The Medical Journal as Whistleblower
January 2013 marks a bold new era in medical journal
publishing. The BMJ has launched a frontal attack on incomplete data
reporting by pharmaceutical companies. It has decided not to publish the
results of human clinical trials if sponsors fail to make all the
relevant anonymous patient level data available on request. For the last
3 years the BMJ has been fighting tooth and nail with the pharma giant
Roche. The bone of contention is data regarding Tamiflu. In 2009 the UK
government commissioned the Cochrane respiratory group to update its
systematic review of neuraminidase inhibitors. But despite various
strong arm tactics, Roche did not hand over all the relevant clinical
data. Apparently about 60% of Roche’s data from phase III trials of
oseltamivir has never been published. This is disturbing when one
realizes that countries have spent billions of dollars stockpiling a
drug for which no one except the manufacturer has seen the complete
evidence base. Indeed the EMA’s (European Medical Association)
unprecedented infringement proceedings launched against Roche last month
suggest that even the manufacturer has never fully evaluated evidence it
has collected on the drug’s adverse effects.
The last few years have seen welcome changes to
improve transparency in medical trial reporting. The first step was by
the International Committee of Medical Journal Editors when they made
registration of all clinical trials post July 2005 a prerequisite for
publication. Then an American law has made it mandatory to submit basic
results of all US clinical trials from September 2007. And most recently
GlaxoSmithKline has decided to make available to scientists the raw data
of all trials carried out since 2007 of both approved and abandoned
drugs. It is time that the shroud of secrecy that drug companies
maintain about efficacy and safety data of drugs is stripped off and the
naked truth is revealed (BMJ 2012;345:e7304, www.guardian.co.uk. 12
November 2012).
The World’s First Hepatitis E Vaccine
The world’s first Hepatitis E vaccine has been
produced in China. It may well be a boon to stem the 20 million
infections and 70,000 deaths attributed annually to Hepatitis E. The
vaccine was born out of a unique marriage of academia and industry. More
than ten years ago, researchers at Xiamen University in Fujian province
developed a protein from a genetically modified strain of E. coli
which induces a strong immune response against hepatitis E. But the
necessary economic thrust to this research was provided by the
Yangshengtang Group, a company with interests in food and health care;
which invested 15 million renminbi (US$1.8 million in 2000) to set up a
joint biotech laboratory in partnership with the university. The lab is
now the National Institute of Diagnostics and Vaccine Development in
Infectious Diseases (NIDVD). The Institute aims to develop more vaccines
for disease routinely neglected by western researchers (Nature 491,
21–22, 1 November 2012).
Burnout In Doctors
A national study in the US comparing rates of burnout
in physicians versus general population has thrown up interesting
results. Of 27,276 physicians invited to participate, 7288 (26.7%)
completed the survey. When assessed using the Maslach Burnout Inventory,
45.8% of physicians reported at least 1 symptom of burnout. The Maslach
Inventory addresses three general areas – Emotional exhaustion
measures feelings of being emotionally overextended and exhausted by
one’s work, Depersonalization which measures an unfeeling
and impersonal response toward recipients of one’s service, care
treatment, or instruction; and Personal accomplishment
which measures feelings of competence and successful achievement in
one’s work. Highest rates were among physicians at the front line of
care access (family medicine, general internal medicine, and emergency
medicine). As compared to the general population, physicians were more
likely to have symptoms of burnout (37.9% vs 27.8%) and to be
dissatisfied with work-life balance (40.2% vs 23.2%) (P < .001) (Arch
Intern Med. 2012;172:1377-85).
Dengue- the Diabolical
In 1970, less than 10 countries were endemic for
Dengue. Today this number has shot up to 100. The global incidence of
DHF and DSS has shown a rise by 30%. Why has Dengue become increasingly
malevolent? The initial clinical observations suggested that certain
viral strains were associated with more severe disease. Others observed
an increase in disease severity in patients who had been infected by
more than one dengue virus serotype; this became known as the immune
enhancement phenomenon. The truth as always lies probably in between.
Fresh introduction of genetic material into prevalent strains have made
them more virulent and phylogenetic and epidemiological analyses suggest
that the more virulent genotypes are now displacing the mild ones.
Dengue virus transmission does not occur in isolation,
but is embedded within a complex fabric of human social contexts.
Detailed studies by the National Institute of Virology shows that the
Dengue Virus (DENV) serotypes have changed in India over time relating
to mass movement of people between countries. The American genotype of
the DENV 2 was imported 100 years ago due to high traffic between South
America and India. DENV 1 virus serotypes were imported from Singapore
and Africa in the 1960’s. In the 1980’s new genotypes were introduced
from Sri Lanka which correlates with human movements during the Sri
Lankan conflict. NIV has also initiated a study on development of
anti-dengue drugs from natural medicinal plants available in the
country. Work on the Dengue vaccine is also on and expected to bear
fruit by 2015. (The Times of India 26 October 2012, The Hindu 11
November 2012).