopping and starting and dragging on for months. But while it’s true New Zealand ultimately eliminated the virus, at the time of the survey no one knew that would be the case.
One of the most worrisome findings has to do with women. Unfortunately, while reducing movement and keeping people in the home can save lives in a pandemic, it can also put lives at risk. Consistent with local media reports, the survey found domestic violence had risen during New Zealand’s lockdown.
Reported levels of physical assault, sexual assault, harassment, and intimidation in the home were between three and four times higher than normal, according to the survey, matching a similar rise in domestic abuse the world over as lockdown measures continue.
The survey sounds like a lot of bad news when the world really doesn’t need any more, but there are some reasons to remain hopeful. Not only was New Zealand’s strict lockdown shortened by its success, the majority of respondents in the survey said they could see the positives of remaining in isolation, whether it be for themselves or for society.
Even in parts of the world where lockdown likely won’t eliminate the virus, isolation measures have helped reduce its spread and save lives.
In New Zealand, for instance, working from home, spending more time with family, and living in a quieter environment reportedly gave people the opportunity to pause, reflect and consider their priorities, according to the survey.
Obviously, there’s only so long you can do this before the novelty starts to wear off, and it’ll be interesting to note how mental health is impacted by longer lockdowns in other parts of the world.
Research has only just started, but a recent survey in the United States found a modest negative impact across the board in the early months of the pandemic, with younger adults and those with pre-existing health conditions reporting more psychological distress.
But positively, in this study participants generally felt better at the end of the research than they had at the beginning, which suggests lockdown may take some getting used to.
It might even be helping us cope with the stress of the pandemic. The same survey found hand-washing, social distancing, and masking were associated with better mental health.
In some ways, it’s easier to blame all our frustrations on the lockdown instead of the virus itself, but in reality, it’s hard to say how the world would be faring mentally if we weren’t taking any public health measures during a pandemic.
“It is clear that the consequences of the pandemic will be pervasive and prolonged,” says Every-Palmer.
“Governments should make providing mental health support a similar priority to other health measures, such as contact tracing, provision of personal protective equipment, and procurement of ventilators,” she adds.
The study was published in PLOS One.
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Diabetologists look to newer drugs that enhance insulin producing cells as diabetes becomes a concern
Diabetologists are looking at newer drugs that enhance insulin producing cells as diabetes becomes a concern with its increasing prevalence. These are the GLP1 analogues which were usually injections, but recently, an oral GLP1, which can enhance growth of insulin producing cells in the pancreas was developed.
As a run up to the World Diabetes Day observed annually, this year it is observed with its theme as ‘The Nurse and Diabetes’ that endeavors to raise awareness around the crucial role played by them. Especially during the pandemic and the related lockdowns, patients have not been able to access their healthcare providers physically but connect with them virtually. To this end, there has been a need to control sugar levels among those with co-morbidities to prevent COVID-19.
Over the last several years there has been an explosion of new drugs for diabetes. Traditional drugs like sulfonylureas and metformin, are safe and effective and continue to be used. Then came the DPP-IV inhibitors that proved to be safe. Later the GLP-1 agonists and SGLT2 inhibitor classes of drugs were launched. After initial treatment with metformin, provided there are no contraindications drugs are to be tailored according to the co-morbid conditions that patients have, said Dr. Priya Chinnappa, consultant endocrinologist & diabetologist, Vikram Hospital Bengaluru.
The aim of identifying and treating diabetes early is to prevent patients from developing these complications. Among the newer drugs are a group of drugs called SGLT2 inhibitors which help to reduce weight and are protective in certain types of heart diseases. There are newer insulins which are easy to administer and have lower risk of hypoglycemia. There are drugs called GLP1 analogues which were usually injections but there is a recently developed oral GLP1 which can enhance growth of insulin producing cells in the pancreas. Attempts to develop oral insulin are in the research stage. It is to be noted that no drug should be attempted without consulting a doctor, noted Dr Subrata Das, senior consultant – internal medicine & diabetology, Sakra World Hospital.
In 2020, International Diabetes Federation estimated 463 million diabetics globally and 88 million people in the South East Asia, of which 77 million are in India. Its prevalence in the population is 8.9%.
According to Dr Vidya Bhat, medical director, Radhakrishna Multispecialty Hospital, some of the new combination medications are metformin, alpha-glucosidase inhibitors which includes drugs like acarbose, miglitol and dipeptidyl peptidase-4 inhibitors or the DPP-IV inhibitors for type 2 diabetes. Then there are drugs that help pancreas to release more insulin such as, canagliflozin, dapagliflozin, empagliflozin, ertugliflozin and sulfonylureas. There are also many different types of insulin like insulin aspart, insulin degludec, insulin, glargine and amylin analogue. While there are many commonly used drugs still available, these new drugs provide additional benefit.
Commenting on the impact of diabetes on the eye, Dr Deepa Shilpika, ophthalmologist, Maxivision Superspecialty Eye Hospital, Hyderabad, said that this condition with its concomitants of hypertension and cholesterol causes retinal damage and eventually leading to blindness. All this is completely preventable with a simple retinal examination.
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Scientists have developed a new hydrogel able to quickly heal animal wounds while minimising scarring, with the immune system’s help. It could potentially work as an upgrade on our body’s injury-healing abilities.https://aeacdcc2dc1fb90ff17fc371547fcb57.safeframe.googlesyndication.com/safeframe/1-0-37/html/container.html
The microporous annealed particle (MAP) gel had previously shown promise as a structure designed to support tissue growth and speed up wound healing. Here, the MAP gel was modified to trigger a particular immune response too.
So far, the research has only looked at wound healing in mice, but it could potentially help people with burns, cuts, diabetic ulcers, and other types of wounds that would otherwise leave damaged, scarred skin behind.
A repaired wound with hair follicles shown in green. (Duke University)
“This study shows us that activating the immune system can be used to tilt the balance of wound healing from tissue destruction and scar formation to tissue repair and skin regeneration,” says biomedical engineer Tatiana Segura, from Duke University.
Scar tissue is formed as part of a rapid reaction to injury by the body: it reduces pain and limits the chance of infection. However, the regrown skin isn’t complete, lacking sweat glands and hair follicles, and it’s also more susceptible to future injury.
Having already used MAP gels as a way of organising cells to fix wounds faster, here the team tried to keep the biological scaffold in place for longer by flipping the peptide structure of a particular chemical linker in the gel so the body wouldn’t see it as being familiar and – in theory – make it more difficult to break down.
“Previously we’d seen that as the wound started to heal, the MAP gel started to lose porosity, which limited how the tissue could grow through the structure,” says biomedical engineer Don Griffin from the University of Virginia.
“We hypothesised that slowing down the degradation rate of the MAP scaffold would prevent the pores from closing and provide additional support to the tissue as it grows, which would improve the tissue’s quality.”
However, in experiments on mice, the team’s attempts to prolong the lifetime of the scaffold by making it more alien to the body had the opposite effect: the gel had almost entirely disappeared from the wound site by the time it had healed.
The peptide structure flip did trigger a different immune response, but from the more specialised adaptive immune system – it uses different types of cells and a more regenerative reaction to do its work.
The antibodies and macrophage cells that were triggered in this case were better able to remove traces of the hydrogel, as well as repairing skin in a way that was more like the original skin (including hair follicles).
This process still needs to be adapted for the human body, of course, but we share a lot of the repair mechanisms with other mammals, and the scientists are hopeful that a modified version of their hydrogel could eventually be used to repair wounds faster and more naturally – and perhaps even contribute to vaccine development.
“I am excited about the possibility of designing materials that can directly interact with the immune system to support tissue regeneration,” says Segura. “This is a new approach for us.”
The research has been published in Nature Materials.
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The Department of Pharmaceuticals (DoP) has issued revised guidelines for implementing the provisions of public procurement (preference to Make in India) Order (PPO)- 2017 DPITT guidelines for procurement of Make in India medical devices.
The Department for Promotion of Industry and Internal Trade (DPIIT), pursuant to Rule 153 (iii) of the general financial rules 2017, had issued PPO – 2017 dated June 15, 2017 which was partially modified on May 28, 2018, May 29, 2019 and September 16, 2020.
According to Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD), “The guidelines on PPO- 2017 are basically to align the PPO of DPITT with earlier guidelines.”
This is envisaged to promote manufacturing and production of medical devices in India with a view to enhancing income and employment of local population. It is aimed to give maximum preference to local companies.
“This will be a big boost to Indian companies as earlier it was restricted till drugs with reference to Drugs and Cosmetics Act (D&C) Act. With the inclusion of new medical device rules (2017) under the D&C Act, medical devices will also get preference as per the DoP and DPITT guidelines,” said All India Drug and License Holders Foundation (AIDLHF) president Abhay Pandey.
DPIIT in order to facilitate the implementation of the PPO 2017 dated August 14, 2017 has identified Department of Pharmaceuticals (DoP) as the nodal department for implementing the provisions of the PPO 2017 relating to goods and services related to pharmaceutical sector. DPIIT has now decided that the nodal department for product category medical devices shall be DoP.
DoP in supersession of the guidelines issued earlier dated October 16, 2018 and December 12, 2019 has issues the revised guidelines.
The DoP move gives priority to bidders of government contracts that use more local content. The revised order has introduced a concept of Class-I, II and non-local suppliers, based on which they will get preference in government purchases of goods and services. Class-I local suppliers will get the most preference in all government purchases because their domestic value local content addition is 50 per cent or more. They will be followed by Class-II suppliers, whose local content value addition range is more than 20 per cent but less than 50 per cent.
For verification of local content, the Class I and II suppliers shall be required to indicate percentage of local content and provide self-certification that the item offered meets the local content requirement norms. Concept of Class-I supplier has been introduced so that in cases where local suppliers are to be given the order, even within that group we should give first preference to the ones whose domestic value addition is significantly high.
Under the revised guidelines, it is envisaged that all Central government departments, their attached or subordinate offices and autonomous bodies controlled by the Government of India should ensure that purchase preference will be given to domestic suppliers.
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Although it is not the only vaccine in the late stages of testing, the large size and careful design of the trial, not to mention the promising results, have caused understandable enthusiasm around the world.
As we get nearer the long-awaited start of a COVID-19 vaccine roll-out, it is worth looking at how statisticians help medics establish the safety of vaccines.
How effective is the vaccine?
It is not easy to find out how effective a vaccine is. First, researchers need to know whether just an act of injecting somebody can help. The trials involve a large number of people, with half of them given a vaccine and the other half a placebo.
Then the participants need to be exposed to the infection with the expectation that most of those in the control group become ill, but vaccination protects at least some in the treated group.
For coronavirus, the researchers need to rely on natural infection because no study, at the moment, intentionally exposes participants to the coronavirus. As a result, the efficacy calculation is based on a relatively small number of those who caught COVID-19 by contact with other infected people.
Vaccine efficacy reflects a proportion of the number of those who became ill in the vaccinated group and in the non-vaccinated group. The Pfizer/BioNTech trial involved nearly 44,000 participants, with 21,999 given the vaccine.
The researchers use statistical analysis to set up milestones at which they can be increasingly confident that the vaccine works – or it does not – as the cases trickle in.
If the numbers are small, it would not be clear whether the difference in the outcomes between the placebo and the treated groups is real or just a result of a random fluke.
Statisticians use the so-called “power analysis” to discover how many cases we need to observe. For the Pfizer and BioNTech vaccine, the target was 164 cases when the final estimation of efficacy can be made, but this was based on the assumption that the vaccine is only 60 percent effective.
This was based on the seasonal flu vaccine efficacy. However, with the numbers exceeding expectations, the company decided to release the results at one of the interim analysis points.
Ninety-four cases were reported and the split of about 86 cases in the placebo group and eight cases among vaccinated yielded 90 percent efficacy. This level of protection against infection is remarkable.
Even though the study is based on a relatively small number of cases, statistical analysis allows the researchers to extrapolate to what might happen when the vaccine is rolled out.
The trial included different ages as well as people from different ethnic minority groups, but more studies would be needed to assess how the most vulnerable groups are protected.
The final efficacy is likely to be lower, as administering the treatment is difficult for many logistical reasons, including the requirement of mRNA-based vaccines, of which the Pfizer vaccine is one, to be stored at very low temperatures.
In the real world, the vaccine might not be stored at the correct temperature and hence may spoil.
How safe is the vaccine?
If the vaccine is to be widely applied, the medical community and the public need to be reassured about its safety.
The Pfizer vaccine was administered to 21,999 people. Some people reported a reaction similar to the one after the seasonal flu vaccination, but so far no serious side-effects have been reported. But how can we be sure that this holds if the treatment is rolled out to millions of people?
Statisticians came up with the “rule of three”. The rule tells us that if 21,999 participants were treated with no side-effects, then with 95% confidence, the probability of a side-effect from the vaccine is expected to be less than three (hence the name) divided by 21,999 and so less than one in 10,000.
The chance of these side-effects is probably even lower, but the researchers will be keen to extend the trials further to confirm this.
Safety is just as important as efficacy. If you take a probability of one in 10,000 and extrapolate that out to the 300 million population slated for vaccination in the US alone, the number of people with side effects could be as high as 30,000.
How to use the vaccine so it is effective and safe?
Medical authorities are now designing ways to implement vaccination in nationwide programmes, but the details on how to do this depend on several factors.
The UK government has ordered 40 million doses of the Pfizer vaccine, which – with two-dose treatment – would vaccinate 20 million people, that is, everyone aged 55 and up. However, the roll-out will not be fast since production and delivery will take time.
The strategy also depends on what the vaccination programme is supposed to achieve. Childhood vaccines, such as measles, are given to newborns to maintain herd immunity. In this case, only a relatively small proportion of the population needs to be vaccinated. With the rapid spread of COVID-19 – and high levels of existing infection – the proportion would need to be much higher.
Predictions for the level of immunity required to reach herd immunity depend on our estimate of the COVID-19 basic reproductive number, R. In absence of any control measures, R is estimated to be around 3 and so at least 67 percent of the public need to be fully immune just for the epidemic to stop growing.
Higher values would need to be achieved if the aim is to eradicate the virus.
This level will hardly be achievable with 60 percent efficacy, even if the whole population is vaccinated. The value of R=3 assumes the return to the behaviour before the pandemic. If we keep some level of restrictions and use masks, R could be lower and the herd immunity easier to achieve.
On the positive side, our simple models might be too pessimistic about the herd immunity levels. Additionally, if perhaps as many as 20 percent of the public already have had COVID-19, the required level of vaccination might be much easier to achieve.
Alternatively, vaccination can be applied to these segments of the society who are either at high risk of infection (healthcare and care home workers) or high risk of death (vulnerable, care home residents). This is the recommended strategy in the UK.
Are we there yet?
The results of the Pfizer vaccine trial are highly promising. But the road to eradicating the coronavirus is likely to be long and difficult.
Besides establishing the potential for the vaccine to protect against the virus, we also need to know whether it gives a lasting immunity or whether it would need to be applied repeatedly, for example, as with tetanus or seasonal flu vaccines.
While it is easy to dismiss these concerns, they need to be taken seriously if the vaccination is to be successful.
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