00:00It's health o'clock and today's new story pic is really going to be very fascinating
00:05I'm sure for a lot of you. Ozempic is now in India. Ozempic, the global blockbuster and one
00:12of the biggest names of drugs, forget just weight loss, drugs has officially now got the green
00:18lights to enter the Indian market. India's drug regulators, the CDSEO, has approved it
00:25but not for weight loss. That's a headline remember. Instead, the approval is for type 2 diabetes
00:31and also for reducing the risk of serious heart problems and even kidney damage. Now that's a
00:38first for India. Also, remember India already has similar drugs with the same molecule available
00:45in the market. There is Vigovi, mainly for weight loss and there is Manjaro which treats both
00:51diabetes and obesity. Now interestingly, Vigovi and Ozempic come from the same pharma company
00:57Novo Nordisk. So, what's the difference? Why two drugs with the same molecule? Well, both
01:03contain semaglutide, right? And the same active ingredient that helps lower the blood sugar
01:08and as a side effect of it, it also brings down your weight. But Vigovi uses a higher dose.
01:15That's a simplified way of saying that it's been approved in higher dosages here in India
01:20and approved for weight loss. Ozempic, on the other hand, is a lower dose. Means approved
01:25for lower doses, targeted at type 2 diabetes. Now with this approval, Novo Nordisk now has
01:32two injectable semaglutide drugs in India plus their oral semaglutide pill as well. That's
01:37already available in India since January of 2022. The launch of this, remember this is just
01:43an approval. That means it's not out in the market just yet. The launch will happen soon.
01:48But with this, we have another drug now, another treatment option available for millions of
01:53Indians managing diabetes and its long term complications. But how are you and I to sort
01:59of see this news? We've now done multiple stories on GLP-1 drugs and what they do. But let's try and
02:05take this Ozempic story forward with Dr. Rajesh Rajput joining us. He's the Director for Endocrinology
02:12and Diabetes at the Medanta Gurgaon. Dr. Rajput, thank you so much for your time. The confusion
02:19about so many drugs which have practically the same molecule, practically the same composition,
02:26sometimes from the same pharma company as well, but come under different names and is for different
02:32use. Can you simplify this for our audiences, please? Right. So, thank you very much for inviting
02:40me. Now, to understand and simplify this confusion which you are asking, we have to just go back into
02:47the history. Now, see, semaglutide as a molecule initially was researched in a clinical trial program
02:55which is known as sustained program. Now, based on sustained program where the dosage of semaglutide
03:02used is 0.25 milligram, 0.5 milligram and 1 milligram, the drug got approval from US FDA for
03:12treatment of type 2 diabetes irrespective of your BMI. See here, BMI is not here. Irrespective of your
03:19BMI in 2017. So, it is 2017 when Ozempic got approval for type 2 diabetes by US FDA. But then,
03:30as the drug was researched, it was found that it also results, the usage also results in
03:36large number of weight loss, good degree of weight loss. So, the research continues and for weight loss,
03:43there is a clinical trial program which is known as STEP clinical trial program. I was part of STEP
03:50clinical trial program from India and based on STEP 1 clinical trial program, in 2021, in a dose of 1.7
04:01and 2.4 milligram, the drug got approval from US FDA for management of obesity. That is those people who
04:11are having BMI more than 30 or more than 27 with one or the other co-morbidities like hypertension,
04:19dyslipidemia and diabetes. So, frankly, two clinical trial programs were done at different
04:25parts in the history. The drug for diabetes was launched in 2017, drug for obesity was launched in
04:332021 by US FDA approvals and then to avoid this confusion and to keep the things simplified because
04:41the indication for use is different. Dr. Rajput, you are basically saying that Hyundai and Toyota,
04:52the engine is the same. It's just under two different brands.
04:55Dr. Rajput, Maruti and Toyota, thank you so much for correcting me and my auto knowledge over there.
05:03So, Maruti and Toyota have both the same engine but come under different brand names. It's basically
05:09that. So, people now have toโฆ I think another news point out of this which has perhaps been missed out
05:15in other reports has been that this is perhaps for the first time, the drug controller has mentioned
05:21heart and kidney issues as to be used for a GLP-1 drug. That's happened for the first time?
05:28No, no. Already, the drug has approval from USFD. Again, it is based on sustain 6 program
05:35and flow trial clinical program. Now, you know, in these two important trials,
05:40patients of type 2 diabetes who have established cardiovascular disease or in flow trial,
05:46patients of type 2 diabetes with established chronic kidney disease were studied.
05:50And when semaglutide ozampic in a dose of 0.25, 0.5 and 1 milligram is used,
05:57the results are very promising. In sustain program, the three-point MACE stands for
06:04major adverse cardiovascular event. It is reduced by around 26 percent. And the NNT,
06:11that is number needed to treat is only 45, which means you need to treat 45 patients for two years
06:18to prevent one MACE event. Similarly, in flow trial, the benefit is by 24 percent,
06:26which means if patients who are given ozampic, they have reduced risk of progression to ESRD,
06:33that is end stage renal disease or requirement for dialysis or reduction of EGFR by more than 50 percent
06:42of CV death. So, these are very hard end points. So, the drug has got benefit and that's why the regulators
06:49have given approval.
06:50Dr. Rajput, last question then, if somebody who is looking at treating diabetes with GLP-1,
06:57how much does the brand really matter? How much should they be thinking, should I go for
07:03ozampic, should I go for Vigovi, should I go for, you know, Manjaro?
07:07Now, see, as a doctor, it is our duty to choose a brand is not important. For us, what is important
07:16is a drug, the molecule. Now, we are going to choose a molecule based on evidence which has been
07:24generated with that molecule. So, say for example, I will simplify this. I will see a patient of type 2
07:31diabetes who has already suffered myocardial infarction, which means heart attack. Now,
07:36patient is also having diabetes. Now, I have to choose a drug. Then, based on that data, I am
07:42going to choose ozampic based on data. Similarly, based on flow clinical trial, if patient is having
07:49an EGFR of less than 60, presence of micro or macro LB minuria, type 2 diabetes, and patient is already
07:56receiving standard of care for management of CKD and diabetes, then probably it's time we should
08:02also add ozampic in those patients because of the hard endpoints, benefits which has been shown with
08:09ozampic in these trials. So, it is duty of the doctor actually to find out who is the right patient
08:15for which molecule and even within the same molecule, which name or which brand.
08:21That's right. And I think the key takeaway for anybody watching is that please don't self-prescribe.
08:28Please go to an endocrinologist if you're curious about this and you want to understand more.
08:32Please do not ask your dermats for aesthetically wanting to take GLP-1. Please don't ask your dentist.
08:38Please don't ask anybody else. They don't know. Ask your endocrinologist. That's very important.
08:43We leave it there for the moment. Thank you so much, Dr. Shukla, for joining us.
08:46Thank you. All right. Moving on to some more health news. Worrying one coming in this time.
08:53Mysterious death of 14 children in just 30 days. This isn't making headlines yet, but it should.
09:01In the past one month, 14 children under the age of 15 have died after being admitted to hospitals in
09:07Nagpur, Maharashtra and in Chindwara, Madhya Pradesh. The cause? Still unclear. The doctors are calling it
09:13acute encephalitis syndrome diagnosis, often used when the brain suddenly becomes inflamed or stops
09:21functioning without any confirmed trigger. Now, here's what we know about this so far. Now,
09:25these children arrived with high fever and quickly deteriorated, some within 24 hours. Most went into
09:31acute renal failure, producing no urine. Several required dialysis and ventilator support. Six of the
09:38deaths were from paralysis and from Parasea block in Chindwara, which is now being treated as a high
09:45alert zone. And all the children between three and ten years old were the ones who were found to be
09:52infected by it. CSF and blood tests have ruled out any known bacterial or any viral infection as well.
09:59And as of now, the NIV, that's National Institute of Virology in Pune, and the NCDC, that's the National
10:05Centre for Disease Control, have sent teams to that hotspot area to investigate and see what exactly is
10:12going on. Surveillance is being stepped up in rural Vidharb and nearby districts as well, admitted to
10:17also Nagpur's hospital in similar condition. Doctors have begun classifying some of the newer cases as acute
10:24sort of encephalotopy and rather than classical encephalitis in this case and subtle but more important
10:31difference that affects how these children are treated. But here's what we don't know. No exact cause has
10:39been identified. No known pathogen, no toxin known or any environment trigger that has been confirmed.
10:46Whether this is a new infection agent or poisoning or some environmental sort of, you know,
10:52environmental cause that's also under investigation. Why this is happening now? Why it's affecting, you know,
10:59otherwise healthy young children? We don't know. Whether there are any milder or undetected cases in the
11:04community? We don't know. Whether this is contained or if this could spread to other districts or states? We don't
11:10know. So a lot of unanswered questions and people are losing kids. Young kids are dying. Like I said, 14 kids in just
11:1930 days. That's a worrying, worrying number. Let's cut across to Dr. Nihar Parikh now joining us. He's a
11:24pediatrician and director for CHURS Childcare. Dr. Parikh, very, very worrying news. Chap, you know,
11:30encephalitis, I thought that was largely a UP problem. I've reported from Gorakhpur for years
11:35to understand how it goes. It's a terrible, terrible disease. It generally spread across UP in Bihar. But in
11:42this area, we hadn't heard of this. What, what is your basic understanding of what's going on?
11:48So the understanding is still, we know what is causing the, we know the symptoms of the disease, but we don't know
11:57what is causing the disease. We don't know whether it's a viral, we don't know if it's a bacterial, we don't know if
12:02it's infectious or non-infectious. Non-infectious comes into the category of an autoimmune phenomena, where a child's body
12:09recovers from an infection, but the body fights an infection much more aggressively than it should,
12:15and then technically starts hammering different blood vessels of the different parts of the body,
12:20causing multi-organ involvement, starting with the brain, kidneys and everything. So, because what I
12:27read also and found out also that the blood, the tests that they did, the blood cultures, draining the
12:34fluid of the spine, checking for infections, has come clear for bacterial and viral. So still,
12:39we don't have evidence whether it's an infective pathology or a non-infective pathology, which goes
12:44in the favor of an autoimmune. But what is important and a takeaway message for all parents is that the
12:51minute the child has fever, if there are rashes followed by fever, if there is lethargy, giddiness,
12:58drowsiness, persistent vomiting, where the child is not able to retain, they should not sit at home
13:04and keeping this mind, keeping in mind this AES-like picture, they should show their pediatrician
13:09immediately, because the most important thing is the diagnosis of AES in time and getting the right
13:16medication to reduce the pressure in the brain. Yes. Dr. Parikh, because this disease is now localized,
13:25it's happening in similar areas spread across the border. Doesn't that tell us about the kind of
13:31infection it could be? So, again, it goes in two favors because, you know, this can be a viral or
13:37bacterial and we have not pinpointed. Plus, National Institute of Virology is already on it. So, soon we
13:43should find the cause, which is extremely important, but it's otherwise next possible to find out whether
13:50it is a post infection phenomena, like a random infection causing this as a complication, or the
13:56actual infection causing it. But isolating it, finding the cause of it, pinning it down to a bacterial or viral
14:04is of the key and the most important next step, which the people have reached there, the team, the task force is
14:11there and we should have an answer in the next 24 to 14 hours. And we'll keep a tap on those answers
14:16as well. Just because the story is not happening in Delhi and Mumbai doesn't mean we shouldn't be
14:19worried about it. We should care about every child. Encephalitis largely does not, it's not a rich man's
14:25problem, largely said, but we should still keep an eye for it. Thank you, Dr. Parikh, for joining us with all
14:31those details. No problem.
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