Monday, August 17, 2009

The Business of Swine Flu

By Jennifer O’Connell

“Joe brought it home from the office,” the lady in the voiceover cheerily explains, as a moustachioed Joe hangs his coat in the hall, and plants a kiss on his wife’s eagerly proffered lips.

“He gave it to Betty,” the sing-song voice goes on, as Joe hugs a child in plaits on the stairwell, “and to one of his kids. And Betty’s mother.”

Joe is on the porch now, seeing Betty’s mother off in a taxi with another of his toxic kisses.

“Betty’s mother went back to California the next day. On her way to the airport, she gave it to a cab driver, a ticket agent, and one of the charming stewardesses. Joe’s kids gave it to some other kids. And Mrs Merrill got it, and gave it to her husband. In California, Betty’s mother gave it to her best friend Dotty.”

The voiceover artist is starting to sound a bit panicked now.

“But Dotty had a heart condition. And she died. But before she died, Dotty gave it to her girlfriend, the pizza boy, and the vet when she went to pick up her Chihuahua…”

If you’d been living in America in the autumn of 1976, chances are you’d have been able to recite the woes of Joe and Betty off by heart. Along with your foilpack TV dinner of mystery meat, grey-looking veg and powdered mash, and The Brady Bunch or Walter Cronkite on the news, this ad would have been part of your evening’s entertainment.

The ‘it’ responsible for felling all these pizza boys and air stewardesses is, of course, swine flu.

All over the country, millions of Joes, Bettys and Mrs Merrills watched the ad, and obediently rolled up their sleeves to allow themselves to be injected with a dose of what would later turn out to be an untested vaccine, X53-a. Forty six million, to be precise.

In the end, the ad was about as accurate as it was subtle: swine flu never spread beyond the Fort Dix army base where it was originally detected. Only one person died – from the virus, that is.

But 25 people died from the vaccine.

A further four thousand took cases against the government, amounting to $3.5 billion in damages, for side effects they claimed to have suffered as a result of inoculation – two thirds of them relating to neurological damage. Five hundred people contracted Guillain-Barre[AC] syndrome, a neuromuscular disorder that can cause temporary or permanent paralysis, as a direct result of the inoculation.

The single death caused by the virus was that of a soldier in Fort Dix, New Jersey who had been in bed with respiratory problems, but was forced out in the bitter cold of a January night to take part in a hike with his regiment.

Thirteen of his fellow recruits also came down with swine flu by early February and recovered; 500 soldiers showed antibodies which suggested they had come into contact with the virus and fought it off without ever getting sick.

By the time millions of Americans began lining up for the vaccine on October 1 1976, there had not been a single confirmed case of swine flu anywhere outside of Fort Dix, and no case anywhere since February.

Now, 33 years on, the H1N1 strain of the influenza virus is back, and this time the threat to public health seems real.

Millions of people are ill with it. An estimated 800 have died. Nowhere is safe from the virus, which has spread to every country in the world.

Once again, we are being told that a still-to-be-developed vaccine, along with some anti-viral drugs, will be a key part of our armoury in the fight against it.

There probably won’t be time to fully test the vaccine before they give it to us, health officials admit, but it will – we are assured - be safe. There will be no repetition of the mistakes of 1976.

The trouble is that we still really don’t know what went wrong with X53-a.

Several studies have been undertaken since 1976 to examine the link between flu vaccination and Guillain Barre[AC] syndrome (GBS). Some have found no risk; others found that the flu shot increased the risk of developed GBS by anywhere between 45 and 70 per cent.

But most agreed that if there was an increased risk, it was so low as to be barely detectable in the general population – until, of course, the general population turns out in force to roll up its sleeves.

You would imagine that the debacle that eventually brought down Gerald Ford’s presidency would make everyone – governments, public health officials, pharmaceuticals companies cautious.

But the reality is that there may not be time for caution. There’s far too much at stake – and not only people’s lives.

Don’t expect pharmaceuticals companies to declare this from their rooftops, but many of them have banked for years on a pandemic just such as this one.

Experts expect new flu strains to emerge, on average, once a decade – in fact, it was this rationale that contributed to the rushed and ultimately unwise decision to vaccinate the entire American population in 1976.

The World Health Organisation (WHO) has been shouting itself hoarse for the past few years with warnings of an ‘overdue’ pandemic, but likely candidates such as SARS and avian flu failed to live up to the hype.

Since 2006, pharmaceuticals companies have been stockpiling their resources in the fight against possible future outbreaks of H5NI, H7NI and H9N2. H1N1 appears to have taken them rather by surprise.

But that’s the thing about the flu. It is, as the official report into the 1976 debacle so neatly puts it, a “slippery” little germ.

The experts have issued dire warnings about the possibility of the virus mutating, but the reality is, the influenza virus is constantly changing. And as the report on the 1976 scandal states: “As for severity, the specialists are almost wholly in the dark. Nothing is sure, not even the reasons why 1918 was the worst flu of all.”

So this time around, those responsible for protecting public health are leaving nothing to chance.

The WHO is warning that one in three of the world’s population “could ultimately be affected” by the virus. The pandemic “could cost” three trillion dollars.

The US Center for Disease Control, which masterminded the disastrous 1976 vaccination campaign, claims that hundreds of thousands of Americans “could die” over the next two years if the vaccine and other control measures for the new H1N1 influenza are not effective, and, at the pandemic's peak, as much as 40 percent of the workforce “could be affected”. Estimates from the Dept of Health here are more conservative: one million people, or 25 per cent of the population, “could” get swine flu.

After the tragic deaths of two pregnant women with swine flu, the warnings reached hysterical levels. Women “should” delay getting pregnant, according to the British National Childbirth Trust. Pregnant women “should avoid going out”, or they should go out “carefully” the British health secretary intoned.

All these coulds, woulds, shoulds, mights and maybes. Yet, amidst all the speculation and scare-mongering, what we do now for sure is that, for most people, this is a very mild illness, that a few days in bed and a dose of Paracetamol should be able to sort.

Not that that makes for very exciting headlines or go a long way to justifying the WHO’s budget.

Public officials have an obligation not to scare people, drive them to needless expense, or encourage them to take drugs they may not need. But in every health scare, there are myriad vested interest competing with the concern for public interest: media-hungry doctors and researchers anxious to secure funding; public health officials keen to justify their budgets; pharmaceuticals companies intent on boosting their bottom lines.

The race to get the first vaccine to market is not even in its final stages, but the reality is that we are already in the throes of what one analyst calls ‘the swine flu gold rush’.

The investment bank JP Morgan reported recently that governments have ordered drugs centred around swine flu valued at over €3 billion ($4.3 billion) - a figure that, the Financial Times newspaper estimates, could rise another €1.8 billion ($2.6 billion) this year.

The announcement sparked a flurry of speculation on share-tipping blogs and investment advice sites about the next companies in line to benefit from the pandemic. These sites have been abuzz since April with ghoulish reports of the latest figures from the WHO about the spread of the virus.

The London-based pharmaceuticals firm, Astra Zeneca, for instance, looks set to finally make good on its so-far dubious investment in the company that makes FluMist, a flu vaccine which is administered by nasal spray, and which – until the arrival of swine flu - remained very much a niche product.

Analysts are expecting a boost in sales from GlaxoSmithKline, which has sold 150 million doses of its soon-to-be-developed swine flu vaccine – sales of the vaccine and the antiviral Relenza are expected to reach €3.5 billion by January. Other pharmaceuticals in line to reap profits from the pandemic include Roche, Sanofi-Aventis, Novartis and Baxter.

The news last week that Tamiflu is being prescribed in Britain at roughly seven times the rate of infection there may have dismayed public health officials, but it’s very good news for Roche, which recently reported a 200 per cent sales increase on the same period last year.

Its chief competitor, the inhaled antiviral Relenza, which is manufactured by GlaxoSmithKline, has enjoyed a 2,000 per cent boost is sales.

Even those not in the front line of drug production are benefiting from the swine flu boom: the manufacturer of Carex hand gel announced recently that its antibacterial cleansing gel is flying off the shelves, with sales up by 200 per cent.

Pharmaceuticals company Reckitt has enjoyed an 8 per cent sales boost across all its products, an increase that it admits is mainly driven by the strong performance of such products as Dettol, Lemsip and Nurofen.

The British supermarket chain Asda announced recently that sales of the paracetamol syrup Calpol are up by 40 per cent; thermometers are up 200 per cent; and hot water bottles are selling 225 per cent faster than this time last year.

There is no escaping it: this pandemic is big business.

When the World Health Organisation raised the status to ‘pandemic level 6’ (having to change the definition of a level 6 pandemic in order to do so), it did more than just send the pharamaceuticals companies into overdrive: it effectively put the world on a war footing against swine flu.

Historically wars have been no place for whingers - especially not those raising concerns about public safety and comfort, or banging on about drug side effects and untested vaccines.

But there are certain questions that beg to be asked. Such as, are you really sure you want to take that Tamiflu?

Tamiflu, or oselatmivir, is the antiviral that has been doled out like Smarties in GP surgeries in Britain since swine flu first started showing up there – at least until last week, when a study published in the British Medical Journal revealed that it may not be that effective in preventing complications in the very young.

In any climate other than one of all-out hysteria, it’s hard to imagine anyone taking their chances with some of the side effects listed on the patient information leaflet - let alone inflicting them on their already-unwell children. Yet that’s what parents all across Britain seem to have been doing at the first hint of a temperature or stuffy nose.

“Mild to moderate” nausea and vomiting are the most common side effect, affecting up to forty per cent of those with side-effects, in one recent study. Insomnia and nightmares are another. According to the leaflet, children and adolescents “may be at an increased risk of self injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior”.

Figures from Japan suggest that a small proportion of those who took it during the avian flu scare suffered psychiatric episodes and may have been at increased risk of suicide, though the link to Tamiflu is not proven. A more recent British study found that one in five children who were given the drug as a preventative reported having a neuropsychiatric side effect, such as poor concentration, inability to think clearly, problems sleeping, and feeling dazed or confused. Another study found that half of the children given it preventatively in April and May in Britain suffered at least one of the listed side effects.

But as of last week, the HSE still regarded the antiviral as ‘appropriate’ for use in children. “Our advice remains that it is appropriate to prescribe anti-virals to children with pre-existing conditions, or in children under the age of five, and more particularly under the age of three,” Dr Kevin Kelleher, the HSE’s head of health protection said.

One of the Oxford researchers, Dr Carl Heneghan, doesn’t agree. He believes it is “inappropriate” to give children Tamiflu or Relenza when they have only a mild form of the illness. “The downside of the harms outweigh the one-day reduction in symptomatic benefits,” he said.

The alternative, zanamivir - which goes under the tradename Relenza - is not much better. Its impressively varied list of side effects includes cough; diarrhea; dizziness; headache; nausea; sinus inflammation; sore throat; stuffy nose; vomiting; abnormal behaviour; confusion; hallucinations; irregular heartbeat; mood or mental changes; myalgia; lymphopenia and neutropenia; seizures; shortness of breath; trouble swallowing; malaise; fatigue; facial edema; abdominal pain; wheezing; asthma or exacerbation of asthma; bronchospasm; respiratory arrest; dyspnea; lung tightness; and/or decline in lung function – and lots more, from seizures to serious skin rashes to cardiac arrhythmia.

In trials, one in 13 patients with asthma taking the drug suffered an episode of bronchospasm. More worryingly, the safety leaflet includes the information that: “abnormal behavior and delirium leading to injury, with fatal outcomes in some cases, with the use of zanamivir in influenza patients have been reported.”

The widespread prescription of these drugs to anyone with the merest hint of what is, in most cases, a mild dose of flu anyway, begins to look like giving a lobotomy to cure a headache – especially when you consider that anti-virals don’t claim to do much more than reduce the duration of the illness by a day.

The only surprise in the advice from the Oxford University researchers last week is that it took so long for someone to say it.

In common with the pandemic itself, much of what we can say about the flu vaccine is, at this point, largely speculation.

But some things are clear. The vaccine – when, and if, it arrives - will not be a panacea. For a start, traditional flu shots have been shown to be largely ineffective in protecting the under-2s – and according to the WHO, it is the very young who are most at risk in the current pandemic. Overall, the flu vaccine is effective only about 75 per cent of the time.

The side effects of the regular flu shot are similar to those of most childhood vaccinations – a short-lived fever, aches, chills and soreness at the site of the injection.

The difficulty gathering data on other, rarer potential complications has already been highlighted: until large numbers of people start getting the shot, we just won’t know.

And in the case of the shot specifically engineered to combat the H1N1 strain of flu, we are really administering shots in the dark.

The European Medicines Agency (EMA), the drug regulatory body for the EU, is accelerating the approval process for the vaccine, so that member states can start using it as soon as it is cleared. ‘Accelerating the approvals process’ is code for bypassing large scale human trials. Tests will be carried out instead on an avian flu vaccine, on the premise that the basic ingredients are the same. The most vulnerable groups, such as pregnant women and young children, will be given it first.

If this strikes you as risky, you’re right, it is. It certainly seems to strike the WHO as risky.

Dr Keiji Fukuda, the organisation’s flu chief, said recently that: “There are certain areas where you can make economies, perhaps, but certain areas where you simply do not try to make any economies.”

But it’s not entirely true to say that caution has been pushed aside in the race to develop the vaccine.

Just as they did in 1976, the US Secretary of Health and Human Services, Kathleen Sebelius, recently signed a deal offering vaccine makers and federal officials immunity from any lawsuits that might arise if the vaccine goes wrong. Money is already being put aside for a government compensation fund, just in case.

As the hysteria and scaremongering reaches fever pitch over the coming months, and the race to profit from the gold rush appears to keep steamrolling over the public interest, it might be worth bearing in mind the words of one mother of a British swine flu patient.

Having decided not to give her son his prescribed dose of Tamiflu, she posted about her experiences on the parenting website, Mumsnet, last week.

“I think along with under-diagnosing, i.e. missing other illnesses, they are also over-diagnosing. With such a powerful drug, [giving it to him] could make him a lot worse than he is. My 2 year old has had much worse viruses. I have given him ibuprofen, and his temperature is back down for the first time today. He is happy and playing now. This is the most pathetic flu I have seen.”