Vaccines: Policy for public good or private profit?

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Vaccines: Policy for public good or private profit?

Indian J MedRes 127, January 2008, pp 1-3

M. Puliyel and Yennapu Madhavi

Editorial

A quantum leap in science and technology in themid 1970s brought in

its wake a new genre of highly profitable vaccinesin the mid 1980s. A

slew of new vaccines has come to the market andnumerous others are in

the pipeline. Not all of these meet the actualneeds of the majority.

The methods used by economically well-offnations to gain control over

economically poor countries by accessingtheir markets and creating

demand for medical technologies/ vaccines,irrespective of local

needs, have been documented extensively( 1-5).

As a new product is being readied, research is published to highlight

the number of deaths in the country caused due to the absence of that

vaccine. The estimates are often outright exaggerations or reflect

poor research design. The limitations of such models have been

pointed outpreviously (6). The recent announcement by the National

AIDS Control Organization (NACO) that the prevalence of HIV/AIDS is

only half of the earlier estimates is the first official admission of

methodological fallacies(7).

This comes close on the heels of an admission by authorsbased in

Centres for Disease Control (CDC) Atlanta (authors who use aWorld

Health Organization (WHO) Geneva address, alternatively) , that the

model used to calculate hepatitis B mortality in India (which enabled

them to inflate the figure 50-fold) was missing(8).

Public-privatepartnerships disguise the role of the pharmaceutical

company in such research. Pharmaceutical companies can drive the

agenda but be hiddenwithin agencies like GAVI.

A recent study from Bangladesh on Hemophilus influenzae type b (Hib)

(9) acknowledges funding from the Asian Development Bank and USAID,

technical help from WHO, and Hib vaccinecosting millions from Sanofi

Pasteur. The role that the manufacturer, Sanofi Pasteur, had in the

study design is not explicitly stated. Overseas international

agencies are more than willing to help.

This role of international agencies and their nexus with

multinational companiesin influencing the public health priorities of

developing countries hasalready received some critical analysis(10,

11). The general principal,that `the one who pays the piper calls the

tune,' applies to vaccineresearch as well.

International agencies have obliged vaccine manufacturers in other

ways also. The WHO used to advise massvaccination only for diseases

like hepatitis B when the prevalenceexceeds 2 percent(12) but they

have dropped this condition in recent years to favour the

introduction of new vaccines like hepatitis B in the mass vaccination

programmes of developing countries. Cost-benefit studies used to be

performed in developed countries, before introduction of a vaccine.

Comeau in the Canadian Medical Association Journal notes that with

the arrival of Gardasil, a vaccine against humanPopillomavirus, (the

most expensive childhood vaccine proposed for mass use – it currently

costs $404 for the 3 required doses) – there have not been any cost

effectiveness analyses to determine whether the proposed vaccination

programmes will result in fewer cancer deaths(13).

The assistance to vaccine manufacturers has not always been subtle.

A protest was recently published against the WHO and its organ the

National Polio Surveillance Project (NPSP), for experimenting on

human subjects without their consent, a new monovalent oral polio

vaccine(mOPV1) that was 5 times stronger than the earlier licensed

mOPV(14,15).No mechanism was put in place, to monitor adverse effects

beside routine`acute flaccid paralysis' (AFP) surveillance.

Interestingly, Dr J.Wenger the NPSP author of the article(14,15) ,

moved from the NPSP to CDC in Alaska and the new NPSP chief has said

no new vaccine was used. TheLancet paper(14) on the `new vaccine' has

however not been retracted. No matter what the gloss that is put on

the matter, it erodes confidence in this organization.

The WHO position paper published in November 2006on Hib vaccine is

revealing(16) . It states that " in view of the demonstrated efficacy

and safety, conjugated Hib vaccine must be included in all routine

infant immunization programs. Lack of local surveillance data should

not delay introduction of the vaccine " .

It can be taken to mean that if a vaccine is effective, it must be

used every where, even in places where the disease is non existent.

Thus India(where WHO-conducted local surveillance data have

repeatedly shown that there is no need for the vaccine) must now use

the vaccine based on datain Indonesia and Africa. (The position paper

predates the Probe Studyfrom Bangladesh).

Strangely, the paper(16) recommends that surveillancefor Hib disease

must be carried out after introduction of the vaccine to document

impact of the vaccine. Given that the position paper was prompted by

the need to propagate vaccine use in places where vaccineneed could

not be demonstrated in spite of repeated attempts at surveillance,

favourable comparisons of post-vaccine data will presumably be made

against pre-vaccination prevalence in othercountries.

The paper of WHO advocating universal vaccination with Hib,

irrespective of an individual country's disease burden, irrespective

of natural immunity attained within the country against the disease,

and not taking into account the rights of sovereign states to decide

how to prioritize use of their limited health resources, is an

example of top down approach of global organizations like the WHO.

Individual countriesmust decide if they will permit this erosion of

their rights especially given that Hib disease has little potential

of becoming an international public health problem.

In the face of bourgeoning and aggressive marketing of vaccines of

doubtful utility, we have a widening demands-supply gap in Expanded

Programme on Immunization (EPI)vaccines(17) .

Over the last few decades, due to the decline of the public sector

and the growing disinterest of the private sector, the number of

firms supplying EPI vaccines has declined drastically both in India

and abroad, prompting the UNICEF to express its serious concerns

about the short supply of EPI vaccines(18, 19).

Private manufacturers prefer to sell them as `value-added cocktail

vaccines' at exorbitant prices in the open market, rather than supply

to EPI. The universal tendency to combine EPI vaccines with non-EPI

vaccines not only creates an artificial scarcity for affordable EPI

vaccines, but also creates a backdoor method for the entry of

expensive and perhaps unnecessary non-EPI vaccines into the universal

immunization programme, riding piggyback on the EPI vaccines(20) .

The combination of DPT with hepatitis B raises the price of DPT

immunization 17 fold. Moreover, the relative safety and efficacy of

these cocktail combinations are much lower than their individual

counterparts( 21-24). Yet, we have many cocktail vaccines flooding

the market including DTP-IPV, DTP-HB, DTPHib,DTP-HB-Hib, DT-Hib, DTP-

Hib-IPV, and DTPHB- Hib-IPV.

Only a ban against combinations of EPI and non-EPI vaccines, and a

stipulation that only those private manufacturers who supply EPI

vaccines to the government will be allowed to sell them in any form

in the open market will savethe EPI as well as the consumers. Dire

situations call for drasticaction.

There are lessons from this, both for the public andGovernments of

developing countries. Developing countries cannot expectinternational

agencies like WHO to be an honest broker betweenthemselves and

private for-profit vaccine manufacturers.

• The public need to maintain a healthy skepticism of the `facts and

figures'provided by vested interests and of the international

agencies that are influenced by such vested interests.

• The Government must developmethods and means so it can derive its

own data through well-planned epidemiological surveillance and it

must rely more on such data.

• It must develop strong governance mechanisms to regulate private

manufacturers not withstanding the bogey of `license raj' that

willinevitably be orchestrated.

• It must resuscitate the ability tomanufacture EPI vaccines within

the public sector so public health is not held to ransom by agencies

overseas.

Within the emerging scenario where expensive vaccines swallow up the

less expensive options(25),India could emerge as the ethical EPI

vaccine supplier to theworld.

M. Puliyel

St s Hospital

TisHazari, Delhi 110 054, India

puliyelgmail (DOT) com

Yennapu Madhavi

National Institute ofScience Technology

Development Studies, K S Krishnan Marg

New Delhi110 012, India

y_madhavi01@ hotmail.com

References

1. Greenough P,Streefland P. Social science and immunization, New

possibilities andprojects. New York: Social Science Research Council.

1998, vol. 52; p.1-10. 2. Stoker A, Jeffery R. Pharmaceuticals and

health policy: AnIndian example. Soc Sci Med 1988; 27 : 563-7.

3. Muraskin W. The global alliance for vaccines and immunization: Is

it a new model for effective public-private cooperation in

international public health? Am J PublicHealth

2004; 94 : 1922-5.

4. Blume S, Zanders M. Vaccine independence,local competences and

globalisation: Lessons from the history of pertussis vaccines. Soc Sci Med 2006;

63 : 1825-35.

5. Walt G.Globalization of international health. Lancet 1998; 351 :

434-7.

6. Rao JV, Ganguly NK, Mehendale SM, Bollinger RC. India's response to the HIV

epidemic. Lancet 2004; 364 : 1296-7.

7. National AIDS ControlOrganisation. HIV data. Ministry of Health

and Family Welfare,Government of India, New Delhi.

Available from:http://www.nacoonli ne.org/Quick_ Links/HIV_ Data/,

accessed on December28, 2007.

8. Puliyel JM. Letter to the Editor on Policy analysis of theuse of

hepatitis B, Hemophilus influenzae type B, Streptococcuspneumoniae-

conjugat e and rotavirus vaccines in the national

immunizations chedules. Health Econ 2004; 13 : 1147.

9. Baqui AH, Arifeen SE, SahaSK, Persson L, Zaman K, Gessner BD, et

al. Effectiveness of Haemophilusinfluenzae type B conjugate vaccine

on prevention of pneumonia andmeningitis in Bangladesh children.

Pediatr Infect Dis J 2007; 26 :565-7.

10. Muraskin W. Crusade to immunize world's children, Theorigins of

Bill and Melinda Gate's children's vaccine programme and thebirth of

Global Alliance for Vaccines and

immunization. USC MarshallGlobal biobusiness books Initiative, USA

2005; 294.

11. Madhavi Y.Transnational factors and national linkages: Indian

experience in human vaccines. Asian Biotechno Dev Rev 2007; 9 : 1-43.

12. WHO Hepatitis Bvaccine. Wkly Epidemiol Rec 1991; 3 : 11.

13. Comeau P. Debate beginsover public funding for HPV vaccine. CMAJ

2007; 176 : 913-4.

14.Grassly NC, Wenger J, Durrani S, Bahl S, Deshpande JM, Sutter RW,

et al.Protective efficacy of a monovalent oral type 1 poliovirus

vaccine: acase-control study. Lancet 2007; 369 : 1356-62.

15. Puliyel J,Sathyamala C, Banerji D. Protective efficacy of a

monovalent oral type 1poliovirus vaccine. Lancet 2007; 370 : 129.

16. WHO Position paper on Hemophilus influenzae type b conjugate

vaccines. Wkly Epidemiol Rec2006; 47 : 445-52.

17. Madhavi Y. Vaccine research: A case for nationalinnovation

strategy. Curr Sci 1997; 73 : 25-30.

18. United NationsChildren's Fund (UNICEF). Procuring supplies for

children; vaccine security. Available from: http://www.unicef.

org/supply/ index_vaccine_ security. html,

accessed onNovember 16, 2007.

19. Madhavi Y. Vaccine policy in India. PLOS Med2005; 127 : 0387–0391.

20. Madhavi Y. New combination vaccines:backdoor entry into India's

Universal Immunization Programme? Curr Sci2006; 90 :1465-9.

21. Food and Drug Administration. Guidance for Industry for the

Evaluation of Combination Vaccines for Preventable Diseases:

Production, Testing and Clinical Studies. Washington DC: USDepartment

of Health and Human Services, Food and Drug

Administration,Center for Biologics. Eval Res, April 1997, Docket No.

97N-0029.

22.Combination vaccines for childhood immunization: recommendations

of the American Academy of Pediatrics (AAP) and the American Academy

of FamilyPhysicians (AAFP). Pediatrics 1999;103:1064- 77.

23. Buttery JP, RiddellA, McVernon J, Chantler T, Lane L, Bowen-

J, et al.Immunogenicity and safety of a combination

pneumococcal- meningococcalvaccine in infants: a randomized

controlled trial. JAMA 2005; 29 :1751-8.

24. Wouter H. Who can be confident about multiple vaccines ininfancy?

BMJ, 22nd April 2006, Rapid Response for Banatvala et al,hepatitis B

immunization in Britain: time to change? 2006, 8th April,332 (7545)

804-5.

Available from: http://www.bmj.com/ cgi/eletters/ 332/7545/

804#132291, accessed on December 28,2007.

25. Sathyamala C, Puliyel JM. Polio vaccine and Gresham's law.Indian

J Pediatr 2004; 71 : 1141.

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