31st May, 2010

Amit Sen Gupta


THE publication of a claim that scientists have created “life” from “four bottles of chemicals” in the American journal, Science, has attracted considerable attention. Reactions have been varied, with one commentator even hailing it as “one of the most important scientific achievements in the history of mankind”. Others have been more muted and many researchers in the field of biotechnology have questioned whether it is appropriate to claim that “life” had actually been “created” in a laboratory. Many other reactions have come in from religious groups decrying “man’s attempt to play God” and from those raising concerns that the release of “synthetic” organisms pose a threat to nature.

CRAIG VENTER: BIO-ENTERPRENEUR ICON

Perhaps the publicity around the claim would have been less extragavant if at the centre of it there was not a person called Craig Venter. A larger than life figure in the field of biotechnology, Craig Venter has been described by one commentator as a “bio-enterpreneur icon”. It is an accurate description, for Venter is better known as an enterpreneur working in the field of science, rather than as a person working at the cutting edge of science. So, while analysing the very important claim that Venter makes, his persona and past history needs to be factored in.

In 2001, Venter was in the centre of another widely reported event – the mapping of the human genome. The unveiling of the map of the human genome was greeted with the accolades that it deserved. But, for the first time in the history of science, the details of such a pathbreaking event was published separately by two different sets of scientists in two different journals! The two sets of scientists represent, respectively, the public funded Human Genome project, and a private company called Celera Genomics. Celera Genomics was a company that Craig Venter had started in 1996. The former published its results in the journal Nature, and the latter in the journal Science (the same, incidentally that has now published Venter’s recent work!).

The story of the human genome project provides us clues about how Craig Venter sees science and its utility. He left the premier public funded research institute in the US -- the National Institute of Health (NIH) -- in 1991 because he wanted the institute to patent individual genes that were then being discovered, in the early days of the human genome project. His biggest opponent at that time was James Watson, part of the Watson and Crick duo who first explained the structure of DNA – the basic building block of life that makes up the genome of any living organism. Watson is famously know to have said at that time that the patenting scheme was "sheer lunacy" and that "virtually any monkey" could do what Venter’s group was doing. In 2001, the public funded Human Genome project (in which many countries including India collaborated) published its data at the same time that Celera Genomics did. Many commented that this had saved science from a huge disaster -- because if Craig Venter had been the first to publish he would have made sure that the information available through the decoding of the human genome would have been locked in by thousands on thousands of privately held Patents.

WAS LIFE REALLY CREATED?

Let us fast forward to 2010 and examine what Craig Venter and his team have achieved. Venter claims that his team has created life from four bottles of chemicals. Let us try to understand what was actually done. Venter’s team first analysed the entire genome of a single-cell bacterium called Mycoplasma mycoide. This was a huge exercise, which took about 15 years, cost $40 million and required 25 researchers to accomplish. The genome is the portion of any living cell (bacteria are single celled organism but complex organisms such as humans are made up of by millions of cells with specialised functions) that contains the code that tells the cell how it should function. The code is written into the genome by millions of permutations and combinations of four basic sugar molecules – in bacteria these sugar molecules are adenine, guanine, cytosine and thymine. In the case of the Mycoplasma mycoidegenome that Venter’s team worked with, over a million bits of code (1.08 million bits to be exact) in the bacterium’s genome was recorded in a computer. Exact copies of each bit of code was then synthesised artificially and assembled together by techniques that are now available. To differentiate the genome from a naturally existing one, “watermarks” were added – a few sequences that do not have any useful code written into them but were a form of signature added by the team to stamp their ownership over the synthetic genome. The final step involved the transplanting of the synthetic Mycoplasma mycoides genome into recipient cells of a related bacteria (Mycoplasma capricolum). To ensure that the recipient cell did not reject the newly inserted genome a gene responsible for producing a “restriction” enzyme in the recipient cell had to be inactivated. To put it in Venter’s own words, “on March 26, the synthetic genome was "booted up" -- and it worked! The new bacterium started doing what bacteria do best – i.e. it started replicating and making copies of its own self.

Can we say that Craig Venter’s team actually “created” life? If we cut through the hype of newspaper reports, the answer is no. What the team of scientists did was not insubstantial, but they definitely did not create life. They diligently copied millions of instructions in an existing bacterium and then inserted these instructions into another existing cell. There should be no hesitation in accepting that it was a huge computational exercise. But it was just that and no more. The team blindly copied the code without any means to know what each bit of code actually meant. It was like making an exact copy of the Mona Lisa on a different canvas, without the copier being able to claim that he had been transformed into Leonardo Da Vinci. For while the copier could claim to have made an exact copy, unlike Da Vinci he would still not have acquired the knowledge of how each brush stroke would blend into the next. In other words, he would not know how to make another masterpiece on his own. The same is true for Venter’s team. If they do not have an existing genome to copy from, they cannot create another synthetic genome.

The above does not imply that sometime in the future we shall not have the knowledge and the technique to really create life from first principles. What it does, however, show is how far away we still are from being able to do so. For, in order to do so, we would need to know exactly what each of the over a million codes in the genome does. Only then can we create the bits, knowing their functions, and then assembling them to create an artificial organism whose functions and characteristics we would have defined. Remember that here we are discussing the synthesis of the most primitive one-celled form of life. Imagine how much more complex it would be to attempt to synthesise multi-celled living beings which can each have millions of cells, each with millions of buts of code. Hence it is mere speculation to infer that Venter’s accomplishments would lead to the synthesis of a wide range of useful products such as bacteria to tackle oil spills or to produce medicines.

In some ways recombinant technologies used to create genetically modified organisms (GMOs), where the genetic code of useful characteristics of one organism are identified and then inserted into another organism, is much nearer to the process of creating an entire new organism. Today this technology is still very primitive, and we are barely able to use it to identify, extract and insert one or a few (among millions) characteristics.

UTILITY OF & CONTROL OVER SCIENCE

Let us turn to the real issues that need to be addressed in the wake of what Venter’s team has accomplished. There have been the usual “knee jerk” reactions about the need to stop “messing” with nature and the need to restrict research in areas about the consequences of which we do not know enough. Such doomsday prophecies have two problems. While we have started “messing” with nature at the cellular level only recently, we have been doing so for the last hundreds of thousand of years – ever since the human species left the trees and started changing nature to suit its needs. Settled agriculture, urbanisation, industrialisation, etc., have been changing much of nature as it existed for centuries and more. Yes, we are reaping the consequences of some of our actions – as best evident from the looming climate crisis. But does the answer to that lie in our going back to living in the wild and foraging for roots and berries? We would argue that the answer lies, rather, in increasing our knowledge about nature, so that we are better able to decide how much we can extract from nature and still keep the planet habitable and able to provide to every inhabitant of the planet what she or he needs. Further, if all that we do in science was to be predictable, we would not be doing science! Which does not mean science should not have boundaries. But such boundaries need to be negotiated between the concern that we need to know more and that we should not use this knowledge to create something that can cause irreparable harm.

Of more immediate concern, as regards the feat achieved by Venter’s team, relates to how the knowledge that has accrued will be used and controlled. The use or misuse of knowledge can have boundaries only if it is open to public scrutiny and not bottled up in private hands through secretive means. This is of particular importance given Venter’s earlier track record of wanting to create knowledge monopolies through patents. It is incorrect to characterise what Venter’s team has done as an invention. Nothing new has been created. Rather, we have seen the demonstration – albeit at a hitherto unknown grand scale – of how we have the technique available to copy one of nature’s products. Athena Andreadis, Associate Professor of Cell Biology at the University of Massachusetts Medical School, writing in the Huffington Post, puts Venter’s work in clear perspective when she says: “The Venter work is not a discovery, let alone a paradigm shift. It's a technological advance and even then not of technique but only of scale. The experiment is merely an extension of a well-known principle that every biology lab uses routinely: namely, that bacterial genomes can be modified almost at will (barring a few indispensable regions) and in such ways as to turn the bacteria into potent mini-factories for specific proteins. The Venter bacterium is actually pedestrian because it carries an exact duplicate of a naturally occurring genome. Its only artificial aspects are the molecular "flags" that its makers included in the synthesis to mark the artificial genome for further tracking - standard operating procedure in all such modifications”.

But such labeling of his work is unlikely to deter Craig Venter from using the opportunity to fence off large areas of research through applications for broad patents. This is already being talked about. John Sulston, chair of the University of Manchester’s Institute for Science, Ethics and Innovation, said to the BBC recently: “I’ve read through some of these patents and the claims are very, very broad indeed… I hope very much these patents won't be accepted because they would bring genetic engineering under the control of the J Craig Venter Institute. They would have a monopoly on a whole range of techniques.” John Sulston is someone who would know well what he is talking about, having previously worked on the human genome project and having been a bitter opponent of Craig Venter’s attempt to patent the work related to the mapping of the human genome in 2001.

So, while we continue to wait for humans to break one of the final frontiers of science – creation of life – we need also to be vigilant of the smaller skirmishes that threaten our ability to widen the boundaries of knowledge that deepen our understanding of the world around us.

May 02, 2010

Prabir Purkayastha

THE near fatal radiation exposure in the Mayapuri scrap has led to hospitalisation of 11 people. The cause has now been identified as radioactive cobalt 60 sources that were mixed up in the scrap. What neither the Atomic Energy Commission nor the government has disclosed is that it is not the first time that we have found radioactive cobalt 60 in metal scrap. Almost two years back, Germany reported finding radioactive steel coming from India. The French followed with reports of radioactive buttons in elevators originating from radioactive steel, again from India. It is amazing that even after this and known dangers to the people who would be inadvertently exposed to high radiation, the government of India and its agencies took no steps regarding the prevention of such incidents. Neither do we have any clarity on how such incidents have occurred or from where the offending radioactive material originated.

The Atomic Energy Commission, the keeper of the nation's nuclear safety has virtually washed its hands off the affair, claiming that the radiation material appears to have originated from imported scrap and AEC had no responsibility regarding this. This is what Prithviraj Chavan has also echoed in the parliament. What this shows is the utter callousness with which the government authorities conduct their nuclear affairs. To add gratuitous insult to radiation injury, Prithviraj Chavan tried to relate it to the Nuclear Liability Bill pending in the parliament – apparently this bill has provisions relating to radiation damage from scrap. The truth is that the Nuclear Liability Bill covers only nuclear reactors, and the last we know, there are none in Mayapuri!

Now it transpires that the radioactive material originated from the Delhi University Chemistry Department, which had disposed of as scrap a gamma radiation equipment with an active source of cobalt 60. Therefore, this falls squarely within Atomic Energy Regulatory Board (AERB) /AEC's jurisdiction, as they are supposed to track all radioactive sources in the country.

The story of radioactive scrap is not new. In August 2008, a container from India containing bars of steel to be sent forward to Russia, was detected by port authorities in Hamburg to have very high radioactivity levels. In one day, the radioactivity level was equal to what is a safe dosage for a year. Neither was this an isolated incident. According the Spiegel Online International (Finds of Radioactive Steel on the Rise in Germany, Christian Schwägerl, 02/16/2009), “For months, similar cases have been found across Germany, all involving bits of metal contaminated with radioactive cobalt. And most of them come from the same source: three steelworks in India, in particular a company called Vipras Casting, based in Mumbai”. Later reports indicated that apart from Vipras Casting, there were another five companies involved. They were Bunts, Laxmi Steels, SMK Steels, Pradeep Metals, Goradia Special Steels Ltd.

The Atomic Energy Commission and the Atomic Energy Regulatory Board (AERB) has total responsibility in the country for all such matters.  Satya Pal Agarwal, head of the radiological safety division of India’s Atomic Energy Regulatory Board stated at that time that AERB was tracking the whole supply chain. We have yet to hear what happened after the supply chain was “tracked”. Instead, we hear exactly similar sounding statements emanating from AERB. The only grudging additional information given is that scanners are supposed to be installed in all the ports, which are lagging behind. No details of what are the steps that AEC or AERB took after the last round of radioactive contamination was reported.

The issue is clear. Radioactive material is mixed up in scrap – either imported or local -- and finding its way into steel making. Obviously, iron and steel scrap is used extensively in India and elsewhere for making steel. This steel is not only exported but also finds its way into domestically manufactured engineering goods. This is the danger – such “hot” steel is circulating in India already and the government is taking no steps regarding such danger to its people. If more than 150 tonnes of steel have been reported to have such radioactive contamination, how much is circulating here? It would be foolish to think that only exported steel has been contaminated and not domestic manufacture.

LESS IMPORTANCE FOR PEOPLE’S LIVES

In today's day and age, peoples lives are assumed to have less importance than the value of our exports. Obviously, if the steel used in engineering industry gets contaminated, this poses a huge risk for our 23 billion dollar exports in this sector. If not for the health of its people, at least for protecting its industry and its exports, we would have expected the Indian government to carry out an aggressive program with respect to import of suspect iron and steel scrap. Yet, after almost two years, we find that the scanners and radiation measuring instruments to monitor imported scrap is yet to be functional in our ports. The government has passed the buck to the steel makers telling them that they must check for radioactive contamination of all their inputs.

In a statement to the press, Dr S Banerjee, chairman of the Atomic Energy Commission said , "Whatever happened in Delhi had nothing to do with the activities of my department. The scrap materials come from other countries and it was not possible for the Department of Atomic Energy to check at the entry points if there were any radioactive materials in them. Checking all the containers laden with scrap was not possible. Instead, scanning could be done. While a decision to install scanners had been taken, implementation was taking time." This statement makes clear – according to AEC – they are not responsible for radioactive material if it is mixed up in imported scrap. According to Dr A Goplakrishnan, former chairman, AERB, AEC chairman's position is not in conformity with the constitutional responsibilities that AEC and its subordinate institutions have. Under the country's law – the Atomic Energy Act of 1962, it is their responsibility and this is an attempt by AEC and AERB to evade their legal responsibilities. If we take into account that AEC and AERB have been fully aware of the risk of imported radioactive scrap, their evasion of responsibilities becomes even more glaring.

As Dr Gopalkrishnan points out (http://news.rediff.com/column/2010/apr/22/delhi-radiation-case-aec-aerb-also-culpable.htm), the Act's sections 16 and 17 makes clear that monitoring all such possible radioactive substances is a part of AEC's duties. Subsequently, Atomic Energy Regulatory Board was set up in 1983 and this part of the mandate was transferred to AERB. Dr Gopalkrishnan points out, “One of the responsibilities legally assigned to the AERB through its founding notification is to review operational experience in the light of the radiological safety criteria recommended by the International Commission on Radiological Protection (ICRP), International Atomic Energy Agency (IAEA) and other similar international bodies, adapt them to suit Indian conditions, and thereby evolve major safety policies.

This aspect is especially relevant in dealing with issues of missing and misplaced powerful radioactive sources, a subject in which IAEA has enormous experience and data bases. IAEA has also, over the years, developed procedures for preventive and corrective action, in consultation with various countries. After evolving appropriate national policies based on this world experience, the AERB is to implement them and maintain a high degree of nuclear safety and security in the country”.

The AEC Chairman cannot wish away the statutory obligations that the Act imposed on AEC. In fact, the radioactive steel cases in Europe were all dealt with their respective nuclear agencies who also put in place the measures to prevent such occurrences as well as the safe disposal of the radioactive steel. Contrast this with India, where the steel company was told to bury the 21 tonnes of radioactive steel in its premises. The company also complained that AERB was not very cooperative on this question. (http://www.timesnow.tv/India-dumping-ground-for-radioactive-waste/articleshow/4333103.cms).

One of the advantage of radioactive contamination for post mortem purposes is that it does leave a physical trace. The people are entitled to ask what happened last time when AEC/AERB traced the path of radioactive scrap going into steel plants? Is it the same source that caused the problem last time that is responsible now also for the Mayapuri incident or is it a new source? Where did the scrap originate last time and what are the steps that AEC/AERB took then? None of these questions have been answered and given AEC/AERB's record of opaque functioning and stonewalling all questions of safety, none may materialise.

INDIA BECOMING A HAZARDOUS DUMPING GROUND

India is already offering itself as a hazardous dumping centre to the world. Ship-breaking in Alang has come under the repeated scanner of environmental groups. It now seems with its lackadaisical attitude to radioactive waste and failure to install scanners even after two years of such known cases of dumping, we are signalling a window of opportunity for unscrupulous nuclear waste disposal companies abroad. Come and dump your radioactive cobalt here, we will take some more time before we can even monitor such shipments.

The Delhi University case also shows that AERB needs to strengthen its monitoring and tracking of all radioactive sources. Sadly, the response from AERB and AEC does not show and increased awareness of this. This is what we need to rectify to avoid more such incidents.

April 11, 2010

Amit Sen Gupta

“Yes we can”. This was the slogan that galvanised millions of Americans and voted Barack Obama into the White House in 2008. A rainbow coalition of Americans, representing the working people, people of colour, hispanics and Asians – traditionally sections that have lost out while pursuing the great “American Dream” – thought they were voting for a different America. They believed they were voting to start a process that would dismantle an apparatus that thrived on exploitation and greed.

Perhaps nowhere is the evidence of crass greed taking precedence over peoples needs more apparent than in the health care system in the US. That is why one of the major planks of President Obama’s election campaign was a reform of the health care system in the US. In the past year, the Obama Presidency has been engaged in cobbling together a package of reforms for the US healthcare system. The efforts culminated in the signing of two bills in March this year. The Patient Protection and Affordable Care Act (known as the "Senate bill"), became law on March 23, 2010 and was shortly thereafter amended by the Health Care and Education Reconciliation Act of 2010 which became law on March 30.

Is this the reform that people were looking for when millions cheered on President Obama in his victory ceremony? By all accounts, the answer would be a resounding no! Who are the people who are cheering from the sidelines? We do not see the same faces that cheered on President Obama as he swept towards victory. In fact President Obama’s approval ratings are at an unprecedented low. Instead the cheers are led by a very different kind of constituency – the American Medical Association, the pharmaceutical industry, and the Insurance Industry.

So what went wrong? Why this gap between rhetoric and delivery? To find some answers we need to first understand how much of a problem healthcare is in the United States and how it is organised.

US HEALTH CARE : MOST EXPENSIVE & LEAST EFFICIENT

Health care in the US is the most expensive in the world – the country spends a greater portion of its GDP on health than any other country. It is estimated that spending on health care in the US is about 16 per cent of its GDP. In 2007, an estimated $2.26 trillion was spent on health care in the United States. Further, health care costs are rising at a rate that is much higher than the inflation rate and it is projected to reach 19.5 per cent of GDP by 2017. We can look at this figure in another way – total health care costs in the US is about twice that of India’s entire GDP – which means the US Health Care Industry is twice the size of India’s entire economy! The US also spends the most on pharmaceuticals per capita in the world and the US pharmaceutical market is about 1/3rd of the entire market for medicines in the world.

Yet, this enormous expenditure on health care does not translate into secure care for millions of Americans. In 62 per cent of all personal bankruptcy in the United States, medical debt is cited as a factor -- the biggest single factor of reasons cited. Studies indicate that the number of uninsured in the US (for all or part of the years 2007-2008) was 86.7 million, i.e. about 29 per cent of the US population, or about one-in-three among those under 65 years of age. The important thing to understand is that if you are not insured in the US, you either go bankrupt or die. Only a small percent (mainly the old and disabled and those designated as poor) can legally access subsidised care provided by the government. Well known US academic and health care analyst, Vicente Navarro, estimates that between 18,000 and 100,000 deaths could be prevented in the US if people had access to health care. Moreover, in the US, being insured does not guarantee secure health care. It is estimated that one of every four Americans families have problems with paying medical bills – a majority of whom have health insurance.

The US stands 38th in life-expectancy (i..e. the average number of years a person is expected to live), behind all other G7 countries (Canada, France, Germany, Italy, Japan, UK, US) and even behind developing countries such as Cuba and Chile. In 2000, the World Health Organisation (WHO) ranked the US 72nd by overall standards of health enjoyed by its citizens.

STRUCTURE OF HEALTH CARE IN THE US

The reason why the US health system is held out as an example of how not to organise health care lies in how it has historically been structured. As we discussed earlier, Americans are already paying enormous amounts to access health care. About 40 per cent of this expenditure is borne by the government and the rest by individuals – directly or through insurance premiums. So clearly, lack of resources is not the constraint. The real reason lies in the way private corporate interests – pharmaceutical companies, insurance companies and health management organisations (HMOs) – combine to make huge profits and undermine the health care of millions of ordinary Americans.

The current system of health care in the US is based on the 1948 Taft-Hartley Act, that gives freedom to employers to negotiate with individual insurance companies. This is very different from the “single-payer” system that exists in most other developed countries – in Europe, Canada, etc. In the latter case the government manages the insurance coverage available, ensures that the coverage is adequate (covers all conditions) and universal (covers all citizens). The US system allows individual insurance companies to negotiate different terms and conditions with employers. Further the US system leaves out a huge number of people who are not employed or whose employers find ways to dupe them and negotiate inadequate deals with insurance companies. A part of this gap is covered in the use by government run health care programmes – Medicare and Medicaid – that target the old (over 65) and the poor, respectively. However the coverage in these cases is grossly inadequate. Those under government schemes have to pay out-of-pocket when their medicines budget exceeds the cap on medicines expenditure. Such expenses are often enormous, given that medicines in the US are about the most expensive in the world.

The US system, thus, depends critically on the negotiating power of trade unions. Typically, packages available where unions are strong (viz. in the manufacturing sector) are comparatively better. This also explains the very wide variation in insurance packages that are available to Americans. Interestingly, the linking of health insurance to employment also compromises the bargaining power of workers, because workers who lose their jobs also lose the health insurance coverage. It has been argued that this phenomenon, in part, explains why the United States is the country with the fewest working days lost due to strikes

There is another side to this form of structuring of the health care system in the US. The insurance and the pharmaceutical industries are the two most profitable industry sectors in the US – in 2008 they had profits of $12 billion and $49 billion respectively. Put in another way – just the profits that the US pharma industry makes is four times the total turnover of the pharma industry in India! Clearly, US drug companies not only exploit patients in other countries, it makes a large part of its profits by consistently over-charging ordinary Americans for every single medicine that they consume.

THE POWER OF LOBBYISTS

It is easy to understand the enormous clout of vested interests that have a stake in continuing the present system of health care in the US. America's health care industry is understood to have spent hundreds of millions of dollars in 2009 alone to block the introduction of public medical insurance and stall other reforms. It is estimated that there are six registered health care lobbyists for every member of Congress in Washington.

During the 2008 US presidential elections, the Center for Responsive Politics in the US estimated that (as of February 12, 2008), the insurance industry had contributed $525,188 to Hillary Clinton, $414,863 to Barack Obama, and $274,724 to John McCain.

It is instructive to hear what the pharma industry had to say after the signing of the bill on health care reforms. The Pharmaceutical Research and Manufacturers of America (PhRMA) responded thus: “The legislation, signed into law amid much fanfare on 23 March, is 'not perfect' but represents a step in the right direction by helping to ensure that all Americans have access to high-quality and affordable healthcare”.

Clearly the lobbyists have won, and the American public has lost – once again!

PROPOSALS IN THE BILL

Let us, in the above background, examine the reforms that President Obama has finally managed to push through. His reforms package will cover an additional 32 million Americans who are currently uninsured. Those covered by the government run medicare scheme will not have to make out-of-pocket payments to procure prescription medicines beyond a certain cap. The government run medicaid will be expanded to include families under 65 with gross income of up to 133 per cent of federal poverty level and childless adults. Insurers can no longer deny coverage to those with pre-existing conditions. The uninsured and self-employed will be able to purchase insurance through state-based exchanges and low-income individuals and families wanting to purchase own health insurance will be eligible for subsidies. Those not covered by Medicaid or Medicare must be insured or face fine. Part of the excess costs to the government will be paid for by and extra cess on high income tax payers.

What is however more important is what the reforms package has not done. It has left intact the freedom of employers to negotiate with individual insurers. Its coverage of uninsured people still falls grossly short of the real need. It has no ways to significantly curb the profitability of pharmaceutical and insurance companies. Most importantly, it does not promote a single payer system, and thereby does not curb the power of private insurance and health management companies. Whatever new money is going to be pumped into the system will go to further strengthen the triumvate of insurance companies, pharmaceutical companies and health management organisations.

Seldom has any president in the United States been endowed with so much goodwill at the start of his presidency. Most importantly, this groundswell of support came primarily from the poor working people of the United States. If the Health Care Act is any indication, Barack Obama stands in danger of losing this support faster than he acquired it. He will do well to remember the experience of his Democrat predecessor to the White House – Bill Clinton. The American electorate punished Bill Clinton for reneging on his promises to make America a more humane society – including on his promise on health care reforms. 2012 may well see the same happen to Barack Obama if he continues to remain captive to the system.

March 28, 2010

Amit Sen Gupta


IN the early 1960s, across Europe, doctors were confronted with a strange and distressing phenomenon. Hundreds of reports started pouring in about babies being born without arms and legs. They had flippers or fingers emerging from their shoulders. Many were born with eye and ear deformities, and severe internal damage such as malformed kidneys and anal  atresia (a condition where there is no external opening to the bowel). Some were born with deformed genitals, or no genitals at all.

The deformed babies had one thing in common: their mothers had taken a drug called thalidomide, that was marketed during the 1950s and early 1960s as a sedative. By the time the drug could be withdrawn, over 8,000 thalidomide babies were born worldwide.

FIFTY YEARS AFTER THE THALIDOMIDE TRAGEDY

The Thalidomide tragedy brought out into the open a practice that the pharmaceutical industry indulges in on a regular basis even today. The Thalidomide tragedy occurred because the German drug company, Chemie Grunenthal, and a number of other companies worldwide, produced and marketed thalidomide, without paying attention to existing evidence that the drug could be extremely toxic. They were following what was standard industry practice – keep denying reports of toxicity and influence doctors to prescribe a toxic medicine even if it jeopardises the health of thousands.

Before the drug was marketed, Grunenthal’s own studies showed that the drug was toxic, but the company continued to recommend that the drug was absolutely safe. The company even started selling the drug as a sedative for children as well. Grunenthal’s campaign to “prove” the drug’s safety included 50 advertisements in major medical journals, 200,000 letters to doctors around the world, and 50,000 circulars to pharmacists. In Britain, Grunenthal's distributor -- Distillers Company Biochemicals Ltd. (DCBL) --  sent pamphlets to doctors claiming that: "Distaval (the brand name for thalidomide in Britain) can be given with complete safety to pregnant women and nursing mothers without adverse affect on mother or child."

By the winter of 1961, neither Grunenthal nor DCBL could ignore the information detailing thalidomide's devastating effects. In November, Grunenthal pulled the drug off the market and in December, DCBL followed suit. But this came too late for thousands of women who were to deliver deformed babies – finally over 8,000 thalidomide babies were born in 46 countries, and some estimates put the number of stillbirths (babies born dead) at twice that number.

PROMOTION OF MEDICINES – PROFITS BEFORE PEOPLE

The Thalidomide saga ended with the companies involved finally having to pay millions as compensation to the families of victims. But, sadly, little changed as regards how drug companies market medicines. Fifty years have passed since the thalidomide tragedy, but companies continue to put profits before the lives of people across the world. It is estimated that one-third of the cost of a medicine is made up of by money that the manufacturing company spends in promoting the drug.

Among all industry sectors, the pharmaceutical industry is by far the most profitable in the world. The industry, in order to maintain this extremely high level of profitability, uses different methods to influence how medicines are used and prescribed. They need to do this because most new medicines that they introduce are not real advances over existing medicines. In fact many of them are inferior to existing medicines and may also have unacceptable side-effects. Studies show that, in the last decades, less than 3 per cent of medicines that were introduced, actually could be termed as major advances over known treatments. The challenge, then, before the industry is to promote medicines that have little additional benefit to offer, and in addition may have serious adverse effects. To circumvent this problem the industry has built a vast network, whose sole aim is to influence doctors, chemists and consumers into prescribing, selling or consuming medicines that they may not need or which may have serious side effects.

This network, aimed at promoting medicines, uses all kinds of means – fair or foul – to solicit higher sales for medicinal products. Inappropriate promotion of medicines is the norm rather than the exceptions. The World Health Organisation (WHO) has for long taken note of this phenomenon. It defines drug promotion as: “all informational and persuasive activities by manufacturers and distributors, the effect of which is to influence the prescription, supply, purchase or use of medicinal drugs”. There have been several attempts to curb unethical, and often criminal, methods employed by companies to promote medicines. The WHO has attempted to promote a “model code of conduct” on promotion of medicines, which has consistently been obstructed by the pharmaceutical industry. Many countries, especially developed countries, now try to monitor the promotion of medicines. There is also a growing attempt by associations of medical professionals in many parts of the world to curb the complicity of doctors in promoting medicines. However, most such efforts have been only partially successful, and the bane of unethical promotion continues to afflict the health sector like a festering sore, that distorts rational and scientific practice of medical science.

THE INDIAN STORY – TRAIL OF CORRUPTION

India is typical of what happens as regards drug promotion in many countries in the world today. Indians spend, approximately, Rs 50,000 crore every year in buying medicines, i.e. Rs.2,000 for every family in the country. It has been estimated that at least 50 per cent of this expenditure is incurred on irrational or unnecessary drugs. This adds up to a colossal waste of Rs 20,000 - 25,000 crore every year.

An estimated 80,000 brands of various drugs available in the Indian market, while the WHO lists a little over 300 drugs which can take care of an overwhelming majority (over 95 per cent) of the health problems of a country. A majority of the estimated 80,000 products in the market are either hazardous, or irrational or useless. The pharmaceutical companies and the government regulatory bodies are both to blame for allowing such a situation to develop in this country. But all this would not be possible without the active involvement of the medical profession, who contribute by prescribing such irrational and useless drugs. One reason for this is the fact that there is almost no source of regular unbiased, authentic information on drugs available in the country. Given the rapid changes in treatment procedures and introduction of a large array of new drugs (many unnecessary as we have discussed earlier), medical practitioners need to update their knowledge regularly. Such a system of continuing medical education is largely absent in this country, and most doctors do not find the need to take time out from their busy practice to update their knowledge by reading the most recent books and journals. Thus we have the sad practice of a bulk of medical practitioners depending on promotional material supplied by Pharmaceutical companies. Obviously such promotional material only provides biased information to doctors, with a view to maximising the sale of the products being promoted.

The drug industry in India spends 20 per cent of its annual sale – approaching Rs 10,000 crore – in promoting medicines. This works out to about Rs 100,000 per doctor per annum and each doctor prescribes drugs worth Rs 50,000 per annum. The practices adopted by the industry to promote medicines has been documented by various studies, including one that was published in the Indian Journal of Medical Ethics (April – June 2007). As we have discussed earlier, the most prevalent method of “pushing” medicine sales is through distribution of drug information that conceals more than it reveals. But this is just the tip of the iceberg.

Representatives of drug companies are taught to give small gifts to doctors, to keep their brand in the doctor's memory. These "brand reminders" vary from desktop items to minor medical equipment, including prescription pads and rubber stamps (with the names of drugs manufactured by the company). Such apparently innocuous “gifts” constituted the bulk of “gifts” from drug companies to doctors even a few decades back. But today the situation has started changing rapidly and brand reminders are increasingly being replaced by gifts of greater value. These range from jewellery to electronic items such as air conditioners, washing machines, microwaves, cameras, televisions, and even automobiles! Pharmaceutical companies offer larger “incentives” to consultants and specialists who are considered "good" prescribers, as verified by neighbourhood chemists. Doctors in public teaching hospitals are also considered a prize catch as they are in a position to influence new entrants into the field (medical students and junior doctors).

To ensure that the “incentives” actually work in generating more prescriptions for a particular brand of a medicine, such incentives are now linked with the number of prescriptions generated. Printed handouts are distributed by companies giving targets for doctors, with incentives like a cell phone handset for prescribing 1,000 tablets, an air cooler for prescribing 5,000 tablets and a motorcycle after 10,000 tablets were prescribed!

The story becomes murkier still. Select doctors are sponsored for foreign conferences organised by drug companies under the garb of “scientific” conferences -- registration fees, air tickets and stay for doctors and their spouses are paid for by the company. Not just individual doctors, associations of medical professionals are prime targets as well. Over the past decades, conferences of medical associations have moved out of academic institutions to five-star hotels which serve lavish cocktail dinners – entirely paid for by drug companies.

In perhaps the most blatant display of corrupt practice yet, companies have even abandoned the fig leaf of “scientific conferences” to justify all-expenses paid trips for doctors to exotic locales, and have been known to announce such trips to locales ranging from the Sunderbans to Bali.

TIME TO BREAK THE UNHOLY NEXUS NOW!

Clearly, such practices make a mockery of the Hippocratic oath and jeopardize the health of millions of unknowing patients – many of whom receive medicines only because his physician has been unduly influenced into prescribing it. As we have noted earlier, a part of the solution to this state of affairs lies in instituting mandatory continuing medical education (CME) programmes for all doctors and by regularly producing unbiased drug information (on the lines of the British National Formulary, for example).

In recent months two initiatives instituted by the Department of Pharmaceuticals (DoP) and the Medical Council of India, need to be taken note of. The DoP has been engaged in persuading industry associations to adopt an Uniform Code of Pharmaceutical Marketing Practices (UCMP). Several meetings have been held and while the department claims that such a code has been finalised, other sources indicate that the associations representing big companies are attempting to dilute the model code to make it unworkable. Concerns have been raised about the fact that this is a “voluntary” code, and no punitive measures are indicated against those who violate the code.

In parallel, the Medical Council of India moved an amendment last year in the Indian Medical Council Act and inserted an additional Section 6.8, titled: “Code of conduct for doctor and professional association of doctors in their relationship with pharmaceutical and allied health sector industry”. The amendment is designed to bar doctors from receiving gifts, sponsorships, etc. from the industry and from promoting specific medicines in any other manner. Recently, the chairperson of the MCI has indicated that the MCI is going to recommend to the government quantum of punishment for those who violate the new amendment to the MCI’s regulations. In themselves, these are welcome measures. Concerns however remain regarding how these measures will be implemented. The MCI and the state Medical Councils, till now, have earned the reputation of being toothless bodies and very few actions have been initiated against erring doctors by them. Amendments to the Act need to be followed up with granting of statutory powers to the MCI that allows it to take suo moto note of violations of the Act (at present the MCI acts only if there is a complaint). Further, the amendments moved by the MCI cover individual doctors but do not address the nexus between the industry and professional associations.

The nexus that exists between the drug industry and a section of doctors in the country is extremely deep and well organised. Powerful vested interests have a stake in making infructuous any attempts to break, or even dent, this nexus. The government needs to play a much more proactive role in breaking this chain of corruption and malpraxis that hits at the very root of rational practice of medicine.