A coronavirus vaccine could split America

In the battle between public science and anti-vaxxer sentiment, science is heavily outgunned writes Edward Luce in The FT

It is late October and Donald Trump has a surprise for you. Unlike the traditional pre-election shock — involving war or imminent terrorist attack — this revelation is about hope rather than fear. The “China virus” has been defeated thanks to the ingenuity of America’s president. The US has developed a vaccine that will be available to all citizens by the end of the year. Get online and book your jab.  

It is possible Mr Trump could sway a critical slice of voters with such a declaration. The bigger danger is that he would deepen America’s mistrust of science. A recent poll found that only half of Americans definitely plan to take a coronavirus vaccine. Other polls said that between a quarter and a third of the nation would never get inoculated. 

Whatever the true number, anti-vaccine campaigners are having a great pandemic — as indeed is Covid-19. At least three-quarters of the population would need to be vaccinated to reach herd immunity. 

Infectious diseases thrive on mistrust. It is hard to imagine a better Petri dish than today’s America. Some of the country’s “vaccine hesitancy” is well grounded. Regulators are under tremendous pressure to let big pharma shorten clinical trials. That could lead to mistakes. 

Vaccine nationalism is not just about rich governments pre-ordering as many vials as they can. It is also about winning unimaginably large bragging rights in the race to save the world. Cutting immunological corners could be dangerous to public health. 

Such caution accounts for many of those who would hesitate to be injected. The rest are captured by conspiracy theories. In the battle between public science and anti-vaxxer sentiment, science is heavily outgunned. It faces a rainbow coalition of metastasising folk suspicions on both the left and the right. Public health messages are little match for the memology of social media opponents. 

It is that mix of technological savvy and intellectual derangement that drives today’s politics. Mr Trump did not invent postmodern quackery — though he has endorsed some life-threatening remedies. The irony is that he could fall victim to the mistrust he has stoked.  

Should an effective vaccine loom into view before the US goes to the polls in 95 days, Mr Trump would not be the ideal person to inform the country. The story is as old as cry wolf. Having endorsed the use of disinfectants and hydroxychloroquine, Mr Trump has forfeited any credibility. Validation should come from Anthony Fauci, America’s top infectious-diseases expert, whose trust ratings are almost double those of the president he serves. 

Even then, however, the challenge would only just be starting. There is no cause to doubt the world-beating potential of US scientific research. There are good reasons to suspect the medical establishment’s ability to win over public opinion. 

The modern anti-vaxxer movement began on the left. It is still going strong. It follows the “my body is my temple” philosophy. Corporate science cannot be trusted to put healthy things into our bodies. The tendency for modern parents to award themselves overnight Wikipedia degrees in specialist fields is also to blame. 

Not all of this mistrust is madcap. African Americans have good reason to distrust public health following the postwar Tuskegee experiments in which hundreds were infected with syphilis and left to fester without penicillin. Polls show that more blacks than whites would refuse a coronavirus vaccine. Given their higher likelihood of exposure, such mistrust has tragic potential. 

But rightwing anti-vaxxers have greater momentum. America’s 19th century anti-vaccination movements drew equally from religious paranoia that vaccines were the work of the devil and a more general fear that liberty was under threat. Both strains have resurfaced in QAnon, the virtual cult that believes America is run by a satanic deep state that abuses children. 

It would be hard to invent a more unhinged account of how the world works. Yet Mr Trump has retweeted QAnon-friendly accounts more than 90 times since the pandemic began. Among QAnon’s other theories is that Covid-19 is a Dr Fauci-led hoax to sink Mr Trump’s chances of being re-elected. Science cannot emulate such imaginative forms of storytelling. 

All of which poses a migraine for the silent majority that would happily take the vaccine shots. Their lives are threatened both by a pandemic and by an infodemic. It is a bizarre feature of our times that the first looks easier to solve than the second. 

Don't blame addicts for America's opioid crisis. Here are the real culprits

America’s opioid crisis was caused by rapacious pharma companies, politicians who colluded with them and regulators who approved one opioid pill after another

Chris McGreal in The Guardian



‘Opioids killed more than 33,000 Americans in 2015 and the toll was almost certainly higher last year.’

Of all the people Donald Trump could blame for the opioid epidemic, he chose the victims. After his own commission on the opioid crisis issued an interim report this week, Trump said young people should be told drugs are “No good, really bad for you in every way.”

The president’s exhortation to follow Nancy Reagan’s miserably inadequate advice and Just Say No to drugs is far from useful. The then first lady made not a jot of difference to the crack epidemic in the 1980s. But Trump’s characterisation of the source of the opioid crisis was more disturbing. “The best way to prevent drug addiction and overdose is to prevent people from abusing drugs in the first place,” he said.

That is straight out of the opioid manufacturers’ playbook. Facing a raft of lawsuits and a threat to their profits, pharmaceutical companies are pushing the line that the epidemic stems not from the wholesale prescribing of powerful painkillers - essentially heroin in pill form - but their misuse by some of those who then become addicted.


The amount of opioids prescribed in the US was enough for every American to be medicated 24/7 for three weeks”

In court filings, drug companies are smearing the estimated two million people hooked on their products as criminals to blame for their own addiction. Some of those in its grip break the law by buying drugs on the black market or switch to heroin. But too often that addiction began by following the advice of a doctor who, in turn, was following the drug manufacturers instructions.

Trump made no mention of this or reining in the mass prescribing underpinning the epidemic. Instead he played to the abuse narrative when he painted the crisis as a law and order issue, and criticised Barack Obama for scaling back drug prosecutions and lowering sentences.

But as the president’s own commission noted, this is not an epidemic caused by those caught in its grasp. “We have an enormous problem that is often not beginning on street corners; it is starting in doctor’s offices and hospitals in every state in our nation,” it said.

 ‘This is an almost uniquely American crisis.’

Opioids killed more than 33,000 Americans in 2015 and the toll was almost certainly higher last year. About half of deaths involved prescription painkillers. Most of those who overdose on heroin or a synthetic opiate, such as fentanyl, first become hooked on legal pills. 

This is an almost uniquely American crisis driven in good part by particular American issues from the influence of drug companies over medical policy to a “pill for every ill” culture. Trump’s commission, which called the opioid epidemic “unparalleled”, said the grim reality is that “the amount of opioids prescribed in the US was enough for every American to be medicated around the clock for three weeks”.

The US consumes more than 80% of the global opioid pill production even though it has less than 5% of the world’s population. Over the past 20 years, one federal institution after another lined up behind the drug manufacturers’ false claims of an epidemic of untreated pain in the US. They seem not to have asked why no other country was apparently suffering from such an epidemic or plying opioids to its patients at every opportunity.

With the pharmaceutical lobby’s money keeping Congress on its side, regulations were rewritten to permit physicians to prescribe as many pills as they wanted without censure. Indeed, doctors sometimes found themselves hauled before ethics boards for not supplying enough.


It’s an epidemic because we have a business model for it. Follow the money


Unlike most other countries, the US health system is run as an industry not a service. That gives considerable power to drug manufacturers, medical providers and health insurance companies to influence policy and practices.

Too often, their bottom line is profits not health. Opioid pills are far cheaper and easier than providing other forms of treatment for pain, like physical therapy or psychiatry. As Senator Joe Manchin of West Virginia told the Guardian last year: “It’s an epidemic because we have a business model for it. Follow the money. Look at the amount of pills they shipped in to certain parts of our state. It was a business model.”

But the system also gives a lot of power to patients. People coughing up large amounts of money in insurance premiums and co-pays expect results. They are, after all, more customer than patient. Doctors complain of patients who arrive expecting a pill to resolve medical conditions without taking responsibility for their own health by eating better or exercising more.

In particular, the idea has taken hold, pushed by the pharmaceutical industry, that there is a right to be pain free. Other countries pursue strategies to reduce and manage pain, not raise expectations that it can simply be made to disappear. In all of this, regulators became facilitators. The Food and Drug Administration approved one opioid pill after another.


The Food and Drug Administration approved one opioid pill after another.


As late as 2013, by which time the scale of the epidemic was clear, the FDA permitted a powerful opiate, Zohydro, onto the market over the near unanimous objection of its own review committee. It was clear from the hearing that doctors understood the dangers, but the agency appeared to have put commercial considerations first.

US states long ago woke up to the crisis as morgues filled, social services struggled to cope with children orphaned or taken into care, and the epidemic took an economic toll. Police chiefs and local politicians said it was a social crisis not a law and order problem.

Some state legislatures began to curb mass prescribing. All the while they looked to Washington for leadership. They did not get much from Obama or Congress, although legislation approving $1bn on addiction treatment did pass last year. Instead, it was up to pockets of sanity to push back.

Last year, the then director of the Centers for Disease Control, Tom Frieden, made his mark with guidelines urging doctors not to prescribe opioids as a first step for chronic or routine pain, although even that got political pushback in Congress where the power of the pharmaceutical lobby is not greatly diminished.

There are also signs of a shift in the FDA after it pressured a manufacturer into withdrawing an opioid drug, Opana, that should never have been on sale in the first place. It was initially withdrawn in the 1970s, but the FDA permitted it back on to the market in 2006 after the rules for testing drugs were changed. At the time, many accused the pharmaceutical companies of paying to have them rewritten.

Trump’s opioid commission offered hope that the epidemic would finally get the attention it needs. It made a series of sensible if limited recommendations: more mental health treatment people with a substance abuse disorder and more effective forms of rehab.

Trump finally got around to saying that the epidemic is a national emergency on Thursday after he was criticised for ignoring his own commission’s recommendation to do so. But he reinforced the idea that the victims are to blame with an offhand reference to LSD.

Real leadership is still absent – and that won’t displease the pharmaceutical companies at all.

If you can’t beat Jeremy Corbyn, you’d better try to learn from him

Andrew Rawnsley in The Guardian


Speaking shortly before the re-coronation of Jeremy Corbyn, one Labour MP gloomily remarked of Owen Smith’s failed challenge: “It was always a kamikaze mission.”

Oh no, it has turned out much more desperate than that for Labour’s parliamentarians. Back in July, when the challenge was launched off the back of a no-confidence vote by MPs and mass resignations from the frontbench, few of his colleagues thought Mr Smith could win. The purpose of the exercise, or so they calculated, was not to install a new leader but to take the shine off the incumbent. Mr Smith was designed, and in more than one sense, to be the anti-Momentum candidate. If Mr Corbyn could be run reasonably close, so backers of the challenge hoped, it would diminish the “mandate” that he and his supporters have spent the last 12 months brandishing in the face of Labour MPs.

When the result was announced from the conference stage in Liverpool, it was instantly clear that the reverse has happened. Jeremy Corbyn has not only been reanointed as leader, he won by a larger margin than last year, he won in all three segments of the selectorate and he won on a higher rate of participation. The challenge has not diminished him; it has swollen the size of his congregation. The immediate fear of Labour MPs is that this will now be self-reinforcing. Mr Corbyn will further consolidate his grip on the commanding heights of Labour if centre-left members who have stuck with the party despite all the ugliness of the past year are so demoralised by his victory that they give up and quit.

Examining the entrails of defeat, many who originally backed it now acknowledge that this was the wrong challenge at the wrong time with the wrong candidate. Mr Smith ended up as the anti-Corbyn standard bearer on the grounds that a relative unknown from the soft left – “a clean skin” – had the best chance of getting a hearing from Labour activists. His first handicap was that he spent the beginning of the campaign having to say who he was. He had barely started to introduce himself before a ruthlessly efficient effort by Team Corbyn had already defined him as a former employee of big pharma and a “Trojan horse” for Blairite revanchism. He largely positioned himself in the same ideological zone as the incumbent in the belief that this would be the best way to appeal to Corbynistas. That strategy would have been no more effective had he also put on a fake beard. For this invited and received an understandable response from that constituency: why vote for an imitation when you can re-elect the real thing?

His claims that he would make a more credible and competent leader were undermined by his propensity to gaffe. One hundred and sixty-two of his parliamentary colleagues nominated Mr Smith. The more conventionally minded of us might think that, in a parliamentary democracy, it is quite important for a party leader to command the confidence of his MPs. Yet for those to whom Mr Corbyn is an appealing figure, it is one of his virtues that his parliamentary party are so hostile to him. Being the MPs’ candidate was not an asset for the challenger – it was massive liability. I have talked to a lot of Labour MPs who spent time canvassing members. They universally report that many activists blamed the party’s predicament and Mr Corbyn’s abysmal personal poll ratings not on the leader, but on the mutinous behaviour of Labour parliamentarians. The depiction of the challenge as a “coup” and the framing of the contest as Members v MPs, Grassroots v Westminster was toxic.

So Labour is back to where it was at the beginning of the summer, with a vast chasm between a leader with a mandate from the members and MPs claiming a rival mandate from their voters. With this difference. Those divisions are now more starkly exposed, more deeply entrenched and more poisonously bitter. One MP speaks about “taking bodyguards” to protect him at the conference. Another expresses genuine fear that fist fights – or worse – will break out in Liverpool.

If there can’t be a genuine peace between the two sides, could there at least be some form of truce? In his victory speech, a much crisper and more polished performance than 12 months ago, Mr Corbyn made magnanimous-sounding noises about wiping the slate clean. His campaign manager and shadow chancellor, John McDonnell, tells us that the party can move on from the venom that has flowed over the summer. “What is said on tour, stays on tour.” Even some of Mr Corbyn’s most implacable critics know that it would sound churlish to snipe this weekend and have largely fallen silent for the moment.

Beneath the surface, though, it is already evident that the party is as riven as ever. There will now be a struggle for control of the party machinery at both national and local levels. There is also the question, of importance to the country as well as to the Labour party, of whether it can become at least semi-functional as an opposition to the Tories in parliament. I can find some MPs willing to unresign and return to take on a frontbench role. Some will do so for fear of retribution in their constituencies or for careerist reasons. Some argue that the parliamentary party now has to make at least a show of being co-operative or the membership will carry on blaming the MPs, rather than the leader, when things go wrong. One of this tendency says: “We have to stop being an excuse for his failings.”

Others are prepared to return to the frontbench on the grounds that it is their duty to be a voice for the 9 million people who voted Labour at the last election and to provide an opposition to the Tories. Yet many say they will only do so if the parliamentary party is allowed to elect at least some of the frontbench. That would give them a way of returning on their terms and with at least some shreds of dignity. Mr Corbyn’s circle sound extremely resistant to that. From their point of view, they have good reasons not to accept the demand. They don’t see why he should agree to elections that would surround him with hostiles in his top team.

Nor do they see why he should concede to the demands of the parliamentary party when he has just seen off its attempt to unseat him. The general emollience of his victory speech had a streak of menace when he warned Labour MPs “to respect the democratic choice that has been made”.

With or without shadow cabinet elections, a lot of senior Labour figures will not serve in his team anyway. They say they cannot bite their tongues for long when, as they see it, the Labour party they love is being destroyed. They ask how it is possible to sit on Mr Corbyn’s frontbench when 172 of them have publicly declared him unfit to be leader of the opposition.

One thing they will now have time to ponder on is why their advice was rejected by the party. It might be convenient for moderate Labour MPs to blame the failure of the challenge entirely on the flaws of the challenger, but it would also be wrong. What the last three months have exposed again are fundamental weaknesses on the centre-left. Labour MPs often express dismay at Mr Corbyn’s claims to be building a “social movement” superior to his parliamentary party. They mock it as the politics of protest and a betrayal of Labour’s founding purpose, set out in Clause I of the party constitution, to aim for power. The former frontbencher Tristram Hunt wittily despairs that his party is becoming “the political wing of the Stop the War coalition”. They are right to say that there is a big difference between rousing rallies of the already converted and the harder challenge of moving enough of the wider population into your column to win a general election.

Sound as that analysis might be, you can see why Team Corbyn are not receptive to lectures about electability from critics who can’t win – can’t get anywhere near winning – an election in the Labour party. Comprehensively out-organised by Team Corbyn and their union backers in last year’s contest, the anti-Corbynites vowed to do much better this time. They have developed some infrastructure in the form of the groups Labour Tomorrow and Saving Labour. The latter claims to have signed up 120,000 new members. But the result speaks for itself. Momentum out-recruited and out-organised them. Labour has now become the largest political party in western Europe. That may say nothing about its capacity to win a general election under its current leadership, but it does say something.

Love him or loathe him, Mr Corbyn – or what he represents – is capable of attracting and enthusing support. If they are ever to get their party back, his opponents will have to do the same. And they will have to offer a more enticing prospectus than begging people to join Labour to save the party from itself. They have again failed to beat Jeremy Corbyn. Perhaps the best thing Labour moderates could do now, strange as this may seem, is to try to learn from him.

The Indian Pharmaceutical Sector

 

By Jill E. Sackman, PhD,Michael Kuchenreuther

Biopharma companies should not overlook India's growing market.

ABHIJITMORE/ROOM/GETTY IMAGES

Recognizing that emerging markets continue to play a significant role in terms of future growth, most major pharmaceutical companies have accelerated efforts to strengthen their presence within these markets through R&D investment, licensing deals, acquisitions, or other partnerships. However, with global markets facing dynamic demographic and disease trends, changing market demands, and evolving regulatory requirements, it has been hard for manufacturers to devise the strategies needed for success in each of these areas.


India, a member of the BRIC nations (Brazil, Russia, India, and China), is much more comparable to the United States in terms of market size and must be included in this list of promising potential markets for global pharmaceutical manufacturers. Recent changes in India’s population and economy have contributed to a shift in the country’s epidemiological profile towards ‘lifestyle’ diseases that are more prevalent in Western markets. Such changes have increased the demand for better healthcare and for medications that address chronic diseases. Furthermore, India’s own pharmaceutical industry, a recognized world leader in the production of generic drugs, offers manufacturing expertise to organizations looking to outsource or create networks of collaboration and discovery. However, a more granular assessment of India’s pharmaceutical market reveals growing concerns over patent protection, price capping, quality, and safety. Understanding this country’s complex market dynamics will be crucial for manufacturers exploring new opportunities for growth in India.

India health and pharmaceutical market overview

India is the second most populous country in the world with about 1.27 billion people, and is projected to surpass China by 2028 (1). As the Indian population has continued to grow in recent years, so too has the country’s economy. Over the past decade, India’s economy grew above the Organization for Economic Co-operation and Development (OECD) average, which can be attributed to rising average income levels, an expanding middle class, and a drive toward urbanization (2). These socio-economic changes are contributing to a significant shift in India’s epidemiological profile. With working-age adults accounting for the majority of the overall population and more people becoming affluent and living longer, Indian health service users are facing increasing challenges associated with the prevention and treatment of chronic diseases such as obesity, heart disease, stroke, cancer, and diabetes (3).

At the same time, India continues to be challenged by a range of infectious disorders. Despite economic advancements, significant income inequality still exists throughout the country. In fact, per capita gross national income in India was only $3,391 in 2012 when adjusted by purchasing power parity (compared to $50,000 in US) (4).  In rural areas, where two-thirds of the nation’s citizens are located, hundreds of millions of people are still living in severe poverty, and vaccination coverage for children remains poor.

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Taken together, this high incidence of infectious and chronic disease and the large number of disadvantaged communities have created an even greater need for patient access to quality healthcare delivery as well as new and innovative therapeutic products. Historically, India has had one of the world’s lowest levels of health spending as a proportion of gross domestic product (GDP). In 2011, India’s total health expenditure was 3.9% of GDP (public expenditure was only 1.2% of GDP) compared to 10.1% of GDP, an average across all G-5 countries (4). The lack of government funding in healthcare has led to significant gaps in the quality and availability of public facilities and has pushed an increasing proportion of Indian patients to use private healthcare facilities that are associated with high costs. Where other countries have a well-established insurance sector that seeks to reduce this economic burden, health insurance in India is still in its infancy.

Approximately 243 million people are covered by different forms of government-sponsored insurance schemes while approximately 55 million rely on commercial insurers (5). With the vast majority of people in India uninsured, out-of-pocket payments are among the highest in the world. According to the World Health Organization (WHO), 70% of Indians are spending their entire out-of-pocket income on medicines and healthcare services (6). On top of this, most insurance plans only provide coverage for inpatient healthcare services and do not include coverage for outpatient treatments, including prescription medicines. Thus, it is no surprise that approximately 90% of India’s pharmaceutical market is currently made up of branded generic drugs (7).

Against this backdrop, India’s Ministry of Health has been focused on improving access to healthcare facilities, increasing population coverage by way of healthcare insurance, and creating initiatives for the prevention and early stage management of chronic diseases. In 2012, as part of the country’s 12th Five-Year Plan, the government proposed to double its public expenditure on healthcare to 2-3% of GDP in an effort to boost local access and affordability to quality healthcare. In light of these efforts, the Indian healthcare industry as a whole is expected to reach $158 billion by 2017 (8).
India’s pharmaceutical market accounts for about 10% of the global pharmaceutical industry in terms of volume and represents a major component of growth for the country’s healthcare industry (9). The Indian pharmaceutical market was estimated at $18.4 billion in 2012 and is expected to almost double by 2016. Although India’s market is currently dominated by generic drugs, rising incomes, enhanced medical infrastructure, and insurance coverage could provide a valuable opportunity for manufacturers’ higher-priced branded healthcare products moving forward.  

Key market challenges and considerations

Regulatory. Similar to many other countries, India’s medical regulatory structure is divided between national and state authorities. The Drug Controller General of India (DCGI) is the national authority responsible for the regulation of pharmaceuticals. The DCGI registers all imported drugs, new drugs, and biologicals in selected categories and has responsibility for approving clinical trials and quality standards in the country. Recently, these standards have come under question by FDA, citing quality-control problems ranging from data manipulation to sanitation. While FDA and regulatory bodies in other countries step up inspections of Indian plants in response to these developments, global manufacturers have had to reassess their contracted relations with these plants and give careful consideration to developing new strategic partnerships in this country moving forward (10).  

Concerns over quality and data integrity have also impacted manufacturers’ perception of India’s clinical trials system. India’s large and diverse patient pool and low drug trial costs have made the country an attractive destination for multinational pharmaceutical clinical trials. However, India has recently seen the number of clinical trials fall dramatically among allegations that protocols were not being conducted properly and that companies were taking advantage of disadvantaged patients (11). In response to these developments, manufacturers have been forced to either shift their trials to another country or encounter significant delays in clinical trial approval--both of which are holding their organizations back.

Market access and pricing. The high prevalence of self-pay generic drugs throughout the country has created little incentive for the development of certain market access disciplines such as health economics and outcome research (HEOR) and reimbursement. Government affairs and pricing functions, on the other hand, play an important role and have been broadly cited as the most crucial challenges global manufacturers face in the Indian marketplace.

India’s National Pharmaceutical Pricing Authority (NPPA) controls product pricing throughout the country. In 2013, the NPPA expanded the National List of Essential Medicines (NLEM) to include 652 drugs, a substantial increase over the 74 drugs previously listed. These products will now be subject to price controls that are projected to reduce prices by more than 20% for half the drugs (12). As if this did not challenge manufacturers enough, the Indian government recently decided to revise the NLEM later this year in response to complaints that the list should include all dosages, strengths, delivery mechanisms, and combinations of these previously identified drugs (13). The NPPA is also allowed to control prices of patented drugs that lie outside this list, and last month the government began exploring the possibility of using a reference pricing system for these products (14).  With intense generic competition already driving down drug prices in India, these additional controls pose a significant threat to international manufacturers’ ability to generate revenue.

Intellectual property. Aside from pricing, patent protection has also come under the microscope as of late. In an effort to ensure greater accessibility to higher-cost, branded drugs, India, as well as other BRIC countries, has begun to allow generic-drug manufacturers to market these drugs at dramatically reduced costs without consequence through compulsory licenses.  While only one compulsory license has been approved by India’s government to date (Bayer’s Nexavar), other manufacturers have recently had their patents weakened, revoked, or rejected. While appeals to some of these rulings are still in process, precedents have been set, leading manufacturers to question their future investment in India.

Implications for successful market entry 

Despite the aforementioned challenges, major pharmaceutical companies recognize the long-term prospects of this market and continue launching new patented drugs and pursuing unique business opportunities in India. To encourage future investment, the government has made tax breaks available to the pharmaceutical sector, including a weighted tax deduction of 150% for any R&D expenditure incurred. In addition, the government recently declared that all drugs that offer some form of innovation would be exempt from price regulation for the first five years following approval. Here, innovation refers to drugs or drug delivery systems that arise from native R&D efforts or existing drugs that are improved upon by an Indian company. This measure is aimed to spur growth in the domestic pharmaceutical market and to ensure that pricing regulations do not turn global manufacturers away from India. Thus, companies that develop strategic partnerships with local businesses and outsource some of their R&D and manufacturing activities will be well-positioned to maximize revenue by avoiding steep price cuts. This opportunity for manufacturers will only apply, however, for those products that offer true innovation by providing economic and/or clinical value.

Uncertainty over patent security and obstacles to clinical trials are discouraging Western companies from conducting drug research in India. With that said, the government has already initiated clinical research reform efforts through new amendments and regulations that could quickly restore the growth of clinical trials throughout the country.  At the same time, there is speculation that a transfer of power in India’s upcoming election could dampen fears of additional compulsory licenses (15). Manufacturers should closely monitor these internal developments and react accordingly.

Moving forward

A growing middle class that is projected to see a significant rise in noncommunicable diseases provides an excellent opportunity for global companies to launch their premium products and expand their market share. India’s underdeveloped insurance industry and high poverty rates, however, require that manufacturers first develop a careful pricing strategy. Pricing products appropriately can go a long way towards ensuring future growth as well as avoiding disputes over patent protection and licensing agreements.  In a country that holds about one-fifth of the world’s population, India’s market is too big for pharmaceutical companies to shy away from, despite all of the hurdles placed in front of them.  

Defending India’s patent law

Prabha Sridevan in The Hindu

No one can attack India’s well-founded Intellectual Property regime as being weak merely because a drug that is claimed to be an invention fails the test of law

India and its intellectual property (IP) laws have been the subject of sharp criticism recently. Now, there is talk of the government invoking emergency provisions with regard to Dasatinib, a cancer drug. The decibel level may go up several notches.

Let us look at our law. The sovereignty of a country includes its power to make laws. Any person who pursues commercial interests in another country must submit himself/herself to the laws of the country. No one can attack our regime as being weak only because his/her invention did not stand up to the test of our legislation. Nor can India be accused of robbing Peter to pay Paul. It sounds romantic, but it is still robbery.

The Novartis case and the Nexavar case of compulsory licence (CL) are what have impelled this attack. Innovation and invention have speeded up in myriad ways in the last few decades and our country had committed itself to the obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights. Therefore, it was necessary for India to revisit its patent law; in 2005, the Indian Patents Act was amended, Section 3(d) being one of the amendments. It was the basis of the Novartis case.

TRIPS recognises that members have the right to use/adopt measures to protect public health so long as they are consistent with TRIPS. A recent study notes: “Policy makers in developing and developed countries need to base their implementation of intellectual policy rules on these pro-public health and pro-access principles.” The Doha Declaration is an affirmation of the right to use the flexibilities in TRIPS, especially by developing and less developed countries, regarding access to medicine. The language of the Doha Declaration emphasises the importance of implementing and interpreting the TRIPS Agreement in a way that supports public health.

“The TRIPS agreement does not limit the grounds on which compulsory licences can be granted, and does not prevent patent applicants from having to demonstrate enhanced efficacy for their allegedly new and useful inventions. There are many problems affecting access to and rational use of medicines in India but the provisions within the country’s patent laws, if more extensively and properly applied, should help rather than hinder such access. India’s laws and experiences could provide a useful example for low-income and middle-income countries worldwide.”

About patentability, not price

In Novartis, the Supreme Court said that while harmonising the patent law in the country with the provisions of the TRIPS Agreement, India had attempted to balance its obligations under the international treaty and its commitment to protect and promote the public health considerations of people in the country and elsewhere. The ‘thorn in the flesh’ Section 3(d) had been challenged by Novartis before the Madras High Court earlier. But the court upheld its constitutionality and rejected the attack on the grounds of vagueness and arbitrariness. Novartis did not file an appeal against that judgment. Novartis claimed a patent for Gleevec, a cancer drug which was refused. Novartis then appealed to the Supreme Court.

The intellectual property of the inventor lies in the invention which is claimed to be novel, inventive and patentable. The patent is a creature of law by which the state bars public access to that invention for a fixed period. The economic reward from the invention is earned during this time after which it goes to the public domain. Section 3(d) is a test of patentability. With reference to Gleevec, it is enough to know that 3(d) inter alia says that in the absence of evidence of enhancement of known efficacy, the mere discovery of a new form of a new substance is not an invention deserving the grant of patent. Imatinib Mesylate was the known substance and Novartis claimed a patent for its (the substance) beta-crystalline form.

The Supreme Court asked: “Now, when all the pharmacological properties of beta crystalline form of Imatinib Mesylate are equally possessed by Imatinib in free base form or its salt, where is the question of the subject product having any enhanced efficacy over the known substance of which it is a new form?” If an invention fails the 3(d) test, it means there was no inventive step. There was no intellectual property in the alleged invention, and nothing that could be stolen. Our lawmakers meant to check any attempt at repetitive patenting or extension of the patent term on spurious grounds, and blocked attempts to keep an invention “evergreen.” If those who attack the Indian patent regime claim that a minor tweaking of chemicals is a giant step forward for an invention, then our legislators begged to differ. The Supreme Court said that it was not ruling that all incremental innovations were non-patentable and that every case would be examined. Our law says that new forms of known substances which do not have enhanced efficacy are in effect advances without real innovation. Therefore, Section 3(d) is actually a catalyst for genuine inventions.

The Supreme Court said that Novartis had attempted to get a patent for a drug which would otherwise not be permissible under our law. Filtering doubtful patents is the strength of our law and not its weakness. The Novartis judgment was not about price but about patentability.

Let us look at the compulsory licence (CL) case, i.e. Bayer vs. NATCO. The mechanism of CL is essentially about balancing patent rights with access to medicine. The words “social and economic welfare,” “public health,” “national emergency” and “public health problems/crises” used in the Act are all pointers to the CL provisions being centred around access to medicine.

A CL is granted subject to three conditions; one of them is about price. The reasonable requirement of the public with regard to the invention should be satisfied. The price at which it is made available should be reasonably affordable. It should be worked in India. A CL may be granted if the answer is a “no” to any of the three conditions. The interpretation of the word “working” by the Controller-General was criticised. It is incorrectly projected that the CL was granted on this score alone. Bayer failed in the other two tests. As far as working is concerned, the question is this: should the inventor manufacture the invention locally or is it sufficient to import it? The Controller held that “working” meant local manufacture to a reasonable extent. The Intellectual Property Appellate Board (IPAB) said that “working” could in some cases mean local manufacture entirely, while in others, only importation, and that it would depend on the facts and evidence of each case. “Working” is not defined in the Act. This issue will be settled by the superior courts on review. The power of review by the superior courts is sufficient to show that our law provides for safeguards.

Compulsory licence

Even in the U.S., it is believed that CL would be a beneficial addition to its patent system, would not significantly impact the incentives for innovations, and that, “a compulsory licensing provision would ensure that the American public is adequately supplied with a product. If the patentee is unable to produce enough supply to meet the demand for the product, another producer should be able to license the product to meet the demand.” This is precisely what our law says!

In all these years, there has been only one instance of the grant of compulsory licence. In fact it was refused recently for Dasatinib, the drug that is now in the news. And Section 3(d) has been invoked by our patent office only rarely. If Gleevec was refused a patent, it is only because it failed the test of Indian law. Refusal is not an act of robbery, for it means there was no invention and hence no property in the first place. There is really no case made out for there being a weakness in Indian law. The pharmaceutical industry’s anxiety behind the clamour against Indian law cannot be on account of any inherent weakness in our law, but only because other countries will follow it.

(Prabha Sridevan is a former judge, Madras High Court.)

Pfizer's bid for AstraZeneca shows that big pharma is as rotten as the banks

Global pharmaceutical companies are dodging the risks by loading R&D costs on to taxpayers

• Mariana Mazzucato
• The Observer, Sunday 11 May 2014

Every one of Pfizer’s patented drugs benefited from decades of taxpayer funds. Photograph: Canadian Press/Rex

Countries around the world are seeking long-run, innovation-led growth in the "real economy". This is born of a wish to move away from speculative growth led by short-term financial markets. For this reason, industrial policy is back on the agenda after years of being a near blasphemy.

The life-sciences industry is top of the list, for both Barack Obama and David Cameron, of "real" industries to nurture through such policy. But this month they have been reminded of an uncomfortable truth: big pharma is just as sick as the banks. And, like speculative finance, it is hurting taxpayers in the process.

Pfizer wants to buy AstroZeneca, a British firm, to cuts its high overheads and especially to pay the lower UK tax rate (20%) – the cheap way the UK attracts "capital"– rather than the 40% US tax rate. This is nothing new as Google and Apple have been shifting profits around the world to avoid tax. Even within the US, Apple moved one of its subsidiaries to Reno, Nevada to avoid paying higher tax in Cupertino, California. Let's call it a race to the bottom.

What makes this dynamic particularly problematic for the taxpayer is that the knowledge behind Apple and Pfizer products – the key to their long-run profits – has been virtually bankrolled by that same taxpayer. As I discuss in my book The Entrepreneurial State: Debunking Private vs Public Sector Myths, every technology behind the iPhone was publicly funded (internet, GPS, touch-screen, Siri) and every one of Pfizer's patented drugs benefited from decades of taxpayer funds through the US National Institutes of Health, which in 2012 alone spent £32bn (£19bn).

Indeed, Pfizer's recent shift of one of its largest R&D laboratories from Sandwich in Kent to Boston was not due to the lower taxes or regulation in Boston but to be closer to this pot of gold. Coming back to the UK only to suck more blood out of the system should warn the government of the kind of image it wants to present of itself. Is it happy to be played front and back?

And what is happening to big pharma's research and development? In the name of "open innovation" – the admission that most of their knowledge comes from small biotech and large public labs – big pharma have been closing down their own R&D (reducing total numbers of researchers), as well as moving the remaining ones to be close to those labs.

Big pharma is no longer in the innovation business, using its own resources to fund the high-risk ideas, most of which will fail. It has become more risk-averse and prefers to focus on the D of R&D and please shareholders. Mergers and acquisition strategies reduce expensive overheads and costs (of which research infrastructure is the highest).

Things become even clearer when we look at the numbers behind one of their biggest expenditures: share buybacks. These are geared to boost stock prices, stock options and executive pay. Indeed it is this type of dynamic that has been driving the extreme inequality described by Thomas Piketty. The calculations of Professor William Lazonick suggest that in 2011, along with $6.2bn paid in dividends, Pfizer repurchased $9bn in stock, equivalent to 90% of its net income and 99% of its R&D expenditures.

While the justification for such buybacks is often that there are no "opportunities for investment", the increased public funds in pharma research shows who is funding the opportunities and who is free-riding. Though in the end both lose since without an engaged private partner, innovation suffers.

To make matters worse, these "innovative" companies advising governments on their "life-sciences" strategies are constantly seeking handouts through R&D tax credits, or more recently through the UK  Patent Box tax scheme introduced in 2013 (as well as in the Netherlands, Belgium and Spain, and soon in the US), with a 10% tax for income earned on patented drugs.

Patents are already monopolies with 17 years' protection. There is no reason to increase profits even more during that time. Especially as what drives the research that leads to patents is not the "cost" of the research, but the opportunities that are perceived—historically driven by large amounts of risk-loving public funds.

Experts from the Institute for Fiscal Studies have argued that this policy will diminish government revenue by about £2bn a year, and have no effect on business investment in research – which was meant to be the point. Indeed, private investment tends to follow well-funded public investments, that are of course undermined by the constant bashing away at the ability of government to collect tax revenue. This not an innovation strategy but a City-like speculation strategy.

The parallel goes even further: just like the banks, big pharma socialises the risk, but privatises rewards. The few drugs that are coming out would not have emerged without taxpayer-funded research. Yet the taxpayer then pays twice: first for the research then for the high prices, justified by the supposedly high risk that big pharma is taking on. This is almost surreal: what risk? And what about taxpayer risk?

Rather than empty words on a life-sciences strategy, what is needed is for policymakers to become more confident in their negotiations with business. The 1980 Bayh-Dole act that allowed publicly funded research to be patented says that government should have a say on the prices of the drugs. The fact government has never exercised this right shows who has the upper hand.

But things can change. Innovation policy should be linked to corporate governance – why should companies that spend more on share buybacks than R&D benefit from public research funds? Then "intelligent" R&D tax credits could be created, linked not to the income generated from R&D but the research labour hired to conduct it (as introduced in the Netherlands).

Government could also retain a golden share of the intellectual property rights (patents) which public research produces, and/or make sure that the prices of the new drugs reflect how the taxpayer paid for the most high-risk research. And, finally, given the high dependence of the industry on publicly -funded R&D, do not allow acquisitions that undermine the underlying research base the companies themselves should commit to - and for which they constantly request handouts.

In short, we need to start fostering a more symbiotic innovation eco-system. It's time to put an end to the current, increasingly parasitic one. We could start by realising that government does have power to actively shape and create markets, and not just fix broken ones.

Big Pharma, my cancer patient and me

My patient was refused compassionate access to a cheap chemotherapy. Why? Because pharmaceutical companies are often guilty of selling an ethically murky kind of hope

• 
• • Ranjana Srivastava
  • theguardian.com, Friday 2 May 2014 00.43 BST

'We both knew that the gesture will be more therapeutic than the drug itself'. Photograph: Christopher Thomond

After failing two types of chemotherapy for advanced cancer, my patient knew that her lease on life was short, but a cherished family event stood in the way. "My son is going to propose at the Christmas table, I just want to make it there." Her son has been her anchor throughout her challenge; I could see why his engagement mattered so much. But Christmas was still some months away, and I feared the feat will be difficult.

"I am not afraid to die but I just want to know that I gave it my all." This is an all too frequent exchange, unfailingly poignant, often heart-wrenching. An entirely reasonable answer would be to gently reiterate the lack of meaningful chemotherapy, broach the benefit of good palliative care, and allow for regret at both our ends. Contrary to popular belief that mythologizes every patient raging against cancer to the very end, for many this discussion eases the burden of expectation and allows for a peaceful end.

But this relatively young mother was simply not ready yet. "I would happily die right after he proposed" she smiled, reminding me that her goalposts had never changed. When a patient like that looks you in the eye, it isn’t easy to separate foreboding statistics and human longing into two neat piles and deny hope.

My head said that another chemotherapy drug wouldn't make a significant survival difference. But my heart urged me to try, if not to boost survival, then merely to reassure her that she gave it her best shot. Put simply, we both knew that the gesture will be more therapeutic than the drug itself, hardly a rare observation in medicine.

I wrote to a large pharmaceutical company for compassionate access to a common chemotherapy that’s not government subsidised for her precise type of cancer (most likely because patients typically don’t live long enough to need it). It is a relatively old and cheap drug, importantly with manageable toxicity, and I requested a month’s supply to gauge response. I added that the patient does not expect recurrent funding in case she responds to the drug, addressing a legitimate concern. In a world where we frequently push the boundaries or prescribe chemotherapy in more questionable circumstances, I feel comfortable that what I am really doing is asking the company to be my partner in nurturing hope. Which is after all what every pharmaceutical representative has told me for as long as I have known.

So I simply don’t believe it when my request is declined. Thinking this to be a mistake, I protest further up the chain, pointing out to a senior executive that only recently the company had offered me conference sponsorship worth thousands more than the small cost of the chemotherapy. The apologies come fast, but the explanations are notably absent.

'If subsidy looks unlikely, access schemes are retired, sometimes abruptly'. Photograph: Stefan Wermuth/Reuters

My naive puzzlement slowly turns into the realisation that almost every instance where a company has facilitated compassionate access to a product, it has been as a form of marketing as a means of gaining lucrative, government-subsidised listing. In the era of astonishingly expensive blockbuster drugs, government subsidisation is the holy grail of big pharma. The cost of treating a few hundred or even a few thousand patients for free (and in the process, securing the backing of doctors), is negligible when the ultimate prize is full government subsidy. Indeed, individuals and organisations including the UK’s NICE and Australia’s PBS are now questioning the feasibility of subsidising drugs that can cost as much as AU$200,000 a year for ambiguous benefit.

Compassionate access schemes for these incredibly expensive drugs might facilitate access for selected patients but they are not truly compassionate in the way that the average person understands. Pharmaceutical companies sell an ethically murky kind of hope than what doctors and their patients might understand. The benefit to the company must ultimately outweigh the benefit to the individual patient. If subsidy looks unlikely, access schemes are retired, sometimes abruptly. When a commonplace drug is neither vying for market recognition nor fighting for subsidisation, there is no incentive to provide it to a patient like mine, whose story would anyway never be the stuff of headlines.

You might ask the obvious question as to why it would take so long for an oncologist to figure out that a pharmaceutical company is not a charity. The common argument is that companies must necessarily recoup the cost of drug development, as only a small minority succeed in the marketplace.

But for every dollar spent on research, nearly twice is spent on lobbying and marketing – and it is also this expense that companies want to recover. From the time they are students, doctors are exposed to relentless advertising that big pharma is their companion in healthcare. The glory days of advertising saw doctors offered egregious forms of largesse, from conferences hosted in ancient castles and on cruises to lavish dining and entertainment. Then there were the rivers of pens post-it notes, stress balls and cute toys to influence prescribing. Regulation is much tighter today, but there is still plenty of money in sponsorships, paid speaking tours, adding one’s credible name to journal articles, and just promoting a drug to one’s peers, especially if you are anointed a key opinion leader.

Drug companies think nothing of sending a representative to wait for three hours in a clinic to spend five minutes with a doctor. Unlike other people, these people never ever express frustration at the ludicrous wait and are unfailingly courteous. They ask subtly about you, your family and your holidays. They probe your prescribing habit and tell you why your peers prefer their drug. They routinely ask what would make it even easier for you to prescribe their drug. It is impossible to navigate the discussion towards cost or what makes for the greater societal good.

And to be honest, it’s unseemly to be anything but polite towards someone who has waited hours to see you, seems genuinely nice, and from whom you might need a favour for your next patient. These favours are rare but the younger you are, the more impressionable. No wonder many medical schools and hospitals have banned pharmaceutical representative visits, hopefully signalling to doctors that the sandwiches have a hidden cost.

Eventually, I tell my patient that my request for compassionate access was denied. Crushed, she asks if she wasn’t important enough. "That’s not true", I say unconvincingly, "it’s just the way it is." She dies, with a few weeks to go before Christmas, leaving me to wonder whether the drug might just have bridged the small gap. I will never know, but feeling morally compromised by the whole exchange, I tell the drug company that I won’t see its representatives in future.

I didn’t expect an acknowledgment but when it came, it sounded like a thinly veiled warning that the visits were an essential prerequisite to receiving favours. An incredulous representative exclaims, "you would really do that, stop seeing us due to what happened with that one patient?"

But "that one patient" represented the human face of what happens when the interests of a patient and the pharmaceutical company don’t align. That one patient’s crushed hope felt no less important than the renewed hopes of another. What happened with that one patient finally opened my eyes to what has gone before.

It seems only right to start by paying tribute to my patient, while acknowledging my complicity in the thorny tangle of doctors, patients and drug companies.

Closed drug trials leave patients at risk and doctors in the dark

 

Drug companies can hide information about their drugs from doctors and patients, perfectly legally, with the help of regulators. We need proper legislation

We need muscular legislation to ensure that all information about all trials on all currently used drugs is made available to doctors Photo: Alamy

By Ben Goldacre

8:13PM BST 25 Oct 2012

34 Comments

This week, Daily Telegraph readers have been astonished by revelations about the incompetent regulation of implantable medical devices. This paper has clearly demonstrated that patients are put at risk, because of flawed and absent legislation. But many of these issues apply even more widely, to the regulation of all medicines, and at the core is a scandal that has been shamefully ignored by politicians.
 

The story is simple: drug companies can hide information about their drugs from doctors and patients, perfectly legally, with the help of regulators. While industry and politicians deny the existence of this problem, it is widely recognised within medical academia, and meticulously well-documented. The current best estimate is that half of all drug trials never get published.
 

The Government has spent an estimated £500 million stockpiling Tamiflu to help prevent pneumonia and death in case of an avian flu epidemic. But the manufacturer, Roche, continues to withhold vitally important information on trials of this drug from the universally respected Cochrane Library, which produces gold-standard summaries on medicines for doctors and patients. Nobody in the Department of Health or any regulator has raised a whisper about this, though Roche says it has made “full clinical study data available to health authorities around the world”.
 

In fact, while regulators should be helping to inform doctors, and protect patients, in reality they have conspired with companies to withhold information about trials. The European Medicines Agency, which now approves drugs for use in Britain, spent more than three years refusing to hand over information to Cochrane on Orlistat and Rimonabant, two widely used weight loss drugs. The agency’s excuses were so poor that the European Ombudsman made a finding of maladministration.
 

Even Nice, the National Institute for Health and Clinical Excellence, plays along with this game. Sometimes chunks of its summary documents on the benefits and risks of drugs are redacted, because data has only been shared by companies under unethical “confidentiality agreements”. The numbers are blacked out in the tables, to prevent doctors seeing the benefits from a drug in each trial; and even the names of the trials are blacked out, as if they were code names for Russian agents during the Cold War.
 

This is a perverse and bizarre situation to have arisen in medicine, where decisions are supposed to be based on evidence, and where lack of transparency can cost lives. Our weak regulations have been ignored, and if we don’t act quickly, the situation will soon get much worse. The European Medicines Agency’s sudden pledges of a new era of transparency are no use: it has a track record of breaking such promises. We need proper legislation, but the new Clinical Trials Directive, currently passing through the European Parliament, does nothing to improve things.

Are you glazing over at the mention of European directives? This is where it all went wrong. Sunlight is the best disinfectant, but these issues have been protected from public scrutiny by a wall of red tape, while the people we trust to manage these complex problems have failed us. Regulators have lacked ambition. Politicians have ignored the issue. Journalists have been scared off by lobbyists. Worst of all, the doctors in medical membership bodies, the Royal Colleges and the Societies, even the patient groups – many of them funded by industry – have let us all down.

This must change. We need muscular legislation to ensure that all information about all trials on all currently used drugs is made available to doctors. We need the members of patient groups and medical bodies to force their leaders to act. And we need EU medicines regulators to be held to public account, for the harm they have inflicted on us.

Ben Goldacre is a doctor and author of 'Bad Pharma’ (4th Estate 2012)

Pharmaceutical companies putting health of world's poor at risk

India makes cheap medicines for poor people around the world. The EU, pharmaceutical firms and now the US are pressuring the 'pharmacy of the developing world' to change tack

Customers buy medicine at a pharmacy in Mumbai. Photograph: Kuni Takahashi/Getty Images

India is often called the pharmacy of the developing world, which is no great surprise as more than 50% of its $10bn annual generic medicine production is exported.

But the domestic drug industry behind India's role as global pharmacist stands to emerge rather poorly from the free trade agreement (FTA) that Europe is proposing for India. In late-stage negotiations over the terms of the long-awaited agreement, the EU is calling for intellectual property rights enforcement that goes well beyond India's obligations as a member of the World Trade Organisation and would make it all but impossible for generic drug manufacturers in the country to continue in their present structure.

This could delay the introduction of cheaper medicines in India and elsewhere at a time when the global financial crisis has already put the squeeze on life-saving medicines across the world (last year the Global Fund to Fight Aids, Tuberculosis and Malaria cancelled its 11th funding round due to the crisis).

Yet protests on the streets of Delhi against the unfair terms of the EU-India FTA have been little noticed in the west, where such agreements are increasingly being promoted as a route out of domestic crises. For European leaders, they represent a foreign policy counterpart to calls for a growth pact at home. In a recent editorial, however, the former EU high representative for foreign and security policy, Javier Solana, all but admits that a similar agreement that Europe is tying up with Peru and Colombia may be "denying their weaker citizens [human] rights in favour of the interests of business".

In India, such fears are perilously close to being realised, because the EU-India FTA negotiations are not the only way in which the health of Indian citizens is coming under attack from Europe. In an effort to boost falling profit margins in the west, and to prise open more profitable markets elsewhere, European pharmaceutical companies are also chipping away at India's judicial system.

Next month, the supreme court of India will hear final arguments in a long-running case between Swiss pharmaceutical giant Novartis and the Indian government. Novartis is seeking extended intellectual property protection for a marginally modified anti-cancer drug, Glivec, for which the original patent has run out. This is a practice known asevergreening, seen by many as an unfair way for pharmaceutical companies to maintain artificially high drug prices in developing markets. That is certainly the view of the Indian government, which, in 2005, inserted a clause into its intellectual property law deliberately intended to prevent the practice.

That clause has proven to be a literal lifesaver many times since, and it ensured thatNovartis's original case was thrown out of court in 2006. But Novartis has filed new litigation in an attempt to breach India's legal defences. The final ruling is next month and there is every chance Novartis may succeed. If it does, other pharmaceutical companies will be able to impose higher prices on drugs in India too.

The Novartis case coincides with a third major assault on India's pharmaceutical industry: the final spear in a triple-pronged attack on its generic drug manufacturers by the west.

This involves the attempt by German pharmaceutical company Bayer to revoke the recent granting of a compulsory licence for an Indian firm, Natco Pharma. The licence was to produce a cheaper version of its anti-cancer drug Sorafenib. Bayer does not manufacture the drug in India, and imports in such small volumes that only a tiny fraction of potential patients could benefit. For its brand, Sorafenib, Bayer has charged Indian patients about $69,000 for a year of treatment, an unaffordable amount for most Indian households. Under the licence, Natco will sell the same medicine at 3% of this price, while paying a licence fee – and still make a profit.

But now Barack Obama's administration has weighed in on behalf of Bayer's battle for continued monopoly pricing. Testifying before the House of Representatives subcommittee on intellectual property on 27 June, the deputy director of the US Patent and Trademark Office said US officials are "constantly being there on the ground" pressuring the Indian government to desist from compulsory licensing.

It is not only Indian patients who stand to suffer from this triple-pronged attack. So, too, will charities such as Médecins Sans Frontières, which relies on Indian generic producers to supply 80% of the antiretrovirals it uses around the world. As MSF spokeswoman Leena Menghaney puts it, India is "literally the lifeline of patients in the developing world". In 2006, MSF launched an international campaign against Novartis, signed by half a million people, including Archbishop Desmond Tutu and the author John le Carré, to get Novartis to drop their pursuit of what the campaign argues is exploitation.

The campaign may not have reckoned on the scale of the assault under way, however. It is not only the pharmaceutical industry that needs to be addressed but the continued and ruthless lobbying by western politicians to secure the profitability of their own industries.

We ought to be asking why governments in the rich world still seem happy to checkmate the lives of poor people to save their political skins. And why the pharmaceutical industry sees India as such a threat. Could it be that they detect the whiff of real competition?

• Hans Lofgren is associate professor in politics at Deakin University, Melbourne. He is the editor of two forthcoming volumes (Palgrave Macmillan and Social Science Press) on pharmaceutical policy and access to medicines in India and the global south