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Indian Pediatr 2013;50:
250 |
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News in Brief |
Gouri Rao Passi,
Email:
[email protected]
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Rota Virus Vaccine Advertisement Pulled Off
Glaxo Smith Kline’s advertisement about rotavirus
diarrhea has been retracted after Nalini Abraham acted as whistleblower.
Dr Nalini Abraham, a public health specialist in Delhi, wrote to the
Advertising Standards Council of India (ASCI), a voluntary self
regulatory body of the advertising industry. Her arguments were that
first, vaccines are prescription drugs. In the past when the chicken pox
vaccine was advertised the IMA had objected to it. Second it amounted to
misrepresentation of facts when the advertisement claimed that "the
vaccine is the only way to reduce the incidence of infection and steps
like frequent hand-washing do not help." She also argued that there was
not a single study till date that showed that the vaccine was effective
in India to reduce the incidence of diarrhea or deaths due to it, as
there were numerous local strains of the virus. She quotes Lodha et al’s
article in Indian Pediatrics June 2012 to drive home her point that
Indian strains are different and may not get cross protection from the
strains currently in the vaccine. It is clear that the advertisement
contravened Chapters 1.1 and 1.4 of the ASCI Code. Chapter 1.1 says
advertisements must be truthful and any claims should be capable of
substantiation. According to Clause 1.4, advertisements shall neither
distort facts nor mislead the consumer through implications or
omissions. After deliberating on the complaint, the ASCI’s Consumer
Complaints Council concluded that the claim in the advertisement,
"vaccine is the only way to reduce the incidence of infection," was
inadequately substantiated. And the statement, "Rota virus vaccine is
the only way to treat Rota virus," was misleading (The Hindu 15
December 2012).
FDA Approves the First Drug for TB After 1970
After a hiatus of 40 years the FDA has approved a new
drug for tuberculosis. Bedaquiline, is a diariquinolone developed and
marketed by Janssen Pharmaceutica as Sirturo. It does not inhibit the
DNA gyrase like other quinolones but affects the proton pump for ATP
synthase. The FDA also granted Sirturo fast track designation, priority
review and orphan-product designation since it is one of the few drugs
which has been show to be effective in MDR tuberculosis. Sirturo’s
safety and effectiveness were established in 440 patients in two Phase 2
clinical trials. Patients in the first trial were randomly assigned to
be treated with Sirturo plus other antitubercular drugs or a placebo
plus other antitubercular drugs. All patients in the second trial, which
is ongoing, received Sirturo plus other TB drugs. Both studies were
designed to measure the length of time it took for a patient’s sputum to
be free of M. tuberculosis. Results from the first trial showed
patients treated with Sirturo combination therapy achieved SCC (sputum
culture conversion) in a median time of 83 days, compared with 125 days
in patients treated with placebo combination therapy. Results from the
second trial showed the median time to SCC was 57 days, supporting the
efficacy findings of the first trial (www.fda.gov 31 December 2012).
Polio Workers Attacked in Pakistan
Pakistan is one of the 3 countries still endemic for
polio. It had registered a impressive 65% drop in cases this year.
However the 3 day national wide immunization drive planned in mid
December was sabotaged when 9 health workers were shot dead by
terrorists. Then on 1st January 2013, 6 female health workers and one
male doctor were shot dead. The youngest to die was a 17 year old school
girl. Opposition to the campaign had grown when it was shown that a
doctor had run a fake vaccination campaign to help the CIA track down
Osama Bin Laden in Abbottabad. Though nobody has claimed responsibility,
it is widely believed to be the Taliban. The Taliban has systemically
undermined the health programs in the Swat region of Pakistan by
specifically targeting the Lady Health Workers. A BMJ study on how the
Taliban undermined community health care in Swat, Pakistan showed that
maternal mortality has increased and 29% of the health facilities in the
Khyber Pukhtunkhwa region have been damaged. This province accounts for
40% of all Pakistan’s polio cases. Repercussions for neighboring
countries are invariable. For example China had an outbreak in 2011
after being polio free for more than a decade. The virus had been
imported from Pakistan and 18 people were paralyzed and 1 died in that
outbreak. These killings could just be the ‘game changer’ like the
2003-2004 immunization boycott in Nigeria by religious and political
leaders. That had lead to a rebound not only in Nigeria but also 15
other African countries and Indonesia. The global community has to stand
up and speak out against the terrorist, an invisible enemy who destroys
the carefully planted seeds of social wellbeing in a second of mindless
violence (BMJ 3 January 2013, The Lancet 5 January 2013)
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