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Public Health
Nefarious Design to Legitimise Exorbitant Prices PDF Print E-mail

Amit Sengupta

4th January 2012

The Government has recently made public the “Draft National Pricing Pharmaceutical Policy, 2011” The circulation of the draft policy, supposedly to make medicines more affordable, comes in a situation where studies show that out-of-pocket medical costs push over 2% of the population below the poverty line in one year. A major part of expenditure on health in India, that people have to meet from their own resources, goes towards buying medicines. This is so because the government spends too little on health care and medicine prices are too high. Unlike in countries with well developed public health systems, where a major proportion of medicines consumed is provided by the public health system, in India around 85% of medicines consumed are bought by patients from chemists shops.

Drug Price Control: Past Experience

While medicine prices have been controlled in some manner since 1962, the first comprehensive drug price control order (DPCO) was introduced in 1979. Since then, the DPCO was amended in 1987 and 1994. While in 1979, most medicines were brought under price control, amendments to the DPCO in 1987 and 1995 resulted in most drugs being removed from price control. (see Table)

Table: Change in Drug Price Control

DPCO

Year

No. of Drugs under

Price Control

Percent of Market

Covered in Price Controlled

Category (approx.)

Mark-up (profitability) allowed

1979

347

80-90%

40%, 50% and 100% in three categories termed “life saving”, “essential” and “non essential”

1987

142

60-70%

75% and 100% in two categories, subsequently one category with 100% mark up

1995

74

25-30%*

100%

*Even less now as many of the 74 drugs are now obsolete and just over 30 of the drugs in the price control list have any public health relevance

Thus, over time, the prices of an overwhelming majority of medicines in the market have been decontrolled. While the Government has continued to reason that such decontrol is necessary for the health of the industry, it has had a serious and continuous impact on drug prices – which have grown exponentially over time (see Chart below).

Chart: Price Rise in the Pharma Sector

DruDrDrug

Drug prices have risen in the past decades because of price decontrol and through manipulation of the market by pharmaceutical companies. That the market for medicines is rigged by drug companies is clear from the fact that top-selling brands of medicines are often the most expensive or one of the most expensive. This is clearly not a free market situation where competition helps stabilize prices, but a situation where large companies maintain high prices by bribing doctors and chemists to promote their more expensive medicines even though the same drug is available at 1/5th or 1/10th of the price charged by many top selling brands.

In 2002 a new drug policy was announced, that if implemented, would have further slashed the number of drugs under price control from the 74 in the 1994 policy. However a PIL challenged the policy in the Karnataka High Court on the grounds that it did not effectively control drug prices. The Karnataka High Court issued a stay on the implementation of this Policy. This order was challenged by the Government in the Supreme Court. The All India Drug Action Network joined this PIL in the Supreme Court which vacated the stay vide its order but observed:

we suspend the operation of the order to the extent it directs that the Policy dated 15.2.2002 shall not be implemented. However we direct that the petitioner shall consider and formulate appropriate criteria for ensuring essential and life saving drugs not to fall out of the price control and further directed to review drugs, which are essential and life saving in nature till 2nd May, 2003”.

Since then there have been several calls for the introduction of a fair pharma pricing policy. These calls have also been echoed by the Parliamentary Standing Committee on Health and by the Supreme Court. The Government responded to such calls by constituting several Committees e.g the Sandhu Comitteee and the Pronob Sen Committee. A ‘Group of Ministers’ was constituted during the term of UPA I to effect a fair resolution of the issue. It remains a mystery why the group failed, in seven long years, to find a solution.


Safeguard for Industry, not for Peoples Health

It is in the above background that the draft Pharma policy, 2011 has to be seen. It has been formulated in a situation when: 1) Most medicines are outside price control; 2) There is complete anarchy as regards prices of medicines outside price control, with clear evidence that the same medicine is being sold at prices that vary enormously. 3) The prices of top selling brands of the same medicine are often the most expensive.

The proposed policy starts with a radical and welcome proposal that all drugs (348) in the National Essential Drug List brought be brought under price control. But this proposal hides a much more nefarious design that seeks to legitimize the rampant practice of profiteering in the pharmaceutical market. It does so by proposing that henceforth prices of medicines shall be fixed based on “market based” criteria. Till now, drug prices were fixed by using a ‘cost plus’ formula. The price of the finished product sold in the market was fixed by calculating the cost of manufacturing and then by placing a ceiling on the post manufacturing expense. The post manufacturing expense (MAPE) allowed included the profit for the company – as per the 1995 DPCO it stands at 100%. Thus if the cost to manufacture a formulation is Rs.1.00, it can be sold at Rs.2.00.

The new policy makes two significant departures from the existing methodology of calculating the price of a medicines.

1) It will only fix the prices of formulations (finished medicines sold in the market) and not of bulk drugs (raw material used to manufacture the finished product)

2) It will not use the earlier cost-plus formula but shall use what it calls “market based” pricing

In its defence the draft policy says that: “The emphasis on price control starting at the bulk drug stage itself has in recent times, resulted in amongst other reasons shifting of manufacture of drugs away from the notified bulk drugs under price control. In fact only 47 bulk drugs out the of the 74 notified in the First Schedule of the DPCO, 1995 are now under production. This has had a cascading effect on the formulations manufactured from the concerned bulk drugs which in turn has affected the availability of such formulations”. This is a patently false argument. First, companies shifted production away from notified bulk drugs, not because the bulk drug price was controlled, but because prices of formulations that could be made from the bulk drug, were controlled. In fact the industry has never clamoured for an upward revision of bulk drug prices. Its emphasis has always been on asking for decontrol of formulation prices. The reason is simple. Bulk drugs are not sold to consumers but to manufacturers of formulatuions. Hence bulk drug prices cannot be manipulated in the market like formulation prices and competition works to keep these prices stable. On the other hand, by unethical promotional practices, formulation prices can be manipulated as these are sold through recommendations by doctors and chemists.

 

The even more blatant manipulation of facts is in evidence when the policy argues for “market based pricing”. The draft policy argues: “The Indian economy is today largely market-driven and, particularly in the area of pricing of manufactured products, prices are determinedby market conditions and market forces. Administered prices exist in a few areas, such as pricing of petroleum products and procurement prices of food-grains but these are closely connected with a regime of subsidies paid by the Government. The Pharmaceutical Industry is a 1 lakh crore industry of which about Rs. 48,200.00 crores is the domestic market”. The cat is finally out of the bag! What is important for the policy is to safeguard the interests of a 1 lakh crore industry, not of lakhs of people who die or are pushed below the poverty line because of high drug prices. It may be pointed out that in many areas like electricity, telephone (both landline and mobile), govt. puts a ceiling on prices.

 

So what is this “market based pricing”? The draft policy says: “The formulation will be priced only by fixing a Ceiling Price (CP)…. The Ceiling Price would be fixed on the basis of Weighted Average Price (WAP) of the top three brands by value”. This constitutes complete capitulation to the interests of the drug industry and complete denial of the rights of poor patients. By fixing the prices of drugs based on the cost of top-selling brands (which often means the most expensive) the government wishes to allow top companies to continue charging exorbitant prices for their medicines. In the case of a life-saving product, one would expect that prices fixed in a price-control regime would be the ‘floor price’, i.e. the price being charged by least expensive brand. Instead, the new policy, seeks to price drugs at the level charged by the most expensive brands. It is clear, whose interests such a policy will serve.

 

Last Updated on Tuesday, 10 January 2012 07:25
 
Games in the Time of Dengue PDF Print E-mail

Amit Sen Gupta

10th October, 2010

 

THERE are genuine reasons for the nation to exult as India showcased its capabilities through the truly spectacular opening ceremony of the Commonwealth Games in Delhi. A nation, reeling from the continuous disclosures of ineptitude and corruption in the run up to the Games, breathed a collective sigh of relief. There will be occasion later to make sense of why a country, supposedly poised to take its place among the most developed nations of the world, should have made such a complete mess of the preparations for the Games. Notwithstanding how many accolades the organisation of the Games are able to now garner, the fact remains that the Kalmadis and their ilk have not shamed themselves – they have shamed a proud country and its people. They have, through their acts, allowed the country to be subjected to ridicule, some of which were thinly veiled examples of persisting racist prejudices.

THE CLEANSING OF DELHI

This column, however, is not about the Commonwealth Games. It is about another Delhi – a city where people live, work and die. A city where the working people are expected to be used but not to be either seen or heard. For Delhi is a city where the poor have been banished to the periphery, so that the rich and the affluent are not faced with the moral dilemma of having to constantly contrast their plush lifestyles with those who make Delhi function. Mercifully, Mumbai, Kolkata or Chennai still do not offer them this option – the poor still retain some rights to share the same physical space as the sons and daughters of ‘Shining India’. But Delhi has been almost entirely cleansed of its poor – at least from places where the gaze of the rest of the world is likely to be focused. This started many years before the Games, beginning with the Emergency and then with the move to relocate industries and workers from the centre of the city. The Games has been but another excuse to further sanitise the city.

The grand facades that welcome visitors to the Games do not stand testimony to the efforts of the now completely discredited Organising Committee of the Games – they are a creation of the blood and sweat of tens of thousands of workers who were brought into the city to showcase modern India’s accomplishments. Curiously, it is these people who the Delhi Government is desperate to hide. The attempts at denying that poor working people actually constitute a majority of the city’s population would have been comic were it not for the tragedy that it hides. The past few weeks have witnessed frenzied attempts to drive away the poor in the few remaining pockets in the centre of the city, where they still lived. Newspapers have reported how the police and administration held out threats of dire consequences to force migrant workers – who built the Games infrastructure – to leave the city. Those who could not be driven out are hidden from view behind giant cutouts that welcome visitors to the city. The city seems to be under a virtual siege and bus services used by the working people to commute to the city centre have been withdrawn for reasons difficult to understand.

The poor are much more magnanimous than the rich and famous that they are forced to serve. They do not grudge the fact that a few shall have a place in the sun at their behest. They are proud to be Indians and want to see the nation of 1.2 billion people take its rightful place among the community of nations. They are even willing to overlook the severe disruptions in their daily lives caused by the conduct of the Games – for they do not have the luxury to go on an extended holiday as some of the rich and famous have declared their intentions to. All they however would like, is to be seen, and acknowledged, and heard. For they have stories to tell that completes the picture of the real India.

DENGUE EPIDEMIC IN DELHI

As the cacophony regarding the Games reaches a crescendo, something else -- that has affected the life of ordinary citizens in the city -- has been quietly buried. Few in the media even care to report any more that Delhi is experiencing one of the severest epidemics in recent decades. Talk to people in Delhi and everybody knows of some friend or relative who’s suffering from dengue fever. While official figures peg the number of cases of Dengue to about three thousand, the real numbers would be anything between 10-100 times that.

Dengue has been a constant companion of the citizens of Delhi. Every year, after the monsoon showers, Delhi welcomes the onset of a Dengue epidemic. We also know that the severe epidemics are seen in cycles of 3-4 years, ie, while every season sees a number of Dengue cases, there is a sharp spike every 3-4 years. There is a reason why this happens, but it has nothing, unfortunately, to do with any public health efforts by the Delhi government. Like all epidemics, the dengue epidemic starts slowing down when a sufficient number of people have been infected by the virus as those affected get immunity to the disease -- known as “herd immunity”. After a lapse of 3-4 years the effect of this herd immunity weakens and the epidemic is seen in a more severe form.

Dengue is a viral disease transmitted by mosquitoes. The reason why Dengue epidemics occur just after the rains is twofold. First, rainwater collection promotes mosquito breeding. Further, moderate temperatures in the monsoon season provides optimum conditions for both mosquitoes to breed and survive and for the virus to thrive. This is also why the epidemic starts petering out as winter sets in – Delhi’s harsh winter acting as a deterrent to both mosquito breeding and the transmission of the virus.

While in most people Dengue runs a relatively benign course, with a few days of fever and pains, in a small percent of those affected it can acquire a much more severe and life threatening form. In these patients there is a sudden drop in a kind of blood cells, called platelets that are vital for the clotting of blood. When the number of platelets fall below a certain level,  the person affected can have spontaneous bleeding from different sites of the body. If not treated in a hospital setting such patients can die due to blood loss or other complications. This form of Dengue – called Dengue hemorrhagic fever – affects children and adolescents more than others, but other age groups can also be affected. The reason why Dengue patients have to be treated with extreme care is that there is no way to anticipate which of the infected patients will eventually get Dengue hemorrhagic fever. Consequently, all Dengue patients need to be observed carefully for symptoms of Dengue hemorrhagic to be expressed.

DELHI GOVT’S MASTERLY INACTIVITY

This is why a Dengue epidemic is a major public health problem. Unfortunately, the Delhi government has mastered a unique manner of addressing this problem – every Dengue season the government goes into a state of masterly inactivity! The reason for this lies in the almost total lack of a public health system in the city – not just health facilities but other public health measures such as mosquito control, sanitation, etc. Delhi’s health system, is afflicted with the same malaise that affects the entire country’s public health system. Every year, during the dengue season, we see ritual pronouncements about public health measures being undertaken such as spraying of mosquito repellants, and destruction of breeding sites. Clearly, such measures are far too inadequate. Moreover such measures do not have a major impact once an epidemic is established – they have to be continued throughout the year. Unfortunately every year is a new experience for the Delhi government, having learnt nothing from the experiences of previous years!

When an epidemic does get established, it is natural that a large number would be affected – not a few thousand as the government claims but tens of thousands. Again it is important to understand what the figures the Delhi government really means. There is no legal requirement to notify Dengue cases – so an overwhelming number of cases are never notified. This is especially so for the private sector, where a majority of Delhi’s citizens seek care, given the very poor state of public facilities. Second, Dengue can be conclusively diagnosed only through an expensive test for the antigen of the virus. A very large majority of people, who contract Dengue, are not tested for this antigen. In other words, the reported number of cases are those that by some miracle actually get reported. This failure is a failure of health surveillance – a necessary requirement for any epidemic control mechanism is a public health system.

The story does not end here. The Dengue season is a bonanza for the private health system. Private hospitals rake in huge amounts as people flock to these facilities, in the absence of public health services. Most of these facilities pump unnecessary drugs into Dengue patients though the disease runs its own course and does not respond to antibiotics. In a functioning health system almost all Dengue patients could be cared for at home under the care of a primary care physician. Those that would eventually require hospitalisation (a small fraction of all dengue patients) can be detected in time if they are monitored by the health system. In the absence of such a system incidence of expensive hospitalisation is much greater than what it should be.

Before we finish let us once again return to the Games. It is estimated that the total expenditure on the Games was twice that of the annual public expenditure on health in the entire country. We contrast these two figures, not as an argument for not organising the Games. But it is definitely an argument for balancing the need to showcase “shining India” with the need to address the needs of the real India! The Delhi government’s negligence of the Dengue epidemic is but a small example of the systematic and deliberate neglect of the needs of an overwhelming majority of people in this country.





Last Updated on Tuesday, 19 October 2010 12:27
 
Faltering Progress in Combating Infectious Diseases: India’s Record in Achieving Millennium Development Goals PDF Print E-mail

25th July 2010

Amit Sen Gupta

LAST month saw the release of the India Country report for 2010, regarding progress made till date towards achieving specific targets in eight different areas, set by the United Nations in 2001 – known as the Millennium Development Goals (MDGs). The MDG targets are supposed to be achieved by 2015. While official pronouncements were an occasion to indulge in self congratulatory claims, a closer look at the real progress made, paints an entirely different picture. We examine here the claims being made and the reality as regards Goal 6 of the MDGs, titled: “Combat HIV/AIDS, malaria, and other diseases”.

HIV-AIDS: NO ROOM FOR COMPLACENCY

The 2010 India country report on MDGs states that: “However, the spread of HIV/AIDS in the country shows a downward trend: from 2.73 million (0.45 per cent) people living with HIV/AIDS in 2002, the number has declined to 2.31 million (0.34 per cent) by 2007. The prevalence rate of HIV infection in the country also seems to have stabilised over the last few years”. These figures are, at best, an educated guess based on surveillance data generated by the National Aids Control Organisation (NACO). We may recollect that in 2007 the estimate of HIV positive cases in India was drastically reduced from 5.7 million cases (as estimated then by UNAIDS) to less than 3 million. This reduction was not a consequence of any remarkable public health effort but because it was felt that earlier estimates were based on faulty data. The crux of the problem lies in the fact that data on HIV is estimated from that generated by surveillance centres, numbering just a few thousand. This again is a function of the moribund public health system in India, which is not geared to serve as medium of surveillance and treatment. The National Aids Control Organisation (NACO) has, as a consequence, built up a parallel structure that intersects very little with the government health system. In addition to the obvious problem of duplication of efforts, this means that data available on HIV in India has a narrow base and cannot be relied upon entirely.

The table below provides comparison with other countries in a similar situation (low and middle income countries where the HIV epidemic is characterised as “concentrated,” i.e. limited largely to specific ‘high risk’ groups) regarding availability of HIV testing and counseling services. In India one such centre is available per 1,30,000 population of people over 15 years of age. India continues to lag behind most countries in a similar situation, in spite of recent efforts to scale up the availability of counseling and testing centres.

Table: Facilities with HIV Testing and Counseling Services

 

Country

>15 population per   Testing and Counseling Centre

Niger

36,000

Senegal

21,000

Somalia

215,000

Cambodia

37,000

China

125,000

India

130,000

Indonesia

231,000

Nepal

107,000

Thailand

37,000

Viet Nam

203,000

Bolivia

21,000

El Salvador

6 000

Kazakhstan

3 000

Ukraine

13,000

Source: Towards Universal Access: Progress Report 2009, World Health Organisation

There has been significant scaling up of antiretroviral treatment (ART) availability but it still lags significantly behind requirement. The following table from NACO’s annual report for 2010 gives details of ART treatment access.

Table: People on ART in India

 

Persons registered for ART

8,93.567

Persons ever Started ART

4,37,435

Persons alive and on ART

2,94,900

Source: NACO, Annual Report, 2010 (Data Till January 2010)

Thus less than 50 per cent of those registered actually have been started on ART. More importantly about 33 per cent of those who started treatment have either died or not continued treatment (meaning that they are at risk of succumbing to the disease). Moreover, if we take the estimate of 23 million HIV positive cases as the baseline, we would expect that an excess of 7,00,000 patients would require to be on ART. In contrast, only about 40 per cent of them are receiving ART.

An emerging threat is the poor roll out of second line ART, i.e. treatment with newer (and more expensive drugs) for those who become resistant to the first line drugs. At present there are just 10 centres in the entire country that provide treatment with second line drugs. NACO reports that 2,750 patients have been referred for second line treatment and 970 patients are on such a regimen. This is a clear under-reporting of the requirement, and a large number of patients are being denied second line treatment because of lack of infrastructure and medicines. It is, furthermore, a problem that is likely to increase exponentially in the coming years.

To sum up, there is clearly little room for complacency. While significant progress has taken place in the last decade, India still sits on the brink of a generalised HIV epidemic. The claim that India is poised to meet its MDG targets vis a vis HIV is foolhardy and can disarm continuing efforts to scale up interventions.

MALARIA: VERY LITTLE PROGRESS

The Country Progress report of 2010 states that: “The incidence rate of Malaria and deaths due to Malaria in recent years show that while incidence of Malaria has declined … the percentage of deaths of Malaria patients has not declined”. Evidently this is not a very encouraging report! The official data indicates a marginal decrease in incidence with no significant decrease in the number of deaths. All mortality and morbidity data in India is open to being questioned, because of the poor state of the public health system, and its ability to carry out surveillance in any meaningful manner. This is particularly so in the case of malaria, where several reports and expert opinions indicate that actual incidence rates are 10 times or more higher than reported rates. Even scientists at the National Institute of Malaria research have commented on this in a paper published in 2007, stating: “It is now well accepted that the reported incidence of malaria at the national level on the basis of surveillance carried out in the primary health care system at best reflects a trend and not the true burden of malaria.”

In 1953 when a national eradication programme was launched, some 75 million malaria cases and eight lakh deaths were estimated to be occurring in India which then had a population then of about 360 million. With the eradication programme in full swing, incidence of the disease dropped rapidly. By 1965-66, there were just one lakh cases and deaths were completely eliminated. But malaria, instead of being wiped out from the country, made a comeback. After renewed efforts (in a period when the malaria eradication programme was renamed as the malaria “control” programme, reported incidence ranged between 2-3 million per year, and deaths reported were between 200 – 1,000 per year. As against this the MDG 2010 report indicates that between 2005 and 2008, the number of reported cases ranged between 15 and 18 million and reported deaths were between 10,000 to 17,000 per year. In other words, official data indicates that there has been a ten fold rise in the number of malaria cases and in the number of malaria deaths in this decade, as compared to the last decade! If we extrapolate the official data with the widespread understanding about under reporting, we are looking at 50-100 million cases in a year and 50,000 to a 100,000 deaths each year due to malaria. Even this may be an under-estimation -- a paper published in the open-access journal PLoS Medicine, put the extent of disease caused by P falciparum (which currently accounts for about half of malaria cases) in India at about 102 million cases in 2007. Clearly, we are nowhere near a situation where we can claim that the country is on its way towards meeting its MDG goal as regards malaria control.

Of particular concern is the fact that about half, and in some districts a large majority (such as the forested areas inhabited by adivasis in the states of Orissa, Jharkhand, Madhya Pradesh and Chhattisgarh), of the cases of malaria are being caused by the most virulent strain of malaria – plasmodium falciparum. The emergence of falciparum malaria in such a large epidemic form has complicated malaria treatment, and in endemic areas conventional treatment with drugs such as chloroquine are proving to be virtually useless. Newer drugs, such as mefloquine and the artemisinin based combinations have been introduced. These are more expensive (Artemesinin is 20-30 times more expensive than chloroquine) and toxic and have made the treatment of malaria more complicated. After the introduction of Artemesinin, there are no new drugs on the horizon. There is a real threat that the widespread (and often unnecessary use of this last line drug) will lead to resistance, and the emergence of malarial super-parasites that would be immune to all available drugs.

TUBERCULOSIS: AT THE BRINK OF A RESURGENCE

Tuberculosis is a disease of poverty and poor environment. The developed world saw the eradication of TB in the 1920s (including in most countries in the entire continent of Europe) a good 15 years before the introduction of the first medicine to treat Tuberculosis. Yet about a quarter of a million people die of TB in India every year. India is clearly indicated as the Tuberculosis capital of the world – every fifth person suffering from TB in the world is an Indian.

There have been fairly impressive advances made in India in the last decade and a half, since the rollout of the Revised National TB Control Programme(RNTCP). As a consequence the number of deaths due to TB has halved, from about half a million to a quarter of a million each year. Much of this advance has taken place, not because of improved public health measures, but because of global technological advances – especially with the introduction of new ant-TB drugs that are more effective and have reduced the average duration of treatment from 18 months to just 6 months. However prevalence rates and the number of deaths due to TB remain unacceptably high.

Further, a new threat looms large. With widespread use of the new anti-TB drugs, we are witnessing the emergence of what is known as multi drug resistance TB (MDR TB). The present short course therapy is ineffective in MDR-TB and cure rates have generally been less than 60 per cent. Treating such cases can be extremely expensive – up to 10 times as expensive as with the short course therapy. A recent paper published in the Indian Journal of Tuberculosis estimates about half a million MDR-TB cases emerge every year amongst new and previously treated cases, with half being in China and India. Estimates for 2007 suggest that India has the highest burden of MDR-TB in the world, with 131,000 cases of MDR-TB. In India, MDR-TB amongst new cases is estimated at 2.8 per cent and amongst previously treated patients at 17 per cent. As long as the RNTCP does not offer easy and heavily subsidised (or free!) access to quality assured diagnostic and treatment services for MDR-TB, patients will seek unaffordable and inappropriate care in the private sector, which will result in further emergence and spread of highly resistant M/XDR-TB strains. There are thus indications that we are poised on the brink of a resurgence of a new TB epidemic unless steps are taken to remedy the situation.

GROSS NEGLECT OF PUBLIC HEALTH

The above situation needs to be seen in a context. India continues to be one of the worst performers in world as regards public provision of health services. The Indian health system is one of the most privatised in the world and government expenditure (as per cent of GDP and in real terms) one of the lowest in the world (see following table).

Per Capita Public Expenditure on Health (in ‘purchasing power parity’ US dollars)

 

Country

2000

2006

Bangladesh

7

12

China

42

88

India

14

22

Iran

143

344

Laos

13

15

Malaysia

151

242

Nepal

10

16

Sri Lanka

47

81

Thailand

97

170

It is no mystery, thus, why India is poised to miss out on achieving the targets set in the MDGs as regards health care. Only a sustained and incremental strengthening of the public health system can remedy the situation. Till then pronouncements of “achievements” will continue to obfuscate the real situation.

 

 

Last Updated on Wednesday, 28 July 2010 11:06
 
Creating Life from Four Bottles of Chemicals? PDF Print E-mail

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.










Last Updated on Wednesday, 02 June 2010 11:12
 
Hot Steel and a Cold Govt: Mayapuri Radioactive Exposure PDF Print E-mail

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.










Last Updated on Saturday, 01 May 2010 07:13
 
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