Cleveland Clinic Top 10 Medical Innovations for 2020 (Part 1)

1.Dual-acting osteoporosis drug:The recent FDA approval of romosozumab, a new dual-acting drug is giving patients with osteoporosis more control in preventing additional fractures.

2.Expanded use of minimally invasive mitral valve surgery:Expanding the approval of a minimally invasive valve repair device to a population of patients who have failed to get symptom relief from other therapies provides an important new treatment option.

3.Inaugural medication for transthyretin amyloid cardiomyopathy: It is a progressive, underdiagnosed, potentially fatal disease in which amyloid protein fibrils deposit in, and stiffen, the walls of the heart’s left ventricle. But a new agent to prevent misfolding of the deposited protein is showing a significantly reduced risk of death. Following Fast-Track and Breakthrough designations in 2017 and 2018, 2019 marked the FDA approval of tafamidis,the first-ever medication for treatment of this increasingly recognized condition.

4.Therapy for mitigation of peanut allergies: Development of a new oral immunotherapy medicationo gradually build tolerance to peanut exposure holds the opportunity to lend protection against attack.

5.Closed-loop spinal cord stimulation:Implantable devices provide electrical stimulus to the spinal cord but unsatisfactory outcomes due to subtherapeutic or overstimulation events are common. Closed-loop stimulation is allowing for better communication between the device and the spinal cord providing more optimal stimulation and relief of chronic pain.

(To be continued)

(Source: Cleveland Clinic)

Chiranjivi Hriday HCFI PHM Consensus: Immediate initiation of excellent CPR is crucial to survival in sudden cardiac arrest

Incidence of sudden cardiac arrest in the general population is 50 to 100 per 100,000.

Important Guidelines

• Immediate recognition of sudden cardiac arrest by noting unresponsiveness or absent/gasping breathing (breathing that does not look normal) is key.
• Health care professional rescuers should not take more than 10 seconds to check for a pulse.
• Immediately initiate excellent cardiopulmonary resuscitation (CPR); “push hard, push fast” (but not too hard nor too fast). ....read more

Healthcare News Monitor

U.S. FDA says carcinogen not found in alternatives of Zantac and its generics

ET Healthworld- Reuters

The U.S. Food and Drug Administration said on Wednesday that alternatives to popular heartburn drug Zantac and its generic versions, known chemically as ranitidine, have not been found to contain the probable cancer-causing impurity that ranitidine has been linked to. U.S. retailers Walmart Inc, CVS Health Corp Walgreens Boots Alliance Inc and Rite Aid Corp have all removed Zantac off their shelves after some drugs containing its key ingredient ranitidine were found to have traces of the impurity, N-nitrosodimethylamine (NDMA). Early tests of alternatives to over-the-counter ranitidine, such as Pepcid, Tagamet, Nexium, Prevacid and Prilosec show no NDMA, the agency said. The FDA said earlier this month it found unacceptable levels of NDMA in drugs containing ranitidine. The regulator asked ranitidine makers to conduct their own testing to assess levels of the impurity and to send samples of their products for testing by the agency. French drugmaker Sanofi SA last week said it would recall Zantac in the United States and Canada.

Centre likely to cap veterinary drug prices

ET Healthworld – Teena Thacker

After medical devices and stents, the government is considering capping the prices of veterinary drugs in a bid to push Prime Minister Narendra Modi’s new scheme to control livestock diseases. An expert committee has been tasked with preparing a list of veterinary drugs that should be available in adequate numbers and assured quality at all times at affordable prices. A new catalogue of drugs and vaccines for animal use will be created, people familiar with the matter told ET. The move could impact companies in the animal healthcare business in India, including Zydus Cadila, Intas Pharmaceuticals, MSD and Zoetis.

Tuticorin doctor in the dock for overtreating fever in child

ET Healthworld- Pushpa Narayan

CHENNAI: As part of the fever audits done by the state health department, in line with the maternal death audits, the directorate of public health has filed a complaint with the state medical council against a Tuticorin-based doctor for not following “fever treatment protocol”. The complaint says “the treatment is not in line with the standard protocol” and that “it endangers lives of patients”. Director of public health Dr K Kolandaswamy filed a complaint against Dr Selvakumari of Selva Nursing Home in Sawyerpuram. The complaint was based on an inspection report of deputy director of health services Dr Geetha Rani. She found a nine-year-old patient (name withheld) was admitted to the hospital and administered ceftriaxone (antibiotic) as an intramuscular injection. The patient was also prescribed paracetamol three times a day, cough syrup and “T Stcrof”. Dr Selvakumari was not available for comment. “Even in medical school, we tell students not to give injections for treatment of viral fevers. It leads to complications such as bleeding and shock,” said Dr Kolandaswamy. “We found another patient treated by her using a similar treatment. The patient’s deposition has also been attached with the complaint,” he said.

Health ministry directs all states to establish peritoneal dialysis services under PMNDP

Pharmabiz India

The Union health ministry has directed all states to establish peritoneal dialysis services under Pradhan Mantri National Dialysis Program (PMNDP). The programme was launched in 2016 to provide free dialysis care to the patients in district hospitals. There are two main types of dialysis namely hemodialysis and peritoneal dialysis. In Hemodialysis (HD), commonly known as blood dialysis, the blood is filtered through a machine that acts like an artificial kidney and is returned back into the body. HD needs to be performed in a designated dialysis centre. It is usually needed about 3 times per week, with each episode taking about 3-4 hours. In peritoneal dialysis (PD), commonly known as water dialysis, the blood is cleaned without being removed from the body. The abdomen sac (lining) acts as a natural filter. A solution (mainly made up of salts and sugars) is injected into the abdomen that encourages filtration such that the waste is transferred from the blood to the solution. The Ministry recently came up with guidelines for establishing peritoneal dialysis services under the PMNDP marking an important step to tackle kidney disease in India. The guidelines are aimed at serving as a comprehensive manual to States that intend to set up peritoneal dialysis and for providers of peritoneal dialysis as a best practice document for ensuring delivery of high quality, cost-effective service and supplies to develop a clinically safe and effective program for children, young people, adult women and men.

NGOs ask WHO to update Guidelines on Similar Biotherapeutic Products for facilitating access to new biologic medicines

Pharmabiz India

A large number of NGOs working in the health sector have urged the World Health Organization (WHO) to update the WHO Guidelines on Similar Biotherapeutic Products for facilitating access to New Biologic Medicines. In a letter to Prof. Klaus Cichutek, chairperson, Expert Committee on Biologic Standardization (ECBS), WHO, the Civil Society Organizations asked the ECBS to update the 2009 WHO Guidelines on Evaluation of Similar Biotherapeutic Products at its upcoming meeting as mandated under the WHO resolution WHA67.21. This is a critical step to expedite access to the biologic medicines included in the WHO Model List of Essential Medicines (EML), they stated. In the letter, the NGOs pointed out that current evidence suggests that biotherapeutics therapies (BTPs) play an important role in advancing therapeutic outcomes for several autoimmune and degenerative diseases and in cancer treatment. However, BTPs are extremely expensive and consequently not accessible to patients, especially in Low and Middle-Income Countries (LMICs). For example, the cost of one vial of adalimumab (for the originator product Humira from AbbVie) would cost about US$ 1,000 - almost equivalent to the average annual wage in a low-income country. The high prices are a reflection of protected monopolies in the biotech sector. Unlike in the case of generic equivalents of small molecule originator drugs, there is no effective competition in the market for BTPs even in situations where the patents of the originator molecules have expired. Beyond the technological or intellectual property barriers, regulatory challenges are the main reason for the lack of competition and therefore high prices.