Saturday, September 21, 2013

Telangana And Political Ploys

For nearly ten years Congress, the ruling party at the centre brushed aside demands for a separate Telangana state. This is the fourth time that the issue has become a national political issue since the formation of Andhra Pradesh in 1956. Political leaders and parties either raised the demand for a separate state or supported agitations purely based on electoral considerations. Marri Chenna Reddy’s somersaults on the issue are a case in point. In 1956 he was for a united Andhra Pradesh. He later changed his stance and became a votary of a separate Telangana state. In 1968 the AP High Court annulled his election to the state assembly and debarred him from contesting elections for six years. ‘Vandemataram’ Ramachandra Rao of the Arya Samaj (and later the BJP) challenged Chenna Reddy’s election on the grounds that he appealed to the religious sentiments of the Muslims. (See Election Law Reports Volume XXXVII p 269 - 349). The judgement was upheld by the Supreme Court. Forced out of electoral politics he floated the Telangana Praja Samithi (TPS) to remain relevant in politics. His TPS won 10 Lok Sabha seats in the 1971 general election. After his return to electoral politics and after being suitably rewarded by the Congress party he merged his TPS with the Congress.
In 2001 Chandra Babu Naidu walked into a trap cunningly laid by Y S Rajasekhara Reddy. CBN had a problem in that he had too many claimants from the Velama community and too few cabinet berths. But those were heady days for him. The blemish of back-stabbing his father-in-law was behind him and he returned to power for a second time in 1999, riding on the coat tails of Atal Behari Vajpayee. Confident he would be able to contain the fallout he relegated K. Chandrasekhara Rao to the post of Deputy Speaker.
With a deft Machiavellian stroke YSR inveigled KCR to come out of the TDP and form a new party. Thus was the TRS born. YSR aligned with the TRS just before the 2004 general election, with a promise to help the formation of the Telangana state, a promise which he had no intention of keeping. During his tenure (and life) he had repeatedly proved that the demand for Telangana did not enjoy popular support. The TRS’ tally in the state assembly and local bodies had continually declined.
In 2009 CBN wanted to do a YSR but he lacked the latter’s deft touch and perhaps his finesse. After tasting power and been in office for nine years Chandra Babu Naidu could not stomach the 2004 defeat. He should have taken it in his stride. A good leader does not sacrifice his core beliefs for temporary gains. But that was what CBN did. By 2009 CBN was ready to walk up a wall if it would make him 'CEO' again. Seeking to make substantial inroads into Telangana and probably misled by the overconfidence of his own regional leaders he blundered into an alliance with the TRS. However, during the closing phases of the election campaign KCR deserted CBN and walked into the NDA camp but that was a different matter. At this time, the TDP gave its consent for the formation of the Telangana state.
It was CBN’s somersault that breathed new life into the Telangana agitation, which was getting nowhere, and forced the Congress party’s hand. It also brought matters to a head from which there was no return. Therefore the people of Seema-Andhra will have to thank CBN for the bifurcation of the state. Till then, YSR’s view on the issue prevailed and the Congress was against the formation of the new state. It did not have to pronounce its stand, the excuse being the state’s principal opposition party was opposed to the formation of the Telangana state.
CBN’s consent for Telangana and YSR’s death in September 2009 changed the political dynamics and in a way foreclosed the issue. K. Rosaiah who succeeded YSR as the interim Chief Minister could not withstand the political turmoil caused by KCR’s fast unto death on the one hand and YSR’s son’s revolt within the party on the other. Based on his recommendation the centre was forced to concede the demand for the new state. The ‘victory’ made KCR a hero in Telangana. For the centre, there was no going back and it was only a matter of time before a decision had to be taken. 
The stand of the CPM on the Telangana issue was true to its character, Janus-faced. The party could always reconcile diametrically opposite views. While as a principle it opposed formation of new states, it would not oppose the formation of Telangana if the centre wished to do so.      
Just before the 2009 election, the wily YSR struck with another of his machinations. This time he contrived the formation of Chiranjivi’s PRP. Had he been alive the merger of the PRP with the Congress would have been sooner. But his calculation was right. The PRP splintered anti-Congress votes and Congress was returned to power.
When in alliance with the TDP, the BJP stoutly argued against the bifurcation of the state. After the TDP severed its ties with the BJP, ostensibly because it lacked secular credentials (which the TDP seems to have suddenly discovered!) the BJP reverted to its advocacy of smaller states. Both the parties now find themselves in a quandary in the Seema-Andhra region and do not know how to come out of it.
Why did the Congress party which has been dillydallying on Telangana for more than four decades suddenly awake to the need for decisive action? It doesn’t require great intelligence to find an answer. As many political analysts opined, it is based on electoral calculations for 2014. However it is the behavior of its Seema-Andhra leaders that is far from exemplary. They knew for quite some time that the decision to split the state was in the offing. Yet, lured by the crumbs of power thrown at them, they pretended that it was not happening and fooled their constituents. They have underestimated the emotional attachment their constituents have with Hyderabad (it is all about Hyderabad!). ‘You cannot fool all the people all the time’, might be a cliché but it is nevertheless true. 

Saturday, July 20, 2013

An Agenda For Cleansing Our Political System

Here is an e-mail I have received from Mr. K. Gopal, a former colleague. (To be frank, he did not claim authorship. He has probably received it in what the mainstream media pejoratively likes to call a 'chain-mail'.) I have tweeted the points mentioned in it twice, the whole message in the Twitlonger format a few days ago and as individual tweets yesterday. Mr. Rajendra Shukla, a friend on Twitter, suggested that it is worth sharing with all. I am therefore reproducing it here with slight editing.

Winds of Change.... 

If you agree with this please pass it on. If you are RIGHT don't GIVE Up... 

Please share it with a minimum of twenty people among your contacts and in turn request each of them to do likewise.

In three days, most people in India will have this message. 

This is one idea that really should be passed on.

REFORM ACT 2013

NO TENURE / NO PENSION Parliamentarians collect a salary while in office but should not receive any pay when they're out of office.

NO RETIREMENT PLAN Parliamentarians should purchase their own retirement plans, just as all Indians do.

NO RIGHT TO VOTE PAY RAISE Parliamentarians should no longer vote themselves a pay raise. Their pay should be linked to the CPI or 3%, whichever is lower.

NO SPECIAL HEALTHCARE Parliamentarians should lose their current health care system and participate in the same health care system as the Indian people.

NO LEGAL IMMUNITY Parliamentarians MUST also abide by all laws they impose on the Indian people.

ANNUL CONTRACTS All contracts with past and present Parliamentarians should be void effective 1/1/13. 

NO DYNASTIC / FAMILIAL SUCCESSION Total ban for five years of any family members of elected members of Parliament / Legislature becoming members of Parliament and state Legislature during and for 3 years after cessation of membership. Any violation will attract penalty of withdrawal of recognition of party / right to stand for election of the individuals!

The Indian people did not make this contract with them.  Parliamentarians made all these contracts for themselves. 

Serving in Parliament is an honor, not a career. The Founding Fathers envisioned citizen legislators, so ours should serve their term(s), then go home and back to work.

If each person who receives this message contacts a minimum of twenty people then it will only take three days for most people in India to receive the message. Don't you think it's time?

If you agree with this, please pass it on. 

Thursday, May 16, 2013

What is Salman Khurshid Up To?

The aphorism ‘No nation has friends, only interests’ and its variations were attributed to the former French President, Charles de Gaulle and the English Statesman Lord Palmerston. Some believe it predates even these politicians. An article in Time Magazine (May 9, 1955) obliquely attributes it to the English Statesman. For now the authorship of the aphorism is not the issue but whether Indian politicians were / are wise enough to pursue the course defined by it. Surprisingly, India’s foreign policy from the days of Jawaharlal Nehru has functioned at complete variance from the wisdom the aphorism advocates. Another interesting feature is that although Indian Prime Ministers in general seem to have a penchant for the foreign ministry, probably because it helps them to frequently fly abroad and rub shoulders with other world leaders, Nehru never let go of the foreign affairs portfolio. He was his Foreign Minister throughout his tenure as Prime Minster from September 2 1946. He relinquished both the posts only when he died on May 27 1964. The following article was originally published in South Asian Idea (SAISA), the official website of the South Asian Institute of Strategic Affairs as, ‘What is Foreign Office Up To?

Does the Indian government have a strategy to counter the latest Chinese incursion deep into Indian territory on April 15? If it does, it is shrouded in mystery and obfuscation. The first reports indicated that the Chinese penetrated ten kilometres inside from the Line of Actual Control (LAC) and pitched tents. The government finally admitted that they intruded nineteen kilometres. (Dr.!) Salman Khurshid, the dermatologist heading the Indian Ministry of External Affairs (MEA) described it as a spot of acne on the India-China relations! Such expressions appear colourful in sophomore essays or university debates. However Khurshid is neither a sophomore nor was he writing an essay for a college magazine.

The recent incursion is not the first (more than 200 Chinese incursions into Indian territory have been reported since 2008) but what made it disturbing was, this time around the Chinese did not indulge in a niggling in-and-out inroad but seemed to have come to stay put. Equally disturbing is the Indian response which seems to be following the disastrous course of the 1962 script.

One would like to forget what happened in 1962 but for the indelible scar that the humiliating defeat left on India’s collective psyche. There were varying versions of what went wrong. There was an extreme view projected by the then undivided Communist Party of India (CPI) which overtly functioned as the Chinese fifth column. The left wing Chinese sympathizers in the academia and their fellow travellers in the media did their bit to cloud the picture. Several generals of the defeated army added to the cacophony by offering self-serving apologias.

Then there are accounts of foreign journalists like Neville Maxwell (1970. India’s China War). An Australian national born in London and educated in Canada, Maxwell was The Times’ foreign correspondent in Washington for three years, before being posted to New Delhi as the paper’s South Asia correspondent. Though extensively researched, the book appears to have been written to absolve Britain of any responsibility for the mess it left behind. In an article he wrote for Rediff in 2002, Maxwell observed that ‘[t]hrough the early 1950’s Nehru’s covertly expansionist policy had been implemented by armed border police…’ (Rememberinga War).

Even his worst enemies would not have credited Nehru with an expansionist mindset. Quite the reverse; he was hugely enamoured of China and its culture and wanted its friendship not enmity. (The CIA documents mentioned below confirm this.) He meekly acquiesced when the Chinese usurped Tibet, although Sardar Patel warned him years earlier, about Chinese ambitions over it. Patel foresaw that the disappearance of a buffer state between India and China would only fuel the latter’s expansionist ambitions further. The Chinese proved Patel right. In 1956-57 they quietly built a road to Aksai Chin and occupied it. It was a monumental failure of the Indian intelligence but the Indian government came to know of it only in 1958 according to secret CIA documents declassified in 2007.

Isn’t 2013 a poignant parallel? With all the technology and spy satellites that are available to them, the Indian intelligence agencies (again) failed to notice the Chinese creeping in till they pitched their tents nineteen kilometres inside India. That is not all. There are ground reports that the Chinese have been nibbling at Indian territories for years and altering the contours of the borders. 

Nehru first denied the Chinese incursions into Indian territories (as Khurshid now seeks to minimize it) and when it was no longer tenable to do so informed parliament that the Indian army was asked to ‘throw the Chinese out’. The Chinese fifth column in the Indian polity latched on to that phrase and claimed that it hurt the Chinese pride and in a way triggered the war. After the war, the Indians were left with only shame, not pride! There is no dearth of Chinese sympathizers even today. Academics of the JNU variety argue in television debates that the incursions occur because of differing perceptions about the border. They never pause to ponder why, because of similar differing perceptions Indian troops do not wander into China? Isn’t it precisely because, it is not a settled and demarcated border it is called the ‘Line of Actual Control’ and not an international border?

Maxwell had access to the ‘Henderson Brookes-Bhagat Report’, an Operations Review of the debacle, commissioned by Gen. J. N. Chaudhuri, who became the army Chief after the war. The report is still classified and not available to the Indian public. Nehru revealed more about the Indian army’s capabilities to the Chinese Premier, Zhou Enlai (trained in military and intelligence matters) by taking him on a conducted tour of Indian ordnance factories than the Henderson Brookes-Bhagat report conceals from the Indian public.   

Maxwell and others opine that the Indian army was forced to take on a more superior army in terms of training and equipment. But the war was probably lost in the minds of the generals much before it was on the ground. There is the old saying that ‘The Battle of Waterloo was won on the playing-fields of Eton!’ (It may be an uncorroborated version but a veteran of the war whom this writer met in a train journey said that the Chinese were not as well equipped as it was made out to be. They carried one rifle for four to six soldiers.) The generals hoped till the end that Nehru would somehow find a diplomatic solution to the vexed border problem. He failed them and they failed him.

Haven’t the Americans met their Waterloo in Vietnam and the Russians in Afghanistan in spite of their vastly superior arms and equipment? Therefore the inferior quality of arms and equipment was not a valid argument for the defeat in 1962. Similarly, China’s numerical superiority of arms and equipment is not a valid argument for inaction in 2013. The rule is to be able to stare the enemy in the face. As an emerging economy and aspiring world power, China has as much at stake as India. 

There was a view that Nehru’s overweening ambition to win a Nobel peace prize was at the back many of his political decisions which resulted in disastrous consequences. One hopes the present leadership would not consider trading off national interests for some elusive personal monument for itself! The nation will not approve it. Therefore Salman Khurshid should keep the nation informed about his game plan for securing the safety and integrity of the nation. More importantly the nation would like to have an assurance from the Defence Minister that his armed forces are fully capable of securing the nation’s safety, security and integrity. 

Saturday, April 13, 2013

Is 2002 a decoy for 1984?

How do you make a line smaller without touching it?’ is a question which kids use while playing games. It is a sort of a children’s equivalent of an IQ test. It would be more appropriate to rephrase it as ‘How do you make a line appear smaller without touching it?’ The answer would of course be ‘by drawing a larger line adjacent to it.’

Why would adults play a kids’ game? But they do. They do. Human rights activists do. Intellectuals do. Media analysts do. Politicians do. Social activists do. They do and have been doing it, in spite of the issue under discussion being, as macabre as the butchering of thousands of men, women and children in the national capital. They do although one unnatural death (death by wanton murder) is one too many.

The riots in Gujarat following the burning of a wagon-load of karsevaks in February 2002 could be discussed as a standalone riot. There is another strange aspect to it. It is as if India had no history before 1992 and no history after 2002. Therefore the demolition of the ‘Sri Rama Janma Bhumi – Babri Masjid’ in 1992 and the riots that followed the burning of a wagon-load of karsevaks in 2002 are discussed ad nauseum as standalone incidents as if they had no context. In the case of 2002, only the riots are discussed. The burning of a wagon-load of karsevaks that preceded them is airbrushed as if it never happened. If it was ever mentioned it was done so, as an after-thought. ‘Yes, it happened. Unfortunate.

When it comes to discussing the Sikh massacres of 1984 (an inconvenient issue that cannot always be avoided), the issue of 2002 had to be invariably invoked as if it was somehow it was the incident that triggered it. Stranger still, even in a discussion about the massacre of 1984, the riots of 2002 become the focal point and the massacre of 1984 an addendum. These are the ways of our secular polity and objective media!

This was the background for Vivek Kaul’s ‘1984 riots: The original ‘maut ka soudagars’ set tone for future’. The issue came back to limelight after the Delhi High Court ordered reopening the Jagdish Tytler case, which, CBI, India’s premier investigation agency sought to bury umpteen times in the last twenty-eight years. It was not due to its ineptitude that the premier investigation agency sought to bury the case but because the oft-quoted dictum ‘the law will take its course’ is applicable only to ordinary mortals but not to the high and mighty. There is a separate jurisprudence for them!

Kaul relies heavily on Ramachandra Guha's book (India After Gandhi –The History of World’s Largest Democracy) to put across his point of view. There are many inaccuracies - deliberate and mala fide - in both Kaul's and Guha's versions. Guha writes, “…The mobs were led by Hindus who lived in and around Delhi…” That the massacre had nothing to do with Hindus or Hinduism has been conveniently ignored. That it was the private revenge of the Congress party was intentionally ignored. That the Congress party’s most cynical, if not macabre game plan was to use the sad incident to derive political dividends by whipping up public hysteria was deliberately not highlighted.

Guha goes on to say, ‘…in Delhi alone more than a thousand Sikhs perished…’ A deliberate attempt, to use Nixon’s famous phrase, to economize with the truth! The fact was, in Delhi more than 3000 Sikhs were butchered and 5000-7000 more were killed in the other parts of the country.

It is at this point Kaul tries to draw his ‘Gujarat 2002 larger line’ to make ‘the 1984 Sikh massacre, the smaller line’. Kaul doubles the number of deaths in the Gujarat riots – off his own bat without any help from Guha! The number of Muslims killed in Gujarat in the 2002 riots was not 2000. It was 790, according to a reply given by a secular Congress Minister of State for Home (MoS, Home) in the Rajya Sabha. There is more to the inappropriate comparison. The 1984 anti-Sikh carnage was a totally one sided affair, truly a genocide, to use a word often inappropriately applied to the Gujarat 2002 riots. In the riots that followed the burning of a wagon-load of karsevaks, 254 Hindus were killed. The number of Hindus dead is a matter of no consequence for secular writers and hence no mention was ever made of them.

Guha’s specious argument about unnamed Karsevaks ‘getting into a fight with Muslim vendors at the Godhra railway station’ as a reason for burning down a whole compartment of Hindus, more than half of whom were women and children is another spin of sick secular minds. This mauling of facts often resorted to by the secular mob since 2002 is a deliberate insult to the common sense of – well, the common man. Do platform vendors routinely store hundreds of gallons of petrol anticipating altercations over a few rupees with their customers, and do they routinely burn customers to teach them a lesson?

While the central government in Delhi deliberately delayed the deployment of the army in 1984 till the blood-lust of the dynasty was satisfied, the army was called in Gujarat in 2002 within 48 hours. (There were no four days between February 27 and March 1 as some over-zealous, motivated commentators tried to make out!) While the accuracy of Rajiv Gandhi’s ‘the earth trembles when a big tree falls’ statement has been fairly well established, the Gujarat Chief Minister’s statement following the riots was deliberately distorted to paint him as a bloodthirsty tyrant.

Another detail which the article deliberately glosses over was that in the Delhi massacre, senior Congress leaders like H. K. L. Bhagat, Sajjan Kumar and Jagdish Tytler led the murderous mobs from the front. The fact that Congress workers were as much part of the Gujarat riots as members of the BJP is too inconvenient for the secular brigade to be bothered about.

Thursday, April 04, 2013

Novartis Vs. The People Of India

Ivan Illich opened his seminal work 
Limits to Medicine’ with the observation that ‘The growth of the medical establishment is a major threat to health. A large part of Illich’s work dealt with iatrogenic (meaning physician-induced) diseases. But to Illich, the ‘medical establishment’, includes the pharmaceutical industry also.

The recent Supreme Court verdict in the Novartisimatinib (Glivec) patent case has generated a lot of heat and uninformed debate in the media. Novartis challenged the order of the Intellectual Property Appellate Board (IPAB), for rejecting a patent for its ‘old wine in a new bottle’, first in the Madras High Court and then in the Supreme Court. Novartis filed world-wide patents for its active molecule imatinib in 1993. In India, the company filed patent in 2003 for imatinib mesylate a beta crystalline form of the active ingredient, under the ‘mailbox provision’.

NOVARTIS Vs. PEOPLE OF INDIA

Novartis’ application for a patent for its beta crystalline form was rejected by the IPAB in 2006 on the ground that the company’s original patent application covered all forms of imatinib. The Madras High Court decreed that IPAB’s rejection of the application under Sec. 3 (d) of the Indian Patents Act as amended in 2005 did not violate Article 14 of the Indian constitution. This is now upheld by the Supreme Court.

The Indian Patents Act of 1970 did not recognize product patents but only process patents. However India agreed to consider patent applications filed from January 1 1995 for granting product patents pending amendment of its laws in line with the requirements of the WTO. The process was known as the ‘mailbox’ provision. Eventually India amended its patents law in 1999, to grant product patents with effect from January 1, 2005. A patent is an intellectual property which has a life of 20 years from the date of filing and which gives its holder exclusive marketing rights. The actual period of exclusive marketing depends on the company’s ability to develop the product for commercialization.

R&D COSTS

In the pharmaceutical industry, Research and Development (R & D) is of course an expensive and risky process. A company begins with thousands of molecules and narrows down its search to a few (less than a dozen) for further experimentation. After initial animal experimentation to establish efficacy, safety and toxicity a candidate drug (known in the industry as New Chemical Entity or NCE) is selected for human clinical trials. A patent application is generally filed at this stage and approval sought for commencing human clinical trials. These are conducted in four phases before it is submitted for marketing approval by the regulators. It is called filing a New Drug Application (NDA). The process takes quite a few years. This means, although a patent is granted for 20 years a company gets to exclusively market it for the residual period after conducting clinical trials and obtaining marketing approval. Even after a drug is approved for marketing it is still tested in a process called, Post Marketing Surveillance (PMS) every year to find out if any hitherto unnoticed side effects come to light. The company has an obligation to market a product only to be used in conditions for which it is approved. However a physician may use it in other conditions if he finds it suitable. This is known as off-label usage.

There are varying estimates about the cost of research and development of drugs. Several years ago an article in the Readers’ Digest put it at between $100 million and $200 million. Recent estimates vary from $500 million to $1 to $2 billion depending on the therapeutic category and method of calculation used, such as inclusion of capitalization and opportunity costs. This does not mean that the entire amount is spent by a company. There is public funding and tax write-offs on R & D spending, which is a not unlikely incentive for bolstering the figures.

Pharmaceutical companies quite naturally argue that they have to make profits out of successful candidate drugs because they have to incur huge expenditure on R & D, which is a long drawn and uncertain process. This is the reason they claim, new drugs cost so much.

MARKET RISKS

However pharmaceutical companies are aware there is an element of uncertainty in the business. For, even if a company is able to come up with a successful candidate drug, there is no guarantee that a rival company with a competing product might not upstage it. As an illustration, see the case of the first anti-ulcer drug cimetidine. It was introduced by the British multinational, Smith Kline & French (SK&F) in the mid-seventies when the only cure for peptic ulcers was surgery. The drug was indeed a boon for patients as it reduced the necessity for surgery in about 90% of cases. The drug marketed by SK&F as Tagamet entered the Guinness Book of World Records for maximum number of prescriptions received in a year. A few years later another British multinational Glaxo came up with an updated version of the drug ranitidine which it marketed as Zantac. It too entered the Guinness Book of World Records in the year of its introduction, and Tagamet lost 50% of its market share. As a result, many heads rolled in SK&F and its Chairman had to resign. The two companies merged in the mid-nineties to become what is now known as GlaxoSmithKline (GSK). (In its process of mergers and acquisitions, GSK has also absorbed several other companies like Allen & HanburysBeecham and Burrows Wellcome.)

The success of the first two molecules, in the class of drugs called H2 receptor antagonists, made other companies board the bandwagon and many variations of cimetidine were launched. These include famotidine, loxitidine, nizatidine and roxatidine. Of these molecular variations only ranitidine and famotidine could achieve significant commercial success, while the others remained small players. For the treatment of peptic ulcer, another class of more powerful drugs known as proton-pump inhibitors emerged with members like omeprazole, esomeprazole, lansoprazole, pantoprazole and rabiprazole, a few years later.

Wouldn’t it be unfair for a company marketing, for instance, roxatidine to claim the same pricing privilege as SK&F which has laid the groundwork for finding a drug for peptic ulcer? On the flip side could SK&F claim that, as there was every possibility of its market monopoly being upstaged, it should be permitted to recover its costs at the earliest? In view of this should the company be allowed to price a tablet of cimetidine at say, $100?

R&D – WESTERN BIAS

It would be unfair to see the Indian Supreme Court verdict as a triumph of left-liberal altruism against Western capitalism for several reasons. Firstly, US courts too held that derivatives of known substances are not eligible for patent protection under the ‘doctrine of inherent anticipation’. Also in the US a patentee cannot claim rights for more than one substance with identical claims, under the ‘doctrine of double patenting’. The third principle governing US jurisprudence in relation to intellectual property rights is the ‘patent misuse doctrine’, which prevents pharmaceutical companies from extending their patent rights by obtaining multiple patents covering essentially the same invention. In her extensively researched paper, ‘Trials And TRIPS-ulations: Indian Patent Law And Novartis AG v. Union Of India, (Berkeley Technology Law Journal, Vol: 23. Mar 21, 2008. 281-313), Lynda L. Lee opined that the stand of the Indian courts ‘indicates that the objective of India’s Section 3 (d) is not a radical departure from international practices to regulate the patenting of derivatives and new uses.’ It must be noted that the article was based on the Madras High Court judgment and written much before the final verdict of the Supreme Court.

The reaction of Novartis to the Supreme Court judgement appeared a bit peevish. In a press statement, the company’s Vice Chairman warned that it will discourage R&D spending by multinational companies in India. This is a bit surprising as multinational companies may have been using India as low cost hub for manufacturing and conducting clinical trials but never seem to be bothered about diseases specific to India. For a long time the healthcare fraternity has been complaining that multinational companies focus on diseases prevalent in the western world for researching remedies. For example, we have not seen new drugs introduced to combat malaria and tuberculosis which are endemic to countries like India, in years. The incidence of both the diseases is seeing a resurgence of virulent, intractable forms. Today tuberculosis resistant to multiple drugs – multidrug resistant TB or MDRTB is quite prevalent. On the other hand new drugs for antiplatelet medications atherosclerosis, cancer, diabetes and hypertension and related diseases are introduced by the dozen, every year.

R&D – ALTRUISM OR BUSINESS STRATEGY? THALIDOMIDE TO GATIFLOXACIN

Multinational companies which have been assuming moral high ground for their altruistic R&D efforts ‘to ameliorate pain and suffering of humanity’ have also been guilty of destroying the lives of millions of people for short term gains.

The introduction and withdrawal of thalidomide is a classic example. In the 1950s, Distillers & Co (the makers of Johnnie Walker whisky) purchased Grunenthal, a small German pharmaceutical company. Grunenthal developed a tranquiliser named thalidomide which was then believed to be so safe it could be prescribed to pregnant women to relieve them of morning sickness. It was introduced in several countries in Europe and freely prescribed for pregnant women. In the early sixties a causal link was established between the use of thalidomide and delivery of malformed babies. This property of a drug which causes foetal abnormalities known as teratogenicity, was unknown till then. By 1961 an estimated 10000 to 20000 thalidomide babies were born and the drug was withdrawn. 

The thalidomide story should have warned the managements of pharmaceutical companies to be extra careful in vetting and promoting their products. Alas no, drugs with serious adverse effects have been introduced by pharmaceutical companies with unceasing regularity. Here are a few examples, some of which may not be as lethal as thalidomide. Analgin (like penicillin) is known to cause anaphylactic reactions so severe that a single tablet could kill a patient. Anti-inflammatory drugs like oxyphenbutazone and phenylbutazone have been known to cause blood disorders. Later arthritis drugs like celecoxib and rofecoxib were found to cause acute termporary visual impairmant. However all these drugs were marketed by multinationals in India for a long time after they were banned in their home countries. The newer pain-relieving drug, nimesulide has been banned in several European countries but is still marketed in India (not by multinationals; by Indian pharmaceutical companies). Terfenedine, introduced as an advanced, non-sedating anti-allergic had to be withdrawn a few years later as it was found to cause heart-problems. The latest in the series of drugs to be withdrawn was the antibiotic gatifloxacin, which was found to cause cardiac problems. Illich mentioned in his book that the American innovator of chloramphenicol (trade name Chloromycetin) marketed the drug for simple conditions like acne. Originally introduced for treating typhoid, the drug is known to cause bone-marrow depression. (The human body produces red-blood cells in the bone-marrow.)

PRICING DRUGS

An argument that was vociferously voiced in the television debates relates to pricing; especially that pharmaceutical companies which spend millions (billions?) should be allowed the freedom to price their products. And any regulation would be a disincentive for them to introduce newer products. This argument lacks substance because the pricing of drugs is not uniform even in the western world. For example the prices of drugs in Canada are far lower than the corresponding prices of drugs in neighbouring USA. In some cases the Canadian prices are about half of their American counterparts.

The marketing of anti-retroviral drugs (used to treat AIDS) in South Africa offers an object lesson for those who blindly take sides with the advocates of free-pricing. Indian companies like Cipla and Hetero Drugs offered to sell a combination of anti-retroviral drugs at $350 for a year’s course. Four multinational companies challenged them in the South African Supreme Court, on the ground that these companies were infringing their patent rights. They were selling the drugs at $10000 for a year’s course. They had to withdraw their suit following worldwide revulsion. For, more than a third of world’s AIDS population lives in Sub-Saharan Africa.

In the television debates, medical doctors representing Novartis claimed that the company has a scheme for providing the medicine free of cost to ‘below poverty line’ patients. This is not entirely true because the company stopped providing imatinib free after two Indian companies were permitted to introduce low cost alternatives in 2006. (See the research paper cited above.) Even if the company has been providing the medicine free to BPL patients, how does one define a BPL patient? Certainly a household with an income of 50000 per month cannot be considered BPL? If the household has a patient who requires imatinib, can it expend 1,20,000 a month? Besides, many cancers require multiple regimens of treatment, which include chemotherapy (drugs), radiation and surgery. The latter two are even more expensive than the cost of medicines.

TAILPIECE: By the by, the promotional or marketing budgets of pharmaceutical companies exceed their R&D budgets by a long chalk.   

Saturday, March 23, 2013

Have political ploys made the law an ass?


Is the law an ass?’ asks a character in Charles Dickens’ famous novel, Oliver Twist. Several incidences over the last few days make ordinary folk wonder whether the law is really an ass?

ITALIAN MARINES CASE The first of these concerns the Italian marines’ case, which raises several questions. Why had the Indian Supreme Court exhibited unseemly generosity in permitting the Italian marines – undergoing trial for first degree murder - to return home first to celebrate Christmas and then to vote in an election?

The Italian marines were undoubtedly undergoing trial for first degree murder as they shot to kill. Their claim that they thought that a pirate ship was closing in and they shot in self-defence does not wash. For, as trained naval officers, could they not distinguish between a pirate ship and a fishing boat? Were the naval officers so scared of a small fishing boat, that they thought that it was closing in to hijack their vessel? If so why did they not fire warning shots to dissuade the boat even assuming that it was closing in, which appears far-fetched?

Could an Indian citizen undergoing trial for first degree murder expect the same treatment from the Indian courts? Had an Indian Court ever permitted a prisoner, undergoing trial for first degree murder, to go home to celebrate Diwali? It would never have occurred to an ordinary citizen in judicial custody, undergoing trial for first degree murder to even pray for such leave. Therefore an ordinary citizen should not be faulted if he wonders why, even for the Indian Supreme Court Italian citizens are more equal than Indian citizens’. On many occasions in the last thirty years, the Indian establishment has demonstrated that for it, Italian citizens are indeed more equal than Indian citizens. The reason for the establishment to bend backwards being the Italian connection of India’s ruling party is quite obvious. But does it matter to the Supreme Court, the highest judicial body and the last arbiter for the ordinary citizen without any clout?

Having blundered twice, the Indian Supreme Court sought to make amends by taking a tough stance in restricting the movements of the Italian ambassador. This put the Indian establishment – especially with its Italian connection – in a quandary. After days of huffing and hawing about Italian perfidy (by the primary and proxy protagonists of the government), the External Affairs Minister grandiosely announced (not without a hint of self-congratulatory glee) that diplomacy succeeded in making the Italians see reason. His tall claims notwithstanding, there are several questions that require answers: 

Why did the Indian government sign a treaty with the Italian government in a hurry while the murder trial was under way? Was it not to benefit the two marines? Do sovereign nations sign bilateral treaties to solve instant crises? 

How would the Italian government have reacted if two Indian naval officers killed two Italian fishermen and were undergoing trial in an Italian court? Would it have been as generous as the Indian government?   

Did the Indian government make a clandestine deal with the Italians to satisfy the Supreme Court and bring back the marines? If this is not so, how could Salman Khurshid assert that the marines ‘will not be awarded death penalty as theirs is not a rarest of rare cases’? If it does not fall in the ‘rarest of the rare cases’ category are Indian fishermen routinely fired at and killed by foreign marines? 

Who should decide which case falls under the ‘rarest of the rare cases’ category or not? Is it the judiciary or the External Affairs Ministry?

The upshot of the deal - which the Minister denies was done - is, the marines will not be taken into judicial custody during the course of the trial; they will stay in their embassy; they will not be awarded death penalty as their case is not in the ‘rarest of rare cases’ category; and if awarded a prison sentence, they will serve it in their own country.

SANJAY DUTT CASE The second case is even more bizarre. It is about the sentence the Supreme Court awarded to Sanjay Dutt, famous film personality, son of a famous film personality and former Congress MP and bother of a sitting Congress MP. The four qualifiers deserve to be stressed to put the case in perspective. The 1993 Bombay blasts (in eleven locations) killed 257 people and severely injured 700 people. According to some sources, the number of injured was 1400.

[Sharad Pawar, Chief Minister of Maharashtra (at the time) later confessed that he deliberately misled people by adding Muslim dominated Masjid Bunder to the list blast locations to pacify communal tensions. See: To keep the peace, I misled people on 1993 blasts: Pawar. This secular balancing of terror has been going on since 1993. Pawar’s confession puts the pronouncements of P. Chidambaram, Sushil Kumar Shinde et al., Rahul Gandhi’s whispering to the American ambassador about Hindu Terror and the NIA ‘investigations’ in certain cases, all in perspective. To grab and retain power, secular politicians would go to any extent to appease the minorities, principally the Muslims. The invention of a phantom Hindu terror is part of the game.]  

The Supreme Court verdict in the case confirms the role of the ISI and several underworld dons. Sanjay Dutt’s role in the blasts has been known almost since the beginning. He had been known to confer with the dons, converse with them over phone and collect and store arms for the attack. His pedigree and the power of his political connections helped in almost getting him off the hook. 

If the CBI could be used to discipline wayward coalition partners to fall in line, it could also be used to save loyal allies. In Sanjay Dutt’s case the CBI did all it could to help him evade the long arm of law. It did not matter to India’s premier investigation agency that it was indeed obstructing the course of justice. It delayed investigation to help Sanjay Dutt destroy evidence, did not pursue leads, presented a weak case in the trial court and did not appeal against the trial court verdict. The CBI did not work for the people, who are its paymasters. It worked against them, and for an individual who declared a clandestine war on the people. Just as in the marines’ case, in Sanjay Dutt’s case too, it has been kinship with the high and mighty that carried the day.

One can understand the clamour of the film fraternity to obtain state pardon for Sanjay Dutt. It has been known for long that the same forces that supplied Sanjay Dutt with prohibited arms and ammunition to wage a war on the Indian state also control the film industry. But why would a retired judge of the Supreme Court and Chairman of the Press Council want to interfere with the administration of justice? That is the sad part.

The highest court in the country has delivered its verdict unambiguously pronouncing Dutt guilty. The Supreme Court has also been magnanimous in awarding the least possible sentence according to law. If in spite of this, as the Law Minister averred, an appeal for pardon is favourably considered, it would amount to subverting the justice system.