What the Tamiflu saga tells us about drug trials and big pharma

We now know the government's Tamiflu stockpile wouldn't have done us much good in the event of a flu epidemic. But the secrecy surrounding clinical trials means there's a lot we don't know about other medicines we take

• 
• • Ben Goldacre
  • The Guardian, Thursday 10 April 2014

Tamiflu capsules. Photograph: Per Lindgren/REX

Today we found out that Tamiflu doesn't work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia.

That is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients. It is simple bad luck for Roche that Tamiflu became, arbitrarily, the poster child for the missing-data story.

And it is a great poster child. The battle over Tamiflu perfectly illustrates the need for full transparency around clinical trials, the importance of access to obscure documentation, and the failure of the regulatory system. Crucially, it is also an illustration of how science, at its best, is built on transparency and openness to criticism, because the saga of the Cochrane Tamiflu review began with a simple online comment.

In 2009, there was widespread concern about a new flu pandemic, and billions were being spent stockpiling Tamiflu around the world. Because of this, the UK and Australian governments specifically asked the Cochrane Collaboration to update its earlier reviews on the drug. Cochrane reviews are the gold-standard in medicine: they summarise all the data on a given treatment, and they are in a constant review cycle, because evidence changes over time as new trials are published. This should have been a pretty everyday piece of work: the previous review, in 2008, had found some evidence that Tamiflu does, indeed, reduce the rate of complications such as pneumonia. But then a Japanese paediatrician called Keiji Hayashi left a comment that would trigger a revolution in our understanding of how evidence-based medicine should work. This wasn't in a publication, or even a letter: it was a simple online comment, posted informally underneath the Tamiflu review on the Cochrane website, almost like a blog comment.

 The UK government spent £0.5bn stockpiling Tamiflu. Photograph: Hanodut/EPA

Cochrane had summarised the data from all the trials, explained Hayashi, but its positive conclusion was driven by data from just one of the papers it cited: an industry-funded summary of 10 previous trials, led by an author called Kaiser. From these 10 trials, only two had ever been published in the scientific literature. For the remaining eight, the only available information on the methods used came from the brief summary in this secondary source, created by industry. That's not reliable enough.

This is science at its best. The Cochrane review is readily accessible online; it explains transparently the methods by which it looked for trials, and then analysed them, so any informed reader can pull the review apart, and understand where the conclusions came from. Cochrane provides an easy way for readers to raise criticisms. And, crucially, these criticisms did not fall on deaf ears. Dr Tom Jefferson is the head of the Cochrane respiratory group, and the lead author on the 2008 review. He realised immediately that he had made a mistake in blindly trusting the Kaiser data. He said so, without defensiveness, and then set about getting the information needed.

First, the Cochrane researchers wrote to the authors of the Kaiser paper. By reply, they were told that this team no longer had the files: they should contact Roche. Here theproblems began. Roche said it would hand over some information, but the Cochrane reviewers would need to sign a confidentiality agreement. This was tricky: Cochrane reviews are built around showing their working, but Roche's proposed contract would require them to keep the information behind their reasoning secret from readers. More than this, the contract said they were not allowed to discuss the terms of their secrecy agreement, or publicly acknowledge that it even existed. Roche was demanding a secret contract, with secret terms, requiring secrecy about the methods and results of trials, in a discussion about the safety and efficacy of a drug that has been taken by hundreds of thousands of people around the world, and on which governments had spent billions. Roche's demand, worryingly, is not unusual. At this point, many in medicine would either acquiesce, or give up. Jefferson asked Roche for clarification about why the contract was necessary. He never received a reply.

Then, in October 2009, the company changed tack. It would like to hand over the data, it explained, but another academic review on Tamiflu was being conducted elsewhere. Roche had given this other group the study reports, so Cochrane couldn't have them. This was a non-sequitur: there is no reason why many groups should not all work on the same question. In fact, since replication is the cornerstone of good science, this would be actively desirable.

Then, one week later, unannounced, Roche sent seven documents, each around a dozen pages long. These contained excerpts of internal company documents on each of the clinical trials in the Kaiser meta-analysis. It was a start, but nothing like the information Cochrane needed to assess the benefits, or the rate of adverse events, or fully to understand the design of the trials.

 Packets of Tamiflu in a drawer at a German pharmacy. Photograph: Wolfgang Rattay/Reuters

At the same time, it was rapidly becoming clear that there were odd inconsistencies in the information on this drug. Crucially, different organisations around the world had drawn vastly different conclusions about its effectiveness. The US Food and Drug Administration (FDA) said it gave no benefits on complications such as pneumonia, while the US Centers for Disease Control and Prevention said it did. The Japanese regulator made no claim for complications, but the European Medicines Agency (EMA) said there was a benefit. There are only two explanations for this, and both can only be resolved by full transparency. Either these organisations saw different data, in which case we need to build a collective list, add up all the trials, and work out the effects of the drug overall. Or this is a close call, and there is reasonable disagreement on how to interpret the trials, in which case we need full access to their methods and results, for an informed public debate in the medical academic community.

This is particularly important, since there can often be shortcomings in the design of a clinical trial, which mean it is no longer a fair test of which treatment is best. We now know this was the case in many of the Tamiflu trials, where, for example, participants were sometimes very unrepresentative of real-world patients. Similarly, in trials described as "double blinded" – where neither doctor nor patient should be able to tell whether they're getting a placebo or the real drug – the active and placebo pills were different colours. Even more oddly, in almost all Tamiflu trials, it seems a diagnosis of pneumonia was measured by patients' self-reporting: many researchers would have expected a clear diagnostic algorithm, perhaps a chest x-ray, at least.

Since the Cochrane team were still being denied the information needed to spot these flaws, they decided to exclude all this data from their analysis, leaving the review in limbo. It was published in December 2009, with a note explaining their reasoning, and a small flurry of activity followed. Roche posted their brief excerpts online, and committed to make full study reports available. For four years, they then failed to do so.

During this period, the global medical academic community began to realise that the brief, published academic papers on trials – which we have relied on for many years – can be incomplete, and even misleading. Much more detail is available in a clinical study report (CSR), the intermediate document that stands between the raw data and a journal article: the precise plan for analysing the data statistically, detailed descriptions of adverse events, and so on.

By 2009, Roche had shared just small portions of the CSRs, but even this was enough to see there were problems. For example, looking at the two papers out of 10 in the Kaiser review that were published, one said: "There were no drug-related serious adverse events", and the other doesn't mention adverse events. But in the CSR documents shared on these same two studies, 10 serious adverse events were listed, of which three are classified as being possibly related to Tamiflu.

 Roche HQ in Basel, Switzerland. Photograph: Bloomberg/Bloomberg via Getty Images

By setting out all the known trials side by side, the researchers were able to identify peculiar discrepancies: for example, the largest "phase three" trial – one of the large trials that are done to get a drug on to the market – was never published, and is rarely mentioned in regulatory documents.

The chase continued, and it exemplifies the attitude of industry towards transparency. In June 2010, Roche told Cochrane it was sorry, but it had thought they already had what they wanted. In July, it announced that it was worried about patient confidentiality. By now, Roche had been refusing to publish the study reports for a year. Suddenly, it began to raise odd personal concerns. It claimed that some Cochrane researchers had made untrue statements about the drug, and about the company, but refused to say who, or what, or where. "Certain members of Cochrane Group," it said, "are unlikely to approach the review with the independence that is both necessary and justified." This is hard to credit, but even if true, it should be irrelevant: bad science is often published, and is shot down in public, in academic journals, by people with good arguments. This is how science works. No company or researcher should be allowed to choose who has access to trial data. Still Roche refused to hand over the study reports.

Then Roche complained that the Cochrane reviewers had begun to copy in journalists, including me, on their emails when responding to Roche staff. At the same time, the company was raising the broken arguments that are eerily familiar to anyone who has followed the campaign for greater trials transparency. Key among these was one that cuts to the core of the culture war between evidence-based medicine, and the older "eminence-based medicine" that we are supposed to have left behind. It is simply not the job of academics to make these decisions about benefit and risk, said Roche, it is the job of regulators.

This argument fails on two fronts. First, as with many other drugs, it now seems that not even the regulators had seen all the information on all the trials. But more than that, regulators miss things. Many of the most notable problems with medicines over the past few years – with the arthritis drug Vioxx; with the diabetes drug rosiglitazone, marketed as Avandia; and with the evidence base for Tamiflu – weren't spotted primarily by regulators, but rather by independent doctors and academics. Regulators don't miss things because they are corrupt, or incompetent. They miss things because detecting signals of risk and benefit in reviews of clinical trials is a difficult business and so, like all difficult questions in science, it benefits from having many eyes on the problem.

While the battle for access to Tamiflu trials has gone on, the world of medicine has begun to shift, albeit at a painful pace, with the European Ombudsman and several British select committees joining the push for transparency. The AllTrials campaign, which I co-founded last year, now has the support of almost all medical and academic professional bodies in the UK, and many more worldwide, as well as more than 100 patient groups, and the drug company GSK. We have seen new codes of conduct, and European legislation, proposing improvements in access: all riddled with loopholes, but improvements nonetheless. Crucially, withholding data has become a headline issue, and much less defensible.

Last year, in the context of this wider shift, under ceaseless questions from Cochrane and the British Medical Journal, after half a decade, Roche finally gave Cochrane the information it needed.

So does Tamiflu work? From the Cochrane analysis – fully public – Tamiflu does not reduce the number of hospitalisations. There wasn't enough data to see if it reduces the number of deaths. It does reduce the number of self-reported, unverified cases of pneumonia, but when you look at the five trials with a detailed diagnostic form for pneumonia, there is no significant benefit. It might help prevent flu symptoms, but not asymptomatic spread, and the evidence here is mixed. It will take a few hours off the duration of your flu symptoms. But all this comes at a significant cost of side-effects. Since percentages are hard to visualise, we can make those numbers more tangible by taking the figures from the Cochrane review, and applying them. For example, if a million people take Tamiflu in a pandemic, 45,000 will experience vomiting, 31,000 will experience headache and 11,000 will have psychiatric side-effects. Remember, though, that those figures all assume we are only giving Tamiflu to a million people: if things kick off, we have stockpiled enough for 80% of the population. That's quite a lot of vomit.

Roche has issued a press release saying it contests these conclusions, but giving no reasons: so now we can finally let science begin. It can shoot down the details of the Cochrane review – I hope it will – and we will edge towards the truth. This is what science looks like. Roche also denies being dragged to transparency, and says it simply didn't know how to respond to Cochrane. This, again, speaks to the pace of change. I have no idea why it was withholding information: but I rather suspect it was simply because that's what people have always done, and sharing it was a hassle, requiring new norms to be developed. That's reassuring and depressing at the same time.

Should we have spent half a billion on this drug? That's a tricky question. If you picture yourself in a bunker, watching a catastrophic pandemic unfold, confronting the end of human civilisation, you could probably persuade yourself that Tamiflu might be worth buying anyway, even knowing the risks and benefits. But that final clause is the key. We often choose to use treatments in medicine, knowing that they have limited benefit, and significant side-effects: but we make an informed decision, balancing the risks and benefits for ourselves.

And in any case, that £500m is the tip of the iceberg. Tamiflu is a side show, the one place where a single team of dogged academics said "enough" and the company caved in. But the results of clinical trials are still being routinely and legally withheld on the medicines we use today and nothing about a final answer on Tamiflu will help plug this gaping hole.

 Star anise provides the principal component of Tamiflu. Photograph: Adrian Bradshaw/EPA

More importantly, for all that there is progress, so far we have only sentiment, and half measures. None of the changes to European legislation or codes of conduct get us access to the information we need, because they all refer only to new trials, so they share a loophole that excludes – remarkably – all the trials on all the medicines we use today, and will continue to use for decades. To take one concrete and topical example: they wouldn't have made a blind bit of difference on Tamiflu. We have seen voluntary pledges for greater transparency from many individual companies – Johnson & Johnson, Roche,GSK, now Roche, and more – which are welcome, but similar promises have been given before, and then reversed a few years later.

This is a pivotal moment in the history of medicine. Trials transparency is finally on the agenda, and this may be our only opportunity to fix it in a decade. We cannot make informed decisions about which treatment is best while information about clinical trials is routinely and legally withheld from doctors, researchers, and patients. Anyone who stands in the way of transparency is exposing patients to avoidable harm. We need regulators, legislators, and professional bodies to demand full transparency. We need clear audit on what information is missing, and who is withholding it.

Finally, more than anything – because culture shift will be as powerful as legislation – we need to do something even more difficult. We need to praise, encourage, and support the companies and individuals who are beginning to do the right thing. This now includes Roche. And so, paradoxically, after everything you have read above, with the outrage fresh in your mind, on the day when it feels harder than any other, I hope you will join me in saying: Bravo, Roche. Now let's do better.

How have these corporations colonised our public life?

Our politicians have delegated power to global giants engineering a world of conformity and consumerism

• 
• • George Monbiot
  • The Guardian, Tuesday 8 April 2014

One of Unilever's ‘real women' series of advertisements for Dove. Photograph: PA

How do you engineer a bland, depoliticised world, a consensus built around consumption and endless growth, a dream world of materialism and debt and atomisation, in which all relations can be prefixed with a dollar sign, in which we cease to fight for change? You delegate your powers to companies whose profits depend on this model.

Power is shifting: to places in which we have no voice or vote. Domestic policies are forged by special advisers and spin doctors, by panels and advisory committees stuffed with lobbyists. The self-hating state withdraws its own authority to regulate and direct. Simultaneously, the democratic vacuum at the heart of global governance is being filled, without anything resembling consent, by international bureaucrats and corporate executives. The NGOs permitted – often as an afterthought – to join them intelligibly represent neither civil society nor electorates. (And please spare me that guff about consumer democracy or shareholder democracy: in both cases some people have more votes than others, and those with the most votes are the least inclined to press for change.)

To me, the giant consumer goods company Unilever, with which I clashed over the issue of palm oil a few days ago, symbolises these shifting relationships. I can think of no entity that has done more to blur the lines between the role of the private sector and the role of the public sector. If you blotted out its name while reading its web pages, you could mistake it for an agency of the United Nations.

It seems to have representation almost everywhere. Its people inhabit (to name a few) the British government's Ecosystem Markets Task Force and Scientific Advisory Committee on Nutrition, the International Fund for Agricultural Development, the G8'sNew Alliance for Food Security and Nutrition, the World Food Programme, the Global Green Growth Forum, the UN's Scaling Up Nutrition programme, its Sustainable Development Solutions Network, Global Compact and the UN High Level Panel on global development.

Sometimes Unilever uses this power well. Its efforts to reduce its own use of energy and water and its production of waste, and to project these changes beyond its own walls,look credible and impressive. Sometimes its initiatives look to me like self-serving bullshit.

Its "Dove self-esteem project", for instance, claims to be "helping millions of young people to improve their self-esteem through educational programmes". One of its educational videos maintains that beauty "couldn't be more critical to your happiness", which is surely the belief that trashes young people's self-esteem in the first place. But of course you can recover it by plastering yourself with Dove-branded gloop: Unilever reports that 82% of women in Canada who are aware of its project "would be more likely to purchase Dove".

Sometimes it seems to play both ends of the game. For instance, it says it is reducing the amount of salt and fat and sugar in its processed foods. But it also hosted and chaired, before the last election, the Conservative party's public health commission, which was seen by health campaigners as an excuse for avoiding effective action on obesity, poor diets and alcohol abuse. This body helped to purge government policy of such threats as further advertising restrictions and the compulsory traffic-light labelling of sugar, salt and fat.

The commission then produced a "responsibility deal" between government and business, on the organising board of which Unilever still sits. Under this deal, the usual relationship between lobbyists and government is reversed. The corporations draft government policy, which is then sent to civil servants for comment. Regulation is replaced by voluntarism. The Guardian has named Unilever as one of the companies that refused to sign the deal's voluntary pledge on calorie reduction.

This is not to suggest that everything these panels and alliances and boards and forums propose is damaging. But as the development writer Lou Pingeot points out, their analysis of the world's problems is partial and self-serving, casting corporations as the saviours of the world's people but never mentioning their role in causing many of the problems (such as financial crisis, land-grabbing, tax loss, obesity, malnutrition, climate change, habitat destruction, poverty, insecurity) they claim to address. Most of their proposed solutions either require passivity from governments (poverty will be solved by wealth trickling down through a growing economy) or the creation of a more friendly environment for business.

At best, these corporate-dominated panels are mostly useless: preening sessions in which chief executives exercise messiah complexes. At their worst, they are a means by which global companies reshape politics in their own interests, universalising – in the name of conquering want and exploitation – their exploitative business practices.

Almost every political agent – including some of the NGOs that once opposed them – is in danger of being loved to death by these companies. In February the Guardian signed a seven-figure deal with Unilever, which, the publisher claimed, is "centred on the shared values of sustainable living and open storytelling". The deal launched an initiative called Guardian Labs, which will help brands find "more engaging ways to tell their story". The Guardian points out that it has guidelines covering such sponsorship deals to ensure editorial independence.

I recognise and regret the fact that all newspapers depend for their survival on corporate money (advertising and sponsorship probably account, in most cases, for about 70% of their income). But this, to me, looks like another step down the primrose path. As the environmental campaigner Peter Gerhardt puts it, companies like Unilever "try to stakeholderise every conflict". By this, I think, he means that they embrace their critics, involving them in a dialogue that is open in the sense that a lobster pot is open, breaking down critical distance and identity until no one knows who they are any more.

Yes, I would prefer that companies were like Unilever rather than Goldman Sachs, Cargill or Exxon, in that it seems to have a keen sense of what a responsible company should do, even if it doesn't always do it. But it would be better still if governments and global bodies stopped delegating their powers to corporations. They do not represent us and they have no right to run our lives.

Letter from a Sri Lankan to an Indian cricket fan

by Abhishek Mukherjee in The Cricket Country

Dear Indian fan:

It had hurt us three years back when we saw those videos from Marine Drive and Connaught Place and Park Street from three years back. We, however, did not vow revenge or anything like that (if the team had, they had not let us know). If you had seen our players tonight, they were never arrogant in their celebrations.

The team did not have time to plot revenge: there was a time in 2011 when they did not get paid for eight months(yes, they had come runners-up in the World Cup despite that). They were offered proper contracts only in July 2012. The next year Sri Lanka Cricket (SLC) had removed the stipulated players’ share from the International Cricket Council (ICC) events (25%), and it was only after Sanath Jayasuriya had stepped in that the players had agreed. They were not given the profit: they were only promised they would be given the same.

  

Can you imagine your men playing under such circumstances? No, I guess.

It did not end there. Jayasuriya did keep his word; when the players demanded 20% of the profit, he had put their proposal forward to SLC. When SLC had announced the fresh set of contracts, the ICC events share was not a part of it.

Take a moment to realise this. Put your men in their shoes. The men have been representing their country in the most high-profile event (and have been turning them into successes; they may not have been winning, but they have not exactly failed either), only to be told by SLC that they would not get a part of the profit from that tournament.

This reminded me of international cricket in the pre-Kerry Packer days when players were often told that if they did not want to play for the side there were plenty who would. Your own CK Nayudu, your first Test captain, had done the same to Vinoo Mankad, you may remember.

Anyway, four days before the tournament, SLC raised the topic to the Executive Committee. The players were announced incentives, but there were no ICC events shares announced for them. When the players insisted on the shares, SLC issued a threat that they would send a second-string side to the tournament. This happened on the day the players left for Bangladesh. Our heroes had left for the tournament without contracts.

You see why we don’t stone their houses the way you did Yuvraj Singh’s today? The reason is simple: they have been stabbed by their own board; we are the only ones backing them. With no assured contract, almost no Indian Premier League (IPL) contract against their names, with our own version of the IPL getting cancelled, the pride and fans are all they have while taking on the best of the world in a country away from home.

That is precisely why we never back out when it comes to supporting them: they have lost one final after the other, but we have never lost hope. Can you believe what you would have done to your men if they had lost four world tournament finals in five years? We had not gone after our players’ blood: instead, we had joked that it was our President’s turning up at the venue midway that had tilted the match West Indies’ way in the 2012 World T20 final.

Do you know something? We have grown up in conditions you have seen in newsreels and have read in newspapers, but have never really (I really hope you do not) had real-life brushes. We have grown up in a country where many of us were not sure of our safe return when we left home in the morning.

“Pressure is a Messerschmitt up your arse,” Keith Miller had said once. He had seen death from close quarters. So had we. Which is why defeats do not mean the end of the world for us. In those dark days of internal turmoil,Arjuna Ranatunga and Aravinda de Silva had kept Sri Lankan cricket alive. The 1996 World Cup had a role more significant in our history than you can imagine.

We fell from that zenith, and rose again; and fell again; in Muttiah Muralitharan we found our greatest cricket hero, in Jayasuriya a murderous marauder, in Lasith Malinga a rebellious freak; and then, in the two men who have quit this version of the sport today, the two icons we were left with.

They have given us a lot, and have got hardly anything back in return. The best we could do for them was to turn up in huge numbers and turn the band on, day in and day out. If they won, we were happy; if they did not, we had to accept it. It was like that in the 1980s. It has been like that in the 2010s as well. Three decades ago we used to lose in the league stages; now we lose the finals.

The fact remained that we had not won anything of note barring the 1996 World Cup. Eighteen years have elapsed since that. This win was long due. They have never given up hope in between: they tried, failed, tried, failed, tried, failed, tried, till they succeeded.

It has been our story all along.

It has been the story of the average Sri Lankan.

It has been the story of the Sri Lankan cricketer.

We may not have the best support, but we dream; and we do not give up when our dreams meet a dead end. We have a team where every man is a Robert the Bruce with no spider to show them the way.

We have not forgotten you, though. You [and Pakistan] had visited us before the 1996 World Cup when Australia and West Indies had refused to. We still owe you that.

Sri Lanka is a beautiful [and of late, rather peaceful] place. Come over for a trip some day. We will discuss all kinds of ICC event finals and have a laugh at how we manage to show up in them every now and then. Till then,

A Sri Lankan fan.

Arundhati Roy explains how corporations run India and why they want Narendra Modi as prime minister

by Charlie Smith on Mar 30, 2014 at 1:51 pm

Indian author Arundhati Roy wants the world to know that her country is under the control of its largest corporations.

"Wealth has been concentrated in fewer and fewer hands," Roy tells the Georgia Straight by phone from New York. "And these few corporations now run the country and, in some ways, run the political parties. They run the media."

The Delhi-based novelist and nonfiction writer argues that this is having devastating consequences for hundreds of millions of the poorest people in India, not to mention the middle class.

Roy spoke to the Straight in advance of a public lecture on Tuesday (April 1) at 8 p.m. at St. Andrew's–Wesley United Church at the corner of Burrard and Nelson streets. She says it will be her first visit to Vancouver.

In recent years, she has researched how the richest Indian corporations—such as Reliance, Tata, Essar, and Infosys—are employing similar tactics as those of the U.S.-based Rockefeller and Ford foundations. 

She points out that the Rockefeller and Ford foundations have worked closely in the past with the State Department and Central Intelligence Agency to further U.S. government and corporate objectives. 

Now, she maintains that Indian companies are distributing money through charitable foundations as a means of controlling the public agenda through what she calls "perception management".

This includes channelling funds to nongovernmental organizations, film and literary festivals, and universities.

She acknowledges that the Tata Group has been doing this for decades, but says that more recently, other large corporations have begun copying this approach.

Private money replaces public funding

According to her, the overall objective is to blunt criticism of neoliberal policies that promote inequality.

"Slowly, they decide the curriculum," Roy maintains. "They control the public imagination. As public money gets pulled out of health care and education and all of this, NGOs funded by these major financial corporations and other kinds of financial instruments move in, doing the work that missionaries used to do during colonialism—giving the impression of being charitable organizations, but actually preparing the world for the free markets of corporate capital."

She was awarded the Booker Prize in 1997 for The God of Small Things. Since then, she has gone on to become one of India's leading social critics, railing against mining and power projects that displace the poor.

She's also written about poverty-stricken villagers in the Naxalite movement who are taking up arms across several Indian states to defend their traditional way of life.

"I'm a great admirer of the wisdom and the courage that people in the resistance movement show," she says. "And they are where my own understanding comes from."

One of her greatest concerns is how foundation-funded NGOs "defuse people's movements and...vacuum political anger and send them down a blind alley".

"It's very important to keep the oppressed divided," she says. "That's the whole colonial game, and it's very easy in India because of the diversity."

Roy writes a book on capitalism

In 2010, there was an attempt to lay a charge of sedition against her after she suggested that Kashmir is not integral to India's existence. This northern state has been at the centre of a long-running territorial dispute between India and Pakistan.

"There's supposed to be some police inquiry, which hasn't really happened," Roy tells the Straight. "That's how it is in India. They...hope that the idea of it hanging over your head is going to work its magic, and you're going to be more cautious."

Clearly, it's had little effect in silencing her. In her upcoming new book Capitalism: A Ghost Story, Roy explores how the 100 richest people in India ended up controlling a quarter of the country's gross-domestic product.

The book is inspired by a lengthy 2012 article with the same title, which appeared in India's Outlook magazine.

In the essay, she wrote that the "ghosts" are the 250,000 debt-ridden farmers who've committed suicide, as well as "800 million who have been impoverished and dispossessed to make way for us". Many live on less than 40 Canadian cents per day.

"In India, the 300 million of us who belong to the post-IMF 'reforms' middle class—the market—live side by side with spirits of the nether world, the poltergeists of dead rivers, dry wells, bald mountains and denuded forests," Roy wrote.

The essay examined how foundations rein in Indian feminist organizations, nourish right-wing think tanks, and co-opt scholars from the community of Dalits, often referred to in the West as the "untouchables".

For example, she pointed out that the Reliance Group's Observer Research Foundation has a stated goal of achieving consensus in favour of economic reforms.

Roy noted that the ORF promotes "strategies to counter nuclear, biological and chemical threats". She also revealed that the ORF's partners include weapons makers Raytheon and Lockheed Martin.

Anna Hazare called a corporate mascot

In her interview with the Straight, Roy claims that the high-profile India Against Corruption campaign is another example of corporate meddling.

According to Roy, the movement's leader, Anna Hazare, serves as a front for international capital to gain greater access to India's resources by clearing away any local obstacles.

With his white cap and traditional white Indian attire, Hazare has received global acclaim by acting as a modern-day Mahatma Gandhi, but Roy characterizes both of them as "deeply disturbing". She also describes Hazare as a "sort of mascot" to his corporate backers.

In her view, "transparency" and "rule of law" are code words for allowing corporations to supplant "local crony capital". This can be accomplished by passing laws that advance corporate interests.

She says it's not surprising that the most influential Indian capitalists would want to shift public attention to political corruption just as average Indians were beginning to panic over the slowing Indian economy. In fact, Roy adds, this panic turned into rage as the middle class began to realize that "galloping economic growth has frozen".

"For the first time, the middle classes were looking at corporations and realizing that they were a source of incredible corruption, whereas earlier, there was this adoration of them," she says. "Just then, the India Against Corruption movement started. And the spotlight turned right back onto the favourite punching bag—the politicians—and the corporations and the corporate media and everyone else jumped onto this, and gave them 24-hour coverage."

Her essay in Outlook pointed out that Hazare's high-profile allies, Arvind Kerjiwal and Kiran Bedi, both operate NGOs funded by U.S. foundations.

"Unlike the Occupy Wall Street movement in the US, the Hazare movement did not breathe a word against privatisation, corporate power or economic 'reforms'," she wrote in Outlook.

Narendra Modi seen as right-wing saviour

Meanwhile, Roy tells the Straight that corporate India is backing Narendra Modi as the country's next prime minister because the ruling Congress party hasn't been sufficiently ruthless against the growing resistance movement.

"I think the coming elections are all about who is going to crank up the military assault on troublesome people," she predicts.

In several states, armed rebels have prevented massive mining and infrastructure projects that would have displaced massive numbers of people.

Many of these industrial developments were the subject of memoranda of understanding signed in 2004.

Modi, head of the Hindu nationalist BJP coalition, became infamous in 2002 when Muslims were massacred in the Indian state of Gujarat, where he was the chief minister. The official death tollexceeded 1,000, though some say the figures are higher.

Police reportedly stood by as Hindu mobs went on a killing spree. Many years later, a senior police officer alleged that Modi deliberately allowed the slaughter, though Modi has repeatedly denied this.

The atrocities were so appalling that the American government refused to grant Modi a visitor's visa to travel to the United States.

But now, he's a political darling to many in the Indian elite, according to Roy. A Wall Street Journal report recently noted that the United States is prepared to give Modi a visa if he becomes prime minister.

"The corporations are all backing Modi because they think that [Prime Minister] Manmohan [Singh] and the Congress government hasn't shown the nerve it requires to actually send in the army into places like Chhattisgarh and Orissa," she says.

She also labels Modi as a politician who's capable of "mutating", depending on the circumstances.

"From being this openly sort of communal hatred-spewing saccharine person, he then put on the suit of a corporate man, and, you know, is now trying to play the role of the statesmen, which he's not managing to do really," Roy says.

Roy sees parallels between Congress and BJP

India's national politics are dominated by two parties, the Congress and the BJP.

The Congress maintains a more secular stance and is often favoured by those who want more accommodation for minorities, be they Muslim, Sikh, or Christian. In American terms, the Congress is the equivalent of the Democratic Party.

The BJP is actually a coalition of right-wing parties and more forcefully advances the notion that India is a Hindu nation. It often calls for a harder line against Pakistan. In this regard, the BJP could be seen as the Republicans of India.

But just as left-wing U.S. critics such as Ralph Nader and Noam Chomsky see little difference between the Democrats and Republicans in office, Roy says there is not a great deal distinguishing the Congress from the BJP.

"I've said quite often, the Congress has done by night what the BJP does by day," she declares. "There isn't any real difference in their economic policy."

Whereas senior BJP leaders encouraged wholesale mob violence against Muslims in Gujarat, she notes that Congress leaders played a similar role in attacks on Sikhs in Delhi following the 1984 assassination of then–prime minister Indira Gandhi.

"It was genocidal violence and even today, nobody has been punished," Roy says.

As a result, each party can accuse the other of fomenting communal violence.

In the meantime, there are no serious efforts at reconciliation for the victims.

"The guilty should be punished," she adds. "Everyone knows who they are, but that will not happen. That is the thing about India. You may go to prison for assaulting a woman in a lift or killing one person, but if you are part of a massacre, then the chances of your not being punished are very high."

However, she acknowledges that there is "some difference" in the two major parties' stated idea of India.

The BJP, for example, is "quite open about its belief in the Hindu India...where everybody else lives as, you know, second-class citizens".

"Hindu is also a very big and baggy word," she says to clarify her remark. "We're really talking about an upper-caste Hindu nation. And the Congress states that it has a secular vision, but in the actual playing out of how democracy works, all of them are involved with creating vote banks, setting community against community. Obviously, the BJP is more vicious at that game."

Inequality linked to caste system

The Straight asks why internationally renowned authors such as Salman Rushdie and Vikram Seth or major Indian film stars like Shahrukh Khan or the Bachchan family don't speak forcefully against the level of inequality in India.

"Well, I think we're a country whose elite is capable of an immense amount of self-deception and an immense amount of self-regard," she replies.

Roy maintains that Hinduism's caste system has ingrained the Indian elite to accept the idea of inequality "as some kind of divinely sanctioned thing".

According to her, the rich believe "that people who are from the lower classes don't deserve what those from the upper classes deserve".

Her comments on corporate power echo some of the ideas of Canadian activist and author Naomi Klein.

"Of course, I know Naomi very well," Roy reveals. "I think she's such a fine thinker and of course, she's influenced me."

Roy also expresses admiration for the work of Indian journalist Palagummi Sainath, author of the 1992 classic Everybody Loves a Good Drought: Stories from India's Poorest Districts.

However, she suggests that the concentration of media ownership in India makes it very difficult for most reporters to reveal the extent of corporate control over society.

"In India, if you're a really good journalist, your life is in jeopardy because there is no place for you in a media that's structured like that," Roy says.

On occasions, mobs have shown up outside her home after she's made controversial 

statements in the media.

She says that in those instances, they seemed more interested in performing for the television cameras than in attacking her.

However, she emphasizes that other human-rights activists in India have had their offices trashed by demonstrators, and some have been beaten up or killed for speaking out against injustice.

Roy adds that thousands of political prisoners are locked up in Indian jails for sedition or for violating the Unlawful Activities Prevention Act.

This is one reason why she argues that it's a fallacy to believe that because India holds regular elections, it's a democratic country.

"There isn't a single institution anymore which an ordinary person can approach for justice: not the judiciary, not the local political representative," Roy maintains. "All the institutions have been hollowed out and just the shell has been put back. So democracy and these festivals of elections is when everyone can let off steam and feel that they have some say over their lives."

In the end, she says it's the corporations that fund major parties, which end up doing their bidding.

"We are really owned and run by a few corporations, who can shut India down when they want," Roy says.