Few weeks ago Angelina
Jolie made it big news by revealing her prophylactic mastectomy. Whether or not
you agree with her decision of going through mastectomy just because of those
silly genes, one thing you would not be able to disagree on that she prompted general public worldwide to google these exotic
sounding words “BRCA1 and BRCA2” genes (now better known as “Angelina Jolie
genes”) which so far used to be the part of only scientific discussions
confined within the fraternity of cancer researchers. Kudos to Angelina Jolie and
her celebrity power that this subject is now being discussed among women worldwide
who indeed need to know about it all more than anyone else. I can’t help but believe
that yesterday’s Supreme Court (US) decision to wipe patents on Angelina Jolie
genes (BRCA1 and BRCA2) was also somehow got positively influenced by the
debate recently initiated by Angelina Jolie’s revelation, otherwise this legal
battle was ongoing in the courts for years with no conclusive outcome as it
happened this yesterday. Irrespective of your quest for findings elements of right
or wrong in this landmark decision, people of all walks of life, especially
scientists and cancer patients have welcomed this court ruling with equal
applause. I will discuss this issue later in my future postings.
Today, the topic that
brought me here is very close to my heart for several reasons including a
personal one. From last week’s breaking advances in the field of cancer
research, I thought of picking this piece of research work, because I consider it as a big
feat achieved by scientists from India, a third world country, where even a thought
of having an standard cancer care infrastructure seems to be a luxury, given
the dire need for general physicians and infrastructure to treat bacterial and
viral diseases. This was one of the highly talked about and praised research work
recently discussed at the American Society of Clinical Oncology
(ASCO) annual meeting in Chicago last week, in which over 26,000 cancer
scientists and clinicians attended this meeting and thousands of research studies,
small and large were reviewed by the scientific fraternity. Because ASCO is the
world’s most dominant oncology specialty group, the discussions and recommendations
set the standard for cancer care in the world.
Well, a research team led
by Surendra Srinivas Shastri, MD, a professor of preventive
oncology at Tata Memorial Hospital (oldest and probably single dedicated cancer
hospital and research center in India, a country of 1.25 billion people) in
Mumbai, India, developed a simple screening technique using an inexpensive chemical
agent, vinegar or acetic acid, dramatically reduced deaths related to cervical
cancer in a large population of Indian women. This powerful study shows that
how just “visual inspection with acetic acid or (VIA)”, conducted by non-medical
personnel trained to deliver basic healthcare (paramedical staff), could cut
the death rate by 31%.
One of the most important aspects
of this finding lies in the fact that this strategy is highly effective and can be
implemented on a broad scale in low-income countries. "There was almost no
overdiagnosis, it doesn't require a laboratory, and it can be widely
implemented in the lowest-resource settings, such as India," said lead
study author Dr. Shastri. "If implemented at national level in India, it
could prevent 22,000 cervical cancer deaths," said Dr. Shastri, who
presented the findings of this large randomized trial during a plenary session at
the 2013 Annual Meeting of ASCO in Chicago. He went on to say that "if
taken globally to the lowest-resource countries, this method could prevent around
72,000 deaths in the developing world."
Cervical cancer is the
leading cause of cancer-related mortality in women in many developing nations,
where access to Pap test screening (gold standard screening
method for diagnosing early stage cervical cancer) is very limited or
nonexistent. Widespread Pap test screening in high-income countries has
significantly reduced the incidence and subsequent death rate from cervical
cancer by 80%. Unfortunately, from my own experience of talking to Indian women
(I am originally from India, and keep visiting India almost every year) in my
own extended family and friends, my impression is that even educated women have
not heard of Pap test screening methods, let alone thinking of asking their
primary care physicians to write a pathology test for this.
Apart from lack of
awareness about health issues among common people in India, "There is no
cervical cancer screening program in India because it is not feasible,"
explained Dr. Shastri. "There is inadequate infrastructure, a lack of
trained human resources, logistic difficulties, and a relatively high
cost."
Therefore, the researchers
looked at VIA, which is a simple visual test that can be done without
laboratory support. "It consists of an application of 4% vinegar to the
cervix, and the results are available in 1 minute," Dr. Shastri
explained. "Paramedical workers can be trained in 4 weeks."
VIA screening method is validated
Another cancer researcher
and leader in the field and also discussant for the study during the plenary
session, Electra D. Paskett PhD, professor of medicine at the Ohio State
University Comprehensive Cancer Center in Columbus is very enthusiastic about
this pioneering study, “What is unique about this study is that it was
conducted in the slums of Mumbai in an unscreened population, and participation
was high and the size of the sample was large. What is essential here is the
fact that both diagnostic and treatment services were available to women in
both arms without any charge."
Dr. Paskett also pointed
out that there are several take-home messages from this study; 1) that the VIA
method has been validated, 2) it has been accepted, 3) it is inexpensive, 4) can
be used in low-resource areas, and 4) can save lives.
Study Details
In this clinical trial, VIA
screening technique was performed by community-based nonmedical primary health
workers trained to provide basic healthcare services in regions that lack
physicians and nurses. The researchers had to pass through several layers of
community barriers, such as community leaders and religious leaders, before
being able to speak with the women. It is noticeable that India is home to
several religiously conservative communities and preventive measures in the past
such as polio vaccination program had to face a lot of resistance in these
communities. "We involved the
community, giving them a sense of participation, and we were able to create as
sense of community ownership," Dr. Shastri said. "This ensured better
participation."
Dr. Shastri and colleagues
initiated this cluster randomized controlled trial in 1998 to evaluate the
ability of VIA screening to reduce cervical cancer mortality. The participants
were 35 to 64 years of age and had no history of cancer. The study design
involved 20 clusters, with an average of 7500 eligible women in each cluster.
Ten such clusters served as the screening group (n = 75,360) and 10 served
as the control group (n = 76,178). From statistical point of view, this is
one of the very large and powerful research studies in the history of recent clinical
trials.
Primary health workers or paramedical
staff did conduct 4 rounds of cancer education and VIA screening at the
intervals of 24 months in each screening group. In the control group (a group of
people, which was not screened by VIA, usually having such population groups
are part of standard study method to conduct a scientific experiment and used
as population to compare the results against), cancer education was offered
once at recruitment.
Reduction in Mortality Rate
Although the researchers
had planned for a 16-year study, they analyzed results at 12 years. Compliance
was high, with 89% participation in screening and 79% compliance with
postscreening diagnostic confirmation. The researchers note that the quality of
screening performed by the primary health workers or paramedical health care
workers was almost comparable to that of an experienced gynecologist.
The incidence of invasive
cervical cancer was very similar in the screening and control groups (26.74 vs
27.49 per 100,000). However, for those with invasive cancer, treatment
compliance was higher in the screening group than in the control group (86.34%
vs. 72.29%). In the screening group, there was a 31% drop in mortality related
to cervical cancer, compared with the control group (P = 0.003).
In addition to the decrease
in deaths related to cervical cancer, there was also a 7% reduction in
all-cause mortality (RR, 0.93; P = .41), possibly due to the
fact that these patients enrolled in VIA screening program had better/timely
access to medical interventions.
On the basis of these
results, the Indian health officials in the state of Maharashtra, a western
province of India, where the trial was conducted, are preparing to train
primary health care workers to provide VIA screening to all women 35 to 64
years of age at 24-month intervals. In addition, the Indian government is
working to implement nationwide VIA screening, and is planning to reach out to
other low- to moderate-income countries to share these results and offer
assistance with training.
Interestingly this study
was financially supported by the National Institutes of Health (NIH), USA, and
Women's Cancer Initiative. Just confirms the belief that science does not care
of physical boundaries, it helps humanity in general.
Take home message – while developments
in state-of-art biomedical technologies are certainly needed to keep this fight
alive against this dreaded disease cancer, we must not ignore the power of old
fashioned scientific methods such as visual inspection with acetic acid (VIA) which
can significantly reduce the death rate by cancers in the major part of the world.
