Scientists Reveal Just How Far Plastic Can Reach Into Your Lungs
Miniscule fragments of plastic pollution invade the human body every day without our knowing it, not just from eating and drinking but from simply breathing.
By some estimates, the average person inhales a credit card’s worth of plastic every week with unknown health effects. In 2022, scientists found microplastics hiding in the deepest parts of the human lung for the first time.
The worldwide spread of plastic has not only crept up on us, it has crept up in us, and scientists are now rushing to figure out where these pollutants go when we breathe them in, how long they stick around for, and if they have toxic effects.
Researchers at the University of Technology Sydney (UTS) have now tracked the passage of plastic as it flows through the respiratory system. Their model builds on a pioneering attempt in 2023 to identify hotspots where microplastics and nanoplastics might gather in our airways.
That prior study focused mostly on modeling the upper airway tract, but the new study considers how air and particles flow through the entire tract, “from the nasal cavity down to the 13th generation of the bronchial tree”.
It also models three different breathing rates – slow, medium, and fast – and three different sizes of plastic fragments; large microplastics, microplastics, and nanoplastics.
The result is a delicate balance, the researchers say, between the way that gravity drags plastics onto a surface and the way that wind blows them along a passageway.
At a normal breathing rate, the model suggests microplastics in the air can come to cover half the surface area of a nasal cavity. At slower breathing rates, medium-sized pollutants were largely deposited in the upper airway, including the nasal cavity, the voice box, and the junction where the windpipe connects to the throat. Meanwhile, smaller, dust-like particles were distributed more evenly throughout the upper and lower respiratory tract.
“Larger microplastics displayed a tendency for rapid deposition in the upper airways, whereas smaller nanoplastics exhibited a higher likelihood of escape or reaching deeper airway generations,” the researchers conclude.
The team says that future models should include information on how plastic particles might infiltrate the alveolar sacs, where the oxygen and carbon dioxide are exchanged, and also how the mucus and cilia in the respiratory tract might trap or clear out plastic infiltrators.
Their findings support previous studies that led scientists to suspect that the smaller the plastic fragment, the more likely it is to penetrate deeper into the lung, possibly infiltrating the alveolar sacs where crucial gas exchange occurs.
It’s not just degraded plastic products, like drink bottles, that are causing this threat, either. Common cosmetic products, like gritty toothpaste, are made purposefully with these tiny fragments. Some reports estimate that in India, toothpaste is responsible for emitting 1.4 billion grams of microplastic particles each year.
When breathed in, experimental evidence strongly suggests that such tiny plastics have the capacity to trigger inflammation, oxidative stress, lung tissue damage, or systemic dysfunction in the respiratory tract. So far, however, research on the potential health outcomes of microplastics is mostly confined to animal models and human cells.
One recent exception was a study among surgery patients, which found that those who had more plastic in a main artery of their body had a higher chance of heart attack, stroke, or death in the following years. Given the ramifications, associations between cardiac health and plastic pollutants needs to be further explored.
“Plastic particle air pollution is now pervasive and inhalation ranks as the second most likely pathway for human exposure,” says mechanical engineer Suvash Saha from UTS.
For the health of humans everywhere, it is crucial that toxicologists fully understand where these ubiquitous particles are going when we breathe them in and what they are doing to our bodies.
The study was published in Environmental Advances.
Source : 1
PCI issues guidelines for institutions prior to commencement of inspection process
The Pharmacy Council of India (PCI) has issued guidelines for the institutions related to the inspection process for the academic year 2024-25, mandating that the students and the faculties should have their smart cards and the infrastructure of the institutions should have mandatory active Quick Response (QR) code at the time of inspection.
The PCI, which recently received a favourable order from the Supreme Court regarding extension of the date for approval and appeal processes for pharmacy institutions for the academic year 2024-25, has informed that it will start the inspection process of the institutions for the academic session at the earliest.
All inspections will be done through the mobile inspection application only as provided in the Google Play store. The Council requested all the institutions to follow the guidelines issued now, during the inspection and verification process.
According to the guidelines, all the students enrolled in the institutions should have mandatory attendance and all the students should have mandatory registration on the PCI portal. All students should have the Smart Card with them at the time of the inspection process.
Similarly, all the faculties enrolled in the institution should have mandatory attendance and all the faculties should be mandatorily present in the institution during the time of inspection process.
If any faculty is on leave, the leave letter has to be submitted to the inspectors and the same to be documented on the app along with the reason for absence. All the faculties should be mandatorily registered with the PCI portal. All faculties must also have their smart card with them at the time of inspection process.
“All faculties must carry their relevant documents with them at the time of inspection and verification process,” said the guidelines.
The infrastructure of the institution should mandatorily have active QR code for classrooms, laboratories, common facility, computer labs and other facilities, amenities, Master degree equipment, Bachelor degree equipment and others. All the equipment in the institution should have active QR code as mandatory during the inspection process.
If any infrastructure or equipment found without the QR code or the QR code not working at the time of inspection, the institutions are to be listed in the deficiency list.
Institutions must possess all the relevant documents with them as per information filled in the Standard Inspection Format (SIF) at the time of inspection and verification process.
These guidelines shall also be applicable for all other information in the SIF filled by the institutions, said the PCI.
The PCI has recently said that the date for approval process of pharmacy institutions and appeal process extended the last date for almost six months, following a Supreme Court order to this effect.
“The Hon’ble Supreme Court has extended the last date for completion of approval process of pharmacy institutions upto October 10, 2024 and appeal/compliance process till November 30, 2024 as requested by the PCI for the year 2024-25….” said the PCI in a circular.
The Supreme Court bench comprising Justice B R Gavai, Justice Satish Chandra Sharma, and Justice Sandeep Mehta has issued the order to the effect, on April 10, 2024.
The approval process has been initiated for schemes including D.Pharm, Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.Pharm), Pharm.D and Pharm.D (Post Baccalaureate), and Bachelor of Pharmacy (Practice).
Source : 1
PCI issues guidelines for institutions prior to commencement of inspection process
The Pharmacy Council of India (PCI) has issued guidelines for the institutions related to the inspection process for the academic year 2024-25, mandating that the students and the faculties should have their smart cards and the infrastructure of the institutions should have mandatory active Quick Response (QR) code at the time of inspection.
The PCI, which recently received a favourable order from the Supreme Court regarding extension of the date for approval and appeal processes for pharmacy institutions for the academic year 2024-25, has informed that it will start the inspection process of the institutions for the academic session at the earliest.
All inspections will be done through the mobile inspection application only as provided in the Google Play store. The Council requested all the institutions to follow the guidelines issued now, during the inspection and verification process.
According to the guidelines, all the students enrolled in the institutions should have mandatory attendance and all the students should have mandatory registration on the PCI portal. All students should have the Smart Card with them at the time of the inspection process.
Similarly, all the faculties enrolled in the institution should have mandatory attendance and all the faculties should be mandatorily present in the institution during the time of inspection process.
If any faculty is on leave, the leave letter has to be submitted to the inspectors and the same to be documented on the app along with the reason for absence. All the faculties should be mandatorily registered with the PCI portal. All faculties must also have their smart card with them at the time of inspection process.
“All faculties must carry their relevant documents with them at the time of inspection and verification process,” said the guidelines.
The infrastructure of the institution should mandatorily have active QR code for classrooms, laboratories, common facility, computer labs and other facilities, amenities, Master degree equipment, Bachelor degree equipment and others. All the equipment in the institution should have active QR code as mandatory during the inspection process.
If any infrastructure or equipment found without the QR code or the QR code not working at the time of inspection, the institutions are to be listed in the deficiency list.
Institutions must possess all the relevant documents with them as per information filled in the Standard Inspection Format (SIF) at the time of inspection and verification process.
These guidelines shall also be applicable for all other information in the SIF filled by the institutions, said the PCI.
The PCI has recently said that the date for approval process of pharmacy institutions and appeal process extended the last date for almost six months, following a Supreme Court order to this effect.
“The Hon’ble Supreme Court has extended the last date for completion of approval process of pharmacy institutions upto October 10, 2024 and appeal/compliance process till November 30, 2024 as requested by the PCI for the year 2024-25….” said the PCI in a circular.
The Supreme Court bench comprising Justice B R Gavai, Justice Satish Chandra Sharma, and Justice Sandeep Mehta has issued the order to the effect, on April 10, 2024.
The approval process has been initiated for schemes including D.Pharm, Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.Pharm), Pharm.D and Pharm.D (Post Baccalaureate), and Bachelor of Pharmacy (Practice).
Source : 1
Intense Headaches Triggered by Sex Are a Real Thing, And Can Be Dangerous
The last thing anyone wants is for sex to be a headache. For some people, though, an increase in sexual excitement can be a real pain in the neck.
Primary headache associated with sexual activity (PHASA) describes at least two bouts of pain in the head or neck brought on by sexual activity. The headache can escalate gradually during sexual activity or it can be an intense headache just before or during orgasm.
PHASA can be intense for between a minute to 24 hours or mild for up to three days. The most common type is a rapid intense headache at or around orgasm. These headaches are two to four times more common in men than women.
It’s estimated that the condition – also known as sex headache, coital headache, orgasmic headache and coital cephalagia – occurs in 1-1.6% of the population at some time in their life. However, the real figures could be higher – PHASA often goes unreported, most likely due to stigma around discussing sex.
The reasons why sex headaches happen are not fully understood but, since people with hypertension are more likely to get PHASA, they are likely associated with high blood pressure.
PHASA is also commonly found in people who normally suffer from headaches or migraines. Sex headaches could also be caused by abnormalities of the veins around the head and neck. Studies found that venous stenosis (a narrowing of the veins) and headaches triggered by coughs or exertion are associated with PHASA.
In April 2024, it was reported that a 61-year-old woman in the US suffered a brain bleed after having sex. The woman, not realising it was a bleed, took an aspirin for the headache.
Aspirin is a blood thinner and, while useful for people who might be at risk from ischaemic stroke (a blocked blood vessel), it could be disastrous for someone with a bleed. This woman took three aspirin which may have contributed to her bleed but thankfully, according to reports, she has now made a full recovery.
Brain bleeds while having sex are more common than you might think. Other forms of physical exertion can also bring on a stroke including running, lifting heavy weights, even sneezing, straining on the toilet, playing the trumpet, and bouts of laughter.
In the US, up to one in 12 patients going to the Emergency Room because of a brain bleed were having sex when the pain started.
A hole in the heart could be a risk factor for stroke during sex. The hole in the heart, or patent foramen ovale (PFO), is a small flap-like hole between the top two compartments (atria) of the heart. This hole is seen in everyone prior to birth and typically closes just before birth.
In a case report of three “unusual triggers for stroke” two of the three patients had PFO. One stroke was brought on by sex while the other from a bout of laughter. Another study has found PFO to be common in people who have a stroke during sex.
A more recent US study trawled medical records for patients who had had an intracranial haemorrhage (brain bleed) during sex. They found 16 recent cases. The average age of these patients was 50, and 13 of the 16 patients were male. Thirty one percent had hypertension.
Half of the patients had an aneurysmal sub-arachnoid haemorrhage – a burst blood vessel in the brain or ruptured brain aneurysm. Two of the 16 had an arteriovenous malformation – a tangle of blood vessels – and two had a deep brain haemorrhage.
If you have had a headache during sex, then you should certainly see your doctor, who can treat you with drugs typically used for hypertension, including beta-blockers and calcium channel antagonists. The doctor might also suggest a more “passive” role during sex or even abstinence while further tests are done to rule our more worrying explanations.
Much is still unknown about who is at risk of stroke during sex. However, if you are a male of around 50 years of age who has experienced a headache during sex you might want to get yourself checked out for an aneurysm or hole in the heart.
It is likely that your headache can be treated quite easily, but there will be some people with unknown and potentially serious underlying health conditions.
Colin Davidson, Professor of Neuropharmacology, University of Central Lancashire
This article is republished from The Conversation under a Creative Commons license. Read the original article.
Source : 1
SEC recommends permission to SII for Omicron XBB 1.5 variant Covid-19 vaccine
A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinical trials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5 variant Covid-19 vaccine with local clinical trial waiver, for restricted use in emergency situation subject to conditions.
The vaccine variant is a different strain from the Covid-19 vaccine the company manufactures under technology transfer from Novovax. SII has been manufacturing Covid-19 recombinant spike protein Nanoparticle Vaccine Covovax in India, following the technology transfer and approval from the national drug regulator.
The SECs recommendation follows SII’s proposal for grant of permission to manufacture Covid-19 Vaccine, Adjuvanted 2023-2024 Formula [SARS-CoV-2 rS Protein (Covid-19) Nanoparticle Vaccine, Omicron XBB.1.5 variant] for sale and distribution in India for active immunization to prevent Covid-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
The firm presented the preclinical studies reports along with interim report of ongoing clinical trial in USA to evaluate the safety and immunogenicity of a XBB.1.5 booster dose (NVX-CoV2601) in previously mRNA Covid-19 vaccinated and baseline SARS-CoV-2 seropositive Covid-19 vaccine naïve participants before the committee. Novovax has approval from various countries including the US, European Union, among others, for NVX-CoV2601, which is branded in some countries as Nuvaxoivid XBB 1.5 vaccine.
The Committee also noted the results of non-clinical studies on the variant and the interim report of the ongoing clinical trial in the USA. It also observed that approximately 42 million doses have been exported to USA and Europe till date and 200,000 vaccine doses have already been administered to the vaccines in the USA with no safety concern till date. The World Health Organisation has also recommended for the emergency use listing of Covid-19 XBB 1.5 variant vaccine, it said.
The safety profile of the vaccine from preclinical and clinical studies conducted globally justify the grant of permission, it says, adding that the Covid-19 continues to be a global health challenge with important genetic and antigenic evolution of the spike protein. The vaccine elicits broadly cross-reactive neutralising antibody responses against circulating SARS-CoV-2 variants, it said, adding that presently, there is no vaccine with XBB 1.5 strain approved in the country.
“After detailed deliberation, based on the above observations, the committee recommended for strain change in the approved Covid-19 vaccine and grant of permission of the Covid-19 Vaccine, Adjuvanted 2023-2024 Formula [SARS CoV-2 rS Protein (Covid-19) Nanoparticle Vaccine, Omicron XBB.1.5 variant] with local clinical trial waiver, for restricted use in emergency situation, subject to various regulatory provisions…,” said the Committee in its meeting held on April 29, 2024.
The Committee put forward various conditions including the company should conduct a phase IV study in the country, with protocol submitted within three months; And the vaccine is indicated for active immunisation to prevent Covid-19 disease in individuals of 12 to 18 years of age as primary series of two doses (0.5 mL each) three weeks apart, and as single precautionary dose in individuals of over 18 years of age, who have received primary series of vaccinations.
The company should submit revised Prescribing Information/Package Insert (PI), Summary of Product Characteristics (SmPC) and Factsheet to the Central Drugs Standard Control Organisation (CDSCO) after incorporating the latest safety and immunogenicity data and the suggestions made during the meeting, and the vaccine should supplied along with factsheet and separate leaflet for the guidance of the healthcare provider.
The SEC also mandated that the firm should ensure that factsheet for the vaccine recipient/attendant is provided prior to administration of the vaccine; the firm should disseminate the instructions & educational material including factsheet, PI, SmPC, storage instructions etc. in their website; It should submit safety, efficacy and immunogenicity data from the ongoing clinical trials in India and overseas for review as and when available.
Besides, the company should submit safety data including the data on AEFI and AESI with due analysis as per the provisions and standard procedures and submit India-specific Pharmacovigilance and Risk management plan.
According to the Union ministry of health and family welfare, the total vaccination against Covid-19 in the country is 220.69 crore as on May 9, 2024, and around 4.45 crore patients were discharged after recovery from the pandemic. There have been 5.33 lakh deaths due to Covid-19 till May 9, it says
Source : 1
AuroBlog | Clinical Research Blog | Aurous HealthCare CRO, India 