THE first case of swine flu death in India occurred on August 3, when a 14-year-old girl, Rida Shaikh, died in Pune because of the failure to diagnose the case in time. Within the next 15 days, the mortality figure shot up to 25. During this period what was in evidence was a knee-jerk reaction from the government, on the one hand, and misplaced panic among the public, on the other. Given the lack of an adequate and clear response from health officials and the hysteria whipped up by the visual medias obsession with tracking and dwelling at length on each and every death, an irrational fear of the new global pandemic gripped India.
At present, the disease, caused by the triple-reassorted flu virus A(H1N1), has spread to 170 countries with a visibly rapid and efficient human-to-human transmission. After the initial period of predominantly imported cases of infection, mainly from North America, swine flu has now firmly established itself in the country, with the transmission having taken root at the community level. Now there is efficient transmission among people who neither travelled abroad nor had direct contact with people returning from abroad.
As of August 18, the total number of positive cases in India was 2,026 with 25 deaths. Pune reported 13 deaths and the others were reported in Bangalore (5), Mumbai (2), Ahmedabad (1), Chennai (1), Vadodara (1), Nashik (1) and Thiruvananthapuram (1). With the sudden spurt in the number of deaths, the contradiction in Union Health Minister Ghulam Nabi Azads claim about 10 days earlier that the swine flu in the country was under control could not have been starker.
Though there is a pandemic preparedness plan on paper, it does not seem to be something that has been well thought out and can be put to operation. There still is no preparedness plan for outbreaks [any outbreaks] leave alone pandemics, said Randeep Guleria of the All India Institute of Medical Sciences (AIIMS), New Delhi.
When Mexico reported the flu, Tamiflu stocks were acquired but no attempts were made to strengthen the laboratories or train people or increase the supply of ventilators and other isolation equipment.
Interestingly, only sometime in August experts from the National Centre for Disease Control (NCDC), New Delhi (formerly National Institute of Communicable Diseases, NICD), began imparting training to doctors and PhD students from the States even as the Centre worked overtime with testing proper swine flu cases. The governments attitude seemed to have been that the disease was mild and nothing was happening, so why stockpile?
There needs to be a push-pull factor, said Guleria. The States do not know what to do. Despite several meetings, there is a sense of lethargy and indifference, while the Centre goes all out once the pandemic is at the doorstep.
Once the pandemic truly hit the country, the government went about the task of acquiring equipment such as ventilators (for critical cases); reagents for real-time polymerase chain reaction (PCR) testing for H1N1 virus; fresh 20 million doses of Tamiflu medicine, in addition to the earlier stock of 10 million; and large numbers of masks. But it appeared to be a case of trying to upgrade the system in a matter of days without any strategy.
Even after the World Health Organisation (WHO) declared that swine flu had become a phase 6 pandemic and its spread could not be contained, the government spent time and resources on screening and testing all instead of focussing on immediate treatment to those with the severe form of the disease.
The airport screening that was initially deployed was pretty much useless because those who were asymptomatic without fever and within the incubation period of seven days did not get detected. The process depended essentially on self-reporting by passengers. However, citing the success of the operation in Andhra Pradesh as an example in defence of the governments initial strategy, V.B. Katoch, Secretary in the Department of Health Research, said the policy of quarantine and isolation had worked initially.
The maximum number of cases were reported in Andhra Pradesh and yet the virus did not enter the community, he pointed out. The reason seemed to be the cooperation of people; they came forward to stay in isolation facilities. Such cooperation seemed to have been absent elsewhere, particularly Pune.
India had enough lead time to learn from the experiences of other countries to prepare itself for the pandemic, but it seems to have learnt few lessons. For example, in the United States, the Centres for Disease Control and Prevention (CDC) took extra efforts to impress upon the public about what was known and unknown about the virus and its behaviour. Its endeavour was to convey to the public that the number of confirmed cases seen was only the tip of the iceberg and that the rate of transmission was much higher than was being picked up as a large number of people could remain unsymptomatic and not know that they were infected.
According to the WHO, about two billion people worldwide 30 per cent of the global population could be infected by the time the pandemic ends. But catching the infection was not as grave as what the public in India had come to believe. According to WHO estimates based on data from various countries, only up to 10 per cent of confirmed cases need to be hospitalised, and fatalities occur in less than 1 per cent of confirmed cases.
In the initial days, no attempt to communicate to the people the exact nature of the infection was evident in India. Added to that was the unnecessary media focus on individual cases. I believe that they were not able to communicate the risk to the population, said Shahid Jameel of the International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi.
People were always only told that this is benign, this is just like simple flu, no problem, nothing will happen. And suddenly a spate of deaths came within a week. This caused panic. If people knew from the very beginning that there was a risk of severity and mortality, and that they had to be prepared, and if the government had emphasised the importance of public participation in control, then I think we would have fared a little better, he added.
The figure of confirmed cases, 2,026, should not be taken as the true number of the infected in the country, and the number of deaths should not be taken to imply that the virus had suddenly turned deadly. As testing for the H1N1 virus is now being done only on those who display symptoms of severe infection, the actual number may be at least 10 times this figure.
The case fatality ratio (CFR) in India is believed to be around 0.2 per cent, which is about the same as the global rate of 0.1-0.2 per cent. In fact, allowing for a general multiplier factor of 10-30 over the number of confirmed cases worldwide, a recent model estimate put the CFR to be in the range 0.06-0.0004 per cent.
If you still see the overall death rate, the overall mortality rate in India is still about 0.2 per cent. But it is just that these deaths have come so very close to each other that it has led to a panic situation, said Jameel. But why have the deaths come bunched like this? I think it is too early to make statements like the virus has become more deadly, and things like that, said Jameel. Maybe there is more awareness and so these deaths have got reported. Otherwise these would have passed unnoticed, he added.
He is of the view that the transmission in Pune seemed to be slightly higher than in other places. This could be because of better awareness in Pune; more people flocking to hospitals and testing centres. I dont think we have any evidence to suggest that the virus is becoming more virulent, or that the virus in Pune is any different from the virus elsewhere in India. Really no such analysis has been done. All they are doing is finding out who is positive, who is negative, Jameel pointed out.
The higher number of cases in Pune was not a case of the National Institute of Virology (NIV), Pune, screening more number of samples than the NCDC, he said. They [at NIV], I believe, are screening about 400-500 cases a day. The NICD also has a similar capacity. I really think it is because of more awareness in Pune, Jameel added.
The lack of complete awareness among the people proved to be counterproductive. By thinking that they may have swine flu, people flocked to hospitals, which probably did more harm than good. Instead of remaining in their homes, which would have been the case if there had been a clear directive, similar to the CDCs, from the government, they were moving about on the streets and getting infected or infecting others.
CONFUSIONSaid Jameel: I have not seen any clear message coming out that people who have got the flu should stay home. There is a fair bit of confusion within the government. If you know that you have the flu, wearing masks is the most efficient way of stopping the transmission. Here we are doing it the other way around. People who dont have the infection are going around buying masks; they have depleted all the masks in the market. And people who have the infection are going around the city infecting others.
Consider the revised guidelines that were issued on August 4 in order to make H1N1 testing more accessible. It said: Any person with flu-like symptoms such as fever, cough, sore throat, cold, running nose, etc., should go to a designated government facility for giving his/her sample for testing for the H1N1 virus. After clinical assessment, the designated medical officer would decide on the need for testing. Except for cases that are severe, the patient would be allowed to go home (emphasis added).
It is these revised guidelines, which are contrary to prevalent wisdom, that drove people in large numbers, including those who may have not had any infection beyond a common cold or ordinary flu, to the different designated hospitals to give their samples, and thereby increasing the possibility of H1N1 infection. The earlier guidelines had said: A person suspected of influenza A H1N1 needs to be referred to an identified government health facility. He/she needs to be kept in an isolation facility in that hospital and, if found positive, treated accordingly.
There has been a serious gap in communication between the health officials and the people, said Jameel. In times like this it is perceptions that matter, more than the reality. So we have not been really able to control that. Make it a part of the guidelines to make people understand that it is the individuals responsibility to limit the spread. We have only been telling people that this is nothing more than seasonal flu, washing your hands regularly is okay. Suddenly, you have these deaths, which I still feel is no cause for panic. But I think the damage is done. But the lessons we have learnt in this round should help us at least in dealing with the second round when it comes, and it will come. There will be a second round and there will be a third round.
NEW GUIDELINESNow there is yet another set of guidelines, issued on August 14, which are somewhat more rational and recommends testing for H1N1 and hospitalisation only for patients with one or more of the following severe symptoms: Breathlessness, chest pain, drowsiness, fall in blood pressure, sputum mixed with blood, bluish discolouration of nails and worsening of underlying chronic conditions. Patients with only high-grade fever and sore throat are recommended Tamiflu and home isolation but no testing. Patients with only symptoms of sore throat but no high fever or bodyache are not recommended Tamiflu or testing. These guidelines have been late in coming but even these do not send out the message clearly on the responsibility of citizens that if they have flu-like symptoms they should stay home unless their condition worsens.
Now, as part of these new guidelines, people are sorted out on the basis of symptoms. Patients are categorised as cases of mild flu, flu with high fever and severe flu having acute respiratory distress syndrome (ARDS), pneumonia, and so on. Only those with severe symptoms of pneumonia or ARDS are tested. Those with mild symptoms are told to go home and asked to come back if they develop serious symptoms.
These selected cases will all be positive because these are sorted out as serious cases. Now, epidemiologically speaking, if the CFR goes up from 0.2 to 0.4 per cent, you cannot say that the virus has become more virulent in India. Since a selection has already been made, the general population is not being tested.
But this strategy is not without problems either. We know that in the initial stages those who became positive did not have the severe symptoms, said Jameel. I think the strategy has simply been put in place because the testing facilities are getting overwhelmed. And, of course, there are costs involved. That is why public responsibility, public participation and communicating the risks to the public, all become important. But it is already too late to do that.
He also could not see a clear strategy for deploying Tamiflu, which is central to the entire disease-control strategy. Jameel explained:
The government has been saying do not go for testing if you dont have the symptoms. Now, symptoms develop only after two or three days after you have the infection. Now, Tamiflu is known to work efficiently only if you take it within 48 hours. So, if somebody follows the government guidelines strictly, Tamiflu becomes the patients responsibility. The logic of giving Tamiflu to people who, according to your own guidelines, should come to you only after three days makes no sense.
The correct strategy should be to trace the contacts and start giving them Tamiflu. This is the only medicine that we have today to fight swine flu and this is going to be most effective only on them. The trouble is the system is so overwhelmed right now that tracing an infected persons contacts, etc., just seems impossible. The government recently ordered 20 million additional doses of Tamiflu without a clear strategy how to deploy them. But it was a good political decision.
The biggest weakness in our response to swine flu has been the lack of surveillance. We do not have flu surveillance in place at all. There are no data, and bird flu happened way back in 2006. Though lots of things are said to have improved after the bird flu spread in India the only thing that has evidently improved is the testing facility.
But even that started after the plague epidemic when there were no facilities, and some, especially the entire NICD lab, were built then. But no exercise at creating a base of data on flu has been undertaken. If you had those baseline models, it would have been useful now. The Union Health Ministry says that things are under way.
So, with no surveillance there was no way any of these cases could have been tracked. Because people reported on their own the disease was contained to an extent. In fact, we are unable to pick up any outbreaks or clusters. It is well known that most often health services in the States and at the Centre get their first information report from the media, when local newspapers or television channels report.
The other strategy I feel, says Jameel, that the doctors have not really talked about is this. If you look at mortality, all the people who died had ARDS. Normally this is caused by secondary infections, which are bacterial in nature. So why are broad-spectrum antibiotics not being deployed? I dont see any guideline saying that. Even the WHO says deploy antibiotics only if secondary infections are serious. I dont see any reason why people who have flu at this time should not be having antibiotics to prevent serious disease. Of course, one could argue that this will lead to antibiotic resistance. But resistance happens only if you take a partial course. It doesnt happen if the entire five-day treatment is done.
Antibiotics in India are far cheaper than Tamiflu, which in any case is not a cure. It only mitigates symptoms. There are all kinds of generic antibiotics available here. It would really make sense to deploy them, but I have not heard this from anyone.
A recent study published in BMJ has, in fact, shown that Tamiflu is not effective in children under the age of 12. Then you may also have others with underlying chronic conditions such as hypertension, and so on.
Again, there is the risk of the virus developing resistance to Tamiflu if it is not deployed properly. The governments argument is that if indiscriminate consumption of this medicine is allowed the virus may become resistant to it. That is why it is not freely available. But, at the same time, it is generally known that the drug is being sold in the market. The rate has gone up about threefold now. When earlier the whole course used to cost Rs.2,500, now one gets five tablets for that price.
TESTING ISSUESAnother of the knee-jerk reactions of the government was that initially it said no private hospitals would be involved. As the numbers rose and the situation began to get out of hand it allowed private hospitals to test. But the point is that the private players are still not on board. And they do not seem to be prepared to do this.
For one, private players will not have the reagents, and the government will have to supply them. Right now, the only validated test is the real-time PCR, which is made by only one company, Applied Biosystems, and the test takes about four hours. The private players will have to get the kits from this company. The governments claim that it is developing its own kit means nothing, points out Jameel. I can also develop a primer and claim that I have a test, but it is not a validated test.
He explained: You should have developed your own controls for validation. Only when it is validated then it becomes a proper test. Also, these private labs will have to have a containment facility where they will have to extract the RNA [ribonucleic acid]. Till the RNA is extracted, this virus material is infectious. So it has to be handled under proper conditions. The Health Ministry should ensure that these facilities are there. Otherwise they cannot become testing centres. Real-time PCR is not the issue. Unless the lab has the proper containment facility, those working there will infect themselves and others. Doing this for HIV, hepatitis B, and so on, is different as these are diseases that are not transmitted through aerosol like flu.
In terms of treatment, many of these public and private hospitals are yet to have strict isolation wards for swine flu patents, which should have been an important part of any pandemic preparedness or disaster management plan.
GENETIC ANALYSISAccording to Jameel, more pertinent from a national strategy perspective is the fact that no genetic analysis has been done on the Indian strains. While it is true that both the NIV and the NCDC are overwhelmed with testing, one would imagine that genetic analysis could have been easily done at one of the many laboratories in the country that have the capability and are not involved in testing for H1N1 virus in samples. The labs which have the virus will not share it with the labs which can do the analysis, says Jameel. This is a critical problem. The ideal situation would have been to share strains with other people who have the expertise to do the genetic analysis. But I dont see that happening. We need to understand the strains and their sequences.
According to Jameel, in fact, there has been no whole genome sequencing of any organism from India. If you go to the genome database on PubMed, on a daily basis H1N1 sequences are being uploaded from different parts of the world. But I have not seen an Indian sequence here. They are uploaded by date. Unless we do the analysis of the virus, we will not know whether it is the same virus or it is different.
According to Guleria, the bird flu virus strain is supposed to have been sequenced but it is not in the public domain. There is a reluctance to share this kind of information, he says.
As regards swine flu itself, the country has done reasonably well in terms of testing facilities for the virus. People doing the testing are doing a commendable job given the kind of pressure they are working under. But from the larger public health perspective beyond swine flu, one can see that research capacity has not been upgraded. Also, none of the vaccine companies is in the loop. They do not want to put in money into building exclusive flu facilities and there is no public sector unit in the vaccine field, which is a setback. So now one is rushing to the private sector to manufacture vaccines.
All of this shows that there is no real plan. Specifically for treatment and training, the appropriate institutions and services have not been upgraded. Regardless of the current pandemic, in the past three years, we have seen chikungunya, dengue, Japanese encephalitis, meningococcemia and several other outbreaks but the existing services in these areas have not responded adequately and effectively.
