Friday, 27 December 2013
Thursday, 26 December 2013
Pallavi and Vikram of Batch-18, presented on the technical topic of European Regulatory (EMA).This presentation gave brief insight about the regulations for drugs and medical devices and also the approval procedures.
Monday, 23 December 2013
Stroke risks increase with high levels of anxiety
The negative health
effects of anxiety, such as increased coronary heart disease risks, have long
been documented and accepted in the medical community. But now, research
suggests that individuals with high levels of anxiety have an increased risk
for stroke.
A stroke occurs when blood flow to the brain stops, and this
cuts off oxygen and nutrients that are vital for the brain. When this happens,
brain cells die, and depending in which side of the brain the stroke occurs,
effects can include paralysis, vision or speech problems, memory loss and
behavioral changes.
Friday, 20 December 2013
Hybrid clotting factor means fewer injections, better disease
control for hemophilia patients
A Phase
III clinical trial led by UC Davis researchers has confirmed that a new
coagulation factor (rFIXFc) dramatically reduces the number of injections
needed to maintain effective clotting for HEMOPHILIA B patients.
The recombinant protein fuses clotting factor IX with an
immunoglobulin (antibody) molecule, which prevents the body from rapidly
metabolizing the hybrid protein. As a result, rFIXFc can be administered once a
week, or even every two weeks, rather than every other (or every third) day.
This extended half-life could have an enormous impact on hemophilia treatment.
Thursday, 19 December 2013
An Apple (or Statin) a Day will keep the MD away
Statins and apples are both iconic. "An
apple a day is known throughout the English-speaking world as a saying for
health, and statins are now some of the most widely prescribed drugs in the
world.
The new American College
of Cardiology/ American Heart Association(ACC/AHA)
guidelines for the management of cholesterol suggest treating
primary-prevention patients if they have an LDL-cholesterol level between 70
and 189 mg/dL and a 10-year risk of atherosclerotic cardiovascular disease >7.5%. In the UK, the guidelines are less aggressive and
recommend statin therapy for primary prevention of cardiovascular disease if
the 10-year risk score is >20%.Wednesday, 18 December 2013
Role play - Trovan trial
There was an outbreak of meninigococcal meningitis in Nigeria, Kano in 1996. It too almost 12,000 lives and affected close to 1,00,000 people in 6 months. Pfizer conducted trovan trial using trovafloxacin in IDH (Infectious Disease Hospital) recruiting 200 children without any informed consent forms, approval from ethics committee and regulatory authority; no GCP Guide lines were followed.
As a result of trial, 11 children died out of which 5 deaths were from trovan and many were left disabled. This was brought into light when it was published in an American journal and case was registered at U.S district court.
There was an out of the court settlement where Pfizer gave 175,000$ to 4 families based on DNA reports. Clinical trials have to be conducted on an ethical basis and government has to make sure that it is done in safe manner and for the benefits of people.
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