Indian doctors devise score to
assess patients’ bleeding risk
A score
has been derived by doctors here to assess the bleeding risk in Indian patients
who are on drugs that prevent clotting of blood.
The
research by geneticists at the Sir Ganga Ram Hospital here focused on deriving
and validating a Genetic Bleeding Risk (GBR) score based on genetic and
non-genetic factors associated with bleeding in patients on long-term
anti-coagulation (blood clotting) therapy, a release said on Monday.
There are already
a few bleeding risk prediction scores available in the world, but most are
derived from the white population and more importantly, none have evaluated the
predictive significance of genetic risk factors so far, it said.
A
substance that prevents clotting of blood, anti-coagulants are being used all
over the world since early 1940s for treatment and prevention of thrombosis –
clot formation in a blood vessel that obstructs flow and affects various body
parts and organs like legs, heart, kidneys, brain and lungs etc.
Despite
its common usage, oral anti-coagulant (OAC) therapy is associated with
significant bleeding complications.
The study
was conducted on 310 patients from departments of vascular surgery, cardiac
surgery and neurology from August 2009 to August 2012 at Sir Ganga Ram Hospital
here. It took approval from the hospital’s ethics board committee and was in
accordance with the ethical standards of World Medical Association.
‘The
report shows that the number of bleeding episodes can be effectively reduced,
thus sparing the patients from adverse outcomes and reducing hospital admissions,’
said Risha Nahar, scientist at the hospital’s Centre of Medical Genetics.
‘The
present study is the first to devise and validate a genetic scoring scheme for
predicting bleeding among first time users of oral anti-coagulants,’ he added.
Both genetic
and non-genetic factors (drug-drug interactions, additional medical conditions,
age, history of bleeding) are known to contribute towards bleeding or
haemorrhage in patients on anti-coagulant therapy.
Source: http://health.india.com
23.10.2013
Supreme Court stands firm on
clinical trial ban
The
clinical trials of 162 new chemical entities will continue to be on the hold as
Supreme Court on Monday said that the technical committee and the apex
committee will examine the benefits of these trials for the country. A bench of
Justice R.M.Lodha and Justice Shiva Kirti Singh said that 157 new chemical
entities which were cleared for clinical trials till December 31, 2012, would
be reviewed by the two apex committees.
‘It is not
possible to pass any order in respect of the clinical trials of 157 new
chemical entities. We are not passing any order. You will tell us the findings
of the apex committee and the technical committee,’ the bench told Additional
Solicitor General Siddarth Luthra who had appeared for the government.
Reviewing
the clearance for clinical trials of 157 new chemical entities by the National
Drugs Advisory Committee and the Drug Controller General of India, the court
said the technical and apex committees would look into the assessment of risk
vs benefits to the patients, innovation vis-a-vis existing therapeutic options
and the unmet medical needs of the country.
The court
said the apex committee will examine whether the new chemical entities that are
being put to clinical trials are actually required in the country.
In respect
of five other new chemical entities for which approval has been granted for the
clinical trials in 2013, the court accepted the statement of Luthra which said
that appropriate directions will be issued with regard to audio visual
recording of the consent of the subject participating in such trials.
The court
directed that such documents in the wake of the video recording shall be
preserved and the principle of confidentiality and transparency would be
observed. In the course of the arguments, senior counsel Colin Gonsales
informed the court of the Aug 30 report of the Parliamentary Standing Committee
which had made damning findings about the working of the office of the Drug
Controller General.
He said
that the Standing Committee has said that it were the invisible hands that were
writing the report and were being approved by the office of the DCGI. At this,
Justice Lodha said: ‘We should have a balanced approach. These are the issues
where you can’t have one sides approach. We should allay their (of the
petitioner) apprehensions reasonably. The clinical trials should help us.’
Gonsalves said that the ministry of health and family welfare was using a
committee headed by Ranjir Roy Chaudhury to derail the regime set up by the
Standing Committee. He sought the disclosure of the 162 new chemical entities.
Assailing
the position of Chaudhury, Gonsalves said that he wanted to make India a hub of
clinical trials even in the phase I and Phase II in which healthy people are
subjected to the testing of the new chemical entities.
The next
hearing of the matter will take place Dec 16.
Source: http://health.india.com
23.10.2013
You must have long range goals to keep you from being frustrated by
short range failures
Charles
C. Noble
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