Morning MEDtalks with Dr K K Aggarwal 22^nd July 2018

Valsartan Update

DCGI has enhanced checking of the Chinese bulk drug Valsartan at the ports after the American regulatory agency recalled Valsartan early this week over potential cancer risks.

The Drugs Controller General of India instructed the ports to examine each and every batch of the imported consignment of a Chinese bulk drug named Valsartan API, manufactured by Zhejiang Huahai Pharmaceuticals.

Earlier this week US FDA recalled Valsartan over potential cancer risk due to the presence of an impurity – a chemical known as NDMA or N-nitrosodimethylamine. Later European Medical Agency too issued an alert. So far, more than 20 countries recalled this Chinese API.Can a tobacco company start a public health initiative?

Under World Health Organisation guidelines, tobacco companies are not allowed to be involved in any public health initiatives, due to the millions of people that their products have killed.

Imaging breakthrough: NIH Clinical Center releases dataset of 32,000 CT images

The National Institutes of Health’s Clinical Center has made a large-scale dataset of CT images publicly available to help the scientific community improve detection accuracy of lesions. While most publicly available medical image datasets have less than a thousand lesions, this dataset, named DeepLesion, has over 32,000 annotated lesions identified on CT images. The images, which have been thoroughly anonymized, represent 4,400 unique patients, who are partners in research at the NIH. 

Similar to a physical bookmark, radiologists save their place and mark significant findings to be able to come back to at a later time. These bookmarks are complex – they provide arrows, lines, diameters, and text that can tell the exact location and size of a lesion so experts can identify growth or new disease.

With the release of the dataset, researchers hope the others will be able to:

1. Develop a universal lesion detector that will help radiologists find all types of lesions. It may open the possibility to serve as an initial screening tool and send its detection results to other specialist systems trained on certain types of lesions.
2. Mine and study the relationship between different types of lesions. In DeepLesion, multiple findings are often marked in one CT exam image. Researchers are able to analyze their relationship to make new discoveries.
3. More accurately and automatically measure sizes of all lesions a patient has, enabling the whole body assessment of cancer burden.

Oxytocin Ban Deferred for Two Months

The government had banned the import of oxytocin formulations and restricted its manufacture to the public sector only from July 1 earlier. "The ban has now been deferred by two months, as decided by the Health Ministry." - S Eswara Reddy, Drug Controller General India (DCGI) 

The government has to put on hold by two months its decision to restrict the manufacturing and supply of oxytocin only through the Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL). Accordingly, this ban is likely to come into effect from 1st September 2018.

Karnataka Antibiotics & Pharmaceutical Ltd (KAPL), a public sector unit (PSU), is the only manufacturer for the drug in the country. KAPL will be the sole supplier to registered hospitals and clinics in both public and private sector. The same order prohibits the retail sale of the oxytocin by chemists and druggists. 

Registered hospitals and clinics in public and private sector in the country are advised to contact KAPL to place their orders with the company at MD KAPL (md@kaplindia.com)

Source: Dr. Dinesh Baswal

How long will my hip or knee replacement last?

There are risks associated with the operation (as is true for any major surgery), there is a long road to recovery even when all goes well.

If the first joint replacement is unsuccessful for some reason (such as infection or loosening), a second (or even third) operation may be necessary. Revision surgery is technically more difficult, recovery can take longer, and success rates may be lower than first operations.

There’s no hip or knee replacement guarantee

Unfortunately, no one can be sure that a hip or knee replacement will be the last operation needed on that joint. No operation is 100% successful, and nothing lasts forever. In addition, a number of factors, including surgical technique and surgeon experience, how many operations a particular hospital or surgeon performs each year, and patient factors (including age, weight and activity level) can all have powerful effects on how long a replaced joint lasts.

But based on present data up to 90% or more of hip or knee replacements would last at least 10 to 15 years.

With better preparation prior to surgery (including “prehab” exercise and loss of excess weight), improved materials in the replacement, better surgical techniques and anesthesia, and better physical rehabilitation after surgery, the joint replacement of the knee or hip is more likely to be successful and last the rest of your life than ever before.

In recent years, there’s been a tendency to operate on younger people. A person with a life expectancy of 15 years has a much better chance of avoiding a future operation than a person with a life expectancy of 30 years. In addition, younger patients tend to be more active and put more stress on their new joint. For these reasons, some surgeons advise younger patients to put off surgery as long as possible, even if that means suffering with pain, stiffness, and reduced mobility.

Published in the April 2017 edition of the medical journal The Lancet, researchers found that:

Among more than 60,000 people who had a hip replacement, only 4.4% required revision surgery in the first 10 years after surgery, but by the 20-year mark, 15% required revision.

Among nearly 55,000 people who had a knee replacement, only 3.9% required revision surgery within 10 years of surgery; by 20 years, 10.3% required revision.

Of those over 70 having hip or knee replacement, the lifetime risk of having a second operation on the replaced joint was about 5%. But up to 35% of men in their early 50s required a second operation.

(Harvard News Letter Excerpts)

Around the globe

1.  The Centers for Disease Control and Prevention found that one in nine adults age 45 and older experienced confusion or memory loss — and is one of the earliest noticeable symptoms of Alzheimer’s disease.
2. Shifts in gut bacteriophages, viruses that infect and replicate within bacteria, are implicated in the pathogenesis of Parkinsons disease said George Tetz, MD, PhD, head of R&D at the Human Microbiology Institute, in New York City
3. One of the studies, which was published online July 18 in the BMJ, shows that from 1999 to 2016, the annual mortality rate from cirrhosis increased by 65%. During the same period, the annual mortality rates from liver cancer doubled.
4. Federal officials in US are investigating a potential link between grain-free dog food and deadly canine heart problems. The FDA says grain-free dog foods that contain peas, legumes, lentils, and potatoes as sources of protein may be leading to a taurine deficiency, which can cause a condition called dilated cardiomyopathy, or DCM.
5. It is this Government that is bringing a programme like Ayushman Bharat that will give top quality healthcare to the poor: PM @narendramodi in the Lok Sabha
6. Ayushman Bharat-National Health Protection Mission: The West Bengal government today signed an MoU with the NHA for implementing the health insurance scheme in the state, following a long-drawn negotiation. The National Health Agency (NHA) is the apex body for implementation of the insurance scheme.

 Participate in survey on Inflammatory bowel disease:

https://docs.google.com/forms/d/e/1FAIpQLSedaDx2iXiwU1vBpYdU6ebfCap-7PYAPSqXRJTeg8ULvNOcLg/viewform

Dr KK Aggarwal

Padma Shri Awardee

President HCFI

Vice President CMAAO