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Medical Care




Aug-sep 2005

August - September 2005
Good Practices of the "Good Practice Study"!
- Dhruv Mankad1
documents studied for setting this example are thestudy report and the compendium produced. Some of Good Practices and their Cost Effectiveness, related the statements are albeit based on self-interview! to Reproductive and Child Health Programme (RCH1) were studied in March 20041 . Such good practices Background of the Study
were drawn not only from the RCH 1 programme, but RCH 1, mainly a project directed to achieve Family also from relevant programme(s) funded by Planning ‘targets' was getting over in 2005. In order Government of India or Development Partners. Good to design a Reproductive and Child Health Programme practices from other countries were also studied and 2005–2010 (RCH 2), the Department of Family Welfare, if relevant, included in the Report.
Ministry of Health, GoI, initiated a series of studies.
Study teams were appointed to conduct the relevant Some of the recommendations of the study are: studies. The topics included like Gender Equity, Health Financing, Public Private Partnership, etc. Good Strengthening of basic health services and public Practices Study was a part of this process.
health services management • Decentralised planning with the involvement The Study Team took into account a number of lessons learned in RCH 1, with particular regard to: • Community involvement in planning and reviewing (i) management and institutional problems; (ii) performance of the health system difficulties related to weak strategies and • Regulation of quality of public private partnership implementation systems; (iii) poor service quality; (iv) • Flexible, local setting based IEC practices inadequate service coverage; (v) poor coordination;and (vi) absence of an approach sufficiently tailored Now, the report and a compendium of case studies to the varying capacities of individual states.
are available in electronic form.2 The study objectives were to: This article shares the background, approach and theresults of the study. At the end, the analysis of the • inform the final stages of the design process of Good Practice study as a ‘Good Practice' is presented.
It represents an example of how a Good Practice wasanalysed and included in the compendium. The • assist in ensuring the high quality of the National and State Programme Implementation Plans (PIPs)through encouraging an evidence-based ap- 2The study team constituted of Dr Christine Thayer, an expertin public health service management, Harish Ramanan, an • enable RCH 2 implementation activities to benefit expert in cost analysis and self.
from lessons learnt.
3Self-run CDs with documents in PDF form. Please contactauthor.
mfc bulletin/Aug-Sep 2005
Approach and Methodology
critical factor in combating maternal mortality.
Reducing maternal mortality in turn saves many The Study Team were concerned to build into their children's lives. This requires the availability of a 24- work the key features of the proposed RCH 2 hour service in properly equipped premises with approach, particularly: (i) keeping in mind the adequate supplies of blood, instruments and programme approach; (ii) working in the context of medicines. Particular emphasis should therefore be an integrated vision of family planning, maternal placed on securing 24-hour staffing of Primary Health health and new-born/ child health as a part of Primary Centres (PHCs). They should be resident and mobile Health Care (iii) working within a comprehensive Auxiliary Nurse Midwives (ANMs) in health sub- sector approach including the private sector; (v) centres. Other key issues are transport availability and focusing on a results-based approach.
blood supplies.
The study was NOT an audit of practice/ programme/ b) Public Health Management Systems
intervention, of the cost or of the System. The studyprovided only a summary or initial list of good There is general need to strengthen public health practices on the high-priority focus areas that were management systems. The decentralisation of drug identified. The study team has not evaluated, reviewed procurement and supply, monitoring of health facilities or tested any system software in the conduct of the performance and of auditing maternal and infant study nor prepared any system documentation.
deaths are some of the particularly useful measuresthat should be introduced.
The Study Team adopted the following definitions: • Good practice - where there is substantial
It is clear that the type of decentralised planning evidence showing that a given practice has had a process, which works well at district level, requires positive impact and/ or has successfully met its strong community participation in implementation and programme objectives and that it is replicable and preferably external technical support, for example from transferable to other settings.
an NGO. At the present time there are several • Promising practice – where a programme/ prac-
interesting models in place, which require indepth tice seems to be working well but evidence of success, replicability or sustainability is lacking.
d) Intersectoral Convergence
The Study Team decided on a list of criteria foranalysing good/ promising practices. These were: It is easier to develop convergence around work on (i) evidence-based; (ii) replicable; (iii) sustainable; specific goals and common activities involving, for (iv) practical; (v) innovative; and (vi) should work example, joint training or shared performance well within the existing system including accepted indicators. Examples of this type of shared goal would by the community.
be family life skills education, averting maternal deaths The Study Team developed a Compendium of and childhood immunisation.
documented case histories that aims to present and e) Community Involvement in Planning and
promote creative, successful and sustainable solutions for use within RCH programmes, interventions andservices.
In a situation where demand for RCH services tendsto be low and where women are uncertain of the The report reflects a collective and not necessarily a services on offer and of their rights, community consensual opinion of the Study Team. However, mobilisation has been shown to be both effective and efforts were made to document the advantages and highly cost-effective. Women who have been trained disadvantages of ALL selected practices as available in RCH issues are often very powerful advocates of in the documents studied.
women's and children's health rights. Careful Analysis of Good Practices
consideration should be given to include a communitymobilisation component in RCH 2.
The Study Team gave an overview of the analyticalwork that it carried out in each of the high-priority f) Partnership with the Private Sector
focus areas listed above.
The social marketing regulatory mechanism urgently a) Strengthening Basic Services
needs updating. It could be done in such a way so asto ensure mainstreaming in relation to the public International research shows clearly that skilled health system, thus introducing a range of products professional help during delivery is probably the most and services, which go beyond fertility regulation. In mfc bulletin/Aug-Sep 2005
the field of private health care, once again, updating cal, managerial, social and economic factors con- of existing out-of-date and ineffectual legislative ducted at block and district level could be used as a instruments is critical for protection of the public as tool to improve the quality of services and co-ordina- also to guarantee good quality services.
tion between various departments. Andhra Pradeshand Karnataka have started this process with promis- g) Information, Education and Communication
The importance of decentralised, flexible, designed (4) Monitoring of institutional activity at primary
programmes adapted to the local setting and with clear health care level
behavioural change messages emerged clearly fromthe work of the Study Team.
RCH is one of the services a PHC is supposed toprovide. Improvement in its performance and infra- h) Mainstreaming the "Systems" Aspect of Good
structure only would generate the level of confidence Practices in RCH Work
in the community to access the available services.
The Study Team recommended to continue the work Without such an improvement, a single programme like on "good practices" and to mainstream it as a tool RCH cannot be expected to perform better.
for the promotion of managerial effectiveness and (5) Ensuring a modified community needs assess-
service quality. The dissemination system could include a web-based information tool, and sponsorssuch as private sector software and hardware firms Community-based planning and monitoring can be a could also be envisaged.
continuous process if PRA methods are used to as-sess the community needs.
Good practices should be disseminated to theprofessionals, paramedics and community level health (6) Ensuring block and district level intersectoral
workers through traditional systems like newsletters, coordination for ICDS
bulletins, journals and through the available Implementation of Certain Key Good Practices
ICDS is the hub for a set of services to the infants within RCH 2
and children. Malnutrition and Communicable Dis-eases like ARI, measles, diarrhoea are interrelated The Study Team identified five areas of good practice causes of deaths particularly in EAGs (Empowered which offer clear health benefits, which are cost Action Groups) and similar blocks in non EAG states.
effective and sustainable, and which they believe Intersectoral Co-ordination between Anganwadi, should be integrated within the core implementation TBA, ANM at the block level in MP, Orissa, Bihar, plans of the state PIPs within the framework of RCH Jharkhand, etc., had promising impact on child deaths.
2. These activities include: Indepth Analysis of Certain Promising Practices
(1) Implementation of the Tamil Nadu drug procure-
a) The Study Team identified six areas of strategic importance that would particularly benefit from This mechanism has worked under the existing sys- detailed follow-up in order to identify clearly good tem in Tamil Nadu, fairly successfully therefore there practices from amongst the various "promising is no reason why it cannot function elsewhere.
practices" which they have studied. These include:• regulation (social marketing/ franchising and (2) Improving blood supplies in first referral units
registration of private hospitals and nursinghomes); Lack of blood supply and absence of specialist is the • transport for obstetric emergencies; biggest hurdle of making referral units function to • use of community volunteers in RCH; provide emergency obstetric care. Availability and • decentralized planning models; storage of blood can save life of a mother even if she • strengthening of intersectoral co-ordination at dis- has to be referred further. Such an experiment in Rajasthan has shown promises. It should be replicable • implementation of an integrated package of mea- elsewhere so that maternal deaths could be averted.
sures designed to activate PHCs.
(3) Audit of maternal and infant deaths
b) In the context of these in-depth studies, it will be It is not the number of maternal or child deaths which important to focus, wherever feasible, on comparative show the systemic causes of deaths, whether they cost analyses of different models of good or promising were avoidable or not. Analysing the causes in clini- mfc bulletin/Aug-Sep 2005
Disbanding the CGHS:
An e-forum Exchange
-Original Message - much the capacity to pay for their own healthcare and From: Deva
should buy their own health insurance. Govt.
employees get free healthcare in public hospitals Sent: Wednesday, March 30, 2005 12:30 PM whereas the poor using public hospitals have to Subject: [mfriendcircle] Disbanding the CGHS pay user fees. This is certainly not equity. Let thegovernment budget be devoted for the large One more move to channel government money into unorganised sector families and use these funds to private sector (see report below).
support a universal health insurance initiative.
TIMES OF INDIA - March 28/03/05
From: Prayas
Sent: Wednesday, March 30, 2005 3:29 PM
Plan panel wants to wind up ailing CGHS
Closure of CGHS is fine because it caters to only Central NEW DELHI: Seeing a little possibility of revival of the Govt. employees and nobody else could seek services ailing and corruption-ridden Central Government HealthScheme (CGHS), the Planning Commission is suggesting from CGHS dispensaries. However, its that it be disbanded. replacement by private sector is a matter of alarmbecause by it the Govt. is trying to convey the In its mid-term appraisal (MTA) of the 10th five- year message that Govt. run health services are not good.
plan, the Commission is all set to recommend a generalhealth insurance scheme for Central government Other important issue is of that Govt. may begin to employees so that they don't need to queue up at their spend more moneythrough new system than now by local dispensaries only to return empty-handed as oftencrucial medicines are out of stock. CGHS as it intends to buy insurances to allits employees and that too of kind in which every single Under the general health insurance, the employees would ailment is covered. Premium of such an insurance per have a choice of government and private hospitals to go person or family could be very high. So privatisation to. Instead of funding the CGHS, the government would of CGHS should be challenged.
have to pay the employees' premium. The suggestion made in the MTA will, however, only be formalised after it gets the approval of the full Planning From: Amitrajit Saha
Commission and the National Development Council. Butwith stories of corruption and inefficiency in the CGHS Sent: Wednesday, March 30, 2005 5:28 PM galore, plan panel officials are hopeful they will get thesupport for this idea. My experience - many years ago - as a CGHS dispensarymedical officer is mixed: on the one hand we saw retired From: Ravi
Principal Secretaries and other Central Govt. bigwigs Sent: Wednesday, March 30, 2005 2:23 PM who took holidays in US, use the CGHS to get themhigh-end prescription drugs like foreign-manufactured The way the CGHS functions today it is best that it is L-dopa and long-acting insulins (this was in 1989-91).
wound up. The CGHS is a tremendous drain on the On the other end were the rank and file Central Govt.
public exchequer and its present modalities of staff who could access costly treatments because they functioning are heavily subsidising private sector had the CGHS cover (someone I know could afford giants like Apollo and Escorts hospitals - govt.
continuous high-end treatment for his SSPE-affected employees use these hospitals instead of AIIMS, son because of CGHS.) Why not bar Class-II and Safdarjang, etc., for various expensive surgeries and upward Govt. employees from CGHS benefits but keep medical treatments and are reimbursed for this them for the lower-end staff? But the service MUST be expenditure at market rates. The private hospitals, which re-vamped and made corruption-free.
are otherwise running at 50% of their capacity, getassured clientele from the public sector to fill up vacant Sent: Wednesday, March 30, 2005 8:57 PM Further I have no sympathy for the government CGHS has also lot of corruption. Beneficiaries take employees who draw fat salaries and have very prescription that contain all irrational and newer mfc bulletin/Aug-Sep 2005
preparations from market-for that they get reimbursement. What they do is instead of takingmedicines they will take shampoos, toothpaste, creams Sent: Thursday, March 31, 2005 8:10 AM and what not. Apart from that it is good realisation for I am in entire agreement with Ravi on this.
Govt. that their ivory towers are simply not working.
But sad part is instead of improving it Govt. just wants to wash its hand off. And now Govt. will pay largeamount to Private Practitioners.
From: Deva
Sent: Saturday, April 02, 2005 6:46 AM
Dear Ravi, Dhruv and Shyam, From: Dhruv Mankad
Sent: Thursday, March 31, 2005 12:00 AM
You are right when you say that the CGHS isinequitable. That it caters more to the wealthier sections It is also a way of subsidising trust hospitals or to put of Indian society. You are right when you say that the it bluntly helping trust hospital to run like a private CGHS is corrupt. It is riddled with corruption and has hospitals. The rates of cataract operation in a trust been the topic of investigation by CBI many a time.
hospital in Mumbai to CGHS members are almost twice You are right when you say that it does not meet the the ‘market rates' in other cities. They are also given needs of the average man. But is this a good enough reimbursible but very expensive medicines.
reason to disband it? However (the) issue is different. It is: Is CGHS like a Because if that were the case, you would have to mini-public health service providing adequate care to disband the entire government health services, for they the majority of CG employees? Is the provision are also inequitable, corrupt and do not meet the needs adequate for that purpose? Is it financially and of the common man. Instead of disbanding it, the technically regulated? Answers seem to be NO! It is Planning Commission should think of some radical difficult to relate CGHS as a service taking care of highly ways of revamping it. And I think that here the main paid CG employees' families only. In fact it covers issue is one of governance. When the users (read the services to pensioners also.
IAS and DHS staff) are also on the Board of Governors, The budget for 2005-06 for CGHS is Rs 221 crores, i.e., naturally there is going to be a conflict of interest. It is approx. Rs 121 per capita. (of CG employee in their interest to maximise the benefits. This is the families). This is not much different from any budget reason why everything is permitted and also not just forstate like Maharashtra. If pensioner and his in the government but also in the private sector.
family were also included it would reduce to almost Because when the IAS officer has an AMI, he needs to go to Escorts. And this is also the reason why thecontributions have always been kept minimal and About 95% of Regular Central Government Employees subsidised. No IAS officer wants to pay a large are Non-Gazetted as per Census 2001. Only 3.7% of contribution out of his pocket. What the Planning total employees are in the scale of Rs 10000 and Commission should do is segregate the governance above, 56% below Rs 4500 with 18% below 3049! If it is from management. Allow an independent organisation true that CGHS is really serving the higher salaried to manage the CGHS. And give them a fixed budget.
employees - the cream 2 %, then the And then you will see the difference.
others are neglected like the ‘Common Man' of India.
Bringing CGHS in health system reforms may be a good And finally - a last word. If you introduce private Health beginning. It is one more example of lack of financial insurance among the CGHS members - I presume that discipline and regulating health services: the government will end up paying for it. In which case, it is not encouraging private or public domain only the government will end up paying about Rs 3000 to which matters.
4000 per person as premium as against the current The solution is regulating the health services for central expenditure of Rs 121. Would that not increase the government employees dispersed in the country - 51% in Class ‘C' or unclassified cities with almost no CGHS based health services. Replacing it with a properlynegotiated group insurance covering with premium paid From: Dhruv Mankad
as per salary scale may be one more solution. It may Sent: Saturday, April 02, 2005 8:17 PM provide some relief to this 51% mostly serving in lowerscales as well as the pensioners leaving at similar The debate is getting very interesting - the real role of mfc bulletin/Aug-Sep 2005
schemes for some not-so-organised sector, Janarogyaschemes. At some point in time they should be You have rightly raised very important risk factors of integrated scrapping the different approaches, rules how a group insurance should NOT be governed with for a standard NSS. A blueprint for such an NSS should conflict of interest and the second issue of be in place even before disbanding CGHS or launching entering private insurance.
First, I agree with you that CGHS should be converted Finally, GIC is anyway considering the Mediclaim as a and run an autonomous board.
social sector scheme. As a corp. it may consider it as aprofit center. But there is adequate buffer from other Secondly, I agree with you that there is a risk of private non life insurance schemes (major share from shipping insurance sector and the GoI may have to pay a very and other industry). It is also still overwhelmingly large high amount then the budget. The average state run corporation as compared to any private gross premium collected by mediclaim in 2003-04 is Rs insurance company in India. So with such a 1290 per person covered.
large bulk of users, a moderate premium can benegotiated by the GoI with GIC for a set of uniformly If the GoI were serious about it, it would increase no. of available health services to all CG employees and persons covered to any insurance company's kitty by their families. Albeit, it would be more than Rs 121 per The problem would premium capita. This is what I mean by an LPI by the GoI.
settlement ratio, an operational issue. However, thesocial insurance operational initiative is overdue. Could we not consider this inequity as a Large Project Initiative (LPI) by the GoI!! From: Ritu Priya
Sent: Sunday, April 03, 2005 1:36 PM
Is it not possible to combine both the roles of the state, From: Ravi
as employer with its responsibility to provide health Sent: Saturday, April 02, 2005 8:59 PM services to employees and as provider of services toall citizens universally? The basic issue to be decided here seems to be—Dowe see the state as a'provider of services', or do we I have also mentioned in my email that we need to look envisage it as merely the ‘financier as payer of at universal health insurance where there is equity in premiums', with the private sector for provisioning? I what state provides and if someone needs more understand that neither are ideal or feasible solutions insurance then they can buy it from the public sector and mixed solutions will have to be balanced optimally. or private sector insurance companies. The state as an As Dhruv has said, a most significant MFC debate employer and the state as a provider of health services is occurring, about this balancing act at policy level.
to the people should not discriminate between the twogroups and hence all state run insurance/social security Given our iniquitous conditions will the better schemes should be integrated into a national social privileged not elbow out the weaker in a universal security scheme which provides basic cover to all, insurance system? How are the poor going to negotiate whether employed or unemployed, equitably.
it to get the benefits, when corruption is rife and fundsinsufficient for all? If they cannot get their due in dealings with the health services howwill they do so with the insurance system? Even the From: Dhruv Mankad
middle class face major hurdles the way the insurance Sent: Sunday, April 03, 2005 8:54 AM systems are run. Social insurance forcollectives and organised groups linked to provision A model can be tested with equity for a set of public of services and a wider debate on ‘quality of services' domain - here it could be the CG employees spread all to set norms of practice in public and private sectors over India, while there may be inequity as seem to be multiple lines of action that together can compared with others to start with.
create a less iniquitous situation.
In fact, universal health insurance schemes elsewhere One way of deriving the balance can be of using the have gone through the process of coalescing of CGHS as a pressure for improving quality of public schemes for different groups. We already have ESIS, sector services. The concern about public health mfc bulletin/Aug-Sep 2005
expenditures going disproportionately to the CGHS the urban areas with non-communicable diseases. And beneficiaries can be dealt with by denying them any a wide spectrum between these two extremes.
financing for going to private services, a There are so many questions that need to be answered.
difficult step no doubt. The Planning Commission's And given the number of risk pools in our country, to taking strong steps for reforming the health sector are expect us to go in for universal health insurance in one to be welcomed, but, as Narendra has said, step would probably be an utopian dream. On the other the direction indicated by the disbanding of CGHS is hand, if we at least cover each risk pool step by step that of giving up on the public services rather than e.g. the central government employees, the state undertaking strong measures to strengthen government employees, the factory workers, the officer them. We had dealt with options for strengthening the workers, the private sector workers, the plantation health service system universally in an article in the workers, the mine workers, the organised informal sector EPW last year, and in that light written (e.g. cooperative members, SHG members etc), then about the CGHS as well (EPW, XXXIX (27), July 3, the chances of increasing the insurance cover is more 2004, p 2971-74). In my view, such difficult but strong measures are what should be attempted.
From: Prayas
From: Deva
Sent: Monday, April 04, 2005 7:13 PM Sent: Monday, April 04, 2005 10:21 AM I have two concerns regarding this interesting 1. I do not understand if there is really a dearth of Universal health insurance - the magic bullet to solve resources in this country both of human beings and of all evils in our health system! finance. If 5846 kms of four and sixlane world class roads in the cost range of Rs 4 to 7 I have some basic questions: crores for each km. could be built in this country in 1) One requires a lot of money to provide universal record time of two years, then why can not health insurance - where is this going to come from? health care be ensured. Building of golden quadrangle The govt has been making promises to increase network of road construction is strong evidence that its spending from 1 to 2% (which by itself is not things could happen in this country of best standard enough), but inspite of "commitment" has not done and in record time with no stories of big corruption.
so. Moreover this increase has to be at the level The issue is that it took very long time for the powered of the state governments (who are the single biggest to be in this country to realise this fact that spenders on health).
building good roads is an investment for ultimate However as all of us know, this is a pipe dream as most savings on petrol/diesel, people dying of accidents of the state govts are bankrupt and are actually reducing and this need to be done urgently. So if there is their expenditure on health.
this realisation that what this country is paying in termsof keeping people in poor health then resources will be 2) Aside from money, as Ritu mentioned, how is this absolutely no problem. The need is to spend more in going to be organised? Would people have to defense of people's health instead of defense of contribute? If yes, how is this contribution going to territorial boundaries through piling of more & more be collected? If no, what is the difference from the lethal weapons. But this thing has to be driven home.
current system of "free" health services? 2. The other concern is with regard to rationalisation of 3) Who are the providers? The existing government care, which can bring huge savings in health care and health services or private health services also? with good health. Use of rational andessential therapeutics coupled with standard 4) And finally given the diversity of our country, do parameters of health care can substantially reduce our you think that one design will satisfy everybody? On cost of health care. I feel this could happen by doing the one hand, we have the poor in the determined reforms within the existing framework as is rural areas that are burdened with communicable done in the case of roads.
diseases? And on the other hand we have the rich in mfc bulletin/Aug-Sep 2005
From: RaviFrom: Ravi
need something like Rs 60,000 crores for UHI. I went to Sent: Monday, April 04, 2005 11:45 PM a recent meeting of the National MacroeconomicsCommission and only for rational drugs for a handful I don't think UHI is a magic bullet. It is a reality, which of conditions their estimate is Rs 54,000 cr.
we should move towards and by UHI I don't mean thateveryone has to contribute. Latin and central American Frankly I do not see any other way than UHI and it has countries have strived towards this by having to be some mix of private and public sector — given contributory social security for the organised sector, the total lack of will to deal with private practitioners.
which we also have in India - all the groups you have In fact, UHI may be the stick/carrot to get all the medical mentioned at the end of your note below have some profession to behave as you are likely to have strict form of social security, including health cover (this norms for treatment and prescriptions.
population is about 15% of India's population), andfor the rest of the population the contribution comes Of course Indian ingenuity will find ways to make from their Ministry of Health. The delivery mechanisms money in this like other schemes.
are a mix of state provision and contracting privateproviders. What many Latin and Central American countries and now a number of Asian countries havedone is at least assure universal primary healthcare toits entire population in some form or teh other. No one From: Deva
is saying that this will happen overnight. It is indeed a Sent: Tuesday, April 05, 2005 2:14 PM process and we have to work towards that. I havewritten about this in a paper published by the ICFAI Journal of Healthcare Law and also an article onfinancing a universal healthcare system for the last If you say that UHI is a step-by-step process and that MFC Annual meet. Let me tell you it is realizable and we need to keep this as our ultimate goal, then yes, not a pipe dream. Of course we have to generate political UHI is a desirable endpoint. Which is why I will. And this is happening slowly - JSA is one effort am not in favour of disbanding the CGHS, because it and we need to keep the pressure on.
would be a move away from UHI. Instead let us tryand improve it.
And of course I am still skeptical about the money for From: Ravi
health care. We have been trying for so many years, Sent: Tuesday, April 05, 2005 12:04 AM but have not seen any change at all. The argumentshave not changed at all - why so much on defence? Narendra, I completely agree. We do not have scarcity Why so much on highways etc. The point is that the of resources but the problem is unplanned and wasteful health ministry is a weak one and has little leverage in use of resources, including in the health sector, both the overall scheme of things. So I am cynical about private and public getting more funds for health care. Given the pastscenario. So rather than watch many more children and mothers die while waiting for the government to implement a better health care programme, let us Sent: Tuesday, April 05, 2005 9:21 AM I remember Ravi Duggal saying in the mfc meet that we mfc bulletin/Aug-Sep 2005
SHGs and RH Services
Involving Self-Help Groups in Reproductive Health:
A Case Study from Alwar, Rajasthan
visits or health education sessions are conducted.
Women have immense and deep-seated capability for Sources of care include the public, private allopathic self-empowerment and action to improve their situa- and informal sectors. The last is most often the first tion in families and communities, be it their economic, choice, but quite frequently ends in referral to a literary or health status. Certain catalytic actions are private allopathic doctor or to the public sector. Major needed to trigger or stimulate this capacity. A two- deterrents to overall care seeking and in the public year intervention (2002-04) in Alwar district of sector were lack of information on sources of care for Rajasthan aimed at strengthening women's under- particular conditions, little understanding of levels of standing of key safe motherhood and reproductive care provided at each facility, perception that health (RH) issues including gender consciousness provider's attitudes could be more friendly, and a and building a rights perspective regarding RH ser- lack of clarity on payments they made, whether for- vice access and quality. This case study describes mally or informally.
the process of raising RH consciousness, supportingand facilitating linkages with the system, through the instrument of increased confidence and knowledgeamong women and a discussion of the women's ex- This intervention took place in the Mewat area in periences with the health system.
collaboration with an NGO, Ibtada, whose primaryobjective is to form and strengthen women's self- help groups (SHG) for micro-credit. The SHGs aremainly composed of Meo Muslim women and women Alwar district, located in North Eastern Rajasthan, from scheduled castes, who are from low income comprises the Rath, Mewat and tribal area. In com- households, largely dependent on wage labor, with parison to the Rath area, the latter two areas have heavy work load and whose access to reproductive poorer socio-economic and health indicators. Over- health related information and services is extremely all health indicators2 for the district are low, although limited. Sixteen Mahila Sabha Health Leaders were in terms of ranking, Alwar ranks ninth in the overall nominated by seven Mahila Sabhas, (with about 31 HDI for the state. Women's status in Alwar is sum- SHGs and a member ship of over 500 women) and marized in its sex ratio (887 women for 1000 men).
were the first level of contact with about groups and Birth Registration is 22% and infant mortality is about the community.
100. Complete immunization is 33.2%, only one inthree deliveries is attended by a trained attendant The year-long training3 , using participatory and ex- (including trained Traditional Birth Attendants), and periential learning methodologies, focused on unmet need for family planning is about 21%. Preg- women's knowledge and experience base, but related nancy and delivery related morbidity is about 57% it to the provision of scientific and factual informa- and among women only one-fifth sought treatment tion. In addition to building the knowledge base, an for a any symptom related to the reproductive tract.
equally important aspect of the training was theemphasis on source of services, quality of care that Public health infrastructure is fairly good, with al- the community has a right to obtain, and the cost most all villages having easy access (all weather road of services. Exposure visits to the Government about 5-8 km distant from a Community Health Cen- Zenana (Women's) and Children's hospital were also ter (CHC). Primary Health Centers (PHC) have medical undertaken as part of the training.
officers visiting on a sporadic basis and only in themorning (when most women and men are out in the Impact: After the training phase, the Mahila Sabha fields). Village level functionaries visit the villages, Health leaders (MSHL) were supported to dissemi- but only a few roadside houses. No house-to-house nate key messages to SHG and general community.
In addition they also helped in referral to healthworkers and facilities. Both sets of actions did begin 1 Email: <[email protected]>2 to result in an increase in number of women to ac- All indicators in this section are taken from the RCH HH survey, 2000. cess services (primarily for reproductive tract infec- Reproductive health issues including: menstruation and menstrual disorders, antenatal care, safe delivery, planning for emergency obstetric tions, family planning methods, and antenatal care) services, postpartum care, abortion, post abortion care, family planning, through the Mahila Sabha Health Leaders. Other RTI/STI management, infertility, and menopause. mfc bulletin/Aug-Sep 2005
women of the SHG groups began taking on a lead- rights from banks, or from the district administration, ership role as well, and were able to perform the same the treatment they receive in the health system function as the MSHL.
heightens their vulnerability and adversely affectstheir self-esteem and dignity. Any setback that they receive jolts their self-confidence even when in acollective. We also observed that a section of the The MSHL were enthusiastic early in the second providers rejected their demands and ridiculed their year, as a result of their increased knowledge and knowledge/information, making the women feel hu- confidence and what they perceived to be linkages miliated and less willing to risk an encounter with the with the health system. Early in the second year, a system, driving them to the private sector.
district level workshop was organized to increasecollaboration with the public sector system, and also No ANMs participated in the group meetings. In to inform providers of the intervention admits poten- one area where the ANM happened to be visiting tial of increasing use by the community. Providers when a Mahila Sabha meeting was in progress, she from sub centers, Primary Health Care Centers, and ridiculed the MSHL and began to conduct the ses- the Community Health Center located in the project sion using English terms and discussing all aspects intervention areas, participated in the meeting. The of maternal health instead of focusing on the issue Mahila Sabha Health Leaders presented their experi- being discussed.
ences with the training, with transmission of themessages in the groups, and experiences with care Initially there were increasing reports of women con- seeking. They highlighted both the positive and fronting providers in the system at various levels.
negative experiences, acknowledging that they were They ranged from asking ANM why they do not still in the learning phase. It was decided that there conduct house visits, to asking medical officers to would be closer linkages and collaboration between document non-availability of medicines and the ratio- SHG members and the ANMs. Quarterly review nale for referral to another center. However these meetings would be organized at the district level to became fewer since the MSHL felt that the resistance assess the effectiveness of the collaboration as was high and it was not worth their while to engage measured by client satisfaction as well increase in in this fashion.
During the training phase, there was substantial dis- As the intervention progressed and women began to cussion on government schemes available for women.
use their newly acquired knowledge on quality of The National Maternity Benefit Scheme (NMBS) was care and service availability, their demands on the discussed in detail and several of the MSHL began system began to increase. This provoked consider- to identify the beneficiaries and support them in able resistance and hostility from the medical officers getting the funds due to them. They encountered and para medical officers. What appeared to be most stiff resistance at every stage, from obtaining the threatening was the ability of the Mahila Sabha Health form at the level of the panchayat secretary, indiffer- leaders to articulate their needs and their heightened ence from the lady Sarpanch, non co-operation from awareness of their rights within the health system.
the ANM in certifying the birth. The women submit-ted a petition to the Collector and the ANM was To us, this was rewarding validation that the women suspended pending enquiry. When the enquiry was were indeed beginning to understand their rights and conducted the MSHL of the village were called in for are experimenting with placing demands on them.
questioning by the examining panel and were treated From the women's perspective however, the negative as if they were liars and troublemakers. Needless to experiences resulted in an increasing tone of frustra- say the ANM was reinstated. None of the women tion that the system was un- responsive to their received the NMBS funds, since it is now due t be ailments. Disinterest, rudeness, frequent referrals to replaced by the Janani Surakhsa Yojana.
the private sector, non-legitimate demands for moneyfrom the public sector system were common. Re- Some of the women continue to remain engaged, but ports of refusal of treatment in PHC, CHC, and the overall there is a perceptible lack of interest in using Zenana hospital were common. In fact the MSHL the SHG as a forum to activate the public sector. The were wary of escorting women to the District women's private sector appears for them a far better option.
hospital because of the reported non-availability of Credit is available because of their membership in the drugs and the rude treatment. This diminished their SHGs, and the treatment they receive is more hu- credibility with the SHG and general community mane. In fact, Ibtada is currently designing an up- scaled version of the intervention (covering over 200 One of our findings was that even though the mem- SHGs), but their provider preference is a panel of bers of the Sabhas and groups were able to demand private allopathic doctors in the town.
mfc bulletin/Aug-Sep 2005
Women's Narratives from Kashmir-3
Nazar, a 22-year-old girl is the second child in a family I was very ashamed of the changes that took place of five. Her father is a teacher in a government school within my body. Why do our bodies have to change? yet she was not able to pursue her education after high Why can we also not be like boys, the change does school. This narrative is a reflection of her thoughts of not cause any difference in them. They continue living her life as she was growing up in the days of militancy.
life as always.
Nazar justifies the restriction of movement on the factthat it was ultimately the women who had to save her Things are not so bad for girls in the cities or outside honour and the best way to do this was to restrict Kashmir. Girls are free there. Every time I go out I feel oneself to the house. She was aware that if something so good. I want to move out of here. Women are free.
happened people instead of being sympathetic would There is no one to stop them from wearing what they blame the woman; she must have done something to want to and living the way they want to. Here we are attract attention, why only her and not someone else… "Tell me was it the woman's fault? No but we had to I remember the time I was in junior school. There were bear the brunt of it all. What could I do in front of no restrictions then. The situation became bad when I reasons like this? I am ultimately the honour of my reached middle school. That is when militancy in Kash- parents am I not? I used to cry all the time and curse mir started. It was like overnight things changed for God for making me a girl…Times were bad, bad things worse. Cover your head, wear proper clothes come were happening to girls…Girls were abducted, raped home on time, don't stay out too late, don't leave the everything we had never dreamt of was happening. In house alone, burqa etc. It was horrible. I used to feel so a scenario like this who would allow girls out of the trapped. All the admiration that I had for the militants house lest alone to college… No one could have faded away. As long as they were not interfering in our thought that a schoolteacher would not permit his daily lives the movement had our support but once our daughter to study. But that is exactly what happened lives were affected in this manner we started praying to me. It is strange how the troubles in the state affect daily lives.
I was totally against the burqa. Why should we have …Till the age of fifteen I was a free bird, allowed to do to wear it? It's not a part of our culture. I do not ever whatever I liked. I could go wherever I wanted to, sit remember any of the women in my family or for that however I wanted to and wear whatever clothes I matter in the village wearing one. I never used to wear wanted to. In-fact there was no difference in my and it. My family and friends used to question and advice my younger brother's clothes both of us used to wear me to wear. But I never did. Were you not scared? To the khan dress. I was a tomboy. But life changed so be honest I was, especially when we heard cases of drastically with my monthlies that I curse god for mak- girls being shot and acid being thrown on girls in towns.
ing me a girl. All my friends had already had their month- It was scary but then I did not want to bow down. I was lies and I would always ask them when mine would aware that people were talking behind my back and start. I did not know that my life would change. My anything could happen to me. Thankfully it did not mother made me wear suits with chunni; people came last long. I was very happy when women openly de- to know about it. They started calling me a big girl, fied the dictate. You cannot imagine how suffocating it started treating me differently. I was no longer allowed is to be in one.
out alone. Earlier I was sent to buy groceries now I was These restrictions made me feel small. I started feeling not allowed to do this. I was stopped from doing ev- ashamed of myself and ashamed of the fact that I was erything. I used to feel very ashamed and confused.
a girl. The army used to chase girls…for what? Girls This shame and confusion soon turned into anger. Why were not allowed to step out alone, to go out alone in should things change like this? I was the same girl why the field why? I feel free today. I am out in the field was I being treated differently, what had happened to working and helping other women. When I visit Srinagar I can move out without bothering with my chunni. In I hate the five days of my monthlies. Normally I like to Srinagar I do not bother (laughs). Outside Delhi I am have a leisurely bath, but on those five days my bath not even bothered if there is no chunni. (Softly) I wear does not last more than 2 minutes. On the sixth day I jeans when I go to Delhi. How I wish we could also live cleanse myself thoroughly. I feel very dirty those five like the girls there. They do not care, I love them, and days. Why do only we have to have this? God is so the freedom they have; what I would not give to be like mfc bulletin/Aug-Sep 2005
Background Note for the Annual Meet, 2006
Quality and Costs of Health Care:
Social Regulation in the Context of Universal Access
-Ritu Priya1
The state of healthcare services is a matter of serious The framework for assessment of quality has to be able concern in most parts of the world. For most of the to address issues related to individual institutions at low and middle-income sections in the low and middle- primary, secondary and tertiary levels; to take a systemic income countries, ie. the majority of humankind, the view with which includes consideration of the issues are primarily of access to whatever are perceived interlinkages between institutions; and to assess quality as good quality basic services. For the better off across of specific public health programmes. It should be the globe, the issues are more of escalating costs and applicable to both public and private sector health care over-medicalisation. Inappropriate models of development and organisation of services as well as alienation ofhealth care providers from the laypeople have been The criteria and standards set for defining quality of carehave to be carefully chosen, and those in use have to widely identified as reasons for the present state of the be examined for their implications. The huge diversity health services. Therefore quality of health services has of epidemiological, social and health care context within to be examined from a public health perspective, which the health care services function means that criteria including but not relying upon clinical criteria alone for and standards may not be applicable universally. Quality the assessment.
criteria for single health service institutions, health servicesystems and specific health programmes will differ in However, even the public health perspective needs to some ways and be similar in others. The nature and load be delineated further. Public Health, as a field of enquiry of health problems to be handled, the level of and action, has two faces. One is the democratic face development of the health service system in the country/ with the potential of its acting as a lever for improving state/district, and the socio-econmic profile of the users quality of life of the poor and other marginalised sections will need to be taken into account. Therefore principles of society. It has, historically, focused on the necessity need to be enunciated for assessing quality and for of fulfillment of basic needs of all, including health care.
implementing quality control mechanisms that can then The second is the anti-democratic face of public health be applied in various contexts.
with its potential for coercion in the name of ‘publicgood'. Instances abound over the past century– from The measures envisaged to ensure improvement in the eugenics to medical research to disease control strategies– quality of health care are going to significantly influencethe setting of standards and steps to achieve them.
that violate rights of individuals and marginalised social Administrative controls, professional peer controls, groups. The definition of quality of care can also be community controls, setting of standard protocols, done in ways that, directly or indirectly, contribute to accreditation mechanisms to inform users, health insurance the practice of one or the other perspective.
systems that set standard protocols, Currently, there is emphasis on healthcare and disease control programmes of the public sector from severalquarters - the World Bank, the Pharmaceutical and Medical Equipment Industry and Medical InsuranceCompanies included. Increasing privatisation of health What principles can be used to guide assessment of care has led to recognition of ‘market failure' due to the quality of services? Efficacy and safety are essential low purchasing capacity of the majority across the attributes of any health care intervention, forming the‘outcome' indicators. Cost, regularity and sustainability world. Thereby public services provide the answer from of services determine adherence to instructions. Clearly both points of view; of the users who need affordable/ resource constraints alone cannot dictate the assessment free health care, and of the sellers of health products since this can mean acceptance of low levels of who need an assured market. While this may seem a effectiveness or safety. If some measures are proven safe win-win situation, what is most likely to get and effective for important public health problems, then compromised is the rationality of health care. Panic the resources must be found for them. On the other scenarios and ‘social marketing' build the demand for hand, state-of-the art technology cannot, by itself, be the programmes so that public funds are siphoned into standard of quality either since, for the above criteria, unnecessary programmes and measures.
the implications of its use can be different in diverse mfc bulletin/Aug-Sep 2005
Increasing expenditure on irrational medical care, and whether the motivation is primarily to provide the best increasing hazards to health from unnecessary medication services or to get the best ratings in accreditation and medical procedures are being documented, and are systems; whether it is profit-oriented, professionalism- widely known. The extent of malpractice rampant in both oriented or service-oriented. Such ‘process' indicators are the public and private health services in India is also important criteria, just as much as are the outcome often justified in the name of ‘quality' as judged by ‘patient demand' and ‘user perceptions'. These includeboth ‘process' and ‘outcome' indicators. Rational drug Also required is the definition of the role of the patient use has been widely discussed and its principles were in deciding the line of treatment. Is it an issue in delineated in the 1970s and 80s. While these need to assessing the quality of services? Does the patient's be re-examined, the use of diagnostics and other right to say ‘no' to the medically recommended state- dimensions of medical management require added of-the-art measures absolve the service provider of the attention. How to decide what is an epidemiologically responsibility or does it mean actively developing the rational and socially appropriate protocol is the question best line of management in keeping with the patient's to be answered.
world view? If standardized protocols are viewed as thesolution to some issues of quality of medical care, how Further, the rationality of public health programmes too will such issues be addressed? has been questioned. For instance the pulse poliocampaign has been shown to be epidemiologically Questions to be Explored
questionable in its claims, creating a threat of massive Some questions to be examined on the theme would paralytic outbreaks in future and the possibility of individual cases of vaccine virus poliomyelitis personswho may otherwise have remained healthy. Similarly, 1) What are the intrinsic components of health care that the programme for Control of Iodine Deficiency are important in deciding the quality of services? Disorders, with a universal ban on non-iodised salt, is 2) What criteria should be used to assess these also contended to be both irrational and hazardous. Both interventions also ignore the basic environmental causesof the problem.
Clinical criteria, eg., of efficacy and safety Public health criteria beyond the clinical, eg., of accessibility under different conditions Cost of technology and facilities required for its use; Health care services are not only about technologies and both clinical or public health analysis will require this good management. The Alma-Ata Declaration on PrimaryHealth Care stated the desirable health care to be that 3) Whose conditions and perspectives should be given which is available, accessible, affordable and acceptable primacy in answering these questions? to the community, given their specific social, economicand cultural context. Lack of access of large sections of The clinical professional the urban poor, rural and tribal populations to basic The patients from the well-off sections health care is a glaring issue, and health sector reforms The patients from the poor sections have worsened the situation, in the name of improving The cost-benefit analysis of the health financier ‘efficiency' and quality of health services.
The public sector providers The private sector providers.
It would be good to discuss these issues in the contextof the reality of the health services in India.
The nature of provider-user interaction is known todetermine the outcome as well as the perception of The background papers could be wide ranging: quality by patients. Rude behaviour, poor communicationand negligence by the providers are well-documented ills Overview papers raising issues or setting out of the health services in both the public and private principles for health care quality assessment sectors. Infrastructure planning also reflects the attitude Issues of quality in clinical management through case of the service planners and administrators; whether it is studies of specific health problems user-friendly or not, whether it gives importance to Issues of quality in health care delivery systems facilities such as water and toilets, catering and space Issues of quality in disease control programmes for attendants to stay etc. The adequacy of manpower, Criteria of quality for choice of technology in health its optimal distribution and work assignment influence the functioning of providers. The nature of working Case studies of quality of health institutions, health relationships between providers directly influences the service systems and disease control programmes.
quality of services. Quality is affected by the work Costing of health care and comparison of optional culture; whether it is one of cooperation or competition; mfc bulletin/Aug-Sep 2005
Blistering Indictment of Pharmaceutical Companies
The Truth About the Drug Companies: How they technology transfer. Senator Bayh, a democrat, and deceive us and what to do about it. Marcia Angell.
Senator Dole, a republican, together sponsored a law 305 pp. Random House, 2004. $ 24.95.
to speed the translation of tax supported basicresearch into new products, the law is known as the Marcia Angell, a well-known authority in the field of Bayh-Dole Act. Angell writes, "This enabled American health policy and medical ethics is also an universities and small businesses to patent outspoken critic of the U.S. health care system. The discoveries emanating from research sponsored by scathing attack of ‘Big Pharma', the collective name the National Institutes of Health (NIH)." The NIH is for the largest multinational drug corporations, in the funded by the taxes collected from American citizens book The Truth About Drug Companies comes not and others paying taxes in the U.S including several from a ‘crazy left wing radical' but from a buttoned- million invisible "illegal residents." Similar legislation down member of the medical establishment. She was also introduced to permit the NIH to directly served as an editor-in-chief of the internationally transfer NIH discoveries to industry by entering into reputed the New England Journal of Medicine for The U.S. Congress represented by the two ruling Angell painstakingly puts together a lot of data to class parties, the Republican and the Democratic show the unholy nexus of big business, in this case, parties, has enacted several laws that have benefited the pharmaceutical industry, the U.S. government, the pharmaceutical companies. Monopoly rights the medical establishment and the publicly funded granting effective patent life of brand-name drugs research institutions. In the introductory chapter itself increased from about 8 years in 1980 to about 14 she refers to the criminal nature of drug companies years in 2000. Without actually referring to the placing profits over people. Under the tongue in underpinnings of capitalism she comments, "…Big cheek heading ‘Your Money or Your Life' we find out Pharma will do anything to protect exclusive marketing that Americans spend "a staggering 200 billion dollars rights….in the face of all its rhetoric about the free a year on prescription drugs." In all 45 million market." The well-researched but recurring themes in Americans do not have health insurance and a her book are represented by the following sentences significant proportion of those who do, lack a on the the pharmaceutical industry. "Instead of being prescription plan to pay for their medicines. Angell an engine of innovation, it is a vast marketing machine.
describes patients trading off drugs against home Instead of being a free market success story, it lives heating or food. She adds, "the people hurting the off government funded research and monopoly most are senior citizens who need more prescription drugs than younger people." The prescription drug sales in the U.S. in 2002 were The two most informative chapters in the book are $200 billion and worldwide $400 billion. In 2002, the "Just How Innovative Is This Industry" and "Me- combined profits for the 10 biggest drug companies Too" Drugs. Angell states that the few innovative in the Fortune 500 were more than the profits of 490 drugs that come to market nearly always stem from big corporations put together. The focus of Angell's publicly supported research sponsored by the NIH book is mainly on how the drug companies operate and mainly done at medical schools and teaching in the U.S. The election of Ronald Reagan as President hospitals. One of the most lucrative cancer drugs, of the U.S. in 1980 led to a striking increase in paclitaxel, sold under the brand name Taxol was ‘corporate welfare' and assaults on the poor and initially derived from the bark of the Pacific yew tree working people in the U.S. The U.S. Congress began in the 1960. The National Cancer Institute (NCI), to enact a series of laws which would lead to again, a publicly funded institute, conducted orsupported the research on the drug for nearly 30 years at a cost of $183 million dollars of tax payers' mfc bulletin/Aug-Sep 2005
money. In 1991, Bristol-Myers Squibb signed a the same year, spent on an average 35% of their cooperative research and development agreement with revenues on ‘marketing and administration'.
the NCI giving the company exclusive access to Marketing also "masquerades" as education for government funded research. In 1992, after the drug was approved by the Food and Drug Administration(FDA), the U.S. drug regulatory agency, Bristol-Myers Her concluding chapter "How to Save the Squibb, a well known pharmaceutical giant was given Pharmaceutical Industry" is, in my opinion, 5 years of exclusive marketing rights. The worldwide disappointing but not altogether unexpected. She use of Taxol generated between $1 and $2 billion a proposes reforms like comparing new drugs with old year for Bristol-Myers Squibb. Similar stories can be ones, strengthening the FDA by repealing the Drug found with several other innovative drugs like Epogen User Free Act, which authorizes drug companies to – to treat anemia in chronic renal failure – imatinib pay for every drug reviewed. In addition she would mesylate (trade name, Gleevec) – to treat a kind of like an institute to oversee clinical drug testing that blood cancer – where the public pays initially for would not be sponsored by the drug companies development of the drug and then as consumers themselves. All of these are certainly useful short pays exorbitant prices for the drug.
term measures. While advocating a curb on monopolymarketing rights she is not critical of the very basis Angell in a stinging criticism and ridicule of the of giving patents to private hands. The wealth of pharmaceutical industry refers to their main business information that the pharmaceutical companies use as churning out "Me-Too" drugs that are versions of to make profitable drugs comes from decades, nay, drugs already in the market. Out of the 415 new even centuries of knowledge passed on from drugs approved by the FDA from 1998 through 2002 generation to generation and publicly funded medical only 14% were truly innovative. While there is a breakthroughs that Angell herself has so convincingly shortage of vaccines, anesthetics and drugs used in demonstrated. Ultimately, science as an institution is cardiac resuscitation, the market is flooded with influenced by the political and economic structure of several different statins - a class of drugs to lower the society. It would be too much to expect the book cholesterol. Another striking example of "Me-Too" to critique the underlying capitalist American state drugs is the plethora of antidepressants in the market, which allows Big Pharma to reap profits at the expense one not that different from the other.
of its people. All in all The Truth About DrugCompanies is a well-researched and lucid expose of The book exposes the inadequacy of clinical trials the pharmaceutical industry but clearly the reforms that are required to show the efficacy and safety of that are proposed at the end will not ‘fix' the system.
drugs. Trials for new drugs are conducted with placebos and not with older drugs, which are now Drug Pricing - What Does R&D Have to Do with it?
generic, substantially cheaper, and have been foundto be efficacious. Most of the 42 clinical trials of .Big pharma would like us to believe that prices of their top antidepressants such as Flouxetine (Prozac) lasted selling drugs have to be high to cover their costs, including for just 6 weeks and, on average, placebos were 80 the costs of all the drugs that never make it to market. Theimplication is that drug companies are just eking out a living percent as effective as the drugs. Clinical trials instead – something we know is a long way from the truth.
of being run with impartiality are conducted largely Furthermore, without any information about how they spend by the drug companies and, not surprisingly, are their R&D dollars, it is impossible to evaluate the extent to biased. Angell gives a few instances of "out and out which profitable drugs subsidize ones that never make it.
suppression of negative results." Nor is it possible to decide whether the R&D is worth it. Ifpatients must pay thousands of dollars a year for a vital In a damning indictment of the alliance between the drug, doesn't the public have a right to know what the markupis and where the money goes? We know that much of it goes pharmaceutical industry, researchers and doctors she to profits and marketing, but we also need to know what talks about the "Lures, Bribes and Kickbacks". In companies spend on which drugs and for what purposes.
2001, the industry had 88,000 sales representatives An industry so beholden to taxpayers for research, patent go to doctors' offices with free samples, personal protection, and tax breaks – in short, for taking most of the gifts and company products. The biggest companies, risks out of the business – ought to do more than just report mfc bulletin/Aug-Sep 2005
total R&D expenditures. It should open the black box.
it more rapid attention. This is called a "priority review."Which is for drugs likely to represent a "significant Despite all the rhetoric to the contrary, this is not a high-risk improvement compared to marketed products, in the industry in any normal sense of the term. In fact, drug treatment, diagnosis, or prevention of disease." The agency companies are not willing to take any chances at all. As one lists these drugs with the abbreviation "P". All other drugs indication, the law mentioned earlier that provides tax credits receive a standard – or "S" – review. A "standard review" equal to 50 percent of the cost of testing orphan drugs extends drug, in the FDA's words, "appears to have therapeutic the credits to other drugs if "there is no reasonable expectation qualities similar to those of one or more already marketed that the cost of developing and making available in the United States a drug for disease or condition will be recovered fromsales in the United States of such drug". In other words, if New molecular entities are not necessarily classified as you can't make a profit, the government will help you out.
priority review drugs. Even brand-new molecules may not This is an industry well protected against losses. Risky be any better than an older drug for the same condition. And businesses have variable returns, but the pharmaceutical likewise, priority review drugs are not necessarily new industry has been, year after year, the most profitable in the molecular entities. It is possible for an old drug to be modified United States. As Alan Sager, co-director of the Health in such a way that it offers a definite treatment advantage Reform Program at Boson University, put it, "If you went over the earlier form. But as a general rule, a drug that can be to Las Vegas with $1000 and routinely came back with $1400, called innovative in any usual meaning of the word is both a could your family accuse you of gambling?" What these new molecular entity and a priority review drug. In other companies are, in fact, claiming is an entitlement not only to words, the drug is a new molecule that will probably be a recoup anything they wish to spend on R&D but to make an significant improvement ove4r drugs already on the market.
exorbitant profit margin as well.
(The industry often uses the word innovative to mean just anew molecular entity, but that leaves aside the all-important The truth is that there is no particular reason to think that question of whether the drug offers any clinical advantages R&D costs, no matter what they are, have anything to do over old drugs).
with drug pricing. The irrepressibly candid Mr. Gilmartin,President and CEO of Merck, seemed to acknowledge that.
So let us look at the yield over the five years 1998 through Referring to the $802 million per drug estimate, he remarked, 2002 – the most recent five years for which I have complete "The price of medicines is not determined by their research data on both the numbers and the properties of the drugs.
costs. Instead, it is determined by their value in preventing Altogether, 415 new drugs were approved – an average of 83 and treating disease. Whether Merck spends $500 million or per year. Of those, 133 (32 percent) were new molecular $ 1 billion developing a medicine, it is the doctor, the patient, entities. The others were variations of old drugs. And of and those paying for our medicines who will determine its those 133, only 58 were priority review drugs. That averages true value." That sounds to me like an admission that the out to no more than 12 innovative drugs per year, or 14 industry will charge whatever the traffic will bear, and it has percent of the total. Not only is the yield very low, but over little to do with R&D costs. And that is about right.
those five years, it got worse. In both 2001 and 2002, only Unfortunately, contrary to Mr. Gilmartin, it does not have 7 innovative drugs (that is, new molecular entities with much to do with medical value either, as I will show.
priority review) were approved each year, as compared with9 in 2000, 19 in 1999 and 16 in 1998. And that is it – the The Output of Innovative Drugs
five-year grand total of innovative drugs from this mightyindustry.
. Even a glance at the industry's output shows that miraclesare few and far between. The evidence is on the U.S. Food Now, just to get a sense of what kinds of drugs are being and Drug Administration (FDA) website < produced and which companies are producing them, let us cder/rdmt/pstable.htm>. As I explained in Chapter 2, before look closely at the fourteen innovative drugs for those last a drug can be marketed, a company must file a new drug two years. Were they miracles from big pharma, as suggested application with the FDA. The FDA then classifies the drug by Mr. Holmer? At the time, there were some thirty-five in two ways. First, it looks at the compound itself, what the members of PhRMA, consisting of the world's major agency calls the "chemical type." Is it a molecule that is pharmaceutical companies and a few of the larger already on the market in some form? Or is it brand new – biotechnology companies. Of the seven innovative drugs what the FDA calls a "new molecular entity (NME)"? If it approved in 2001, five came from companies that were is a new molecule, then it is classified as a number 1 drug.
PHRMA members – two from the Swiss company Novartis Otherwise, it is classified as a chemical derivative, or new and one each from the American companies Merck, Allergan formulation or combination of an old drug. Or it might just and Gilead Sciences (a biotechnology company). The be an old drug with a new manufacturer.
Novartis drugs were the orphan drug Gleevec, for a rare form The second way the drug is classified in according to whether of leukemia (I will come back to this drug in a bit), and it is likely to offer any benefit above drugs already in the Zometa, an injection to treat a complication of widespread market to treat the same condition. If so, then the FDA gives cancer. The Merck drug was Cancidas, an injection to treat a mfc bulletin/Aug-Sep 2005
rate fungus infection when other treatments have failed; the interferon, the drug that Gleevec replaced as the recommended Allergan drug was Lumigan, an ophthalmic solution for treatment for chronic myeloid leukemia. In other words, the glaucoma not responsive to other treatment; and the Gilead price was what the market would bear. In response to the drug was Viread, a drug similar to AZT to treat HIV/AIDS.
outcry over the staggering price to treat this lethal disease,Novartis announced a discounting policy for patients of Of the seven innovative drugs approved in 2002, only three limited means. But according to a 2003 article in the New came from members of PhRMA: Zelnorm, a Novartis drug York Times, the plan had not worked very well so far, for irritable bowel syndrome with constipation; Eloxatin, an particularly n poor countries, where only a handful of patients injection made by the French company Sanofi-Synthelabo, have received the drug free. At a meeting I attended, to treat (although rarely, if ever, to cure) widespread colon someone in the audience complained to Vasella that a friend cancer when other treatments have failed; and Hepsera, a with chronic myeloid leukemia had had difficulty obtaining treatment for hepatitis B made by Gilead Sciences. Nothing the discount for which he was said to be qualified. Somehow, from any major American drug company.
I was not surprised.
That output hardly seems to warrant Mr. Holmer's high- Perhaps the most extreme example of this sort of price gouging flown rhetoric. To be sure, we do occasionally get important is the story of Cerezyme, a synthetic enzyme made by the new drugs. Gleevec, for example, may mean the difference biotechnology company Genzyme. This drug treats a rare between life and death for people with a certain type of abnormality, called Gaucher's disease, which affects only leukemia. Bu in recent years truly innovative drugs like that about 5000 people worldwide. The research and early have come along very frequently. Most of the drugs development was done entirely by NIH funded scientists, mentioned here, even though innovative, were last-ditch two of whom later left their university to start the company treatments – rarely cures – to be used when older drugs had and exploit their work. (The major contributor to the early not worked. And given the trend, we have to ask whether effort, Roscoe Brady, who discovered the cause of Gaucher's the $ 30 plus billion big pharma ostensibly puts into its disease, remained at the NIH.) Genzyme charges patients R&D is well spent. We also have to conclude that, if high on the order of $200,000 to $ 300,000 a year's supply.
prices and profits in excess of any other industry are indeed According to the author and reporter Merrill Goozner, at a stimulus for innovation, drug companies have not kept least one patient is not grateful to the company. "This is their part of the bargain.
government-developed technology," said the boy's father.
"This is not Genzyme working late at night to help sick people. The NIH did it. But as soon as the governmenttransferred that intellectual property to the company, they .Given the contributions of taxpayers to big pharma's lost all control over the pricing." products, you might think the drug companies would give usa break in pricing. But you would be wrong. Let us look at A more recent example is the story of Roche's new HIV/ the pricing of Taxol and Gleevec.
AIDS drug, Fuzeon. Approved by the FDA in 2003, thisdrug is an important advance in AIDS treatment. According When it came on the market, Taxol sold for $10,000 to $20,000 to a detailed story by the Wall Street Journal reporter Vanessa for a year's treatment – reportedly a twenty fold markup Fuhrmans, Fuzeon was discovered at Duke University, over manufacturing costs. Bristol-Myers Suibb, you will developed by a local biotechnology company, and only then remember, put next to nothing into the initial R&D, although acquired by Roche. Despite its minimal contribution to early it has since sponsored clinical trials aimed at expanding the research and development, Roche charges $20,000 a year for uses of the drug. In a blazing act of hubris, the company the drug – three times the price of most AIDS drugs. About fought tooth and nail to extend its exclusive rights on Taxol a fifth of AIDS drugs are purchased by the federal state beyond the original five-year term, and managed to win AIDS Drug Assistance Programs. These programs simply another three years by suing the generic manufacturers who cannot afford to buy Fuzeon for all the patients who need it, wanted to enter the market. As of 2003, the company had so they are restricting access to it, setting up waiting lists, or paid royalties to the NIH of only $35 million on its $9 billion tightening income eligibility criteria. In thirteen states, the in sales of Taxol (the agreement was 0.5 percent in royalties).
program has simply stopped providing Fuzeon to new Going in the other direction, the government paid Bristol- patients. Although Roche is reported to have a patient Myers Squibb hundreds of millions of dollars for Taxol assistance program, the company declined to tell The Wall through the Medicare program.
Street Journal how many people are in it, and it refuses toprovide assistance in states where the drug assistance program Novartis priced Gleevec at about $27,000 for a year's supply.
restricts access to Fuzeon. We are used to hearing about In a recent book, Daniel Vasella, the chairman and CEO of patients with AIDS in the Third World going without Novartis, acknowledged that the drug is already profitable. I lifesaving treatment, but now it may be happening in the would think so, given that its development was so rapid and United States. High prices have real, sometimes deadly, that it qualified for the orphan drug tax credit. He also acknowledged that the price was based partly on the price of mfc bulletin/Aug-Sep 2005
The 10 Worst Corporations of 2004
-Russell Mokhiber and Robert Weissman1 When the Multinational Monitor judges gather to pick the 10 worst corporations of the year, one of theirinstructions is: name no companies that appeared on the previous year's list (barring extraordinary circum-stances).
For the 2004 list, that means no Bayer (even though in 2004 the company pushed for import of geneticallymodified rice into the European Union, polluted water in a South African town with the carcinogen hexavalentchromium, and was hit with evidence that its pain medication Aleve (naproxen) increases the risk of heart attack,among other egregious acts), no Boeing (despite new evidence that the tanker plane scandal costing U.S.
taxpayers tens of billions of dollars is even worse than it appeared), no Clear Channel (even though the radiobehemoth in 2004 stooped to new lows with a "Breast Christmas Ever" contest that promised to pay for breastimplants for a dozen contest "winners"), and no Halliburton (embroiled in a whole new set of contracting fraudand bribery charges in 2004). But at least the no-repeat rule helps limit the field a bit.
And there remained plenty of worthy candidates. Of the remaining pool of price gougers, polluters, union-busters, dictator-coddlers, fraudsters, poisoners, deceivers and general miscreants, we chose the following -presented in alphabetical order - as the 10 Worst Corporations of 2004 [full text available]: Abbott Laboratories: Abbott makes the list for raising the price of Norvir, an important AIDS drug, developed
with a major infusion of U.S. government funds, by 400 percent. The price increase doesn't apply if
Norvir is purchased in conjunction with another Abbott drug, giving Abbott an unfair advantage over competi-
tors and tilting consumers to use the Abbott products on the basis of price.
AIG: The world's largest insurer, American International Group Inc. (AIG) was charged in October with aiding
and abetting PNC Financial Services in a fraudulent transaction to transfer $750 million in mostly
troubled loans and venture capital investments from subsidiaries off of its books. AIG agreed to pay $126 million
to resolve the charges, but it got off light, entering into a "deferred prosecution agreement" -
meaning the charges against the company will be dropped in 12 months time if it abides by the terms of the
Coca-Cola: Workers at the Coke bottling plant in Colombia have been terrorized for years by right-wing paramili-
tary forces. A fact-finding mission headed by a New York City Council member found, among other abuses,
"there have been a total of 179 major human rights violations of Coca-Cola's workers, including nine murders.
Family members of union activists have been abducted and tortured." Coke says it opposes the
anti-union violence and in any case that it hasn't had control of the bottling plant (though it does now, after
purchasing the Colombian bottling company). Coke's former general counsel, and the former
assistant U.S. attorney general, Deval Patrick, resigned in 2004, reportedly in part because Coke refused to
support an independent investigation into the Colombia allegations.
Dow Chemical: The world's largest plastic maker, Dow purchased Union Carbide in 1999. At midnight on Decem-
ber 2, 1984, 27 tons of lethal gases leaked from Union Carbide's pesticide factory in Bhopal, India,
immediately killing an estimated 8,000 people and poisoning thousands of others. Today in Bhopal, at least
150,000 people, including children born to parents who survived the disaster, are suffering from
exposure-related health effects such as cancer, neurological damage, chaotic menstrual cycles and mental illness.
Dow refuses to take any responsibility. In a statement, the company says, "Although Dow never
owned nor operated the plant, we - along with the rest of industry - have learned from this tragic event, and we
have tried to do all we can to assure that similar incidents never happen again."
GlaxoSmithKline: Following revelations and regulatory action in the UK in 2003 and 2004, the story of the
severe side effects from Glaxo's Paxil (as well as other drugs in the same family) - notably that they are addictive
1Russell Mokhiber is editor of the Washington, D.C.-based Corporate Crime Reporter, <>.
Robert Weissman is editor of the Washington, D.C.-based
Multinational Monitor, <>, and
counsel for Essential Inventions, a nonprofit involved in the pricing dispute discussed in the Abbott profile. Mokhiber and
Weissman are co-authors of
On the Rampage: Corporate Predators and the Destruction of Democracy (Monroe, Maine: Common
Courage Press).
(c) Russell Mokhiber and Robert Weissman

mfc bulletin/Aug-Sep 2005
and lead to increased suicidality in youth - finally broke in the United States in 2004. In June, New York AttorneyGeneral Eliot Spitzer filed suit against Glaxo, charging the giant drug maker with suppressing evidence of Paxil'sharm to children, and misleading physicians. Glaxo denied the charges, but agreed to a new system wherebyit would make public results all of its clinical trials. In October, the U.S. Food and Drug Administration orderedGlaxo and makers of drugs in Paxil's class to include a "black box" warning - the agency's strongest- with their pills.
Hardee's: The fast-food maker is bragging about how unhealthy is its latest culinary invention, the Monster
hickburger: "First there were burgers. Then there were Thickburgers. Now Hardee's is introducing the
mother of all burgers - the Monster Thickburger. Weighing in at two-thirds of a pound, this 100 percent Angus
beef burger is a monument to decadence." The Monster Thickburger is a 1,420-calorie sandwich.
Eating one Thickburger is like eating two Big Macs or five McDonald's hamburgers. Add 600 calories worth of
Hardee's fries and you get more than the 2,000 calories that many people should eat in a whole day,
according to Michael Jacobson of the Center for Science in the Public Interest, which calls the Thickburger "food
Merck: Dr. David Graham, a Food and Drug Administration (FDA) drug safety official, calls it "maybe the single
greatest drug-safety catastrophe in the history of this country." Testifying before a Senate committee in Novem-
ber, Dr. David Graham put the number in the United States who had suffered heart attacks or stroke as result of
taking the arthritis drug Vioxx in the range of 88,000 to 139,000. As many as 40 percent of these people, or about
35,000-55,000, died as a result, Graham said. The unacceptable cardiovascular risks of Vioxx were evident as early
as 2000 — a full four years before the drug was finally withdrawn from the market by its manufacturer, Merck,
according to a study released by The Lancet, the British medical journal. Merck says it disclosed all relevant
evidence on Vioxx safety as soon as it acquired it, and pulled the drug as soon as it saw conclusive evidence of
the drug's dangers.
McWane: McWane Inc. is a large, privately held Alabama-based sewer and water pipe manufacturer. In a devas
ating series, the New York Times revealed the company's egregious safety record, and the utter failure of
regulatory agencies to control the company's workplace violence. Nine McWane employees have lost their lives
n workplace accidents since 1995 - and three of the deaths were the result of deliberate company violations of
safety standards. More than 4,600 injuries were recorded among the company's 5,000 employees. According to
the Times, McWane pulled the wool over the eyes of investigators by stalling them at the factory gates, and then
hiding defective equipment. Accident sites were altered before investigators could inspect them, in violation of
federal rules. When government enforcement officials did find serious violations, the Times reported, "the
punishment meted out by the federal government was so minimal that McWane could treat it as simply a cost of
doing business." Riggs Bank: An explosive report from the U.S. Senate Permanent Subcommittee on Investiga-
tions of the Committee on Governmental Affairs, issued in July, revealed that the Washington, D.C.-based Riggs
Bank illegally operated bank accounts for former Chilean dictator Augusto Pinochet, and routinely ignored
evidence of corrupt practices in managing more than 60 accounts for the government of Equatorial Guinea.
Although these and other activities seem to violate U.S. banking rules, the Office of the Comptroller of the
Currency (OCC) did not take enforcement action against the bank after it learned of these matters in
2002. That presumably was not unrelated to the fact that the OCC examiner at Riggs soon thereafter went to work
for Riggs. In May 2004, the bank paid $25 million in fines in connection with money-laundering
violations related to the Equatorial Guinea and Saudi Arabian governments, and it is the subject of ongoing
federal criminal investigations.
Wal-Mart: While Wal-Mart is presently on a bit of a public relations defensive, the company remains the
colossus of U.S. - and increasingly global - retailing. It registers more than a quarter trillion dollars in sales. Its
revenues account for 2 percent of U.S. Gross Domestic Product. For two years running, Fortune has named Wal-
Mart the most admired company in America. It is arguably the defining company of the
present era. A key component - arguably the key component - of the company's business model is
undercompensating employees and externalizing costs on to society. A February 2004 report issued by
Representative George Miller, D-California, tabulated some of those costs. The report estimated that one 200-
person Wal-Mart store may result in a cost to federal taxpayers of $420,750 per year - about
$2,103 per employee. These public costs include free and reduced lunches for just 50 qualifying Wal-Mart
families, Section 8 housing assistance, federal tax credits and deductions for low-income families, and federal
contributions to health insurance programs for low-income children.
mfc bulletin/Aug-Sep 2005
Indian Journal of Medical Ethics NATIONAL BIOETHICS CONFERENCE
Ethical challenges in health care: global
context, Indian reality
November 25, 26 and 27, 2005 YMCA International, Mumbai Central, Mumbai, The Medico Friend Circle bulletin is the officialpublication of the MFC. Both the organisation and the Bulletin are funded solely through membership/subscription fees and individual donations. • Ethical challenges in HIV/AIDS Cheques/money orders/DDs payable at Pune, to
• Ethics of life and death in the era of hi-tech be sent in favour of Medico Friend Circle, addressed
to Manisha Gupte, 11 Archana Apartments, 163 • Ethical responsibilities in violence, conflict and Solapur Road, Hadapsar, Pune - 411028. (Please add Rs. 15/- for outstation cheques). email: • Ethics and equity in clinical trials and other While the conference is planned to cover these sub-themes, submissions will be accepted on Ritu Priya, 1312, Poorvanchal, JNU Campus, other subjects as well. New Delhi -110 067. Email: <[email protected]>MFC website:<> Last date for submission of abstracts: June 30, Conference details, application forms and updates Next Annual Mfc Meet
Next annual meeting theme will be on "Social regula- tion of Costs and Quality of Care in the Context ofUniversal Access to Health Care". The suggested For questions and clarifications e-mail: dates for the annual meet are January 21-22 or Jan 27-28, 2006 and likely venue in Kerala.
Good Practices of the "Good Practice Study"! Disbanding the CGHS Involving Self-Help Groups in Reproductive Health Women's Narratives from Kashmir-3 - Zamrooda Khandey Quality and Costs of Health Care Blistering Indictment of Pharmaceutical Companies - Padma Balasubramanian The 10 Worst Corporations of 2004 - Russell Mokhiber and Weissman Editorial Committee: Anant Bhan, Neha Madhiwalla, Dhruv Mankad, Amita Pitre, C. Sathyamala, Veena Shatrugna,
Chinu Srinivasan. Editorial Office: c/o, LOCOST, 1st Floor, Premananda Sahitya Bhavan, Dandia Bazar, Vadodara 390 001
email: [email protected]. Ph: 0265 234 0223/233 3438. Edited & Published by: S.Srinivasan for Medico Friend Circle,
11 Archana Apartments, 163 Solapur Road, Hadapsar, Pune 411 028.
Views and opinions expressed in the bulletin are those of the authors and not necessarily of the MFC. Manuscripts may besent by email or by post to the Editor at the Editorial Office address.
Registration Number: R.N. 27565/76
If Undelivered, Return to Editor, c/o, LOCOST,
1st Floor, Premananda Sahitya Bhavan
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For BROCK BIOLOGY OF MICROORGANISMS, THIRTEENTH EDITION Michael T. Madigan, John M. Martinko, David A. Stahl, David P. Clark Chapter 26 Microbial Growth Lectures by John ZamoraMiddle Tennessee State University © 2012 Pearson Education, Inc. Microbial Growth Control • Sterilization – The killing or removal of all viable organisms

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I Title Page Monitoring and Evaluation of Watersheds in the Middle East Region b. Submitting Institution: Inventory and Monitoring Institute, U.S. Department of Agriculture, Forest Service c. ID Number: M20-022 d. Investigators: Professor U. N. SAFRIEL*, Director of the Blaustein Institute for Desert Research, Sede Boqer Campus, Ben-Gurion University of the Negev, Israel. 84990 Phone 972-7-6596700 e-mail