With temperatures on the rise, the incidence of Influenza A H1N1 virus, commonly known as swine flu, may be on the decline. Yet, this has not taken away from the risk the virus still poses.
Union Health Minister JP Nadda informed both Houses of Parliament on 24 February that cases of the Influenza A virus currently being reported are of the same strain — H1N1 — as those that took a huge toll in 2009 and 2010. Nadda added that swine flu was becoming a matter of “great concern”, even as the World Health Organisation (WHO) said it was “carefully watching” the situation in India.
“We are working with the government on this to watch what is panning out in India. So far, there are no signs of the makings of a large outbreak. But we are watching carefully,” Flavia Bustreo, assistant director general, WHO, told reporters in New Delhi. She said that in the wake of the Ebola outbreak in West Africa last year, “a lesson has been learnt that one can never be too careful and too cautious when there are epidemics that are appearing in countries”.
Data available with the health ministry revealed that 875 people had died of the disease in various parts of the country till 23 February, while 15,413 people had been affected by the flu. Nadda added that the number of reported cases in 2009 was 27,236 and in 2010, there were 20,604 cases. There were 981 fatalities in 2009 and 1,763 deaths in 2010.
As per health ministry data, Rajasthan has seen the highest number of casualties, at 225 deaths, with 4,734 people being afflicted by the deadly virus.
Ruling out vaccination for the public to counter the viral disease, Nadda said, “Vaccination of the general public is not advocated as a public health strategy at this juncture. The vaccination becomes effective after about three to four weeks of the injection and the immunity is only for about one year. Moreover, vaccination may not provide full protection against the virus.”
The minister denied claims about a shortage of Oseltamivir, the generic drug (brand name Tamiflu) used for treating Influenza A H1N1 or swine flu, and said it is manufactured in India. “We have held meetings with the manufacturers on two occasions. These indigenous manufacturers have confirmed that they have sufficient capacity and stocks of active pharmaceutical ingredients to meet requirements,” he told reporters.
“It has been confirmed, both by the National Institute of Virology and the National Centre for Disease Control, New Delhi, that the cases of Influenza A currently being reported are of H1N1. It is the same virus as in 2009 and there is no mutation. Consequently, the drug Oseltamivir used during the time of the swine flu pandemic of 2009-10 remains effective for treatment now also,” Nadda said in a statement, amid fears that the virus might have mutated. Symptoms of swine flu include high fever, headache, muscle pain, diarrhoea, vomiting, stomach pain and internal and external bleeding.
PROFITING FROM YOUR ILL-HEALTH
When the masses are struck by panic, businessmen stay calm and profit from it. The mantra is drilled into the minds of students in business schools, practised by entrepreneurs and promoted by rich and famous investors. Increasing panic around the spread of swine flu across the country has proven to be one such opportunity for doctors, diagnostic labs and pharmaceutical majors alike.
First in the rank of profit-makers are doctors. A case in point are physicians in Haryana. Last week, a few private doctors in Gurgaon accused the state health department of discouraging tests for swine flu. They argued that testing patients was necessary for treatment and the state health department’s advisory of ‘no test’ for patients in the first two stages of the flu was a ploy to keep the numbers down.
District health authorities rebutted by accusing private hospitals of unnecessarily advising all patients with symptoms of cough, cold and fever to undergo the swine flu test, further creating panic. A district health authority official said in a media interview that the privately practising doctors and private hospitals were doing so “for a little extra money”.
The doctors have been criticised not just by the government but the national doctors’ association, too, for playing on people’s panic. Dr Sanjay Sood, vice-chairman of the Indian Medical Association (IMA) explains: “Not all swine flu cases end up seriously; in fact, most do not. Eighty to 90 percent of the cases will not even be known. Testing and anti-viral drugs should be used only in cases where conditions worsen.”
The IMA’s website goes into more detail, advising physicians to select appropriate patients for testing, anti-viral drugs and/or hospitalisation. Such patients include children, elderly, pregnant women or those with chronic medical conditions such as asthma or heart disease, who have a high risk of developing complications. In case of healthy adults, treatment and testing is recommended only for those who are either hospitalised, or suffering from severe or complicated flu.
“It is because of the panic reaction of the public that labs are making a killing and some doctors are advising tests when not needed,” Dr Sood added.
The IMA and most state health departments have divided swine flu into four stages based on its severity. First is asymptomatic swine flu. A quarter of those infected may remain asymptomatic, according to the ima. The second stage is mild or uncomplicated swine flu, which also requires no treatment, no hospitalisation and no investigations. The symptoms at this stage include fever, cough, sore throat, nasal discharge, muscle pain, headache, chills and, sometimes, diarrhoea and vomiting. The third and fourth stages, which include the above symptoms in addition to chest pain, low blood pressure and severe dehydration, among other symptoms, indicating severe illness requires testing, treatment and hospitalisation.
The Delhi and Haryana health departments’ public advisory specifically, in accordance with the IMA, stated that there was no requirement of test during the first two stages. Only serious patients reaching stage three needed to be tested for H1N1.
The second category benefiting from the swine flu panic are the testing labs. In Delhi, the government has recognised seven private labs that can conduct swine flu diagnostics test for a maximum of Rs 4,500. However, eating into the fears of the public even for a simple cough, common cold or fever are many private labs that are conducting tests and many of them for a much higher price, in some cases up to Rs 9,000, without a doctor’s recommendation.
Dr Sudha Gupta, North District Surveillance Officer of the Delhi health department, says that unlike 2009, when swine flu first came to India and immunity among the people was low, now it is behaving like common flu and, in most cases, is not a deadly disease anymore. “It is a self-limiting disease like any other flu, but the fear among the people is leading to panic and they are going for tests at private unauthorised labs, which are benefiting from it. However, since it is an epidemic-prone disease, labs need to meet certain rules and regulations to test for it, which most do not meet,” she explained.
Though the government advisory has also asked the accredited laboratories, which meet the WHO guidelines, to conduct the tests only if prescribed by a doctor, the Delhi health department has already issued two notices, following surprise checks, to labs for conducting the tests when they were not authorised and for overcharging for those tests.
Unlike Delhi, where the state government has put a ceiling on test prices, there is no price cap in most other states. According to media reports from Uttar Pradesh, private labs are charging Rs 5,000 and above, which means labs mint money as a suspected patient would have to spend over Rs 20,000 to get the entire family tested.
MASSIVE PROFITS FROM SALE OF TAMIFLU
Drug manufacturers comprise the third and final beneficiary, who are eating into the pound of flesh.
Oseltamivir, the generic drug used in the treatment of swine flu is sold in India under the brand name Tamiflu. Tamiflu was invented by Gilead Sciences (based in California) and licensed to the Roche Group (headquartered in Basel, Switzerland) in 1996. Roche and Gilead partnered on clinical development, with Roche leading the efforts to produce, register and bring the product to the markets.
In 2005, the Roche Group had granted Hetero Drugs a sub-licence to manufacture the anti-viral drug and sell it to governments of developing countries. Hetero Healthcare named this generic drug Fluvir. In 2009, after the H1N1 pandemic, Roche’s third-quarter sales rose 10 percent to 12.4 billion Swiss francs ($12.2 billion), clearly bolstered by an increased demand for Tamiflu.
In India, apart from Hetero Healthcare, oseltamivir, the generic version of Tamiflu, is also manufactured by Ranbaxy, Natco Pharma, Cipla and Strides Arcolab. While Natco sells the drug as Natflu, Cipla calls it Antiflu and Zanamivir and Strides Arcolab’s generic is sold as Starflu.
DO THE SIDE-EFFECTS OUTWEIGH THE BENEFITS?
A major analysis of one of the world’s most fiercely disputed medicines, the Roche Group’s Tamiflu, has found that although it reduces flu symptoms by a day and can help some patients avoid hospital treatment and complications, the drug can also have side-effects, including nausea and vomiting, which should be balanced against its benefits, said researchers who led the study.
The Roche Group’s website mentions: “Tamiflu is designed to be active against all clinically-relevant influenza viruses and key international research groups have demonstrated, using animal models of influenza, that Tamiflu is effective against the avian H5N1 strain circulating in the Far East. It works by blocking the action of the neuraminidase (NAI) enzyme on the surface of the virus. When neuraminidase is inhibited, the virus is not able to spread to and infect other cells in the body.”
Published in The Lancet (a highly-regarded medical journal in the UK) on 29 January, the pooled analysis included data from all previously published and unpublished trials of Tamiflu, which has been the subject of intense scientific debate for years. The drug is an anti-viral, which was stockpiled and widely used by governments during the 2009-10 H1N1 swine flu pandemic.
Does the drug really work? Over the past couple of years, it has become evident that it may be as effective against swine flu or any other flu as simple paracetamol. Even then, Tamiflu is approved by regulators worldwide and is on the who’s ‘essential medicines’ list and the Center for Disease Control and Prevention, US, recommends it as one of the medications for treating swine flu. Why is it so? Because the drug company withheld vital information on its efficacy.
According to the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, Roche withheld vital information on its clinical trials. The organisation investigated and found that Tamiflu has little or no impact on the complications of flu infection, such as pneumonia. It has also claimed that the drug does not prevent the spread of the virus. It just helped control the symptoms to a small extent.
The report by Cochrane Collaboration concluded that the drug reduced the persistence of flu symptoms from seven days to 6.3 days in adults and to 5.8 days in children, making it similar to paracetamol. Further, the drug is associated with a number of side-effects, including nausea, headaches, psychiatric events, kidney problems and hyperglycaemia. The researchers accused governments of throwing money “down the drain” by buying huge stocks of the drug.
The Lancet study, led by Arnold Monto of the University of Michigan School of Public Health and Stuart Pocock of the London School of Hygiene and Tropical Medicine, along with Prof Richard J Whitley, analysed data from nine trials comparing Tamiflu with placebos for 4,328 adults with laboratory-confirmed seasonal flu. They found it reduced the duration of symptoms by 21 percent compared with the placebo, from 123 to 98 hours, and significantly cut the risk of hospitalisation and flu complications such as pneumonia.
“The safety and effectiveness of oseltamivir has been hotly debated, with some researchers claiming there is little evidence that (it) works,” Monto said in a comment about the findings. “Whether the magnitude of (its) benefits outweigh the harms of nausea and vomiting needs careful consideration.”
The final ‘interpretation’ of the study’s findings noted: “Our findings show that oseltamivir in adults with influenza accelerates time to clinical symptom alleviation, reduces risk of lower respiratory tract complications, and admittance to hospital, but increases the occurrence of nausea and vomiting.”
Annual sales of Tamiflu, which the Roche Group has always defended as effective, had hit almost $3 billion in 2009, mainly due to its use during the pandemic. They have since declined, although a bad flu season in the US had pushed sales up in the last quarter of 2014. Headquartered in Basel, Switzerland, Roche is one of the world’s prominent research-focussed healthcare groups in the fields of pharmaceuticals and diagnostics. Roche is a self-declared world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in biotechnology giants Genentech and Chugai.
The British Medical Journal, too, has recognised that Roche’s Tamiflu won’t stop flu as there is no evidence to support its efficacy.
According to Dr Mira Shiva from the New Delhi-based All India Drug Action Network, unless one has all the data, one does not know the effectiveness of the drug, but in most cases such data is not made available. “One has to act like a spy and spend considerable time and resources to get unbiased information on drugs, which is not easily made available, resulting in panic,” she says.
With inputs from Varun Bidhuri