Saturday, September 03, 2005

Ministry of Health - one more Ban

(continued from previous)

Rubbing salt.........

Another action of the Ministry of Health, which has met with considerable consternation, is that of banning the sale (and thereby, consumption) of Salt, which has not been iodized, to save the country from Iodine deficiency. This mandatory provision was first introduced in 1997 but was omitted in 2000 after due deliberation by the Government, three years after it was introduced. [ see ]

Salt pans, salt crystals, Iodine grains and table salt

It is recognized that goiter (enlarged thyroid gland), mental retardation and other forms of impairment due to Iodine deficiency are a problem in India. It is also true that giving Iodized Salt is the simple mode to deliver Iodine for consumption to those who are Iodine deficient.

That India needs to rid itself of IDD (Iodine Deficiency Disorders)- in fact of every type of disease - is not in question. However, when a solution that involves force-feeding of 1.1 billion people of India with Iodized Salt and prohibiting them from using ordinary salt is being imposed on the country, the decision needs to be examined carefully.

The rationale for the Government's action is being rightly questioned both from the medical point of view as well as from a more fundamental aspect that involves the freedom of the people to choose.

There is scientific evidence supporting Iodine use to tackle IDD for the simple reason that these diseases by definition arise from deficiency of this micronutrient. Using salt that is Iodized is only a delivery mechanism, which is preferred because it is practical and convenient and the use of salt is universal. At the same time, Iodizing all edible salt would mean that each and every person in the country would be subjected to a dose of Iodine in proportion to his or her own individual salt intake regardless of whether the person is Iodine deficient or not.

Let us now review the situation in India as regards Iodine deficiency.

Is India recognized as a country that is Iodine deficient in general?

W.H.O. is the international organization that is spearheading the effort to eliminate IDD in the world and for this reason, supports Iodized salt for both human and animal consumption. It is interesting to note that India is NOT DESIGNATED as an Iodine deficient country by W.H.O. at all. In its latest Report "Iodine Status Worldwide", which identifies 54 countries as Iodine deficient, India has been classified under two parameters as follows:

Classification of Iodine Intake : ADEQUATE

Classification of Iodine Nutrition: OPTIMAL IODINE NUTRITION

This shows that contrary to the alarming picture that seems to be presented by the Government, Iodine deficiency is NOT a universal condition for the entire country. Therefore, prima facie, there is no justification for lacing the salt consumed by the entire population with Iodine.

Which areas of the country face Iodine deficiency?

The Minister for Health has claimed that in the Ministry's survey of 312 districts (out of a total of 593), 254 were found to be having endemic deficiency. Although details of the methodology as well as results of this survey need to be studied, it is clear that even if the survey is validated and accurate, not all districts are deficient. It does seem peculiar that the W.H.O. Report published in the end of 2004 conveys a different picture than what the Government contends. According to W.H.O. estimates, 329 million out of the total population face inadequate Iodine intake.

Is the entire population susceptible to Iodine deficiency?

Whereas every person needs adequate Iodine intake, there is no NEED for everyone to use Iodized salt. The incidence of Iodine deficiency, sufficiency or excess differs from country to country. Within a country, it can vary not only from region to region or even within the same region, it could also differ from person to person, as it depends upon the local factors coupled with an individual's diet composition. There are also certain groups which require a higher level of Iodine intake viz. pregnant and breastfeeding women. Preschool children, pregnant and breastfeeding women constitute especially vulnerable groups. The RDA (Recommended Dietary Allowance) of Iodine ranges from 90 mcg/day to 290 mcg/day.

If a country decides to provide Iodized salt, it has to decide on an appropriate level of Iodine in the salt based on an analysis of all sources of Iodine in the diet of the people to whom the Iodized salt is to be made available. Logically, the Iodine content would be fixed for a median value. This would mean that a certain number of people would still have to further supplement their Iodine intake in other ways. On the other hand, if the Iodine addition level is set to correspond to the requirements of the Iodine deficient or the most vulnerable groups, others would always be subject to significantly higher levels of Iodine intake than needed. The key to good thyroid function is adequate, but not excessive Iodine intake.

There are serious implications if a significant number of people continuously receive excessive inputs of Iodine in their system. This brings to the fore, the medical issues related to the Universal Salt Iodization plan, which the Ministry hopes to implement and enforce.

It is recognized that excessive Iodine intake could have adverse effects just as deficiency of Iodine has. Some proponents of universal salt Iodization tend to dismiss fears of such adverse effects by saying that most of the Iodine intake is eventually excreted in the urine and further that the risk from excessive Iodine intake is likely to affect only those who are prone to diseases of the thyroid gland.

Such arguments need to be tempered in the light of enough medical data that clearly recognizes the risks of excess Iodization as can be seen from the following sprinkling of relevant literature:

1. Use of Iodized salt and the risk of Iodine overload (Zaidi, Hababa, Idris, Taoufik)
Therapie. 1999

“We conclude that prolonged use of this iodized salt exposes the population to the risk of thyroid disorders.”

2. "A potential reason for thyroid autoimmunity may be the consumption of excess iodized salt as a therapy to regress goitre" and " In previously iodine-deficient populations where iodized salt was introduced to combat iodine deficiency, autoimmune thyroditis and thyroid antibodies had been detected in a number of goiterous adolescents." is the finding reported in a Pakistan medical Journal.

3. An article related to Iodization Programme in Germany not only points out the risks involved in excess intake, but also goes on to say how such a regulation is seen as an infringement of human rights. It further states: "In a press statement issued on 12 March 2002, the Iodine Deficiency Study Group declared that the Iodization Program had unfortunately not so much managed to eradicate illnesses of the thyroid gland, but had rather replaced it. While there are now less cases of goiter there are however more autoimmune illnesses that destroy people's thyroid glands."

4. What's happening to our Iodine: suggests the risk of iodine-induced hyperthyroidism.
Article by John T. Dunn
The Journal of Clinical Endocrinology & Metabolism Vol. 83, No. 10 3398-3400

5. Another article in Mednet discusses the effects of Iodine excess

6. An article further discusses the results of excess Iodine intake

7. Thyroid Iodine Excess and Hyperthyroidism - Article

Iodine induced hyperthyroidism is frequently observed in patients affected by euthyroid iodine deficient goiter when suddenly exposed to excess iodine.

8. Report by Scientific Committee on Food - European Union: on the Tolerable Upper Intake Level of Iodine

9. World Iodine Excess/ Deficiency / Thyroid Health

10. Micronutrient Information, Linus Pauling

11. Iodide Induced Thyrotoxicosis (IIT)

And finally, W.H.O. the Organization that spearheads the Iodization of Salt promotion worldwide, has this to say:

"In 29 countries, iodine intake was slightly too high or even excessive. Daily iodine intake above a safe level may result in iodine-induced thyroid dysfunction in susceptible groups. This highlights the important need to reinforce the monitoring of iodized salt quality so that the level is adequate to ensure optimal iodine nutrition but not too high. WHO also emphasizes that promoting iodized salt should not lead to the over-consumption of salt, which can contribute to hypertension: salt iodization can be carried out with a level of salt consumption compatible with WHO's recommendations of up to 5 g/day."

The above clearly establishes that THERE IS A RISK to at least a segment of the population due to excess intake of Iodine and this raises certain fundamental issues:

1. As the country is recognized even by W.H.O. as having "Optimal Iodine Nutrition", it means that in trying to provide adequate intake to a sub-population, hundreds of millions of people (THE MAJORITY) who DO have adequate Iodine intake will be forced to consume additional quantities of Iodine. Over two thirds of the population - more than 700 million - which has adequate Iodine intake will have to take additional Iodine due to the mandatory Iodization regulation without an opportunity to make an informed decision. It is open to question whether such an action is justified.

2. Whether as a matter of principle, the Government has a right to deprive any person of the right and freedom to consume common salt.

3. Even assuming that a person is part of the vulnerable group, would the person not have the right to decide in what manner he/she takes the Iodine supplement or stretching the argument, whether to take Iodine supplement at all.

4. Whether the Government has the right to force-feed the ENTIRE population with salt to which Iodine has been added, knowing fully well that excess Iodine may pose a risk to at least a segment of the population.

5. If, forced consumption of Iodized salt leads to people suffering from autoimmune thyroditis, other thyroid disorders or worse, WHO WILL BEAR THE RESPONSIBILITY for such consequences. The issue would become of more significance if hitherto unrecognized effects of Iodine excess come to knowledge at a later date.

The critical import of this question should not be underestimated. The Recommendations for Dietary Allowances of Iodine are by no means fixed. The RDA were already the subject of a re-evaluation in 2001. These may change. Continuing to feed the population based on levels fixed by the state of current knowledge of others poses an inherent risk. Furthermore, the question of responsibility will become more relevant if adverse effects are experienced over a long term.

Particularly in the context of the Constitution of India, Public Health is a State subject whereas mandatory Iodization is sought to be imposed by the Central Government. The question of responsibility of the State and the Center for any adverse consequences, therefore, assumes great importance.

Even if the Government should take the responsibility, a citizen still has the right not to subject himself to the potential or perceived risks from the forced intake.

6. Also of significant importance are some practical aspects of the universal salt Iodization requirement. For example, should it become necessary for a part of the population to discontinue Iodized salt for medical reasons, how would non-Iodized salt be made available? Would it, for example, have to be obtained from a chemist's shop against a prescription? Such questions, even if they sound far-fetched, need to be posed when the decision involves hundreds of millions of people.

7. Another practical aspect of the regulation relates to the COST of the Iodized salt as compared to common salt. For the salt manufacturers, Iodized salt is a value added product and priced accordingly. The mandatory provision to sell Iodized salt would, therefore, place an additional economic burden on the common man. The issue of cost is often downplayed. For example, Dr. C.S. Pandav, coordinator of the International Council for Control of Iodine Deficiency Disorders for South Asia, has said that a likely reason for the low production is the misconception that producing iodized salt is expensive. “In reality, [producing] a lifetime’s supply of salt for one person costs no more than a cup of tea,” he said. If that is indeed so, the Government should ensure that Iodized salt and common salt are sold side by side at the same cost so that the common man could be induced to consume Iodized salt on his own rather than being forced down his gullet by law. In the United States, the salt producers co-operated with public health authorities in the past and made available both common salt and iodized salt at the same cost.

8. Enforcement of the Rule is another issue which needs to be appreciated. As the regulation applies to everyone who offers an item of daily need like salt, to enforce it in the right interest would involve controlling millions of retail grocery outlets in the country.

9. One of the most important points that arise out of the regulation is that of monitoring. W.H.O., realizing the risks arising from excess intake has clearly highlighted " the important need to reinforce the monitoring of iodized salt quality so that the level is adequate to ensure optimal iodine nutrition but not too high." Extending this logically, it is not only necessary to monitor just the salt quality, but also the impact of Iodine intake so that the population does not end up having Iodine above the 'safe level' continuously over a long period.

The action of the Government in imposing Iodized salt on 1.1 billion people, therefore, presupposes that it is fully geared to continuously monitor all aspects related to Iodized salt intake. By any account, none of the pronouncements by the Minister of Health indicate whether such monitoring and surveillance would be done and if so, whether the State or the Central Government would be responsible to undertake the task on an on-going basis.

It is open to serious doubt whether the Government at the Center and also the State Governments have a comprehension of all the long term implications of the ban on common salt.

10. Let the incongruity of the whole argument to force only iodised salt on the entire population be summed up below:

First, let us consider the case of the first part of the population, which is supposedly iodine deficient.

The number of people suffering from iodine deficiency in the country are said to be between 200 to at the most 300 million. These are the people who are supposed to have already been diagnosed in some way (assuming this supposition is valid) as suffering from iodine deficiency disorder. This means they should be subjected to a specific treatment by way of sustained higher iodine supplementation and/or other prescribed medical treatment to first cure them of the disorder and bring them to a normal level. It is obvious that simply giving iodised salt in the daily diet would NOT be adequate treatment for this part of the population. They need something more - a specific, supervised treatment till they no longer have the disorder. It follows that forcing them to have iodised salt is neither here nor there and irrelevant if they are given the required treatment, including direct iodine supplements.

Second, let us consider the case of remaining part of the population, that is NOT IODINE DEFICIENT i.e. an estimated 700 to 800 million people.

By definition, this part of the population is already having optimum iodine levels because they are not diagnosed as suffering from IDD. Now, if they are already having optimum iodine levels, it can be safely assumed that their iodine intake has been adequate to maintain the optimum level and will continue to remain so. It is against common sense and reason for anyone to assume that their iodine intake will somehow, suddenly and inexplicably become less than adequate. Therefore, it would be illogical to proceed on the basis that they will become deficient and start suffering from deficiency disorders and should, therefore, start eating salt laced with iodine from a day the Government decides.

It is evident from the above that the rule as proposed is not quite 'what the doctor ordered' for either part of the population. What is needed is to take care of the sections known to be vulnerable to IDD with a targeted approach and those who actually suffer from IDD as and when diagnosed.

A short consideration of the legal aspects of the ban can be seen here.

This is one more instance of the short-sighted and short-cut approaches taken by various Ministries within the Government. Unfortunately, considering the compulsions of coalition politics there is very little that the Prime Minister can do to rein in cavalier Ministers with Quixotic ideas.

A Final suggestion for the Minister of Health:

The country faces serious challenges on the Health front and which need to be tackled by the Central Government on a national basis, challenges much more serious than smoking in movie scenes or iodine deficiency. There are diseases that can be fatal and pose dangers far more grave than the dangers posed by Iodine deficiency. There are serious issues relating to providing quality health care at low cost across the country and not giving sufficient attention to them at this stage could lead to disastrous consequences in terms of the health of the people as well as financial consequences for the country.

The Minister would be well advised to leave the present pet projects like smoking, Iodized salt etc. to the States because Public Health is the domain of the States under the Constitution and also because issues like Iodine deficiency may need to have regional focus which the States would be more competent to provide. At best, the task of his Ministry should be to provide advice, guidance and technical support to the States in educating the general public and in evolving and implementing sensible and practical plans to reach the targeted groups, for consideration by the States depending on their own situations. If at all the Minister is serious in pursuing this issue, he needs to come up with innovative and unique approaches to the problem rather than blindly follow slogans and prescriptions of others that do not take into account the ground realities of a country with 1.1 billion population and growing by 20 million every year.

Thursday, September 01, 2005

Ministry of Health - Ban, Ban....

The Minister of Health in the Government of India, Mr. A. Ramadoss is young and enthusiastic.
But in his zeal to improve the health of the country, he is prone to go overboard. He seems to have a propensity to go for slapdash solutions and in doing so, give short shrift to some basic tenets of the Constitution of India, in particular Part III, to which he has sworn allegiance as a Minister.

Worried about the manner in which psychiatrists, neuro surgeons and other medical specialists were leaving the country to UK for jobs, practice or research, his first instinct was to ban their travel and practice abroad. This is what he said in an interview with a newspaper:
"Initially I was thinking of banning such specialists from travelling and practicing abroad."
His Ministry was also planning for a mandatory practice by the specialists for a certain period in India after passing out, another injudicious approach which, thankfully, was dropped.
He even took up the issue with the British High Commissioner in India, blaming the British National Health Service for the 'brain robbery' according to the news report.
His first thought then, was to ban the specialists from leaving the shores of India. For a Minister in the Government of India, he is expected to exhibit due restraint in expressing his private opinions in public. Even if in his private moments the Minister immediately thought of a lay person's solution of banning their travel, in making his views public, he only displayed a less than mature approach and naivette. He even stated: "But legally, we can't do that".
Not happy with the situation, he even 'took up the issue' with the British High Commissioner. To what end, pray? Perhaps, the British High Commissioner was also amused by the approach of a Minister who represents the Government of India.
As the Minister himself seems to have realized after discarding the half-baked ideas contemplated earlier, the only sensible approach to the problem would be to create more facilities for study and enrolment of larger number of candidates for the specializations.

The next issue about which the Minister seems to be quite exercised is that of the smoking in movies and has proposed a ban on smoking scenes in movies, a knee-jerk action behind which not much thought seems to have gone.
There is a background of his own party's protests a few years back against film star Rajnikanth for smoking and drinking on screen and that seems to be one of the reasons prompting the ban.
But rather than emphasize this past and blame him for taking an emotional and subjective decision, it is better to analyze the matter more objectively.
It cannot be denied that a ban on smoking scenes impinges on the fundamental freedom of artistic expression and for that reason, has been rightly objected to by the film-makers and others.
Further, the decision is sure to create serious difficulties for the implementing authority i.e. the I & B Ministry as it would give rise to a host of fundamental and practical issues. Such an arbitrary ban is likely to snow-ball into demands from various sectors for restrictions with respect to a host of other issues, whether movie-related or not, which the Government would be hard-pressed to handle.
Apart from these two overall considerations, there are other aspects also which need to be considered in an objective manner as regards the relevance as well as the efficacy of the ban on smoking scenes.
It is undoubtedly true that consumption of tobacco is a scourge which needs to be controlled. But the health risks from this menace are such that they cannot be effectively dealt with by the ad-hoc and superficial manner in which the Ministry is seeking to handle the issue.
There are two basic objectives in dealing with and reducing tobacco consumption:
a. Cessation of consumption by those who are already used to the tobacco habit.
b. Preventing the initiation of tobacco consumption by non-users, primarily adolescents and young adults
The proposed ban on movie scenes is obviously not aimed at the the User group as those who are already consuming tobacco are unlikely to cease smoking if they do not see any smoking scenes in movies. Therefore, for this group, it is irrelevant whether scenes involving smoking are shown or not.
Consequently, it is to be assumed that the measure is meant to prevent initiation of consumption by the susceptible group.

Teens smoking...
The reasons why adolescents and young persons take to smoking are complex, involving a mix of economic, cultural and social factors which affect the living environment of each person. In young persons, the two reasons traditionally considered as primary factors are : peer pressure and accessibility of tobacco products. Accessibility is taken both in the sense of affordability and ease of acquiring. Other factors are, promotions and advertising, consumption behavior by parents, friends and siblings and social acceptability.

Celebrities and others.....
Of late, attention is being focused on another possible cause as far as smoking is concerned i.e. depiction of smoking scenes in movies. This view is inspired by the fact that in most of the new movies (in the West) smoking scenes are shown. It is believed that such scenes, especially positive depictions, are particularly likely to induce adolescents at their impressionable age, to take to smoking. A few studies have been done which show the considerable extent to which smoking is shown in movies. A study has also tried to determine how or in what manner smoking scenes might influence young minds. Studies have been made and evidence has been found in the USA, about the unethical practices of cigarette manufacturers in trying to influence smoking behavior by using the film medium. But the real issue is to establish a demonstrable, unequivocal and significant link between the exposure to smoking scenes and actual influence of the same on smoking behaviour.
In proposing the ban, the Minister appears to have simply applied the hypotheses of studies made in other countries to the Indian situation. However no systematic studies seem to have been initiated by the Ministry itself to assess the Indian situation. At least, no evidence has been made available to the general public to show that the ban is indeed essential.
Several measures have already been taken by the Government in the past to try and restrict the consumption of tobacco e.g. age restrictions on selling tobacco, ban on smoking in public places, ban on sponsoring of public events by tobacco manufacturers etc. as well as high level of duties. If at all the Government is really serious about preventing, controlling and reducing consumption of tobacco, it needs to evolve a COMPREHENSIVE strategy after independently studying in depth, various factors affecting tobacco consumption in the country, not blindly following a few studies made in other countries. The Strategy should include economic, regulatory, clinical and educational aspects. As far as economic aspect is concerned, in India at least, the Excise and other taxes seem to have been placed at a sufficiently high level to reduce affordability amongst the adolescents. As far as regulations are concerned, rather than placing a frivolous ban on smoking scenes, regulations for advertising and promotion of tobacco need to be tightened. In the context of films, any sponsorship or paid placements may be prohibited. Alternatively, the film maker could be obliged to disclose at the beginning of the movie, any paid placements accepted in the film. The Government should also be prepared to engage in counter-marketing to discourage use and make it socially unacceptable. The Government needs to also focus its attention on the extremely disturbing trend of more and more adolescent girls taking to smoking.
As far as the Ministry's fear about impact of smoking scenes in movies is concerned, it needs to immediately commission, in conjunction with any other concerned administrative Ministry, studies(see proposed outline) by a reputable institution like Tata Institute of Social Sciences before any conclusion can be reached.
Any measure the Government takes must be relevant, credible and evidence-based.
to be continued...