Editor in Chief Dr KK Aggarwal, Padma Shri Awardee                                                                               Dated:23 November,2019

FDA approves first treatment for inherited rare disease

The U.S. Food and Drug Administration has granted approval to Givlaari (givosiran) for the treatment of adult patients with acute hepatic porphyria, a genetic disorder resulting in the buildup of toxic porphyrin molecules which are formed during the production of heme (which helps bind oxygen in the blood).

The approval of Givlaari was based on the results of a clinical trial of 94 patients with acute hepatic porphyria. Patients who received Givlaari experienced 70% fewer porphyria attacks compared to patients receiving a placebo… (FDA, November 20, 2019)

Two Thirds of Physicians Have Been Named in a Malpractice Suit: Survey

More than 4300 physicians in 29 specialties responded to a new Medscape Malpractice Report 2019. Responses show that specialists were sued more often than those in primary care (62% vs 52%).

Most physicians (59%) who responded to the Medscape survey said they have at some point been named in a malpractice suit, either individually or with others.

Of those physicians, 14% said they were the only party named in the suit. In 2013, 9% said they were the only ones named. ....read more

You look at people the same way as you are

Honest people see everybody as honest and dishonest people see everybody as dishonest. It all depends on the type of people you interact with. If you do not take bribe, nobody will offer a bribe to you and you will feel that everybody is honest. If you take bribes, then you will be offered bribes and you will feel that everybody in the society is dishonest. Never judge people with your personal experience.

I recall a doctor saying that every doctor takes and gives bribe because he was running an imaging center and every doctor who approached him asked for a bribe. But he had not taken into consideration the doctors who did not approach him.

Healthcare News Monitor

USFDA observes major protocol lapses in Aurobindo's sterile drug unit
Business Standard- B Dasarath Reddy

A few inspectional observations made by the US Food And Drug Administration (USFDA) on Aurobindo Pharma Ltd's Unit-4 earlier this month appear to be quite serious, and could have implications on the ongoing operations of the plant, which manufactures sterile injectables. A five-member team of the US drug regulator had inspected Aurobindo's Pashamailaram facility in Hyderabad between November 4 and 13, and issued Form 483 with as many as 14 observations critical of its functioning. Though the company said that none of those observations were related to data integrity issues, the nature and findings of some point to issues that the USFDA has viewed very seriously in the past. Since Form 483 contains inspectional observations that do not represent a final view of the agency, the companies are given a chance to submit their objections or responses, with a proper remedial plan within a stipulated time frame. A copy of the Form 483 with 14 observations was reviewed by Business Standard.

AI solution to design new tuberculosis drug
Yahoo News- ANI

Researchers have developed a software tool that is likely to assist in creating more effective treatments for tuberculosis. "This could replace our traditional trial-and-error system for drug development that is comparatively slow and expensive," said Sriram Chandrasekaran, U-M assistant professor of biomedical engineering, who leads the research. Dubbed INDIGO, short for INferring Drug Interactions using chemo Genomics and Orthology, the software tool has shown that the potency of tuberculosis drugs can be amplified when they are teamed with antipsychotics or antimalarials. "This tool can accurately predict the activity of drug combinations, including synergy -- where the activity of the combination is greater than the sum of the individual drugs," said Shuyi Ma, a research scientist at the University of Washington and a first author of the study published in --mBio. "It also accurately predicts antagonism between drugs, where the activity of the combination is lesser. In addition, it also identifies the genes that control these drug responses," added Shuyi Ma. Among the combinations INDIGO identified as showing a strong likelihood of effectiveness against tuberculosis were: A five-drug combination of tuberculosis drugs Bedaquiline, Clofazimine, Rifampicin, Clarithromycin with the antimalarial drug P218. A four-drug combination of Bedaquiline, Clofazimine, Pretomanid and the antipsychotic drug Thioridazine.

Kochi: Doctors gift new cervix to teen with rare anomaly
ET Healthworld- Preetu Nair

KOCHI: Doctors in Kochi have given a new life to a teenage girl with cervico-vaginal aplasia, a rare congenital anomaly in which the cervix and vagina are absent from birth. The girl had severe pain during her periods for the last two years as the menstrual blood couldn’t be drained out and doctors have now operated on her and created an artificial space (vagina). Gynaecologists said the medical condition occurs in one in 80,000-1,00,000 live births and while it is easier to create vagina, creating cervix is difficult and rare, with very few cases reported in medical journals. The 15-year-old girl had come to the hospital with a complaint that she had not started menstruating but had severe abdominal pain every month. The girl complained that the pain was so excruciating that it affected her day-today activities. She had taken treatment at various hospitals for over a year, without much relief. "On examination, we found that she had normal physical development and secondary sexual characteristics expected in a 15-year-old girl except for the absence of menses. On examination and ultrasound, it was found out that the cervix and vagina were absent. Her cyclical menstrual bleeding was getting collected inside the partially developed uterus, which caused the pain," said Dr P G Paul, gynaecologist and endoscopic surgeon, Paul’s Hospital, Kochi, who performed the cervicovaginal reconstruction surgery on the girl.

Digital radiography unit at AIIMS Bhopal starts operation
ET Healthworld-TNN

BHOPAL: A state-of-the-art Digital Radiography Fluoroscopy unit (DRF), the first of its kind in Madhya Pradesh, was commissioned at the All India Institute of Medical Sciences here on Wednesday. AIIMS director, Dr Sarman Singh, inaugurated the DRF which helps in diagnosing complex gastrointestinal and genitourinary disorders by using contrast media and then assessing the functional status by fluoroscopy. In addition, DRF is also required for various therapeutic non-vascular interventional procedures such as Percutaneus Nephrosotomies, Percutaneus Transhepatic Biliary Procedures, Placement of Nasojejeunal Tubes, Fallopian tube recanalization, interventional spinal procedures and other ailments. It is a flat panel detector based system that delivers high-quality dynamic and static digital imaging. Its comprehensive dose reduction program decreases radiation exposure for patients and staff without compromising the image quality. This new addition of technology will increase the level of patient care at AIIMS-Bhopal, said Dr Singh. Earlier, radiotherapy services had been initiated for cancer patients. The installation and regulatory requirements of Linear Accelarator (Lineac) has now been completed and external radiotherapy treatment will be initiated, said a press release.

UP: Doctors at bareilly hospital remove 9kg cyst from woman’s womb
ET Healthworld- Priyangi Agarwal

BAREILLY: In a unique surgery, a team of doctors at the district hospital successfully removed an ovarian dermoid cyst weighing nine kg from a 19-year-old woman on Wednesday. According to officials, the 19-year-old from Aonla was carrying the cyst in her uterus for over a year. She had consulted a few private doctors, including a surgeon and gynaecologist, earlier but to no avail. Hence, she consulted the doctors at the district hospital’s out-patient department 10 days ago after which they recommended surgery. She was admitted on Tuesday and the surgery was performed on Wednesday. Dr Manish Singh, general and laparoscopy surgeon who was behind the operation, said, “Ovarian dermoid cyst is usually 5cm-long but the patient had a 23cm-long one. Due to this, she was facing breathing problems. It could have been life threatening. However, her condition is stable after the surgery.” Other doctors who were part of the surgery are Sunil Yadav and Digvijay Singh.