Preserving subacromial bursa in rotator cuff repair may improve patient outcomes, finds study

Over 500,000 surgeries are performed every year in the US to repair rotator cuff injuries, but a significant number of these procedures do not achieve the desired outcomes. A recent research published in the Science Translational Medicine journal suggests that a reevaluation of surgical practices like the routine removal of the subacromial bursa may be required.

The subacromial bursa is a synovial-like tissue located between the rotator cuff and the acromion. Traditionally, it has been removed during rotator cuff surgeries due to its perceived role in contributing to shoulder pathologies. However, this study utilized proteomic profiling of bursa samples from patients with rotator cuff injuries provides compelling evidence that the bursa actually plays a beneficial role in the healing process.

The study analyzed the response of bursa to tendon injuries in both human patients and a rat model and found that the bursa not only helped to maintain the mechanical properties of the intact infraspinatus tendon which lies next to the injured supraspinatus tendon, but also protected the underlying humeral head by preserving bone morphometry. This protective mechanism suggests that the bursa has a more complex and constructive role than previously understood.

Further experiments in the rat model revealed that the bursa stimulated an inflammatory response that is pivotal for wound healing in the injured tendon. This was marked by the initiation of genes associated with healing processes like the Cox2 and Il6. The positive influence of the bursa was also observed in rat bursa organ cultures by reinforcing the findings from live animal models.

This study involved the use of polymer microspheres loaded with dexamethasone which were delivered to intact bursae of rats after a tendon injury. The release of dexamethasone from the microspheres effectively reduced the expression of inflammatory markers like Il1b in the injured tendon. This research highlights the potential of the subacromial bursa as a novel target for drug delivery systems to enhance the healing process by modulating inflammation directly at the injury site. Overall, the study suggest that preserving the subacromial bursa during rotator cuff repairs could improve patient outcomes by utilizing the natural protective and healing properties of bursa. 

Reference:

Marshall, B. P., Ashinsky, B. G., Ferrer, X. E., Kunes, J. A., Innis, A. C., Luzzi, A. J., Forrester, L. A., Burt, K. G., Lee, A. J., Song, L., Lisiewski, L. E., Soni, R. K., Hung, C. T., Levine, W. N., Kovacevic, D., & Thomopoulos, S. (2024). The subacromial bursa modulates tendon healing after rotator cuff injury in rats. In Science Translational Medicine (Vol. 16, Issue 744). American Association for the Advancement of Science (AAAS). https://doi.org/10.1126/scitranslmed.add8273

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Justify dose and rationality: CDSCO Panel Tells Dr. Reddy’s Lab on Sacubitril-Valsartan tablets 25 mg

New Delhi: Noting that the proposed protocol is insufficient to prove the clinical relevance of the lower strength of Sacubitril/Valsartan (12mg/13mg), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Dr. Reddy’s Lab to submit a revised protocol with more justification on the proposed dose and its rationality for further evaluation.

This came after Dr. Reddy’s Lab applied for the manufacture and market of Sacubitril and Valsartan tablets 25mg (as additional strength) indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction with bioequivalence (BE) and clinical trial (CT) waiver.

However, in light of an earlier SEC recommendation held on 09/01/2024 on a similar proposal deliberated for another firm wherein the committee opined that the firm should provide more justification on the proposed dose and its rationality.

In line with the above, the firm submitted a Phase II clinical trial protocol titled “A double blind, multicentre, comparative, Phase II study to evaluate the efficacy and safety of low dose sacubitril/valsartan (12mg/13mg) twice daily of Dr. Reddy’s Laboratories Limited in comparison to sacubitril/valsartan (24mg/26mg) twice daily in adult patients with heart failure and reduced left ventricular ejection fraction” and presented their proposal before the committee.

Sacubitril and valsartan combination is used together with other medicines to treat chronic heart failure in adults and cut down on the number of hospital visits for heart problems. It is also used to treat symptomatic heart failure in children 1 year of age and older.

Sacubitril is a neprilysin inhibitor used in combination with valsartan as an adjunct to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.

Sacubitril’s active metabolite, LBQ657 inhibits neprilysin, a neutral endopeptidase that would typically cleave natriuretic peptides, which includes: atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), and c-type natriuretic peptide (CNP). ANP and BNP are released under atrial and ventricle stress, which activate downstream receptors leading to vasodilation, natriuresis, and diuresis.

Valsartan is an angiotensin-receptor blocker used to manage hypertension alone or in combination with other antihypertensive agents and to manage heart failure in patients who are intolerant to ACE inhibitors.

Valsartan belongs to the angiotensin II receptor blocker (ARB) family of drugs, which selectively bind to angiotensin receptor 1 (AT1) and prevent angiotensin II from binding and exerting its hypertensive effects. These include vasoconstriction, stimulation, and synthesis of aldosterone and ADH, cardiac stimulation, and renal reabsorption of sodium among others. Overall, valsartan’s physiologic effects lead to reduced blood pressure, lower aldosterone levels, reduced cardiac activity, and increased excretion of sodium.

Sacubitril/valsartan’s combined action increases endogenous natriuretic peptides while inhibiting the renin-angiotensin-aldosterone system and exerting cardioprotective effects.

At the recent SEC meeting for Cardiovascular held on 21st March 2024, the expert panel reviewed the application presented by the drug major Dr Reddy’s Lab to manufacture and market Sacubitril and Valsartan tablets 25mg (as additional strength) and Phase II clinical trial protocol to evaluate the efficacy and safety of low dose sacubitril/valsartan (12mg/13mg) twice daily of Dr. Reddy’s Laboratories Limited in comparison to sacubitril/valsartan (24mg/26mg) twice daily in adult patients with heart failure and reduced left ventricular ejection fraction.

After detailed deliberation, the committee opined that the proposed protocol is insufficient to prove the clinical relevance of the lower strength of Sacubitril/Valsartan (12mg/13mg).

Hence, the expert panel suggested that the firm should submit a revised protocol with more justification on the proposed dose and its rationality for further review by the committee.

Also Read: Submit global regulatory status of Atezolizumab for IV, SC route: CDSCO Panel Tells Roche Products India

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NBE changes NEET PG 2024 exam pattern last minute, Doctors see red

New Delhi: With the last-minute changes to the NEET PG 2024 exam pattern, the doctors are concerned over the National Board of Examination (NBE) decision. 

Announcing modifications in the exam patterns in all MCQ-based examinations, such as NEET-PG, NEET-MDS, NEET-SS, FMGE, DNB-PDCET, GPAT, DPEE, FDST, and FET, the NBE recently introduced mandatory time-bound sections. However, doctors under the Federation of All India Medical Association (FAIMA) have expressed concern over these last-minute revisions in the NEET-PG 2024 exam pattern opining that such significant changes require adequate time for adaptation and preparation, which the current timeline does not afford.

Medical Dialogues recently reported that through a notice dated 04.05.2024, NBE had announced that it introduced time-bound sections as a measure to enhance the security and sanctity of the exams in light of emerging threats during the examination process. Releasing details of the mandatory timed sections in MCQ-based examinations, NBE mentioned that the question papers in the examinations mentioned above including NEET PG would be divided into multiple time-bound sections.

“For example, in NEET-PG 2024, if there are five time-bound sections (A, B, C, D & E) in the question paper, each section will have 40 questions and 42 minutes of time allotted. Candidates will be restricted from proceeding to the next section until they complete the allotted time for the previous section. Additionally, candidates will not be allowed to review the questions or modify their responses for a section after the completion of its allotted time. The questions for the next section will start automatically after the completion of the allotted time for the previous section,” NBE mentioned in the notice.

The natboard further informed that the candidates would be given the option to mark any question, whether attempted or not, for review. This means that the candidates can go through these marked questions in a section again before the allotted time for that section ends.  As per the NBE notice, the questions marked for review will be evaluated according to the marking scheme as mentioned in the Information Bulletin of the respective examination and the actual number of time-restricted sections in an examination may vary based on the total number of questions in the question paper and operational feasibility in creating such sections.

However, expressing displeasure with the last-minute changes in the NEET PG 2024 exam pattern, FAIMA recently wrote to the NBE Executive Director. While the association acknowledged the importance of maintaining the security and sanctity of examinations and also appreciated the measures implemented to address the emerging threats, it also expressed concerns regarding the recent decision to introduce mandatory time-bound sections in NEET PG examinations.

“As you are aware, NEET PG aspirants already face Immense pressure and time constraints during the exam period. The sudden Introduction of mandatory time-bound sections adds an additional layer of stress and uncertainty, affecting the performance and well-being of the aspirants,” FAIMA mentioned in the letter.

“We believe that such significant changes require adequate time for adaptation and preparation, which the current timeline does not afford. Therefore, we respectfully request reconsideration of the decision to implement mandatory time-bound sections In the upcoming NEET PG examinations. Instead, we propose that these changes be implemented gradually, allowing aspirants sufficient time to adapt and prepare effectively. We trust that you will give due consideration to our concerns and take necessary steps to address them. Your prompt action in this matter is highly appreciated and will contribute to the welfare and success of NEET PG aspirants across the country,” it further added.

Meanwhile, sharing the NBE notice on X (formerly Twitter), the National Chairman of FAIMA, Dr. Rohan Krishnan also urged the authorities to cancel these changes. He wrote in an X post, “We are always against any kind of changes which are last minute. @NbeIndia should refrain from treating young aspirants who are graduates doctors like lab rats. @FAIMA_INDIA_ stands against this last minute modifications in exam/exam patterns. Requesting @NbeIndia to cancel this.”

Commenting on the matter, Dr. Rohan Krishnan told Medical Dialogues, “It is a very last-minute step. The examinees are already very stressed and we are always very particular about this because this is an exam which has 40,000 to 60,000 seats and more than 3-4 lakh doctors who are appearing for this exam. This exam happens only once a year, so it is a very important day and it is going to happen pan-India. So, obviously, it is a very important examination.”

“For any examination, the pattern should be declared before 6 months and after that, there should not be any changes. Now, the exam is going to happen in June itself and at present these changes are only going to create a lot of panic among the students and it is going to create more stress in the already stressful state of the NEET PG aspirants,” he further added.

Also Read: NEET PG 2024 exam pattern revised! NBE introduces time-bound sections in all its computer-based tests- NEET SS, NEET MDS, FMGE and more

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NBE introduces time-bound sections in all its computer-based tests- NEET PG, NEET SS, NEET MDS and more

NEET PG 2024 exam will now have time-bound sections. The announcement in the exam pattern was recently made by the National Board of Examination (NBE) which has decided to introduce mandatory time-bound sections in all its MCQ-based examinations, such as NEET-PG, NEET-MDS, NEET-SS, FMGE, DNB-PDCET, GPAT, DPEE, FDST and FET which are conducted on a computer-based platform.

According to the NBE notice, this measure has been implemented to enhance the security and sanctity of the exams in light of emerging threats during the examination process.
For more information click on the link below:

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Issue of non-payment of stipends to MBBS interns to be considered by SC

The issue of non-payment of stipends to MBBS interns and resident doctors at medical colleges across the country will be considered by the Supreme Court today i.e. on May 6, 2024.

During the hearing on the issue last month, the Apex Court directed the National Medical Commission (NMC) to submit the details of the stipend paid to the MBBS interns in all the medical colleges across all States within four weeks.
For more information click on the link below:

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5 Gujarat medical colleges gets NMC show-cause notice over faculty deficiencies

Taking serious cognizance of the massive faculty deficiencies, the National Medical Commission (NMC) has sent show-cause notices to 5 medical colleges in Gujarat.

According to the Ahmedabad Mirror report, at least five medical colleges and hospitals (MCHs) in Gujarat have received these show-cause notices. Observing severe shortages of medical teachers, tutors, and resident doctors across departments, the Apex Medical Regulator has warned to reduce the MBBS seats in these medical colleges and impose high monetary penalties on these institutes.
For more information click on the link below:

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Kozhikode MCH Sexual Assault Case: Survivor seeks re-investigation into her complaint

Kozhikode: The survivor of the sexual assault case at Kozhikode Medical College Hospital (MCH) has expressed her dissatisfaction with the police investigation report regarding her allegations against the gynaecologist which ruled no negligence on the doctor’s part. She decided to seek re-investigation into the matter.

The report submitted by the police denied the allegations against the doctor regarding the failure to collect scientific evidence and properly document the survivor’s statement. It stated that the doctor had indeed relayed the survivor’s statement to the investigating officers. Additionally, it contended that the investigation team could not find any motive for Dr *** and her junior doctor to help anyone involved in the case.

“Dr ** has written in the case sheet the same things that the complainant said during the examination. The same things have been told to the investigating officers as well. Therefore, no negligence on the part of the doctor was found and no further action is required in the complaint,” said the report.

Also read- Kozhikode MCH Sexual Assault Case: Survivor Resumes Stir Seeking Probe Report

Questioning the authenticity of the report, the survivor stated no junior doctor came along with the gynaecologist during her examination. Claiming several parts of the reports untrue, the survivor plans to meet the Inspector General and demand a re-investigation into the existing probe report.

As per TNIE reports, the police shared the investigation report with the complainant two days ago following a two-week-long protest in front of the police commissioner’s office which ended recently after she received the report. 

Medical Dialogues team had earlier reported that the survivor held a sit-in protest in front of the city police commissioner’s office after the North Zone Inspector General of Police K Sethuraman IPS failed to keep his promise to provide the police investigation report within three days to the survivor despite the Chief Minister’s Office intervention.

Meanwhile, speaking to the Daily, the survivor said, “The name and statement of a doctor, a second-year PG student, have been included in the police report now. No junior doctor came along with Dr Preethi when she examined me. That junior doctor was not a witness in any of the chargesheets filed by the police in court. I will demand a re-investigation,” 

“My statement to the gynaecologist has not been used as evidence in this investigation report, nor those of my relatives. The report is solely based on the statements of the doctor and her associates. I suspect that is the reason why the police were hesitant to share it with me,” she told The Hindu

In March 2023, a woman patient admitted to the post-surgery Intensive Care Unit (ICU) of Kozhikode Medical College Hospital was allegedly raped by a 55-year-old employee at the hospital on March 18. The victim claimed that the employee exploited her while she was in a semi-conscious state after undergoing thyroid surgery at the medical college hospital.

Following this, five hospital staff were suspended for attempting to influence the accused and Chief Nursing Officer and Nursing Superintendent were transferred for failing to address a complaint filed by a Senior Nursing Officer who stood by the rape survivor in the case.

Also read- Kozhikode MCH Sexual Assault Case: Complaint Filed Against Gynaecologist

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Health Bulletin 06/ May/ 2024

Here are the top health stories for the day:

NMC slaps show-cause notice on 5 Gujarat medical colleges over faculty deficiencies, warns of reducing MBBS seats
Taking serious cognizance of the massive faculty deficiencies, the National Medical Commission (NMC) has sent show-cause notices to 5 medical colleges in Gujarat.
According to the Ahmedabad Mirror report, at least five medical colleges and hospitals (MCHs) in Gujarat have received these show-cause notices. Observing severe shortages of medical teachers, tutors, and resident doctors across departments, the Apex Medical Regulator has warned to reduce the MBBS seats in these medical colleges and impose high monetary penalties on these institutes.
For more information click on the link below:

NBEMS implements time-bound sections in NEET PG, MDS, and other exams
NEET PG 2024 exam will now have time-bound sections. The announcement in the exam pattern was recently made by the National Board of Examination (NBE) which has decided to introduce mandatory time-bound sections in all its MCQ-based examinations, such as NEET-PG, NEET-MDS, NEET-SS, FMGE, DNB-PDCET, GPAT, DPEE, FDST and FET which are conducted on a computer-based platform.
According to the NBE notice, this measure has been implemented to enhance the security and sanctity of the exams in light of emerging threats during the examination process.
For more information click on the link below:
Non-payment of stipend to MBBS interns: Supreme Court to hear matter today
The issue of non-payment of stipends to MBBS interns and resident doctors at medical colleges across the country will be considered by the Supreme Court today i.e. on May 6, 2024.
During the hearing on the issue last month, the Apex Court directed the National Medical Commission (NMC) to submit the details of the stipend paid to the MBBS interns in all the medical colleges across all States within four weeks.
For more information click on the link below:
Aspiring doctor left brain dead after friends pushed him into US lake
A young American aspiring doctor is in critical condition after being pushed into a Louisiana lake by friends despite his inability to swim, according to a report from the New York Post. Shocking footage circulating on social media captures the moment Christopher Gilbert was pushed into Lake D’Arbonne in Farmerville on April 14, followed by his friends standing idly by as he struggled in the water.
The video shows a woman attempting to locate Gilbert in the lake before ultimately abandoning the rescue effort. Nearly 10 minutes later, a customer from a nearby restaurant intervened and brought Gilbert back to shore just in time. However, upon arrival at the hospital, Gilbert was declared brain dead, with his other organs failing.

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“Safety is primary focus for all our vaccines”: Covaxin-developer Bharat Biotech

New Delhi: Developer of Covaxin, Bharat Biotech, said in a statement that Covaxin was developed with a “single-minded focus on safety first” amid the recents reports about the possible side effects of the AstraZeneca-Oxford COVID-19 vaccine.

It stated that Covaxin was the “only Covid vaccine” in government of India’s COVID-19 immunisation program to have conducted efficacy trials in India.
“@bharatbiotech announcement – #COVAXIN was developed with a single-minded focus on #safety first, followed by #efficacy,” Bharat Biotech stated in a post on X.
Notably, Covidshield and Covaxin were the vaccines, that were primarily administered in India during the Covid pandemic.
According to ANI, Bharat Biotech, further said in its statement that Covaxin was evaluated in more than 27,000 subjects as part of its licensure process. It was licensed under restricted use in clinical trial mode, where detailed safety reporting was carried out for several hundred thousand subjects.
Safety of Covaxin was also evaluated by the Ministry of Health, Govt of India. Ongoing safety monitoring (pharmacovigilance) was continued throughout the product life cycle of Covaxin.
All the above studies and safety follow-up activities have demonstrated an excellent safety record for Covaxin, without any vaccine-associated incidents of blood clots, Thrombocytopenia, TTS, VITT, pericarditis, myocarditis, etc, it added.
“As seasoned innovators and product developers, the Bharat Biotech team was well aware that, while the efficacy of COVID-19 vaccines may be short-lived, the impact on patient safety could last a lifetime. Hence safety is the primary focus for all our vaccines,” the statement added.
This comes in the wake of a recent admission by AstraZeneca, the pharmaceutical company, that its Covid vaccine Covishield and Vaxzevria “can, in very rare cases, cause Thrombosis Thrombocytopenia Syndrome (TTS).”
According to several UK media reports, AstraZeneca has made the admission in court documents in connection with a case that alleges that the vaccine, developed with the University of Oxford, caused death and serious injury in dozens of cases.
Following the reports, an AstraZeneca spokesperson stated, “Our sympathy goes out to anyone who has lost loved ones or reported health problems. Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines.”
The Serum Institute of India produced COVID-19 vaccine named Covishield but not using mRNA platform. It has been prepared using the viral vector platform. In the vaccine, a chimpanzee adenovirus – ChAdOx1 – has been modified to enable it to carry the COVID-19 spike protein into the cells of humans. This cold virus is basically incapable of infecting the receiver, but can very well teach the immune system to prepare a mechanism against such viruses

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Incorrect distribution of NEET 2024 question paper, NTA allows 120 aspirants to reappear in exam, denies ‘paper-leak’ claims

New Delhi- The National Testing Agency (NTA) has issued a clarification ensuring fair conduct of the NEET 2024 examination and allowed 120 candidates to reappear for the exam after question papers were distributed incorrectly at an exam centre. Meanwhile, several social media posts have claimed that the NEET 2024 question paper was leaked.

An incident of incorrect distribution of National Eligibility cum Entrance Test for Undergraduate (NEET-UG) 2024 exam question papers by the centre superintendent occurred at a centre in Rajasthan- Girls Higher Secondary Adarsh ​​Vidya Mandir, Mantown, Sawai Madhopur.

According to IANS report, angry aspirants created ruckus at the centre prompting the National Testing Agency (NTA), which conducts the NEET entrance test, to allow them to reappear in the test in the evening slot. The NTA issued a letter admitting negligence and said that 120 students will be given a chance to appear in the examination again. The evening slot examination was conducted on Sunday from 6 p.m. to 9:30 p.m.

In the notice, NTA stated that “it assures the public that apart from this isolated incident, the NEET (UG) 2024 examination commenced smoothly and is being conducted peacefully at all other examination centres across the country. The NTA emphasizes that this incident has not compromised the integrity of the examination process at other centres”.

“To uphold the principles of fairness and equal opportunity for all candidates, the NTA has taken proactive measures. The examination of approximately 120 affected candidates from the Girls Higher Secondary Model School examination centre is being conducted today, 5 May 2024, ensuring that their academic aspirations are not hindered by this incident”, the notice mentioned.

Meanwhile, after the incident, many social media posts claimed that the question paper had been leaked. On this, speaking to Indian Express, one senior NTA official said “Where the instances of ‘paper leak’ being claimed are completely false and it is being done just to sensationalise the news. In an isolated incident at Girls Higher Secondary Adarsh Vidya Mandir, Mantown, Sawai Madhopur, Hindi-medium students were given English medium question paper by mistake and by the time the invigilator was correcting the mistake, students forcefully walked out of the exam hall with the question paper”.

He further added “As per the rules students are only allowed to exit the hall with the question paper after the exam, but some students walked out forcefully. Due to this, the question paper was circulated on the internet around 4 pm, but by that time the exam had already started at all other centres across the country. So, there has not been any ‘leak’ of the NEET UG question paper”.

Yesterday i.e. on 05 May 2024, the NEET UG 2024 exam was conducted at multiple examination centers in 557 cities across the country and 14 cities abroad.

To view the notice, click the link below

https://medicaldialogues.in/pdf_upload/fair-conduct-of-neet-ug-2024-examination-5-may-2024-237568.pdf

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