MFCM034: National Tuberculosis Programme: Some Problems and Issues.pdf

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nations tuberculosis programme
s some problems and issuesj
Binayak Sen, CMSS, Dalli Rajhara, MP 491228

1. conceptual problems
IN THEIR seminal 1962 paper on symptom awareness in
tuberculosis, Banerjee and Anderson, re-emphasized the
probelm of tuberculosis as a problem of human suffering,
and outlined a strategy for tuberculosis control based on
this concept. This strategy, abjured a policy of active case
finding. Instead, it concentrated its attention on greater
diagnostic sensitivity towards and adequate treatment for
those people suffering from symptoms suggestive of tuberculosis
who presented themselves at the existing hospitals and clinics.
Together with the Madras Chemotherapy Centre study on domiciliary
treatment, it forms the theoretical basis of our present day
tuberculosis programme.

THE CREDIBILITY of this system rests on the adequacy
with which the entire range of presenting symptoms is
handled. The logical corrolary of the adoption of this approach
would, therefore, be the development of an integrated and
well-defined system for tackling the entire range of tuberculosis
symptomatology.
INSTEAD, THE National Tuberculosis programme has set its
sights on a Mirage - the interruption of bacterial transmission.
To this end, it defines a*case' of tuberculosis as a person
excreting tubercle bacilli, in his sputum. This approach is
unscientific because it is only at a much later stage along
the exponential curve of falling prevalence that the interruption
of transmission becomes even a remote possibility. It also
ignores the fact that never in the history of human tuberculosis
has a reduction in transmission been brought about by a
specifically medical intervention.
AS A result of my four years experience of working in
voluntary institutions participating in district tuberculosis
control programmes - in Hoshangabad and in Durg - I am familiar
with the way in which this approach works in practice. A person
who presents himself at a Public Health Institution with symptoms
suggestive of tuberculosis is not regarded as a person suffering
from a disability and consequently in need of help but simply
as an entity to be categorised, ic., TB or not TB. After a
cursory physical examination he is sent for a sputum test. If
he obliges by producing a positive sputum, that is the end of
the matter. He*can then be placed on a standard treatment
r-.gime. (o^ncrally inh and Thiace-tazono daily) and forgotten
about. Once in a way his sputum may be checked but the treatment
regime is not affected thereby. I have documented evidence
of patients, sputum positive after a year's treatment with INH
and th acet-.zone, being continued on the same drug. When challenged,
the government doctor has explained, "that is th^. only regime
available". In point of fact, in practice this is often true.
BUT WE will come to problems of chemotherapy later. The
point I am trying to make is that from the point of view of
of a desperately sick man, frightened by a dreaded diagnosis,
it is cold comfort to b given 30 tablets and told to come­
back again after a. month's treatment and assured that ho will
get well in 18 months time. This is particularly so since
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A note prepared for the mfc core group meeting (July.84)
at Wardha..
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there arc doctors at every street corner assuring patients
(with considerable honesty) that they will get well with seme
private treatment in six months or less.
LET US now come to the case cf those who were sputum
negative. The cost of a 1 free’ MMR X-ray from Durg to
person in Rajh-ra, is well over Rs. 50-00. Thu cost cf
• a local private X-ray is Rs. 35-00. Which should the. patient
choose?

IT SHOULD be noted that I have been talking all ’along of
the ideal case. We have not token any account of the
government doctor nudging the patient towards his private
clinic; the laboratory technician asking f -r his ’fee’; the
X-ray technician’s rudeness, or the irregularity in drug
supply.
THE PATIENT of tuberculosis is basically a suffering
person. It is the least of his concern that he is
excreting M tuberculosis in his sputum. What he is much more
worried about is the fact that he has cough, chest pein,
fever, body ache and nausea. He cannot work. He feels weak. Ho
loses his sexual potency. His children starve and often fall
ill in their turn. A physically distant and emotionally remote
health centre can offer him nothing. It is well to remember
that the Madras Chemotherapy Centre study on domiciliary
treatment had weekly home visits as part of their protocol.
It is a.great pity that this investigation has formed the
basis for a programme that thinks it sufficient to throw
some tablets once a month at a desperately sick man.

2O primary tb and extra-pulm nary tb

' . TREATING THE problem of tuberculosis as a problem of
suffering people, rather than as a pr blem of successfully
eliminated parasitic mycc-bacteria brings us to two sets cf
illnesses often neglc-cred in the current programmes.

a.

primary tuberculosis

Between 10 & 20 percent of Indian children arc tuberculin­
sensitive by the time they arc five years eld, though seme
surveys (Raj Narayan) yield a lower, estimate. The popular
(medical) concept! n of primary tuberculosis is cf a mild
intercurrent illness that is only incidentally detected in
a chest X-ray and attains clinical significance only in the
’progressive' form. This is not true. In malnourished children
n-t only is infection itself accompanied by significant
morbidity but it is the 'interaction* between infection and
nutrition—that is the factor that needs to be considered.
When we c'nsicLr that, according to ICMR, 65% of Indian children
ar-.. severely malnourished/
the dimension cf the problem
become a little more plain.

It is a com: on misc. ncopticn (even, as I hove discovered,
ameng TB ’Specialists’), that clinically apparent primary
tuberculosis can safely be treated by a short c- urse of INH
clone. This is a notion that g< es against all bacteriological
logic. One only creates a population of INH resistant bacteria
strategically situated tc subsequently pr'duce reactivation
di sc--sc.
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E xtr

P u 1; n. n a ry T ubc r cu 1 o sis

The chapter on Epidemiology in the Text Bo-k of Tuberculosis
(by the Tuberculosis Association cf Indio.) has nothing tc
say about extra pulmonary disease. In my experience this farms
o. significant proportion cf C"ses cf tuberculosis. Th particular,
scr'fula burnt cut tuberculous cervical lymphadenitis is still
a common finding in backward aruqs cf the country.

3. staff pr ~ - bl cms
■SUCH CASES of ignorance among people working in the field
of tuberculosis are not rare. This is because almost the
entire field lcve.1 medical strff of th_ tuberculosis prcgrmme
are * dead-beats’ people whe have bc^n promoted t an admini­
strative position buc '.use their seniority has became- an
o.dminis tro.tive emb eras sment.
IN A Government District Hospital/ despite all the other
problems . nc can atleast meet electors wh' arc inter stad
in their work in the medical, sur- . ical, gynaecological and ether
specialist departments. Net sc in tuberculosis. The department
which should, by all epidemic-logical logic, claim the most
brilliant and dedicated cf cur technical manpower, is invariably
academically dead. In Hoshang-abad, the District Tuberculosis
Officer was simply absent for a long period ■ f time.
THE PARA-MEDICAL staff on the other hand ar often
exceptionally dedicated and able. They often run the
programme practically independent ally. However, they have tc
pay the price for their competence. In Durg, the statistical
assistant—a key pars'n and in this case extremely competent
-and dedicated—h-ns been on full time depute lie n tc the Civil
Surgeon’s office, helping to administer the hospital.

4O ch cm- -therapy

a.

Exi s t i ng patter ns

In thccry, the National Tuberculosis programme provides
- wide choice among sev; r?.l alternative regimes. Thesq. include
daily INH and thiaceta.zcne with or without an initial period
of intensive treatment with daily streptomycin and/or PAS.
The bi-weekly supervised regimes c/ nsisting of INH/SM and
INH/PAS, have been designed specially tc ensure patient
compliance.

Even according tc the treatment manual supplied tc? the
district Tuberculosis Officers, only sputum positive patients
are eligible for all these regimes. X-ray positive, sputum
negative patients often just as sick as their ‘positive’
brethren and about 5 times as numerous, arc eligible -^nly
for the daily self-administered INH/-TH regime. Presumably
compliance isnet a consideration where they are c/ncorned.
In actual practice, the only regime available; with any
regularity is doily INH/TH. (incidentally, pyridoxine tablets
necessary tc c untornct INH induced pyrid- -xin deficiency
are practically unheard of. Patients are told to eat 1 ts of
peanuts1 ) PAS I have not seen in the past one year*
Streptomycin is constantly in short supply so that pair .mts
are often randomly snuffled back and f' rth between regimes
containing 81* and these without. The- effect of such regime
changes in 1 midstre am* , on treatment offactivity, bacteria
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sensitivity, and patient compliance remains, as t,iey say,
a subject for research.

Coming to the INH/TH regime, TH is by no means an
uncontroversial drug. Its use is banned in some countries
but let. that pas^. The incidence of 1 major* toxicity in
a study in Madras showed the following incidence of side
effects°
, Cutaneous Hypersensitivity reactions - 7%;
Jaundice -3%;
Intractable vomiting - 3%

Apart from these, there arc minor side affects such as
anorexia, nausea, vomiting and head ache. Height gain and
rise in haemoglobin level are less in patients on TH as
compared with those on PAS. The effect of such minor side
effects on patient compliance, especially in the absence of
adequate medical•supervision and r assurance, can only be
imagined.
We will consider possible alternative regimes in* the
next section. For the moment let us stick to the first
line/second line chemotherapy model. We have already noted,
some of the problems with the bi-weekly INH/SM regime not
available for sputum negative patients, and limited and
irregular supply of SM. In addition, there is a rule that
SM injections can only be given at the PHC level. In other
words, this regime is effectively available only to those
who live within about 5 kms of a PHC.
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Drug re sis tan co

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Coming now to the problem of resistant tuberculosis
there arc a number of problems in the existing framework
(1) Drug resistance in tuberculosis.is not a rare
phenomenon. Existing studies show that the
prevalence of 'primary drug resistance to both INH
and SM in India are (individually) of the order of
5 to 10 percent. The prevalence of acauired drug
resistance is not known to me. But -the success rate
of the standard, first line treatment regime is of’the
order of 80 to 85 percent under ideal conditions.
(2) There is evidence to sh.pw that pre-treatment drug
sensitivity tests do not affect the outcome of
treatment provided standard two phase--regimes are
used, with an initial intensive phase using three
drugs. However in my experience such regimes are
.available only to a very small proportion of patient-er even
in the district centres, and to practically none in the
peripheral centres. Most patients go on a standard
two drug regime (general INH-TH).
(3) When a patient fails to respond clinically to a
particular regime; there ar no facilities for drug
sensitivity testing even in these selected coses.
Theoretically, in the c:• rating model, they can be
referred to Tuberculosis Sanatoria for'.treatment with
2nd line drugs. In practice, however, . (-a) practically
none of these patients de got referred to- Sanatoria;
and (b) even among those who arestarted on second
lino drugs *at such centres, there are no facilities
to continue such drugs after the patient is discharged.

■■ Tfat/^l'oho- patient :T 'managed to. get ref erred to-oo‘San^tioriUm-’ '■***
in Bhopal emerged after two months looking much better and
clutching a prescription for rifampicin and ethambutol.
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c.

Possible Alternatives

It is well known that there now exists a wide variety
of alternative drug regimes, for the treatment of tuberculosis
many of which result in cure of a higher proportion of patients
in a much shorter period of time than existing standard regimeso
The conventional wisdom is that these alternative regimes
comprise a ’second line' of treatment for patients resistant
to the standard regimes.
The fact that the government itself does net take this
argument seriously is shown by the free availability of the
so called 'second lino' drugs in the open market. Of course,
the price is far beyond the reach of the ordinary tuberculosis
p^ti^nt. As a result, we have in India the ironic situation,
where the District Tuberculosis Officer and the PHC Medical
Officers are the only medical practitioners who (in their
official capacity) have no access to the newer drugs for
the treatment of tuberculosiso

In effect there ar^. today, in tuberculosis, as in ever^other field cf medical and indeed of public life, two sets
of policies in operation—one for the poor and one set for
these who can (even if only with difficulty) pay.
The argument against th newer regimes can now be seen
plainly for what it is a question cf cost . It is worth
going into this question in seme details.

5, the quc-sticn of cost
a.

How much?

Th: cost of a complete course cf treatment with the
newer drugs at current market prices is of the order of
Rs*5-00-00 to Rs. 1000-00. Regimes containing Streptomycin
arc liable to cost mcR. because of the administrative cost
of giving the injection.
We arc not talking of enermeus sums cf money. The cost
cf bi-weekly INH/SM with
initial intensive phase, is net
much less. Neither is the cost cf INH/PAS regimes.. The logic
of the exclusive dependence on INH/TH new become clear.
Put another way, the cost cf treating a case cf
tuberculosis with the newer drugs and the cost cf treating
case cf intestinal obstruction or pyogenic meningitis is
about the same. The cost cf treating a case cf ischaemic
heart disease or lung cancer or brain tumor or diabetes
mellitus or chronic renal failure is several times higher.
The comparison bcc'. mes ridiculous when one carries the contrast
t'* fields cutside medicine—say, tc defence or CHOGM.

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Cost to whom?

The second aspect cf the cost equation, Whatis the 'cost'
cf a twenty percent relapse rate which is tht best result
obtainable with standard ’first lino' regime? What is th^
th 'cost'
of a c'se of thiacetazone induced agranulocytosis or Stcv^nsJc-hnscn Syndrome? What is th- 'cost' of travelling up •’•nd down
fr m- village to PHC, village to.- District centre, village t<
wherever, for 18 months as a ainst the six months with newer
regimes? What is the 'cost' in bus fare? What is the 'cost'
in lost income? What is the 'cost' in the suffering cf a
poor man? This Xs

•questi
n which the policy makers cf
tuberculosis must answer.

6 (objectives of the meet)

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A nctc on the objectives of an mfc annual mceting on tuberculosis
(1) The objectives of the conference- should net include the
framing c/ alternative policies to government programmes.
The existing policies ar- faulty both in concept and in
implementation. Any alternative systems we may be able
to formulate will involve a restructuring too radical
for their acceptance to be feasible, quite apart fre-m any
other factors militating against their acceptance.

(2) An important part •: f the programme for the conference
should bo the understanding of the problem, of tuberculosis
in its national perspective. Not many mfc people have much
an understanding. Unless wc can share a c:rm.n understanding
of the problem, it is useless to try to devise programmes
of action.

Possible pregramme outcomes of the c■ nfcrences
a.

A concerted effort to- work out a solid critique
of existing government policy and its implementation.
The rcsp nsibility would largely be on academics
with access to literature and data.

b.

Working out and executing pilot projects based on
alternative approaches to the problem of tuberculosis,
utilising newer technological as well os s. ciclcgical
insights. These would include intensive small scale
field level studies.
i.

Surveying the problems of tuberculosis, including"'
the much neglected epidemiological implications
of primary tuberculosis in pre-sch cl children,
extent and implications c f drug resistance- etc.

ii. Me.nite ring government activities intensively
including the actual execution of treatment guide­
lines, patient compliance in government programmes
etc.

iii. Working ut alternative approaches including
newer ways to irnpr ve patient compliance, newer
treatment regimes, newer diagnostic approaches
including newer approaches to diagnosing drug
resistance .

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