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Govt seeks complaints but has no system to take action against dissolving stents

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April 15, New Delhi: On April 7, Central Drug Standards Control Organisation has asked patients and doctors to report adverse events associated with bioresorbable stents by sending an email to the Drug Controller General of India (DCGI).

But to the utter surprise, the department has no mechanism, whatsoever, to deal with such cases says a TOI report. The department can neither examine such reports nor take action on them in the absence of any mechanism to deal with such discrepancies in medical services.

The report claims that even the Materio Vigilance programme of India (MvPI) that was launched in July 2015 to monitor safety of medical devices has not commenced yet.

The DCGI GN Singh has said that there is no mechanism to take corrective measures on patients’ complaints or an effective way of disseminating warnings and alerts to the public regarding devices.

He said, they are dependent on device manufacturers to report adverse events. “We have asked Abbott (the manufacturers of the bioresorbable stent Absorb about which the alert was issued) to give an explanation. We are going to be very strict about protecting the Indian patient,” said Dr Singh.

Depending on companies to report something that goes against their own interests is certainly shocking and only exposes the slackened attitude of authorities in meeting the medical redressals.

“Waiting for the company to supply information about adverse events is absurd. Abbott should be made to come forward with all the global clinical data on Absorb. The data, particularly on Indian patients through trials and post marketing surveillance done in India, must be studied by experts,” said Malini Aisola of All India Drug Action Network to TOI. Malini works on the regulation of drugs and medical devices.

Another flaw in the directive of DCGI is it asks patients and medical professionals to write to the manufacturers and importers of these medical devices.

Now why would patients write to companies whose products they are complaining about?

However the Officials at the MvPI said that the Indian Pharmacopoeia Commission in Ghaziabad is the national coordination centre for the materio vigilance programme. The centre has a toll-free number and a medical device adverse event reporting form.

They insisted that the programme is running. “When we get a report of an adverse event related to a medical device, the causality of the event will be determined by the monitoring centre specialising in that device or field of biomechanical engineering.”

He further says that the companies are supposed to report to the DCGI while patients and doctors report to the MvPI. The reports are afterwards collated to take the action by the DCGI’s office explained the officials.

Wefornews Bureau

Health

High Vitamin D levels may reduce breast cancer risk

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vitamin D

New York, June 16: Higher levels of Vitamin D among women may reduce their risk of developing breast cancer post menopause, claimed a new study.

The study found that women with blood levels of serum 25-hydroxyvitamin D (OH) — the main form of vitamin D in blood — above 60 ng/ml (nanograms per millilitre) had one-fifth the risk of breast cancer compared to those with less than 20 ng/ml.

Thus, researchers from the University of California-San Diego determined that the minimum healthy level of 25(OH) in blood plasma should be 60 ng/ml, instead of the earlier recommended higher than the 20 ng/ml.

“Increasing Vitamin D blood levels substantially above 20 ng/ml appears to be important for the prevention of breast cancer,” said lead author Sharon McDonnell from GrassrootsHealth, a non-profit public health research organisation.

The study, published in the journal PLOS ONE, analysed data from two randomised clinical trials with 3,325 combined women and a prospective study involving 1,713 women with average age of 63.

Participants were free of cancer at enrollment and were followed for a mean period of four years. Vitamin D levels in blood were measured during study visits.

“This study was limited to postmenopausal breast cancer. Further research is needed on whether high 25(OH)D levels might prevent premenopausal breast cancer,” said Cedric F. Garland from UC-San Diego.

IANS

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Congenital Heart Disease Often Lead To Mental Illness

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WORLD HEART DAY

More than 1.5 lac infants are born in India annually with congenital heart disease. Around 78,000 infants die of congenital heart disease in India every year.

So What Is Congenital Heart Disease?

Congenital Heart Disease (CHD) is when a child is born with an abnormality in his/her heart. It could be abnormal in the way it’s structured (have parts of the organ missing, have functional problems and/or holes in the chambers. Doctors are often able to diagnose CHD while the child is still in the womb of the mother. CHD is considered to be a life threatening illness and hence can cause emotional turmoil in parents of the child, which in turn affects the psychological development of the unborn child.

Additional alterations immediately after birth for a child can prove to be traumatic, and cause PTSD like symptoms later on in life. For example, a child is often separated from the child’s mother and placed in intensive care immediately after birth, and then they are subjected to invasive medical procedures and tests. An infant with CHD goes through a traumatic event which is often reflected in feeding problems, nightmares and over all behavior of the infant.

According to Dr.Vihan Sanyal, psychotherapist, “Parents of children with CHD can seek the help of a skilled psychotherapist for their children’s psychological health while they are children. This will give the therapist to address the issue early on and help improve the quality of life of the child well into adulthood”

Early stressful experiences of a child can alter the child’s brain development, affect their immune system (the child tends to fall sick more often) and disturb the way a child reacts to stressful events in future life. Studies have proven that children who have been exposed to highly stressful environments early on in childhood often have issues with cognition and in processing of emotions.

Neonatal care, pediatric care, adolescent years and adulthood of a person diagnosed with CHD is often complex and challenging for the person. The psychological impact this creates is profound and can lead to suicide in adulthood if not managed properly.

Dr.Sanyal explains: “Children with CHD have difficulties with motor skills, speech, focus & attention, executive functioning, impulse control, management of emotions and behavior. The change in the structure of the brain and in brain chemistry can tarnish the image a child has of himself. He can quickly form an opinion of himself as being “abnormal”, leading to self esteem issues. It is important for children to be helped by a skilled psychotherapist, who is proficient in dealing with psychological issues of children living with CHD. Timely therapeutic intervention can provide the support a child requires in coping with the emotional challenges of CHD.”

Psychiatric disorders, in particular mood and anxiety disorders are more frequent in Adults with CHD compared to Non-CHD adults.

Life threat to the fetus is an important key factor for emotional disturbance during pregnancy for the parents. It is also an indication of long term psychological disorders faced by the parents of the child with CHD.

Studies have indicated that more than 30% of parents with children who have been diagnosed with CHD show signs of Post Traumatic Stress Disorder (PTSD). 50% of them have shown to have anxiety and depression. More than 80% of these parents have tested positive for psychological stress related disorders.

“MNLP & other modalities of psychotherapy can help the parents of those who have recently been diagnosed with CHD. MNLP can help in building resilience in the parents and equip them to face the challenges which lay ahead without disintegrating emotionally. Hypnotherapy can be used to promote relaxation and to address issues of trauma in the subconscious” Say’s Dr.Sanyal

Contributory Factors While Pregnant Which Can Result In CHD

· Smoking during pregnancy

· Consuming alcohol during pregnancy

· Exposure To Poor Air Quality (pollution)

· Exposure to Toxic Chemicals (Even common household chemicals like toilet cleaners and detergents)

· Exposure to pesticides and insecticides

· Medicines not meant to be consumed during pregnancy

· Obesity in mothers

In addition to the above list, symptoms of anxiety and depression in pregnant women often go undetected and hence, remain untreated. It is also important to mention that a range of symptoms of stress, anxiety and depression, marital harmony and quality of relationship the parents share with each other all have an effect on the fetus’s psychological health.

Dr.Sanyal says: “Many pregnant women of our country are unaware of some of the precautions they need to take during pregnancy. More importantly, they are unaware of the harmful effects the unborn child could face due to their habit and behavior. Many psychological disorders and mental illnesses can be prevented by pregnant women choosing to lead a balanced and a relatively stress free life during their pregnancy.”

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Can sleeping more affect your heart?

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world sleep day

Seoul, June 13: If you thought that only less hours of sleep would affect your health, then you are wrong. Sleeping more than 10 hours per day is also associated with metabolic syndrome, raising the risk for heart diseases, according to a new study.

Those who slept for over 10 hours daily were at risk of elevated waist circumference, high triglyceride levels — a type of fat, low levels of “good” cholesterol, hypertension as well as high fasting blood sugar — referred to as metabolic syndrome and associated with increased risk of cardiovascular diseases.

While sleeping more raised triglycerides levels in both men and women, in women it led to higher waist circumference, blood sugar as well as lower levels of “good” cholesterol.

Conversely, getting less than six hours of sleep was associated with higher risk of metabolic syndrome in men and higher waist circumference among both men and women, researchers said.

“This is the largest study examining a dose-response association between sleep duration and metabolic syndrome and its components separately for men and women,” said lead author Claire E. Kim from Seoul National University College of Medicine in South Korea.

The study, published in the journal BMC Public Health, included data from 1,33,608 participants aged between 40-69 years. The results showed that the prevalence of metabolic syndrome was just over 29 per cent in men and 24.5 per cent in women.

“We observed a potential gender difference between sleep duration and metabolic syndrome, with an association between metabolic syndrome and long sleep in women and metabolic syndrome and short sleep in men,” said Kim.

IANS

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