Questions about India’s drug industry

NARAYAN LAKSHMAN in the hindu

 

Change that supports measures such as surprise checks on manufacturing facilities, and greater transparency in and policing of drug approval processes and clinical trials is a must. Photo: M. A. Sriram

 

Unless a deeper, institutional change is ushered in to break the nexus between drug companies and the regulatory regime, Indians consuming drugs may be exposing themselves to serious risks

Even before I walked into the Mayflower Hotel in the heart of Washington on a crisp autumn afternoon to meet Dinesh Thakur, whistle-blower and former director of India-based pharmaceutical giant Ranbaxy, I had a hunch that this conversation would spark some troubling questions on India’s malfunctioning drug industry.

On May 13, 2013, Ranbaxy pleaded guilty to seven felonies relating to drug manufacturing fraud and agreed to cough up $500 million to settle the case brought by the U.S. Department of Justice (DoJ) after eight years of investigation. The vast evidence in the case, some of it supplied by Mr. Thakur and marshalled by the U.S. Food and Drug Administration (FDA), included inspection reports compiled after multiple FDA visits to Ranbaxy plants in India — in Paonta Sahib, Himachal Pradesh, and Dewas, Madhya Pradesh.

Ranbaxy makes a long list of generic medications — 200 different “molecules”, according to its website — everything from anti-retroviral drugs to treat HIV-AIDS to commonly used antibiotics such as Amoxicillin and Cephalexin (Mox and Sporidex in India). It makes generic combinations of Paracetamol and Ibuprofen, and sells numerous over-the-counter products, such as pain relief gel Volini and cosmetic product Revital in India.

While it is apparent that Indians consume Ranbaxy drugs at a prolific rate — accounting for approximately Rs.2,600 crore, or 18 per cent of the company’s global revenue for 2012 — what is less clear is why the Indian government has not launched a vigorous investigation into the current Good Manufacturing Practices (cGMP) violations that the U.S. authorities found at multiple Ranbaxy facilities.

Go-slow approach

The Drug Controller General of India (DCGI), G.N. Singh, said in June: “When the issue has been flagged, as a regulator it is our duty to see that whatever medicines have been produced here are of assured quality.” But he did not specify the date by which a “review” of Ranbaxy’s past drug applications would be completed, leave alone committing himself to holding surprise visits to facilities aimed at investigating manufacturing standards.

This go-slow approach is all the more baffling given that, despite assurances by Ranbaxy after its admission of guilt in May that all of its other facilities adhered to the required process quality standards, a third plant, this time in Mohali, Punjab, was slapped with an import alert by the U.S. in September.

If any doubt remains about the seriousness of the claims made by the FDA so far, it is worth taking a quick look at the dossier of evidence submitted by the DoJ in the case against Ranbaxy.

Settlement documents make it clear that Ranbaxy admitted that had the seven felony charges brought by the DoJ gone to trial, the government “would have proven … beyond a reasonable doubt” that the company in 2006 had “knowingly made materially false, fictitious and fraudulent statements,” with regard to the stability testing of drugs, and in 2003, it “with intent to defraud and mislead,” failed to submit timely field reports to the FDA.

FDA investigation

According to the FDA’s investigation, Ranbaxy acknowledged violations of cGMP regulations with regard to a U.S.-distributed drug, Sotret, even as far back as 2003. That was at a time when the billionaire brothers Malvinder and Shivinder Singh owned the company. The Singh brothers sold Ranbaxy to Japanese Daiichi-Sankyo in 2008 and walked away with a cool $4.6 billion.

Nevertheless, the Sotret episode marked the beginning of a series of FDA investigations of Ranbaxy facilities in India, particularly of the two that focussed on production for U.S. markets: Paonta Sahib and Dewas, where Ranbaxy manufactured Sotret and two other popular drugs, Gabapentin and Ciprofloxacin.

Inspecting Paonta Sahib in February 2006, the FDA found no fewer than eight deviations from cGMPs. These included failure to include a complete record of all drug testing data as required by FDA guidelines, and failure to establish an adequate testing programme for the stability characteristics of drugs — essential to determine drug storage conditions and expiration dates.

Dewas was also investigated the same month and the FDA found not only a similar unavailability of quality-control data but also a “failure to extend investigations into any unexplained discrepancy,” such as testing deviations noted for specific drug batches.

Quality issues

Additional inspections of the Dewas facility in 2008 unearthed a range of quality problems. For example, there were no separately defined areas for the production and packaging of penicillin that could prevent microbiological contamination of this drug from exposure to other drugs in the vicinity. Again, quality control test failures of certain drugs were not thoroughly investigated.

These early hints ought to have set alarm bells ringing at FDA headquarters: prescribed procedures were not being followed; the required data documenting these procedures were not being compiled; and where deviations were noted, they were not being investigated. They did not appear to raise the red flag — or at least not enough of them.

Thus, in November 2011, the FDA did not see it fit to hold Ranbaxy back from selling generic Lipitor, the popular cholesterol-reducer. Blessed with a six-month exclusivity grant, the company went on to rake in $600 million in sales revenue. Only when “fate” appeared to intervene and glass particles were discovered in samples of the drug did Ranbaxy issue a massive recall notice.

Yet, if the FDA only scratched the surface of drug quality problems at three Ranbaxy facilities, then there is an enormous question mark over the extent to which other Ranbaxy facilities beyond the ken of U.S. authorities are similarly involved — a matter of great importance to the 150-odd countries in which Ranbaxy sells its products, including India.

Poor enforcement in India

In this context, the Indian drug control authorities must share some of the blame for not coming down harder on fraud. The institutional reasons for poor enforcement in India are well known. In the context of drug regulation, the point was made most poignantly by the department-related Rajya Sabha Standing Committee on Health and Family Welfare in its 59th report, on the functioning of the Central Drugs Standard Control Organization (CDSCO).

In 2012, the Standing Committee lambasted the “collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts,” citing in one case the spurious nature of the approvals process for new drug applications made by pharmaceutical companies.

While there is much more that the DCGI and CDSCO could do, it would be unfair to say they haven’t been jolted into action by l’affaire Ranbaxy, and then again by the FDA issuing import alerts against another Indian generics company, Wockhardt.

Earlier this month, the DCGI reportedly ordered a third pharmaceutical major, Sun Pharmaceutical, to suspend clinical research activities and new drug filings and applications at its Mumbai-based bio-analytic laboratory, “after discovering that Sun didn’t have the requisite approval from the Central government for operating the laboratory.”

However, until a deeper, institutional change takes place to break the nexus between drug companies and India’s regulatory regime — a change that incorporates everything from surprise checks on manufacturing facilities to greater transparency in, and policing of, drug approvals processes and clinical trials — there is a strong likelihood that Indian consumers of drugs made by these companies have poison coursing through their veins.

WikiLeaks publishes secret draft chapter of Trans-Pacific Partnership

Treaty negotiated in secret between 12 nations 'would trample over individual rights and free expression', says Julian Assange

• Alex Hern and Dominic Rushe
• theguardian.com, Wednesday 13 November 2013 18.12 GMT

Demonstrators protest against the Trans-Pacific Partnership (TPP) after the May Day rally in Tokyo, Japan. Photograph: EPA/Kimimasa Mayama

WikiLeaks has released the draft text of a chapter of the Trans-Pacific Partnership (TPP) agreement, a multilateral free-trade treaty currently being negotiated in secret by 12 Pacific Rim nations.

The full agreement covers a number of areas, but the chapter published by WikiLeaks focuses on intellectual property rights, an area of law which has effects in areas as diverse as pharmaceuticals and civil liberties.

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Also Read

Transatlantic Trade and Investment Partnership: Wake up people, we’re being shafted

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Negotiations for the TPP have included representatives from the United States, Canada, Australia, New Zealand, Japan, Mexico, Malaysia, Chile, Singapore, Peru, Vietnam, and Brunei, but have been conducted behind closed doors. Even members of the US Congress were only allowed to view selected portions of the documents under supervision.

"We're really worried about a process which is so difficult for those who take an interest in these agreements to deal with. We rely on leaks like these to know what people are talking about," says Peter Bradwell, policy director of the London-based Open Rights Group.

"Lots of people in civil society have stressed that being more transparent, and talking about the text on the table, is crucial to give treaties like this any legitimacy. We shouldn't have to rely on leaks to start a debate about what's in then."

The 30,000 word intellectual property chapter contains proposals to increase the term of patents, including medical patents, beyond 20 years, and lower global standards for patentability. It also pushes for aggressive measures to prevent hackers breaking copyright protection, although that comes with some exceptions: protection can be broken in the course of "lawfully authorised activities carried out by government employees, agents, or contractors for the purpose of law enforcement, intelligence, essential security, or similar governmental purposes".

WikiLeaks claims that the text shows America attempting to enforce its highly restrictive vision of intellectual property on the world – and on itself. "The US administration is aggressively pushing the TPP through the US legislative process on the sly," says Julian Assange, the founder and editor-in-chief of WikiLeaks, who is living in the Ecuadorean embassy in London following an extradition dispute with Sweden, where he faces allegations of rape.

"If instituted," Assange continues, "the TPP’s intellectual property regime would trample over individual rights and free expression, as well as ride roughshod over the intellectual and creative commons. If you read, write, publish, think, listen, dance, sing or invent; if you farm or consume food; if you’re ill now or might one day be ill, the TPP has you in its crosshairs."

Just Foreign Policy, a group dedicated to reforming US foreign policy, managed to crowdfund a $70,000 (£43,700) bounty for Wikileaks if the organisation managed to leak the TPP text. "Our pledge, as individuals, is to donate this money to WikiLeaks should it leak the document we seek." The conditions the group set have not yet been met, however, because it required the full text, not individual chapters.

Related to the TPP is a second secret trade agreement, the Transatlantic Trade and Investment Partnership (TTIP), which ties together regulatory practices in the US and EU. George Monbiot, writing in this paper, referred to the treaty as a "monstrous assault on democracy". Ken Clarke, the minister without portfolio, replied that it "would see our economy grow by an extra £10bn per annum".

Campaign group Fight for the Future has already collected over 100,000 signatures in an online petition against what it calls the “extreme Internet censorship plan: contained in the TPP.

Evan Greer, campaign manager for Fight for the Future, said: "The documents revealed by WikiLeaks make it clear why the US government has worked so hard to keep the TPP negotiatons secret. While claiming to champion an open Internet, the Obama administration is quietly pushing for extreme, SOPA-like copyright policies that benefit Hollywood and giant pharmaceutical companies at the expense of our most basic rights to freedom of expression online."

What Does it Mean to be a Physician?

Whitcomb, Michael E. MD

 Extraordinary changes have occurred during the past few decades in the design and conduct of the medical school curriculum. To a great extent, this reflects a commitment by medical school deans and faculties to better prepare their students for the challenges they will face throughout their professional careers. The changes that have been adopted are truly impressive, yet there is still more to be accomplished. I have suggested on several occasions that in order for the medical education community to be clear about the kind of changes that are needed, the community needs to define more clearly the purpose of the educational program.^1,2 And I have suggested that in order to reach agreement on that purpose, the community must first answer a fundamental question: What does it mean to be a physician?

This approach reflects my belief that one of the primary purposes of the educational program is for students to learn, in depth, what it means to be a physician. After all, the title is bestowed upon them when they graduate from medical school, even though they are not yet prepared for the actual practice of medicine. Even so, shouldn’t they have an understanding of what it means to be a physician when they receive the title? In posing the question I am not seeking a formal definition of the term physician that one might find in a dictionary. My intent, instead, is to seek agreement within the medical education community on the attributes—that is, the personal qualities—that a physician should possess if he or she is to be capable of meeting the public’s expectations of a doctor.

Some have suggested that possessing a body of knowledge and a set of skills that can be applied in the practice of medicine defines what it means to be a physician. Now, there is no question that certain knowledge and certain skills are essential elements of being a physician. But it is also clear that the knowledge and skills required vary depending upon the particular career path a physician has chosen. So, while it is essential for physicians to be knowledgeable and skillful in order to engage in the practice of medicine, it is not possible to define what it means to be a physician by identifying a body of knowledge and a set of skills that all physicians must possess. On the other hand, there is a specific set of personal attributes that I maintain all physicians should possess if they are to meet the public’s expectations, and that it is those attributes that define the essence of what it means to be a physician.

First, a physician must be caring. One of the most famous quotes in the annals of American medicine comes from the address Francis Peabody gave to Harvard medical students in 1925.³ In that address, Peabody stated, “The secret of the care of the patient is in caring for the patient.” There are many texts that describe in eloquent terms the value that patients place on being truly cared for by a physician. But in modern times, members of the medical profession have too often equated caring with treatment, and have tended at times to limit their role to providing treatment leading to a cure. Unfortunately, this approach has too often meant that physicians ignored the importance of a caring manner, no matter what the treatment options were. Worse, once a patient could no longer be cured, too many physicians believed that there was nothing more to be done and attended in only a minimum way to the patient’s needs. In fact, it is now clear that caring for patients becomes more critical in situations in which the patient understands that treatment will no longer be useful and cure is no longer possible.

A few years ago, the Hastings Center initiated a project to define the goals of medicine.⁴ One of the four major goals that evolved from the project was called The Care and Cure of Those with a Malady, and the Care of Those Who Cannot be Cured. It is essential, therefore, that physicians understand clearly that to serve the goals of medicine, they have a responsibility to continue to care for their patients when they can no longer prescribe a particular form of treatment or offer the likelihood of a cure. If they do not continue to provide care under those circumstances—that is, by being caring—their patients will sense that they have been abandoned by their doctor at a critical time. Clearly, the essence of what it means to be a physician requires that a physician not allow this to occur.

Second, physicians must be inquisitive. Medicine has a long tradition of celebrating all that the members of the profession know about mechanisms of disease and the diagnosis and management of various clinical maladies. Indeed, admission to the study of medicine and advancement throughout the various stages of one’s career are often based solely on what one knows. But the fact is that there is a great deal about medicine that is not known, and there is a great deal that individual physicians do not know about what is known.

Given that, the value of physicians’ being inquisitive about medicine is clear. This attribute contributes in an important way to the quality of care provided by physicians by ensuring that they continue to acquire the knowledge and skills they will need to meet their professional responsibilities as the nature of medicine changes during their careers. But it is also important to recognize that this attribute contributes in a more immediate way to the quality of the care provided to individual patients.

In his new book, How Doctors Think, Jerome Groopman⁵ emphasizes that most of the diagnostic errors made by physicians result from cognitive mistakes. He points out that because of the uncertainty inherent in the practice of medicine, there is a tendency for physicians when encountering a patient to lock in too soon on a particular diagnosis or a particular approach to treatment. By doing so, the physician runs the risk of overlooking clues suggesting that the working diagnosis may not be correct. Even though a patient may present with the classic manifestations of a particular malady, the true physician will always pause before making a diagnosis and embarking on a course of therapy by asking himself or herself, What is there about this patient’s presentation that I don’t understand? Or, importantly, What is there about this patient that I should know before proceeding?

And finally, physicians must be civic minded. This is a confusing concept to grasp, because in modern times the civic responsibility of the individual physician tends to be obscure. Over the years, this responsibility has come to be viewed as an element of professionalism that is somehow embedded, at least implicitly, within the context of the social contract that defines the medical profession’s responsibility to the society as a whole—a responsibility manifested largely by how professional organizations relate to the public. But Bill Sullivan⁶suggests in Work and Integrity: The Crisis and Promise of Professionalism in America that it is critically important that individual physicians become more personally involved in meeting medicine’s responsibility to society. In his view, they must concern themselves with ensuring that the professional organizations to which they belong are focused on serving the interests of the public, rather than simply serving the interests of the organization’s members. But the civic mindedness of physicians should go beyond that to include consciously contributing in a variety of ways to the betterment of the communities in which they live by participating in community organizations and bringing their special talents to bear in volunteer efforts specifically aimed at improving the health of the public.

So, I suggest that although a physician who is not caring, inquisitive, and civic minded may be a highly skilled technician involved in the practice of medicine, such an individual will not truly reflect the essence of what it means to be a physician. Given this, it is essential that as medical schools continue to modify their educational programs, they ensure that those programs reflect a commitment to ensuring that their graduates be caring, inquisitive, and civic-minded physicians. Deans and faculties of medical schools must understand clearly that while their graduates will spend their residencies acquiring much of the knowledge and many of the skills they will need for the practice of their chosen specialties, it is in medical school that they must learn the essential attributes of a true physician.

Pasmanda - Muslims that 'minority politics' left behind

KHALID ANIS ANSARI

   

 

The pasmanda’s quest for empowerment will help democratise Indian Islam and deepen democracy in the country

‘Pasmanda’, a Persian term meaning “those who have fallen behind,” refers to Muslims belonging to the shudra (backward) and ati-shudra (Dalit) castes. It was adopted as an oppositional identity to that of the dominant ashraf Muslims (forward castes) in 1998 by the Pasmanda Muslim Mahaz, a group which mainly worked in Bihar. Since then, however, the pasmanda discourse has found resonance elsewhere too.

The dominant perception is that Islam is an egalitarian religion and that Indian Muslims on the whole, especially in the post-Sachar scenario, are a marginalised community. The pasmanda counter-discourse takes issue with both these formulations. In terms of religious interpretation, Masood Falahi’s work Hindustan mein Zaat Paat aur Musalman (2006) has convincingly demonstrated how the notion of kufu (rules about possible marriage relations between groups) was read through the lens of caste by the ‘manuwadi’ ulema and how a parallel system of “graded inequality” was put into place in Indian Islam.

Caste-based disenfranchisement

As far as the social sphere is concerned, Ali Anwar’s Masawat ki Jung(2000) has documented caste-based disenfranchisement of Dalit and backward caste Muslims at the hands of self-styled ashraf leaders in community organisations like madrasas and personal law boards, representative institutions (Parliament and State Assemblies) and departments, ministries and institutions that claim to work for Muslims (minority affairs, Waqf boards, Urdu academies, AMU, Jamia Millia Islamia, etc). The book also underlines stories of humiliation, disrespect and violence on caste grounds that various pasmanda communities have to undergo on a daily basis, at least in northern parts of India.

Thus, pasmanda commentators contest the two key elements of mainstream ‘Muslim’ or ‘minority’ discourse —Islam as an egalitarian religion and Indian Muslims on the whole as an oppressed community. Islam may be normatively egalitarian but actual-existing Islam in Indian conditions is deeply hierarchical. Similarly, all Muslims are not oppressed, or not to the same degree, at any rate: Muslims are a differentiated community in terms of power, with dominant (ashraf) and subordinated (pasmanda) sections. Consequently, the so-called ‘minority politics’, which has been quite content in raising symbolic and emotional issues so far, is really the politics of dominant caste Muslims that secures their interests at the expense of pasmanda Muslims. Not surprisingly, a recurrent theme in pasmanda narratives is that minority politics has singularly failed to address the bread-and-butter concerns of the pasmanda Muslims, who constitute about 85 per cent of the Indian Muslim population and come primarily from occupational and service biradaris.

The notion of ‘minority’ and ‘majority’ communities in India — read primarily in terms of religious identity — is of modern origin and linked with the emergence and consolidation of a hegemonic secular nation-state project. In this sense, while ‘secular’ nationalism becomes the locus of legitimate power and violence, Hindu and Islamic nationalisms become the sites of illegitimate power. The seemingly epic battles that are constantly fought within this conceptual framework — around communal riots or ‘Hindu’/‘Islamic’ terror more recently in the post-9/11 world — have been instrumental in denying a voice to subordinated caste communities across religions and in securing the interests of ‘secular,’ Hindu or Muslim elites respectively. In this sense, the pasmanda articulation has highlighted the symbiotic nature of majoritarian and minoritarian fundamentalism and has sought to contest the latter from within in order to wage a decisive battle against the former. As Waqar Hawari, a pasmanda activist, says: “While Muslim politicians like Imam Bukhari and Syed Shahabuddin add thejodan [starter yoghurt], it is left to the Hindu fundamentalists to prepare the yoghurt of communalism. Both of them are responsible. We oppose the politics of both Hindu and Muslim fanaticism.”

Faith and ethnicity

The structures of social solidarity that pasmanda activists work with are deeply influenced by the entangled relation between faith and ethnicity. The domains of Hinduism and Islam are quite complex, with multiple resources and potentialities possible: in various ways they exceed the ‘Brahminism’ and ‘Ashrafism’ that have come to over-determine them over time. On the one hand, the pasmanda Muslims share a widespread feeling of ‘Muslimness’ with the upper-caste Muslims, a solidarity which is often parochialised by internal caste and maslak-based (sectarian) contradictions. On the other hand, pasmanda Muslims share an experience of caste-based humiliation and disrespect with subordinated caste Hindus, a solidarity which is equally interrupted by the discourse around religious difference incessantly reproduced by upper caste institutions. Since the express object of the pasmanda movement has been to raise the issue of caste-based exclusion of subordinate caste Muslims, it has stressed on caste-based solidarity across religions. As Ali Anwar, the founder of Pasmanda Muslim Mahaz, says: “There is a bond of pain between pasmanda Muslims and the pasmanda sections of other religions. This bond of pain is the supreme bond … That is why we have to shake hands with the pasmanda sections of other religions.”

This counter-hegemonic solidarity on caste lines is effectively encapsulated in the pasmanda slogan ‘Dalit-Pichda ek saman, Hindu ho ya Musalman’ (All Dalit-backward castes are alike, whether they be Hindu or Muslim). At the same time, birth-based caste distinctions are sought to be transcended from the vantage point of an egalitarian faith: “We are not setting the Dalit/Backward Caste Muslims against the so-called ashraf Muslims. Our movement is not directed against them. Rather, we seek to strengthen and empower our own people, to enable them to speak for themselves and to secure their rights and justice … We welcome well-meaning people of the so-called ashraf background … who are concerned about the plight of our people to join us in our struggle.” It is in the midst of such complex negotiations, the punctuated nature of faith and caste-based solidarities, that the pasmanda emerges as a political factor.

Overall, pasmanda politics has relied on transformative constitutionalism and democratic symbolism to attain its social justice goals — the deepening of existing affirmative action policies, adequate representation of pasmanda Muslims in political parties, state support for cottage and small-scale industries, democratisation of religious institutions and interpretative traditions, etc. Obviously, it confronts all the challenges that any counter-hegemonic identity movement faces in its formative phases: lack of resources and appropriate institutions, cooption of its leaders by state and other dominant ideological apparatuses, lack of relevant movement literature, internal power conflicts, and so on. Also, as Rammanohar Lohia said: “The policy of uplift of downgraded castes and groups is capable of yielding much poison. A first poison may come out of its immediate effects on men’s minds; it may speedily antagonise the Dvija without as speedily influencing the Sudras. With his undoubted alertness to developments and his capacity to mislead, the Dvija may succeed in heaping direct and indirect discredit on the practitioners of this policy long before the Sudra wakes up to it.” These are the challenges that the pasmanda activists face while confronting the ashrafiya-dominated minority politics. However, their struggle for a post-minority politics is on and one hopes it will democratise Indian Islam in the long run by triggering a process of internal reform. The pasmanda critique of the majority-minority or the secular-communal dyad will also contribute to a democratic deepening that will benefit all of India’s subaltern communities in the long run.

It's business that really rules us now

 

Lobbying is the least of it: corporate interests have captured the entire democratic process. No wonder so many have given up on politics

 

• 
• • George Monbiot
  • The Guardian, Monday 11 November 2013 20.31 GMT

‘Tony Blair and Gordon Brown purged the party of any residue of opposition to corporations and the people who run them. That's what New Labour was all about.' Photograph: Sean Dempsey/PA

It's the reason for the collapse of democratic choice. It's the source of our growing disillusionment with politics. It's the great unmentionable. Corporate power. The media will scarcely whisper its name. It is howlingly absent from parliamentary debates. Until we name it and confront it, politics is a waste of time.

The political role of business corporations is generally interpreted as that of lobbyists, seeking to influence government policy. In reality they belong on the inside. They are part of the nexus of power that creates policy. They face no significant resistance, from either government or opposition, as their interests have now been woven into the fabric of all three main political parties in Britain.

Most of the scandals that leave people in despair about politics arise from this source. On Monday, for instance, the Guardian revealed that the government's subsidy system for gas-burning power stations is being designed by an executive from the Dublin-based company ESB International, who has been seconded into the Department of Energy. What does ESB do? Oh, it builds gas-burning power stations.

On the same day we learned that a government minister, Nick Boles, has privately assured the gambling company Ladbrokes that it needn't worry about attempts by local authorities to stop the spread of betting shops. His new law will prevent councils from taking action.

Last week we discovered that G4S's contract to run immigration removal centres will be expanded, even though all further business with the state was supposed to be frozen while allegations of fraud were investigated.

Every week we learn that systemic failures on the part of government contractors are no barrier to obtaining further work, that the promise of efficiency, improvements and value for money delivered by outsourcing and privatisation have failed to materialise.

The monitoring which was meant to keep these companies honest is haphazard, the penalties almost nonexistent, the rewards can be stupendous, dizzying, corrupting. Yet none of this deters the government. Since 2008, the outsourcing of public services has doubled, to £20bn. It is due to rise to £100bn by 2015.

This policy becomes explicable only when you recognise where power really lies. The role of the self-hating state is to deliver itself to big business. In doing so it creates a tollbooth economy: a system of corporate turnpikes, operated by companies with effective monopolies.

It's hardly surprising that the lobbying bill – now stalled by the House of Lords – offered almost no checks on the power of corporate lobbyists, while hog-tying the charities who criticise them. But it's not just that ministers are not discouraged from hobnobbing with corporate executives: they are now obliged to do so.

Thanks to an initiative by Lord Green, large companies have ministerial "buddies", who have to meet them when the companies request it. There were 698 of these meetings during the first 18 months of the scheme, called by corporations these ministers are supposed be regulating. Lord Green, by the way, is currently a government trade minister. Before that he was chairman of HSBC, presiding over the bank while it laundered vast amounts of money stashed by Mexican drugs barons. Ministers, lobbyists – can you tell them apart?

That the words corporate power seldom feature in the corporate press is not altogether surprising. It's more disturbing to see those parts of the media that are not owned by Rupert Murdoch or Lord Rothermere acting as if they are.

For example, for five days every week the BBC's Today programme starts with a business report in which only insiders are interviewed. They are treated with a deference otherwise reserved for God on Thought for the Day. There's even a slot called Friday Boss, in which the programme's usual rules of engagement are set aside and its reporters grovel before the corporate idol. Imagine the outcry if Today had a segment called Friday Trade Unionist or Friday Corporate Critic.

This, in my view, is a much graver breach of BBC guidelines than giving unchallenged airtime to one political party but not others, as the bosses are the people who possess real power – those, in other words, whom the BBC has the greatest duty to accost. Research conducted by the Cardiff school of journalism shows business representatives now receive 11% of airtime on the BBC's 6 o'clock news (this has risen from 7% in 2007), while trade unionists receive 0.6% (which has fallen from 1.4%). Balance? Impartiality? The BBC puts a match to its principles every day.

And where, beyond the Green party, Plaid Cymru, a few ageing Labour backbenchers, is the political resistance? After the article I wrote last week, about the grave threat the transatlantic trade and investment partnership presents to parliamentary sovereignty and democratic choice, several correspondents asked me what response there has been from the Labour party. It's easy to answer: nothing.

Tony Blair and Gordon Brown purged the party of any residue of opposition to corporations and the people who run them. That's what New Labour was all about. Now opposition MPs stare mutely as their powers are given away to a system of offshore arbitration panels run by corporate lawyers.

Since Blair, parliament operates much as Congress in the United States does: the lefthand glove puppet argues with the right hand glove puppet, but neither side will turn around to face the corporate capital that controls almost all our politics. This is why the assertion that parliamentary democracy has been reduced to a self-important farce has resonated so widely over the past fortnight.

So I don't blame people for giving up on politics. I haven't given up yet, but I find it ever harder to explain why. When a state-corporate nexus of power has bypassed democracy and made a mockery of the voting process, when an unreformed political funding system ensures that parties can be bought and sold, when politicians of the three main parties stand and watch as public services are divvied up by a grubby cabal of privateers, what is left of this system that inspires us to participate?

Twitter IPO: why the wrong people ended up with the money

If you think the social media company's stockmarket flotation is an advert for starting your own hi-tech company, just look at what happened to the founders

• 
• • Aditya Chakrabortty
  • The Guardian, Monday 11 November 2013 20.00 GMT

Twitter founder Jack Dorsey. Photograph: Rex Features

Every time a Silicon Valley name goes to Wall Street and raises billions, you hear a creation myth. You heard it again last Thursday, as Twitter floated on the stock exchange.

It comes in many flavours, but the ur-myth runs thus: a young man with more ideas than dollars hides in his parents' garage, has a eureka moment and devises some new gadget or program that changes the world – or at least distracts swaths of its population. Then comes the glorious denouement, where our startup hero goes to the stock market and cashes in big. And that, dear reader, is why we have Bill Microsoft, Mark Facebook, and Larry and Sergey Google. The end.

This is capitalism's version of The X Factor.

In the X-Factor economies of Britain and America, you may no longer be able to count on a decent job, affordable home or moderate pension, but still you are offered visions of outlandish success – whether in singing (for the glamorous) or business (for the rest of us). Doctoral theses will some day be written on how, as the arteries of social mobility hardened, the BBC served up ever more versions of the minted entrepreneur: Dragons' Den, Gerry Robinson, The Apprentice. The assumptions are easy to tease out: collective bargaining may be dead, but heroic labour can still earn the individual a string of zeroes.

The story of Twitter, as told over the past few days, snaps perfectly into this bigger jigsaw. A band of T-shirted young men (tick), coding in a flat (tick), come up with a crazy new software application (tick), which soon becomes a global phenomenon. Within seven years is floated on the stock market at a value of $34.7bn – more than most of the companies in the S&P 500. Cue details about how the founders are now paper billionaires, the employees are sitting on options that will make some of them millionaires, and the entire San Francisco HQ celebrated with an "overflowing tower of doughnuts" (tick, tick, tick).

Except the more you look at what has actually happened with Twitter, the more it comes to look like the opposite of the heroic earnings of a few hard-workers. Many of the billions will go to a select group, many of whom have put hardly any work into the company or taken comparatively little risk. That is true of the stock market flotation, of Twitter itself and of its entire business model.

Let's start with what happened last Thursday, when Twitter went to the stock market. On the first day of trading, the company's shares soared 73% – implying that they had been sold for over a billion dollars below what they could have got. By way of comparison, shares in Royal Mail jumped over 40% on opening, forcing Vince Cable to do some explaining.

Yawning gaps between offer price and true value are hardly unusual in flotations: they're often referred to as "leaving cash on the table" – the cash being for the investment banks managing the sale and their mates at other banks and funds who buy some of the shares. If an estate agent asked you to sell your house for £100,000 less than it was really worth, so that they could offer it around their mates in the building trade, you'd probably be straight on the phone to Watchdog. Yet when it comes to flotations, I am still waiting for the BBC report that notes how much the bankers scooped alongside the founders.

Let's also look at the company's story. I spent my weekend reading Hatching Twitter, by Nick Bilton, a biography of the business based on hundreds of hours of interviews with key participants. One of Bilton's achievements is to show how the credit for the idea can be split several ways. First, Jack Dorsey floated the notion of updating friends on one's whereabouts, while Noah Glass championed it and gave the application its name, then Biz Stone was asked to help with building the program by a still-reluctant Evan Williams. Yahoo! tells the minnow team that it's "simply just a messaging service" and a "few engineers could do the same thing in a week".

Look at which of the Twitter team did best from the flotation and the answer is: Evan Williams, who, in Bilton's telling, initially had least to do with the program, and Jack Dorsey. Those two are now worth over a billion dollars apiece. But the other members of the fab four are not even listed as major recipients of company stock. Who is? Typically, finance guys who took big stakes in the business when they could see how it might pay off.

And none of the founders are now anywhere near managing the company: within a few years of it getting off the ground, they'd all been cleared out for managers from big business. I'm not playing a violin for the four founders; but Twitter is hardly an advertisement for the rewards of starting up your own company.

Finally, look at Twitter's business. Or rather, look at its own assessment of its business, as stated in its S-1 stockmarket filing. Early on comes the delicious admission: "Our success depends on our ability to provide users of our products and services with valuable content, which in turn depends on the content contributed by our users." Read that again: Twitter is in the business of selling us to us – our news and views and idle banter. Without those, without us, it is nothing. As with Facebook and Tumblr and all the other social media, we're also part of Twitter's workforce. But I bet you haven't seen any stock options, either.

Alcohol without the hangover? It's closer than you think

Science now allows us to develop a safer way to get drunk. But before we can sober up in minutes, the drinks industry needs to embrace this healthier approach

• 
• • David Nutt
  • theguardian.com, Monday 11 November 2013 19.04 GMT

'If alcohol was discovered today it could never be sold as it is far too toxic to be allowed under current food regulations'. Photograph: Action Press/Rex Features

Imagine enjoying a seasonal drink at a Christmas party without the risk of a hangover the next day, or being able then to take an antidote that would allow you to drive home safely. It sounds like science fiction but these ambitions are well within the grasp of modern neuroscience.

Alcohol is both one of the oldest and most dangerous drugs, responsible for about 2.5 million deaths worldwide, which is more than malaria or Aids. The reasons for this are well known: alcohol is toxic to all body systems, and particularly the liver, heart and brain. It makes users uninhibited, leading to a vast amount of violence and is also quite likely to cause dependence, so about 10% of users get locked into addiction. If alcohol was discovered today it could never be sold as it is far too toxic to be allowed under current food regulations, let alone pharmaceutical safety thresholds. In this health-conscious age, it is odd that these aspects of alcohol are rarely discussed.

The only proven way to reduce alcohol harms is to limit consumption through increased pricing and limiting availability. Most governments have shied away from this because of pubic opinion and fears of lost tax income – the notable exception being Scotland with its minimum pricing strategy. An alternative strategy that offers greater health benefits would be to make a safer version of alcohol.

We know that the main target for alcohol in the brain is the neurotransmitter system gamma aminobutyric acid (Gaba), which keeps the brain calm. Alcohol therefore relaxes users through mimicking and increasing the Gaba function. But we also know that there are a range of Gaba subsystems that can be targeted by selective drugs. So in theory we can make an alcohol surrogate that makes people feel relaxed and sociable and remove the unwanted effects, such as aggression and addictiveness.

I have identified five such compounds and now need to test them to see if people find the effects as pleasurable as alcohol. The challenge is to prepare the new drink in a fashion that makes it as tasty and appealing. This is likely to be in the form of a cocktail, so I foresee plenty of different flavours. The other great advantage of this scientific approach to intoxication is that if we target compounds that affect the Gaba system, then it is possible to produce other drugs that could be sold alongside the alcohol substitute as an antidote.

I have sampled both new forms. After exploring one possible compound I was quite relaxed and sleepily inebriated for an hour or so, then within minutes of taking the antidote I was up giving a lecture with no impairment whatsoever.

All that is needed now is funding to test and put them on the market. A few contacts within the alcohol industry suggest they are interested but do not need to engage until this new invention becomes a threat to their sales. This is a similar situation to that of the tobacco companies when e-cigarettes were being developed. They stood back at first but now own many of the companies making the safer alternatives to cigarettes. Likewise, without investing in a new approach to alcohol, we shall not realise the enormous health potential of a safer alternative.