Baked Milk Immunotherapy Offers Relief for Cow’s Milk Allergy Patients: Study

According to a recent study being presented at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, Baked Milk Oral Immunotherapy (BMOIT) is well-tolerated and results in significant desensitization to both baked and unheated milk.

Cow’s milk allergy is the most common food allergy among young children. This condition persists into adolescence and adulthood for about 20% of cases. Due to the ubiquity of milk, avoidance is challenging, leading to frequent severe reactions as well as social and dietary restrictions. This significantly impacts the quality of life. To address this, an effective treatment is essential. This study was conducted to test the safety and efficacy of a baked milk oral immunotherapy for children with severe milk allergies, and the results were promising, according to primary author Jennifer Dantzer, MD, MHS.
In a phase II double-blind, placebo-controlled study, researchers compared BMOIT to a placebo over 12 months. After one year, the study was unblinded, and the placebo group switched to active therapy while the active baked milk group continued to receive 2000mg of BMOIT for another 12 months. Participants underwent oral food challenges two years later for baked and unheated milk.
Key findings from the study are:
· 24/ 30 randomized patients completed the year two oral food challenges.
· 92% of participants tolerated approximately 2g doses of baked milk (BM)
· 79% of participants tolerated the maximum cumulative dose of 4g, with no difference between those on BMOIT for 12 or 24 months.
· The group receiving BM for 24 months showed a greater tolerance for unheated milk compared to those receiving 12 months of BMOIT or the placebo group. Longer treatment duration also demonstrated increased efficacy.
· Symptoms occurred in 12% of BM doses, primarily mild and without severe reactions. Common symptoms were oropharyngeal and gastrointestinal.
Cow’s milk allergy affects many young children, and currently, no known treatments exist. This study provides promising evidence for potential therapies in the future. After 12 and 24 months of treatment, participants showed significantly reduced sensitivity to milk products.
Reference:
Baked Milk Oral Immunotherapy Found to be Effective Treatment for Cow’s Milk Allergy. American Academy of Allergy, Asthma & Immunology. February 5, 2024. https://www.aaaai.org/about/news/news/2024/baked. Date accessed: February 21, 2024.

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Addition of Metronidazole to Cefazolin Reduces Surgical Site Infections risk in Gynecologic Surgery, finds study

Surgical site infections (SSI) pose a considerable risk in gynecologic cancer surgery due to their potential for complications such as wound dehiscence, abscess formation, and prolonged hospitalization. These infections not only impact patient morbidity and mortality but also contribute to increased healthcare costs. To mitigate this risk, pre-operative antibiotic prophylaxis is routinely administered. Cefazolin is commonly used for this purpose in clean-contaminated surgeries like hysterectomy.

However, recent evidence suggests that adding metronidazole to cefazolin may further reduce the incidence of SSIs by targeting anaerobic bacteria, which are prevalent in the pelvic region. This study was published in the American Journal Of Obstetrics and Gynecology. The study was conducted by Anne K. and colleagues.

Gynecologic cancer surgeries, including hysterectomy and oophorectomy, are associated with an increased risk of SSIs due to factors such as the proximity to the perineum, the potential for contamination from the genital tract, and the complexity of the procedures. SSIs can lead to adverse outcomes such as delayed wound healing, prolonged hospital stays, and the need for additional interventions.

This retrospective cohort study was conducted at a comprehensive cancer center and included patients undergoing gynecologic surgery between May 2017 and June 2023. The study compared two groups of patients: those who received cefazolin alone as antibiotic prophylaxis (pre-intervention group) and those who received a combination of cefazolin and metronidazole (post-intervention group). The primary outcome assessed was the incidence of SSI within 30 days post-surgery. Multivariable logistic regression analysis was performed to identify factors independently associated with SSI while adjusting for potential confounding variables.

The key findings of the study were:

  • Among the 3343 patients included in the study, the majority (76.9%) belonged to the pre-intervention group, while the remaining 23.1% were in the post-intervention group.

  • The overall SSI rate prior to the intervention was 4.7%, compared to 2.6% after the intervention, indicating a significant reduction in SSIs following the addition of metronidazole to cefazolin.

  • The addition of metronidazole to cefazolin resulted in a notable decrease in the odds of developing an SSI.

  • Patients receiving the combination regimen had a 49% lower odds of experiencing an SSI compared to those receiving cefazolin alone.

  • This reduction in SSI risk remained significant even after adjusting for potential confounders.

The findings of this study underscore the significant impact of adding metronidazole to cefazolin in reducing the incidence of SSIs in gynecologic cancer surgery. Providers should consider implementing this combination regimen as part of their antibiotic prophylaxis protocols, especially for patients undergoing procedures such as hysterectomy. By optimizing antibiotic prophylaxis, healthcare providers can improve patient outcomes and enhance the quality of care in gynecologic oncology.

Reference:

Knisely, A., Iniesta, M. D., Marten, C. A., Chisholm, G., Schmeler, K. M., & Taylor, J. S. (2024). Metronidazole and cefazolin versus cefazolin alone for surgical site infection prophylaxis in gynecologic surgery at a comprehensive cancer center. American Journal of Obstetrics and Gynecology. https://doi.org/10.1016/j.ajog.2024.03.043

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Novel CT exam reduces need for invasive artery treatment, study finds

A new study showed that a non-invasive imaging test can help identify patients with coronary artery blockage or narrowing who need a revascularization procedure.

The findings were published as a Special Report in Radiology: Cardiothoracic Imaging, a journal of the Radiological Society of North America (RSNA).

Doctors use coronary CT angiography (CTA) to diagnose narrowed or blocked arteries in the heart. A CTA exam receives a score from mild (0-1) to moderate (2-3) to severe (4-5). Patients with scores above 3 typically require medical treatments and can potentially benefit from stents or surgeries (revascularization) to restore blood flow to the heart.

“CTA tells you the degree to which a vessel is blocked,” said Mangun Kaur Randhawa, M.D., a post-doctoral research fellow in the Department of Radiology at Massachusetts General Hospital (MGH) in Boston. “But the degree of blockage doesn’t always reliably predict the amount of blood flow in the vessel.”

Doctors have traditionally relied on an invasive procedure known as invasive coronary angiography to image vessels and more recently have added other invasive tests like fractional flow reserve (FFR) to identify and assess significant blockages in the vessels. CT-FFR is a relatively new alternative that non-invasively models a patient’s coronary blood flow using CTA images of the heart, AI algorithms, and/or computational fluid dynamics.

To assess the impact of the selective use of CT-FFR on clinical outcomes, Dr. Randhawa’s research team conducted a retrospective study of patients who underwent coronary CTA at MGH between August 2020 and August 2021.

During the study period, 3,098 patients underwent coronary CTA. Of these, 113 coronary bypass grafting patients were excluded. Of the remaining 2,985 patients, 292 (9.7%) were referred for CT-FFR analysis, and eight of these exams were excluded, leaving a final study group of 284.

As expected, most referrals to CT-FFR were patients with scores of 3 or above. CT-FFR was requested in the majority (73.5 %) of patients with a score of 3 (moderate narrowing/blockage).

“In patients with moderate narrowing or blockage of the arteries, there can be ambiguity about who would benefit from invasive testing and revascularization procedures,” Dr. Randhawa said. “CT-FFR helps us identify and select those patients who are most likely to benefit.”

Out of the 284 patients, 160 (56.3%) had a negative CT-FFR result of > 0.80, 88 patients (30.9%) had a positive (abnormal) result of ≤ 0.75, and the remaining 36 patients (12.6%) had a borderline result between 0.76-0.80.

Patients with significant narrowing/blockages on coronary CTA who underwent CT-FFR had lower rates of invasive coronary angiography (25.5% vs. 74.5%) and subsequent percutaneous coronary intervention (21.1% vs. 78.9%) than patients who were not referred for a CT-FFR.

“CT-FFR helps us identify patients who would most benefit from undergoing invasive procedures and to defer stenting or surgical treatment in patients who likely won’t,” said senior author Brian B. Ghoshhajra, M.D., M.B.A., associate chair for operations and academic chief of cardiovascular imaging at MGH. “CT-FFR makes the CT ‘better’, but we found that the benefits were highest when used selectively.”

Dr. Ghoshhajra added that their CT-FFR analysis was successful in the large majority of patients, regardless of challenging factors such as elevated or irregular heart rates and obesity.

“When you objectively measure coronary artery flow with CT-FFR, you induce fewer patients to be further investigated and treated, because you tend to treat not just what the eyeball sees, but what the physiology supports,” he said.

The researchers said the study results demonstrate the utility of CT-FFR in clinical practice, when used selectively, highlighting its potential to reduce the frequency of invasive procedures in patients with significant coronary artery narrowing or blockages without compromising safety.

References: Mangun K. Randhawa* , Angelo K. Takigami*, Vikas Thondapu, Praveen G. Ranganath, Eric Zhang, Anushri Parakh, Reece J. Goiffon, Vinit Baliyan, Borek Foldyna, Michael T. Lu, Albree Tower-Rader, Nandini M. Meyersohn, Sandeep Hedgire, Brian B. Ghoshhajra * M.K.R. and A.K.T. contributed equally to this work. Published Online:Apr 4 2024https://doi.org/10.1148/ryct.230073

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Study reports high success rate for spontaneous space closure in patients treated with early extraction of first permanent molar

Sweden: The early extraction of the first permanent molar (FPM) in orthodontic treatment has long been a debatable topic among dental professionals. A recent retrospective records-based cohort study published in The Angle Orthodontist sheds new light on this subject, focusing specifically on spontaneous space closure following first permanent molar (FPM) extraction.

“The success rate of spontaneous space closure was high (84.3%) and was greater in the maxilla (94.1%) than the mandible (74.1%),” the researchers reported.

Age at the time of extraction and the dental developmental stage of the second permanent molar (SPM) were significant factors for successful spontaneous space closure in the maxilla and mandible, respectively.

FPM extraction is often considered a strategic orthodontic intervention, particularly in cases of crowding or malocclusion. Early extraction provides space for the eruption of permanent teeth, facilitating orthodontic treatment and potentially reducing the need for more invasive interventions later in life.

Against the above background, Yasser Aldahool, Folktandvården Stockholm, Spånga, Stockholm, Sweden, and colleagues aimed to assess the success rate of spontaneous space closure after extraction of the first permanent molar in the maxilla and the mandible. They also identified the factors that make spontaneous space closure most favorable.

For this purpose, the researchers searched the database of the Public Dental Service, Stockholm County Council, Stockholm, for young adults born between 2000 and 2001 who underwent extraction of one or more FPM between 2006 and 2016. They identified 995 extracted teeth, of which 203 teeth in 155 patients met the inclusion criteria.

The researchers reported the following findings:

  • Of the 203 extracted teeth, 81.8% received no orthodontic treatment.
  • The success rate for space closure in orthodontically treated patients was 91.9%.
  • The success rate for spontaneous space closure was 84.3%.
  • All unsuccessful spontaneous space closures in the maxilla occurred in patients older than 12 years.
  • The dental developmental stage of the second permanent molar had a statistically significant association with spontaneous space closure in the mandible.

In conclusion, the following variables were significant for successful spontaneous space closure:

  • Maxillary extractions before age 12 were more favorable than extractions done at or after 12.
  • Extraction site, with more favorable results for extractions in the maxilla compared to the mandible.
  • Dental development of the SPM in stages E and F at the time of the extraction had the most favorable results in the mandible.
  • This study could not verify that engagement of the second premolar under the roots of the primary second molar, mesial angulation of the SPM, or the presence of the third molar was significant for successful spontaneous space closure.

“There has been a lack of agreement on the most important factors for spontaneous space closure following the early extraction of FPMs,” the researchers wrote.

“Spontaneous space closure after FPM extraction is significantly associated with age and the developmental stage of the SPM in the maxilla and mandible, respectively.”

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Breakthrough Ultrasound Technology Offers Noninvasive Pain Relief through Brain Modulation, reveals study

In a groundbreaking study, researchers have explored the
potential of low-intensity focused ultrasound (LIFU) to noninvasively target
and modulate the dorsal anterior cingulate cortex (dACC), a key brain region
associated with pain and autonomic processing. The findings present a promising
avenue for noninvasive therapeutic interventions in pain management.

 

The study results were published in The Journal of Neuroscience.

The dACC, a critical area in the brain linked to pain and
autonomic responses, has long been a target for researchers seeking innovative
ways to alleviate discomfort. The study, conducted with 16 healthy volunteers
(6 males and 10 females), employed LIFU to modulate the dACC while participants
experienced transient heat pain stimuli.


Findings:


  • The results were significant, with LIFU demonstrating a
    remarkable reduction in pain ratings by an average of 1.09 points compared to
    Sham stimulation.

  • This achievement opens doors to noninvasive methods of pain
    relief, potentially revolutionizing how we approach discomfort and its
    management.

  • Crucially, the study also delved into the impact of LIFU on
    cardiac autonomic responses during acute heat pain stimuli.

  • The volunteers’ electrocardiograms (ECG) revealed intriguing
    changes, as LIFU increased heart rate variability, as indicated by higher
    standard deviation of normal sinus beats (SDNN), low-frequency (LF) power, and
    an altered low-frequency/high-frequency (LF/HF) ratio.

  • Despite the substantial effects on pain and cardiac
    responses, LIFU did not show significant alterations in blood pressure or
    electrodermal response (EDR), indicating a targeted and specific impact on
    pain-related brain regions.


  • One particularly noteworthy finding was the 38.1% reduction
    in the P2 amplitude of the contact heat-evoked potential (CHEP) observed with
    LIFU.
  • This result further supports the effectiveness of LIFU in modulating
    neural responses associated with pain, providing a tangible marker of the
    intervention’s impact.


These breakthrough results mark a significant stride in
understanding the brain’s role in pain processing and offer a potential
noninvasive solution for pain relief. The ability to modulate the dACC using
LIFU introduces novel possibilities for therapeutic interventions that go
beyond traditional approaches.

Researchers believe that these findings hold implications
not only for pain management but also for advancing our understanding of human
pain perception and autonomic processing. This research sets the stage for
future investigations into the therapeutic applications of LIFU, with potential
benefits for individuals suffering from chronic pain or seeking alternative
pain relief methods.


In conclusion, the study signifies a major leap forward in
the field of pain research, showcasing the potential of LIFU as a noninvasive
tool for influencing pain perception and autonomic responses. As scientists
continue to unlock the mysteries of the brain, this innovative approach could
pave the way for transformative advancements in pain management and
neurological interventions.

Further reading: Low-Intensity Focused Ultrasound to the Human Dorsal Anterior Cingulate Attenuates Acute Pain Perception and Autonomic Responses. DOI: https://doi.org/10.1523/JNEUROSCI.1011-23.2023

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Netarsudil and latanoprost combo useful fixed dose option for open-angle glaucoma and IOP: Study

A recent study published in the Graefe’s Archive for Clinical and Experimental Ophthalmology compared the effectiveness and safety of two fixed-dose combination (FDC) ophthalmic solutions for treating open-angle glaucoma (OAG) and ocular hypertension (OHT). This study evaluated the efficacy of the FDC of netarsudil 0.02%/latanoprost 0.005% (NET/LAT; Roclanda®) against bimatoprost 0.03%/timolol maleate 0.5% (BIM/TIM; Ganfort®).

Over a 6-month period, the MERCURY-3 study included patients over 18 years with OAG or OHT that was insufficiently controlled by topical medication. The efficacy and safety of NET/LAT and BIM/TIM were assessed at various intervals throughout the study.

The results indicated that NET/LAT was non-inferior to BIM/TIM in reducing intraocular pressure (IOP), with no statistically significant difference between the two treatments. Both treatments demonstrated a mean diurnal IOP ranging from 15.2 to 15.6 mmHg, where NET/LAT showed comparable efficacy to BIM/TIM. Also, no treatment-related adverse events were observed, with most adverse events being mild to moderate in severity.

The most common treatment-related adverse events were conjunctival hyperemia and cornea verticillata, where NET/LAT showed slightly higher rates of conjunctival hyperemia when compared to BIM/TIM. Further, these adverse events were consistent with previous findings and did not pose significant safety concerns.

This research emphasized the significance of the findings by stating that once-daily NET/LAT provides a compelling alternative to the fixed-dose combination treatment option for patients with OAG and OHT. This study offers valuable insights into the efficacy and safety profile of NET/LAT that expands the treatment options for individuals with these sight-threatening conditions.

Reference:

Stalmans, I., Lim, K. S., Oddone, F., Fichtl, M., Belda, J. I., Hommer, A., Laganovska, G., Schweitzer, C., Voykov, B., Zarnowski, T., & Holló, G. (2023). MERCURY-3: a randomized comparison of netarsudil/latanoprost and bimatoprost/timolol in open-angle glaucoma and ocular hypertension. In Graefe’s Archive for Clinical and Experimental Ophthalmology (Vol. 262, Issue 1, pp. 179–190). Springer Science and Business Media LLC. https://doi.org/10.1007/s00417-023-06192-0

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Compounds in female ginseng could lead to new osteoporosis treatments, claims study

With ever-increasing life expectancy comes the challenge of treating age-related disorders such as osteoporosis. Although there are effective drugs for treating this metabolic bone disease, they can be expensive and have side effects, limiting their availability to some people. In the search for alternative drug candidates, researchers reporting in ACS Central Science have discovered and fully replicated a compound from a botanical source, female ginseng, that had potent anti-osteoporotic activity in cellular tests.

Osteoporosis and low bone mass impact 54 million American adults over the age of 50, according to the International Osteoporosis Foundation. The disease can progress to significant disability, such as hip and spine fractures, and financial burdens, such as lost wages and hospitalization. Several drugs have proven effective in either preventing bone loss or promoting bone formation, but each comes with potential side effects, including injury to jaw and leg bones. Searching for alternative treatments, Hao Gao, Xin-Luan Wang and colleagues turned to female ginseng (Angelica sinensis), which has long been used in traditional Chinese medicine to treat osteoporosis.

The researchers performed chemical extraction on the medicinal plant and identified two new compounds, calling them falcarinphthalide A and B, that were structurally unlike anything previously discovered in female ginseng. They also determined potential biosynthetic precursors and metabolic pathways that the plants use to form these compounds. Then, with these mechanisms as starting points, the team devised lab synthesis methods and produced the compounds at quantities sufficient for biological testing. Inspired by the traditional efficacy of female ginseng, the team tested the compounds for their impact on the formation of cells called osteoclasts, which facilitate bone loss. They observed that only falcarinphthalide A and its precursors showed osteoclast inhibitory activity and an anti-osteoporotic effect. Further analysis showed that falcarinphthalide A blocked key molecular pathways involved in osteoclast generation. The researchers say that this study opens up the possibilities for new osteoporosis treatments based on the female ginseng compound, whether in its current form or as a structural template for further drug development.

Reference:

Jian Zou, Zuo-Cheng Qiu, Qiang-Qiang Yu, Jia-Ming Wu, Yong-Heng Wang, Ke-Da Shi, Yi-Fang Li, Rong-Rong He, Ling Qin, Xin-Sheng Yao, Xin-Luan Wang*, and Hao Gao, Discovery of a Potent Antiosteoporotic Drug Molecular Scaffold Derived from Angelica sinensis and Its Bioinspired Total Synthesis, https://doi.org/10.1021/acscentsci.3c01414.

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Novel risk score accurately predicts death without transplant in patients awaiting heart transplantation: JAMA

USA: A recent study has revealed that the novel US-Candidate Risk Score (US-CRS) may be useful in accurately predicting the risk of death in patients awaiting heart transplantation. The study findings were published online in the Journal of the American Medical Association (JAMA) on February 13, 2024.

In the registry-based study of 16 905 heart transplant candidates, the US-CRS based on required laboratory and clinical variables outperformed the current treatment-based categorical allocation system in identifying medically urgent candidates at the highest risk of death without transplantation.

In the United States, there were reportedly 4,500 heart transplantations performed in 2023, a number that has been steadily increasing for at least ten years. Despite the rising number of transplantations, donor hearts remain hard to come by, which has led the Organ Procurement and Transplantation Network (OPTN) to prioritize patients who are at high risk of death unless they receive a new heart.

The US heart allocation system prioritizes medically urgent candidates at a greater risk of dying without a transplant. The current therapy-based 6-status system is susceptible to manipulation and has limited rank-ordering ability.

Against the above background, Kevin C. Zhang, Department of Medicine, University of Chicago, Chicago, Illinois, and colleagues aimed to develop and validate a candidate risk score that incorporates current laboratory, clinical, and hemodynamic data.

For this purpose, they conducted a registry-based observational study of adult heart transplant candidates (aged ≥18 years) from the US heart allocation system listed between 2019 and 2022, split by centre into training (70%) and test (30%) datasets.

A US candidate risk score model was developed by adding a predefined set of predictors to the current French Candidate Risk Score (French-CRS) model. The researchers performed sensitivity analyses, which included percutaneous ventricular assist devices (VAD) and intra-aortic balloon pumps (IABP) in the definition of short-term mechanical circulatory support (MCS) for the US-CRS.

The time-dependent area under the receiver operating characteristic curve (AUC) was used to evaluate the performance of the US-CRS model, French-CRS model, and 6-status model in the test dataset for death without transplant within 6 weeks and overall survival concordance (c-index) with integrated AUC.

The researchers reported the following findings:

  • 16 905 adult heart transplant candidates were listed (mean age, 53 years; 73% male; 58% White); 4.7% of patients died without a transplant.
  • The final US-CRS contained time-varying short-term MCS (ventricular assist–extracorporeal membrane oxygenation or temporary surgical VAD), the log of bilirubin, estimated glomerular filtration rate, the log of B-type natriuretic peptide, albumin, sodium, and durable left ventricular assist device.
  • In the test dataset, the AUC for death within 6 weeks of listing for the US-CRS model was 0.79, for the French-CRS model was 0.72, and 6-status model was 0.68.
  • The overall c-index for the US-CRS model was 0.76, the French-CRS model was 0.69, and the 6-status model was 0.67.
  • Classifying IABP and percutaneous VAD as short-term MCS reduced the effect size by 54%.

“The findings showed that a continuous multivariable allocation score outperformed the 6-status system in rank ordering heart transplant candidates by medical urgency and may be useful for the medical urgency component of heart allocation,” the researchers concluded.

Reference:

Zhang KC, Narang N, Jasseron C, et al. Development and Validation of a Risk Score Predicting Death Without Transplant in Adult Heart Transplant Candidates. JAMA. 2024;331(6):500–509. doi:10.1001/jama.2023.27029

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Misdiagnosis, prescribing wrong dosage, forging of records: Doctor, Hospital slapped Rs 17 lakh compensation

Palakkad: The District Consumer Disputes Redressal Commission (DCDRC) recently held a doctor and a private hospital in Palakkad guilty of medical negligence for administering the wrong dosage of folitrax containing Methotrexate (MTX) leading to the patient’s death and directed them to pay Rs 17 lakh as compensation. The consumer court noted that there was grave negligence on the part of the orthopaedic doctor and the hospital and records were forged to hide vital information of the treatment.

Filing the plea before the consumer court, the deceased patient’s family members alleged that the doctor had administered MTX at 7.5 mg twice daily when the medical protocol dictates that the permissible dosage of MTX is 7.5 mg per week.

Even though the doctor denied this allegation and claimed that he had ordered the administration of the medicine @7.5 mg twice daily once a week, the consumer court concluded that the doctor had concocted the medical records to hide negligence on his part.

The case goes back to 2021 when the patient was taken to the treating hospital for medical treatment for back pain. She was under the care of the treating doctor. During the treatment period, the patient was allegedly administered a medicine, MTX at a dosage that was impermissible and higher than the recommended dosage.

Consequently, the patient had to be taken to the ICU. Since her condition became worse, she was taken to another hospital in Ernakulam, where she died. The legal heirs of the patient filed a consumer complaint and alleged that the impermissible dosage of MTX was the cause of her death. Filing the consumer complaint, the family sought compensation and other consequential and incidental reliefs.

On the other hand, the treating doctor and hospital denied the allegations and submitted that the patient was provisionally diagnosed with seronegative rheumatoid arthritis. She was prescribed MTX and HCQ which are medically accepted standard prescriptions for the management of arthritic pain. It was also submitted that the patient was suffering from other complaints like type-2 DM with peripheral neuropathy. 

The treating doctor detailed various treatments carried out at the hospital and stated that he had advised the stoppage of HCQs on 11.02.2021. Further, he submitted that at the time of the patient’s transfer to another hospital, he was not treating her as her condition had improved and therefore the patient was taken off the treating hospital. The doctor also claimed that the medication prescribed by him was as per accepted pharmacological guidelines.

While considering the matter, the consumer court noted that the complainant’s case was that the doctor had advised the administration of folitrax containing methotrexate (MTX) at 7.5 mg twice, morning and night ignoring medical protocol of administering MTX according to which the permissible dose is 7.5 mg per week. Therefore, the complainants alleged that the dosage administered to the patient was excessive and impermissible under medical treatment protocol. However, the doctor claimed that he had ordered the administration of MTX @7.5 mg twice daily once a week. Thereafter when the patient showed adverse symptoms, HCQs and folitrax were ordered to be stopped. 

The consumer court took note of the referral letter to another hospital and further observed that the case summary of the patient showed that the patient was suffering from “sepsis probably MTX induced”. Further, the admission form for ECHS issued by AIMS showed the provisional diagnosis to be ‘sepsis (methotrexate-induced bone marrow suppression). The medical certificate issued justifying emergency admission also showed the same diagnosis.

It was observed by the Commission that the entry dated 5/2/2021 in the medical records showed that the doctor had advised folitrax. The entry dated 11/02/2021 showed that the doctor had advised cessation of HCQs and “weekly dose of folitrax”. At this outset, the Commission noted, “This entry does not tally with the entry in Ext. B2(a) and the pleadings, wherein the 1st O.P. has advised administration of MTX twice a day(1 – 0 – 1).”

Meanwhile, the Drug Chart in the medical records showed that folitrax was stopped on 06/02/2021 (Day II). “This entry also does not tally with the pleadings that stoppage was effected on 11/02/2021 and the advice in Ext. B2(b) and pleadings,” noted the Commission.

The Nurses’ record made on 10/2/2021 noted that the patient had complaints of oral ulcer. Meanwhile, the doctor’s note dated 11/2/2021 showed that he had directed the stoppage of HCQs and MTX. However, corresponding entries in the nurse’s record showed that the doctor had seen the patient and advised continuation of the same treatment and new medicines were added. On 11/2/2021 and 13/2/2021 the same medication was continued as per Nurses record. On 13/2/2021, the doctor advised the transfer of the patient to the medical side.

Taking note of these records, the consumer court concluded that the medical records were concocted and observed,

“OPs have no case that the treating nurses had acted against the directions of OP1. Therefore, the only conclusion that can be reached from a reading of the discrepancy in the pleadings of the 1st O.P., Exts. B2(a), B2(b) and B2(c) is that the 1st OP has concocted Ext.B2(b).”

“Sheet of paper containing pages 13 & 14 (Ext.B2(b)), the headings are seen made of an entirely different ink pen and the handwriting from those made in other sheets in daily notes. The same hand writing is not seen repeated anywhere else in Ext.B2 file. The Doctor’s note in Ext.B2 is also entirely different in that the handwriting and ink are different from previous and subsequent notes. In page 14, where Dr. *** had entered his findings, the same pen used in page 13 is used to enter the patient details and date and time. Therefore, the same person who had entered the contents in page 13 had entered the details in page 14 using the same colour ink and pen. The same is not observed anywhere else,” observed the consumer court.

Opining that the doctor’s note in the nurse’s record was also concocted, the Commission further noted,

“Further, Ext. B2(a) shows that folitrax was prescribed to be administrated twice a day (1 – 0 – 1). There is no change in any subsequent pages till Ext. B2(b). But entry in Ext. B2(b) is to the effect that folitrax was scheduled on Saturday (on verification of 2021 calendar, it is seen that 11/02/2021 is Thursday). If, even as per the case of the 1st O.P., folitrax was advised daily and no change whatsoever was made until 11/02/2021, the entry on 11/02/2021 directing stopping of folitrax scheduled on Saturday does not appeal to logic. So we are of the opinion that Ext.B2(b) is a forged and concocted document.”

Similarly, the consumer court concluded the drug chart to also be forged to misguide and mislead the Commission. Therefore, the Commission opined that there was grave negligence in the treatment, the Consumer court noted,

“Why would the 1st O.P. resort to forging the documents, if not to hide some vital/fatal flaws? We, therefore, are under the impression that there is grave negligence on the part of 1st OP in diagnosing/misdiagnosing the condition of *** (the patient). He has also resorted to forging of documents so as to mislead and misguide the process of law.”

Holding that there was gross negligence and deficiency in service on the part of the doctor and also holding the hospital and its managing director vicariously liable for the negligence perpetrated and deficiency in service, the consumer court granted the complainants Rs 5 lakh as compensation for negligence, Rs 10 lakh as compensation for forging documents and Rs 2 lakh as cost of proceedings.

“OPs 1 to 3 shall be jointly and severally liable to pay these amounts to the complainants. 5. The aforesaid orders shall be complied within 45 days of receipt of this Order, failing which, each of the OPs shall pay Rs.1,000/- each to each of the complainant (ie. Rs. 2000 x 3) per month or part thereof by way of solatium,” ordered the District Consumer Court.

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/kerala-district-consumer-court-negligence-236110.pdf

Also Read:Medical Negligence During PCNL Surgery: Jaipur’s Manipal Hospital, Doctor Slapped Rs 15 Lakh Compensation

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Govt rebuts Lancet report on healthcare spending, says health investment aims to reach 2.5% of GPD by 2025

New Delhi: In response to a Lancet report highlighting concerns over healthcare spending in India, government sources have contested the findings, asserting that investments in the health sector have reached unprecedented levels. 

The Lancet report claimed that the Indian government’s healthcare expenditure stands at a mere 1.2% of GDP, one of the lowest among G20 nations, with persistently high out-of-pocket expenses for healthcare.

“As per the National Health Policy, 2017, public investment in health is envisioned to reach 2.5% of GDP by 2025. Ministry of Health and Family Welfare (MoHFW) has taken up with States to prioritize allocation to the health sector and enhance their health budgets by at least 10 per cent every year to reach the goal as envisaged,” one of the sources said, reports news agency PTI.

The budget estimates of the Department of Health and Family Welfare have reached Rs 86,175 crore in 2023-24 from Rs 36,948 crore in 2014-15, thereby showing an overall increase of 133.23 per cent during the period, they said.

Also Read:Stopping aspirin one month after PCI significantly reduces bleeding complications in patients with MI: Lancet

According to the report by medical journal Lancet, the government spending on health has fallen and now hovers around an “abysmal” 1.2 per cent of gross domestic product, out-of-pocket expenditure on health care remains extremely high, and flagship initiatives on primary health care and universal health coverage have so far “failed” to deliver services to people most in need.

In response, the sources in the government said the Health Ministry is making continuous efforts to increase allocation in health budget.

Further, the 15th Finance Commission has provided Rs 70,051 crore as grants for health through the local governments, the sources added.

As per National Health Accounts estimates for 2019-20, the key achievements in the health sector, that the total health expenditure was Rs 4,83,259 crore in 2014-15, which in 2019-20 has risen to Rs 6,55,822 crore.

However, government health expenditure as a per cent of GDP has increased from 1.13 per cent in 2014-15 to 1.35 per cent in 2019-20, indicating the commitment of the government to increase investments in the health sector.

On out-of-pocket expenditure, they said it has been decreasing.

“Out-of-pocket expenditure (OOPE) as a per cent of total health expenditure has decreased to 47.1 per cent in 2019-20 from 62.6 per cent in 2014-15.

Moreover, the government highlighted its various flagship initiatives aimed at bolstering healthcare infrastructure and expanding coverage. These include the PM-Ayushman Bharat Health Infrastructure Mission, Ayushman Arogya Mandir, Pradhan Mantri Jan Arogya Yojana, and Ayushman Bharat Digital Mission, alongside recent endeavours such as the Ayushman Bhav campaign. These initiatives aim to provide comprehensive healthcare services across the country, reaching even the remotest areas.

According to a PTI report, Further explaining about the ‘Ayushman Bhav’ campaign, one of the sources said, “It’s a comprehensive nationwide healthcare initiative that aims to provide saturation coverage of healthcare services, reaching every village and town in the country. This groundbreaking initiative builds upon the success of the Ayushman Bharat program and signifies a paradigm shift in healthcare services.”

Other notable initiatives are to provide financial and technical support to States/UTs under National Health Mission (NHM), setting up of new AIIMS, upgrading of Government medical colleges under the Pradhan Mantri Swasthya Suraksha Yojna (PMSSY), support to States/UTs for setting up of new medical colleges as well as for increasing UG and PG medical seats, provision of free drugs and free diagnostic facilities at Primary Health Centres (PHC)/ Community Health Centres (CHC) and district hospital level, substantial increase in availability of government ambulances, implementation of Janani Shishu Suraksha Karyakram, Janani Suraksha Yojana, Pradhan Mantri National Dialysis Program, Mobile Medical Units etc, they said.

On providing affordable generic medicines under PMBJP, telemedicine and e Sanjeevani they said, “Quality generic medicines are made available at affordable prices to all under Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) in collaboration with the State Governments. Affordable Medicines and Reliable Implants for Treatment (AMRIT) Pharmacy stores have been set up in some hospitals/institutions and under National Telemedicine Service, eSanjeevani provides access to specialized medical healthcare across the country by providing facility for doctor-to-doctor consultation and patient-to-doctor consultation.”

Also Read:Stopping aspirin one month after PCI significantly reduces bleeding complications in patients with MI: Lancet

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