New Drug for SLE
Belimumab (trade name Benlysta) is the first drug to be
approved for treatment in SLE after a long 56 years. Industry analysts
expect it to be a blockbuster. The FDA recently approved it by a 13 to 2
vote. The story of its discovery is interesting.
In 1996, Human Genome Sciences discovered a new
molecule called B lymphocyte stimulator (BLyS). Normally B cells which
produce autoantibodies are cleared off by induction of apoptosis. In SLE
the B Lymphocyte stimulator allows these cells to mature and continue
producing autoantibodies. The levels of B Lymphocyte stimulator in SLE are
greatly elevated. Belimumab is a human monoclonal antibody against B
lymphocyte stimulator. It blocks the activity of BLyS and allows
autoantibody producing B cells to undergo natural process of apoptosis.
Two double-blind, placebo-controlled, multi-center
Phase 3 superiority trials – BLISS-52 and BLISS-76 were recently concluded
to assess efficacy and safety of Belimumab. More than 1600 patients in 32
countries participated in the trials. Patients treated with Benlysta and
standard therapies experienced less disease activity than those who
received a placebo and standard of care medicines.
SLE is the prototype autoimmune disease and hence
advances in its therapy will change the way we think and treat many
diseases where our immunological system has gone astray. (The Lancet 26
February 2011:377: 721-31.9 March 2011)
Immunizing Cows to Prevent Childhood Sepsis
Alan Cross, Professor in the University of Maryland has
come up with an entirely original and fascinating idea to combat sepsis in
malnourished children. Seven years ago he published the phase I clinical
trials of a successful vaccine against sepsis. Next he vaccinated dairy
cows with it. The colostrums which they produced was rich in antibodies
against toxins produced by gram negative bacteria such as E Coli.
During the nutritional rehabilitation of malnourished children, sepsis
often retards progress. The vaccine aims to prevent gut derived
bacteremias and so may also be of value in patients with burns and trauma.
Immunizing cows is common and inexpensive and will be much cheaper than
vaccinating humans or treating sepsis with antibiotics. (Scientific
American 31 January 2011)
Euthanasia Guidelines
The Supreme Court has laid down guidelines for the use
of euthanasia in extreme circumstances even as the judges rejected a plea
by Ms Pinki Virani to withdraw life support from Aruna Shaunbaug, a nurse
who has been in a persistently vegetative state in KEM Hospital Mumbai for
the last 37 years. India joins a handful of countries including
Luxembourg, Netherlands, Belgium, Switzerland and the USA who allow some
form of euthanasia. These guidelines will be legally binding until the
parliament passes some legislation.
The Supreme court has allowed "passive mercy killing"
of a patient in a permanent vegetative state (PVS) by withdrawing the life
support system with the approval of a medical board and on the directions
of the High Court concerned. A decision has to be taken to discontinue
life support [to a patient in PVS] either by the parents or the spouse or
other close relatives, or in the absence of any of them, such a decision
can be taken even by a person or a body of persons acting as a next
friend. It can also be taken by the doctors attending the patient.
However, the decision should be taken bona fide in the best interest of
the patient. "Active euthanasia" where life ending drugs are given remains
illegal. "Euthanasia is one of the most perplexing issues" said the panel.
"We fell like a ship in an uncharted sea". (The Hindu 7 March 2011).