Delay in Diagnosing Complications after Bariatric Surgery results in patient’s death: Kolkata Hospital, Doctors slapped Rs 75 Lakh Compensation

New Delhi: The National Consumer Disputes Redressal Commission (NCDRC) recently directed a Kolkata-based hospital and its two doctors to pay Rs 75 lakh compensation and Rs 2 lakh litigation cost to the family of a man, who died due to complications after undergoing sleeve gastronomy, in the form of bariatric surgery.

After the patient’s condition worsened a week after the surgery, he was taken to the hospital again. However, the doctors at the hospital, a doctor of General Medicine and an Anesthetist delayed conducting a CT scan to diagnose the problem. Due to this delay, gangrene developed in the patient’s intestine, opined the NCDRC bench.

The case history goes back to 2015 and concerns the patient, the youngest son of the complainants, who was suffering from issues like diabetes, hypertension, hyperlipidemia and obesity. The patient opted for bariatric surgery after speaking to Dr. Ugale, the treating doctor, who he met for the first time at a common friend’s place, who explained the benefits of bariatric surgery and how this surgery would help the patient to lead a normal life and devoid of such common ailment. He was advised to undergo sleeve gastronomy, in the form of bariatric surgery. 

It was alleged that the doctor had not warned them about the possible complications of the surgery and had assured them that it would help the patient to lose weight. The patient was admitted to the treating hospital- Belle Vue Clinic in Kolkata on 09.01.2015. He was examined by the Anesthetist Dr. Chakraborty and underwent several pathological tests. These reports were examined by another doctor, Dr. Patel. 

Dr. Ugale and his team performed the surgery the next day and two days later, the patient was discharged and went back to his house in Jamshedpur. The complainants alleged that requisite follow-up and post-surgery observation were not done. 

After a week, he felt excruciating pain in his abdomen and was immediately admitted to Tata Main Hospital, Jamshedpur, where the senior Surgeon Dr. Pradhan examined the deceased after conducting a pathological test, he diagnosed that the cause of the pain was infection due to post-procedural acute peritonitis. Therefore, the doctor advised for immediate operation. 

When the complainants consulted the treating doctors in Kolkata, one doctor advised them to get the surgery done in Tata, while another doctor advised them to bring the patient to Kolkata. Accordingly, the patient was shifted to Kolkata from Jamshedpur on 23.01.2015 by a chartered plane.

Allegedly, the patient did not get immediate medical attention and surgery, as promised and was kept on “wait and watch” conservative approach for 48 hours. Following this, a CT scan was conducted, and Dr. Patel, Dr. Chakraborty, Dr. Bavishi, the general surgeon at the hospital, and Dr. Agrawal diagnosed the cause of pain as Mesenteric Vein Thrombosis. At that time, the CT scan report was not supplied to the complainants. Thereafter, a team of doctors conducted surgery on 25.01.2015. It was further alleged that in the operation notes, the name of Dr. Ugale was also mentioned but he was not present at the time of surgery. 

In surgery, 3 ft. out of 25 ft. intestine was found to be gangrenous and had been resected. The condition of the patient was critical post-surgery and he was kept on a ventilator. But the condition did not improve and he died a day later. 

The complainants alleged that the preoperative test reports did not indicate that the patient was fit for bariatric surgery but the doctors conducted the surgery to make financial gain. They also claimed that before the surgery, they signed a blank consent form and the doctors did not disclose anything about the risk of surgery. It was alleged that the operation notes for conducting the first surgery were undated and the discharge summary also did not mention any post-operative advice nor any prescription of medication for the patient.

Referring to the time duration when the patient was kept in “wait and watch” for 48 hours, the complainants alleged that during this long period, gangrene developed for 3 feet of the intestine. They also pointed out irregularities in the consent forms and referring to relevant medical literature, they alleged that there was gross negligence in diagnosing the possible aspects of post-sleeve gastrostomy and undertaking aggressive intensive care through operative therapy. They also pointed out that even though the treating hospital advises itself as “Bariatric & Metabolism, as one of the specialities, apart from Dr. Ugale, there is no other bariatric surgeon in the hospital. They claimed that because of this, even though the patient was admitted to the hospital for the second surgery, the operation could not be done till 48 hours. 

On the other hand, the treating doctors at Kolkata submitted that the patient had a very torrid and critical post-operative period and all throughout he was kept on medical ventilation. They submitted that they did everything best to their knowledge and experience and there was no deficiency on their part.

Dr. Patel, doctor of General Medicine at Kolkata hospital, submitted that he was simply present in the operation theatre as a physician on both occasions as requested by the patient and his family. He also submitted that the patient was given the best treatment and care and there was no deficiency on their part. The hospital also made similar submissions and denied any negligence.

While considering the matter, the NCDRC bench noted that the evidence filed on behalf of Tata Hospital mentioned that the patient was diagnosed with peritonitis and was advised for exploratory laparotomy. However, the relatives were unwilling to conduct the abdominal operation even though advised and expressed their desire to take the patient to the hospital in Kolkata. The Discharge Summary of the patient mentioned the final diagnosis as “Post Procedural Acute Peritonitis”.

After perusing the medical records, the Commission noted that even though Dr. Chakraborty, the anaesthetist, asked the complainants to bring the patient to Kolkata for further management, the doctors (Dr. Patel and Dr. Chakraborty) not only ignored the discharge summary of Tata Main Hospital but also did not conduct CT scan immediately in order to diagnose Peritonitis.

It was only when Dr. Agarwal, another doctor, advised for the CT scan a day later, that the test was done and it was diagnosed that the pain was caused by Mesenteric Vein Thrombosis.

Referring to this, the NCDRC bench noted,

“Dr. *** Patel and Dr. *** Chakraborty did not conduct CT scan for 48 hours although in the case of Peritonitis every hour delay is dangerous. Dr. Tapas Chakraborty asked the complainants to bring the patient in critical condition from a distance of about 400 KM, in order to make money. In order to conceal the negligence, Dr. *** Chakraborty has fabricated a CT scan report in back date. There is not only deficiency in service but also unfair trade practice on the part of OPs-2, 3 and 4.”

At this outset, the Commission referred to the Supreme Court order in the case of Jacob Mathew v. State of Punjab where the Apex Court had clarified that negligence is the breach of a duty caused by omission to do something which a reasonable man guided by those considerations which ordinarily regulate the conduct of human affairs would do, or doing something which a prudent and reasonable man would not do.

Referring to the Apex Court’s order in this case and several other judgments, the NCDRC noted,

“In CT scan report dated 25.01.2015, “extensive thrombosis involving superior mesenteric vein extending portal vein” has been noted. There are various causes of this disease out of which, abdominal surgery is also one of the cause. In CT scan report no abnormality in liver, pancreas or spleen was found. As such, it can be safely inferred that abdominal surgery performed on 10.01.2015 may be cause of this disease. Gangrene in intestine was developed due to more than 24 hours delay in its diagnosing and treating.”

Therefore, considering the age of the deceased and the number of dependents relying on him, the top consumer court directed Dr. Patel, the doctor of General Medicine in the hospital, Dr. Chakraborty, the Anesthetist and the hospital to pay the complainants Rs 75 lakh as compensation and Rs 2 lakh as litigation cost. One Dr. Bavisi, General Surgeon, Belle Vue Clinic was also arrayed as opposite party-4 in the complaint but he died during the pendency of the complaint and his name has been deleted from the order.

“In view of the aforesaid discussions, the complaint is partly allowed with cost of Rs.2 lacs. Opposite parties 2 to 4 are jointly and severally directed to pay a compensation of Rs.75/- lacs with interest @ 6% per annum from the date of death till realization to complainant-2 including cost within a period of two months from the date of judgement,” mentioned the order.

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/ncdrc-rs-75-l-compensation-239864.pdf

Also Read: Baby Born with 90 percent Locomotor Disability: Hospital, Doctor slapped Rs 50 lakh compensation for failure in detecting anomaly during gestation period

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NPPA Revises Ceiling Price of FDC Budesonide Plus Formoterol Inhalation

New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals has fixed and revised the ceiling price of the fixed-dose combination (FDC) the pulmonary drug Budesonide 400mcg plus Formoterol 6 mcg Inhalation (Dry powder inhalers) under the drugs (price control) order, 2013.

The ceiling price of the fixed-dose combination (FDC) of the pulmonary drug Budesonide +Formoterol has been revised from Rs 6.62 to Rs 6.95.

Budesonide is in a class of medications called corticosteroids. Budesonide (Uceris) is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum).

Formoterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.

Budesonide and formoterol combination is used to help control asthma symptoms and improve lung function. It is used when a patient’s asthma has not been controlled sufficiently with other asthma medicines, or when a patient’s condition is so severe that more than one medicine is needed every day

Scheduled formulation means any formulation, included in the First Schedule whether referred to by generic versions or brand name (mainly products covered under the National List of Essential Medicines are Scheduled Formulation). In other words, all medicines covered in the National List of Essential Medicines, which are notified in Schedule 1, by the Govt. are scheduled formulation.

“Ceiling Price” refers to a price fixed by the Government for Scheduled Formulations in accordance with the provisions of the drugs (price control) order, 2013. Ceiling Price is the Maximum Price to the Retailer (excluding Taxes, if any)for the given product.

The notice stated that the National Pharmaceutical Pricing Authority’s notification S.O. 938(E) dated 28.02.2024, further revised vide S.O. 1547(E), dated 26.03.2024 relating to fixation of ceiling price, published in the Gazette of India, Extraordinary, the Entry at Sl. No. 25 and 722 respectively of the Table, both in Hindi and English version, be read as follows:

Instead of

Sl. No.

Medicines

Dosage form & Strength

Unit

Ceiling Price

(Rs.)

(1)

(2)

(3)

(4)

(5)

25 of S.O.

938(E) dt

28.02.2024 and

722 of S.O. 1547(E) dt 26.03.2024

Budesonide (A)

+Formoterol (B)

Inhalation (DPI)

400mcg(A) +6 mcg (B)

1 Dose

6.62

Read as

Sl. No.

Medicines

Dosage form & Strength

Unit

Ceiling Price

(Rs.)

(1)

(2)

(3)

(4)

(5)

25 of S.O. 938(E) dt

28.02.2024 and

722 of S.O. 1547(E) dt 26.03.2024

Budesonide (A) +Formoterol (B)

Inhalation (DPI) 400mcg (A) + 6 mcg (B)

1 Dose

6.95

Further the notice added, “All the notes and other contents mentioned in the original order S.O. 938(E) dated 28.02.2024 and S.O. 1547(E), dated 26th March, 2024 shall remain same”.

Also Read:NPPA Fixes Retail Prices of 69 Formulations, Details

To view the official notice, click the link below:

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CDSCO panel Approves Sanofi’s Protocol Amendment Proposal for to study Fitusiran

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved drug major Sanofi’s protocol amendment proposal of Fitusiran, a subcutaneous investigational small interfering RNA therapeutic, targets antithrombin to rebalance haemostasis in people with haemophilia A or haemophilia B, irrespective of inhibitor status.

However, this approval is subject to the condition that the firm has to submit the that interim analysis reports every 24 weeks of the proposed drug.

This came after the firm presented protocol amendment 03 version 1 dated 20.10.2023 and protocol amendment 04 version 1 dated 24.11.2023 protocol No. EFC1546.

Fitusiran is a monthly subcutaneous RNA interference therapy targeting antithrombin to increase thrombin generation and reduce bleeding in hemophilia with or without inhibitors.

The study medication, fitusiran, employs a unique mechanism of action—small interfering with RNA, or siRNA. The siRNA can be customized to block production of any protein, leading to lower levels of the target protein. In this case it blocks antithrombin, which inhibits a coagulation protein called thrombin.

At the recent SEC meeting for Hematology held on 21st May 024, the expert panel reviewed the protocol amendment 03 version 1 dated 20.10.2023 and protocol amendment 04 version 1 dated 24.11.2023 protocol No. EFC1546.

After detailed deliberation, the committee recommended the approval of protocol amendment as presented by the firm subject to the condition that interim analysis reports every 24 weeks shall be submitted to CDSCO.

Also Read: Novartis Gets CDSCO Panel Nod to Study Iptacopan in Atypical Hemolytic Uremic Syndrome

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AIIMS Nagpur Invites Applications for Entrance Exam to PhD Programme July 2024 session, Details

Nagpur- Through a recent notice, the All India Institute of Medical Sciences, (AIIMS) Nagpur has invited applications for the entrance examination for admission to PhD Programme for the July 2024 session.

As per the official notice in this regard, the date of the entrance examination for admission to the PhD Programme 2024 session is announced to be held on 24 July 2024. The duration of the exam will be of one and a half hours, i.e. from 10:00 AM to 11:30 AM at AIIMS Nagpur.

The application forms for admission to the PhD Programme for the 2024 session are available on the official website of AIIMS Nagpur till 5 pm on 25th June 2024. Meanwhile, the last date for submission of applications by email in the form of scanned copies along with all required self-attested documents is 21 June 2024 by 1700 hrs.

Along with this, candidates also have to submit a demand draft of Rs.1500/- in the name of “Director AIIMS Nagpur” payable at Nagpur along with the hard copy of the application form and self-attested documents.

All applicants are required to visit the website regularly since all subsequent Corrigendum, Addendum and Updates will be uploaded on the website only, the notice added.

All India Institute of Medical Sciences, Nagpur is one among the four AIIMS announced during the budget speech 2014-15 under Pradhan Mantri Swasthya Suraksha Yojna (PMSSY). The Foundation stone for the institute was laid on 14th April 2017. The primary objective of AIIMS is to correct regional imbalances in the availability of affordable/reliable tertiary healthcare services and also to augment facilities for quality medical education in the country through evidence-based medicine with cutting-edge innovation. The courses offered are MBBS, BSc Nursing, BSc Paramedical, MD, MS, MDS, MSc, PhD, DM, and MCh.

To view the notice, click the link below

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Ayurveda Doctor Molestation Case: Kerala HC dismisses bail plea of accused

Thiruvananthapuram: The Kerala High Court has dismissed a criminal writ petition and bail
application related to the alleged assault and molestation of a Ayurvedic doctor at her
clinic. The petition sought to transfer the investigation to a higher-ranking
officer, while the bail application requested anticipatory bail for the accused. 

Due to the serious nature of the allegations, the court emphasized the
need for custodial interrogation, stating it is essential for a thorough and
unbiased investigation. The High Court highlighted the importance of the
accused’s arrest to effectively gather and corroborate evidence, given the
significant accusations involved.

While considering the bail plea, the court stated, “The
complainant urged for arrest and custodial interrogation of the accused to
effectuate meaningful investigation, in a case involving serious allegations.
In such a case grant of anticipatory bail would impede the investigation.
Therefore, the anticipatory bail plea at the instance of the accused cannot be
considered and the same is only to be dismissed.”

Justice Badharudeen carefully examined the evidence, including the First
Information Statement (FIS) and the case diary. The court found the allegations
made by the doctor credible and supported by prima facie evidence.
Additionally, the court considered the rising trend of violence against
healthcare professionals, underscoring the necessity for stringent action.

Mentioning the cases of violence
against doctors, the bench found it relevant to refer to the trend of abusing,
assaulting and manhandling doctors and hospital staff for flimsy reasons considering
that the said acts have now become a common practice. The court stated, “Recently,
when repeated instances of such nature were noticed by the legislature, the
legislature was forced to amend the Kerala Healthcare Service Persons And
Healthcare Service Institutions (Prevention of Violence and Damage to Property)
Act, in the year 2023, by incorporating Section 4, which provides for
punishment for such acts and making the offence as non bailable.”

As far as the writ
petition is concerned, the court observed that the materials produced before
this Court would show that the investigation is going on without scope
for allegations, though the Investigating Officer failed to arrest the accused.
The court also stated, “In this connection, it is to be noted that periodically
the accused filed anticipatory bail applications before the Sessions Court and
this Court and that may be the reason for stalling of arrest of the accused.”

“Therefore, this Court is
of the view that entrustment of the investigation to another Officer is not
warranted at this stage and the present Investigating Officer can continue the
investigation. The Investigating Officer is directed to effectuate fair and
unbiased investigation in this matter,” it further added.

To view the order, Click the link below:

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Johnson & Johnson concludes acquisition of Shockwave Medical

New Brunswick: Johnson & Johnson has announced it has completed its acquisition of Shockwave Medical. Shockwave is now part of Johnson & Johnson and will operate as a business unit within Johnson & Johnson MedTech.

Joaquin Duato, Chairman and Chief Executive Officer of Johnson & Johnson, said, “Through Innovative Medicine and MedTech, Johnson & Johnson is transforming the trajectory of cardiovascular disease, one of the leading causes of death globally. We are delighted to welcome the Shockwave team to Johnson & Johnson and look forward to bringing their innovative IVL technology to more patients around the world.”

Tim Schmid, Executive Vice President and Worldwide Chairman of Johnson & Johnson MedTech, said, “Completing this acquisition is a significant milestone in the expansion of our leadership position in the medtech industry. Shockwave’s differentiated solutions and robust pipeline represent an exciting opportunity for Johnson & Johnson MedTech to bring more innovations to patients in one of the largest areas of unmet medical need. We are excited to begin collaborating directly with the Shockwave team and look forward to a bright future together.”

“This transaction further extends Johnson & Johnson MedTech’s leadership in cardiovascular intervention. Shockwave offers commercially available intravascular lithotripsy (IVL) platform for coronary artery disease (CAD) and peripheral artery disease (PAD) and complements Johnson & Johnson’s leading positions in heart recovery (Abiomed) and electrophysiology (Biosense Webster) to make it a category leader in four of the largest and highest-growth medtech markets within cardiovascular intervention,” the release stated.

Shockwave is ultimately expected to become Johnson & Johnson MedTech’s thirteenth priority platform, as defined by annual sales of at least $1 billion. The transaction is expected to accelerate revenue growth for both Johnson & Johnson and Johnson & Johnson MedTech. Johnson & Johnson expects the transaction to be accretive to operating margin, but considering the impact of financing costs, is expected to dilute adjusted earnings per share by approximately $0.10 in 2024 and approximately $0.17 in 2025.

In connection with the completion of the transaction, Shockwave’s common stock ceased trading on NASDAQ.

Read also: JnJ to buy rights to Numab Therapeutics Clinical-Stage Bispecific Antibody NM26

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Tripura: Agartala Municipal Corporation to open 50-bed hospital

Agartala: The Agartala Municipal Corporation (AMC) is set to open its first 50-bed hospital which will offer free treatment and medicines, with ambulance services available across all 51 wards of Agartala

Endorsed by the Tripura government, the facility is planned for the old municipal building near Jackson Gate. The 24,000-square-foot building, with 80 percent of its construction already completed, will house a 50-bed hospital.

The hospital will offer free treatment and medicines, with ambulance services available across all 51 wards of Agartala. Key officials, including Health Secretary Kiran Gitte, Municipal Commissioner Sailash Yadev, and the Director of National Health Mission, visited the site and finalised plans, news agency ANI reported.

Also Read:Kidney transplant facility to be launched at GBP Hospital: Tripura CM Manik Saha

The inauguration is scheduled for August 15, to be officiated by Chief Minister Manik Saha.

Initially, the state government will supply doctors and nurses and provide economic support for two years. After this period, the AMC will independently manage the hospital. Future expansion is also planned to meet growing demands.

The new hospital will complement existing major state hospitals, providing modern medical facilities to the local population.

According to a ANI report,”Agartala Municipal Corporation, for the first time, is planning to open a hospital for the people under AMC…Today, we visited the place. The old building of the municipality near Jackson Gate has been finalised, and 80 per cent construction is already there with a 24000 square foot area,” AMC Mayor Dipak Majumder said.

Elaborating on the hospital, Majumder said, “We will establish a 50-bed hospital there. There will be free treatment, and free medicines will be provided. And the ambulance facility will be made available for all 51 wards. We will connect all the municipality wards with this hospital.”

The AMC Mayor said that the Health Secretary, Kiran Gitte, Municipal Commissioner, Sailash Yadav, and the Director of the National Health Mission and Health Secretary of the State, have visited the spot and jointly decided that on August 15, the hospital will be inaugurated by Chief Minister Manik Saha.

“According to me, it’s a great opportunity for the people of Agartala. Along with all other facilities, health facilities will be added to the AMC. It’s the first time in our state, and AMC has taken the initiative. And I hope that all the people of Agartala municipality will take the facilities and join us together,” Saha said.

“The hospital will have modern facilities…For the first two years, the state government will provide us with doctors and nurses and will support us economically. After two years, the AMC will run the hospital with its own efforts. In the future, if there is demand, we can extend the hospital,” he added.

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NEET Qualified Candidates Move SC Challenging AYUSH Dept’s Non-Regularization of Provisional Admission in Unani College

New Delhi: Seeking regularization of the provisional admission granted to them by a Unani College in the BUMS Course, eight NEET-qualified students have approached the Supreme Court and filed a plea in this regard.

Initially, these students had approached the Madhya Pradesh High Court seeking admission from the Ayush Department (Bhopal) for their admission into the Bachelor of Unani Medicine & Surgery (BUMS) course for the academic year 2022-2023.

They submitted that after appearing in the National Eligibility-cum-Entrance Test (NEET), 2022, they cleared the exam. However, as per the students, even after securing their names in the merit list, the authorities did not call them for registration and guidance.

Approaching the Court, these petitioner students alleged that the AYUSH department issued admission letters to them only on the last date of admission. Therefore, they were forced to approach Unani College for granting provisional admission. Following this, the college sent them provisional admission letters. However, as per the students the AYUSH Department has not regularized or confirmed their admissions.

Also Read: Separate NEET for BAMS, BUMS, BSMS; Separate NEET for Sowa-Rigpa under NCISM Regulations 2023

On the other hand, the authorities submitted that before the commencement of the first counselling, the petitioners did not register themselves on the online portal. Therefore, the subsequent process could not be started. Referring to this, the authorities argued that it was a case of backdoor admission as the Unani College cannot grant final admission to the petitioners. In this regard, the authorities also pointed out that the relevant academic session has already ended.

While considering the matter, the MP High Court perused all the records and noted that the petitioners had not complied with the procedure envisaged in the National Commission of Indian System of Medicine (Minimum Standard for Under Graduate Unani Education) Regulations, 2020 for admission to Ayurvedic, Homeopathy and Unani education courses in Madhya Pradesh.

“The petitioners were not a part of the counselling process. They took admission illegally in the respondent no.3/college which had no right to grant direct admission to the students without following due procedure. This cannot be termed as anything but illegal,” the HC bench had observed.

Further expressing concerns over the backdoor admissions in medical colleges, the HC bench had noted, “It is high time that such backdoor admissions in educational institutions including medical colleges must be stopped. Lakhs of students across the country work very hard to get admission in educational institutions on the basis of their merit. To permit backdoor admissions in any educational institution would be a grave injustice to those students who, despite having higher qualifications, are denied admission due to seats being taken up and blocked by such backdoor admits.”

As per the latest media report by Live Law, challenging the HC order, the petitioners approached the Supreme Court and claimed that out of eight of them, three had registered on the portal but were still not called for counselling. Further, the plea stated that on the last date of admission i.e. on 03.04.2023, even after the clearance round of counselling, 8 seats of Unani College were vacant. Therefore, the Council granted provisional admission to these students on these 8 seats.

Approaching the top court bench, the petitioners prayed for a stay on the impugned judgment and also sought directions to the response authorities to permit them to appear in the examination for BUMS 1st Year Course scheduled to commence from 12.06.2024. The case has been listed to be heard after a week.

Also Read: Who can practice as Registered Ayurveda, Unani Practitioner? Delhi HC defines eligibility for NExT exam

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Socioeconomic status can influence genetic risk for many complex diseases

Differences in socioeconomic status (SES) are known to be linked to differences in the risk of developing disease. While people with lower SES are more likely to develop complex diseases such as diabetes and cardiovascular disease, those with a higher SES are at increased risk of developing certain types of cancer.

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New ‘armored’ CAR produces responses in patients whose cancers don’t respond to current CAR T cell therapies

While CAR T cell therapy has revolutionized treatment for many blood cancers, including non-Hodgkin lymphoma (NHL), many patients who receive CAR T cell therapy do not experience a long-term remission. For those whose cancers return or become resistant after CAR T cell therapy, the prognosis is poor, with few options left.

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