Category Archives: AIDAN Press Releases

Open letter to DG, WHO – Pentavalent vaccine related deaths in India

To

Dr. Margaret Chan The Director General, World Health Organisation, Geneva

Dear Dr Margaret Chan,

All India Drug Action Network (AIDAN) is a network of not-for-profit civil society organisations that has been campaigning and working for rational use of medicines, largely in the Indian context. We have written to you in the past. We would like to bring your attention to the deaths Pentavalent (DPT + Hib + Hepatitis B) vaccine related deaths in India.

According to the Brighton classification of ‘adverse events following immunization’ (AEFI), re-challenge and recurrence of symptoms in the individual is needed for classification of AEFI as ‘certainly related to vaccine’. Such re-challenge is impossible if in the first instance, AEFI results in death. In the absence of proof from a re-challenge experiment, deaths caused by vaccines can only be classified as ‘probably related to vaccine or possibly related’ to the immunization.

As you would know, there have been several Pentavalent vaccine related deaths in Sri Lanka, Bhutan and Pakistan. Using the WHO approved classification of AEFI many of these deaths are ‘probably related to the immunization’ because no alternate cause for the adverse events has been found. However an expert panel looking at the deaths in Sri Lanka deleted ‘probably related’ and ‘possibly related’ from the classification of Brighton for purposes of their evaluation report, and then certified that the vaccines were ‘unlikely to be due to the vaccines’. This report (Expert Panel Report 23 December 2008 Sri Lanka) is available on the World Wide Web.

One by one the WHO has delisted a number of brands of prequalified Pentavalent vaccine, but the problem has refused to go away. Pentavalent vaccine was introduced in two states in India on 14th December and 17th December 2011, to evaluate the safety of the vaccine in India. According to an affidavit filed in the Kerala High Court by the Government of Kerala India, there have been four deaths in less than two months since it was introduced in the public health system. For your information the full text of the submission by Kerala government can be accessed here.

The reactions in India suggest that the cause of the problem is unrelated to the brand or manufacturer or lot of the vaccine. It appears to be a form of ‘hypersensitivity reaction’ as described in the post mortem report on one of the children in Kerala. The vaccine can be administered to many patients without problems and there is no available method at present to predict which infant will react adversely. The US FDA has pointed out that vaccines are aimed mostly at healthy individuals for prevention of diseases to which an individual may never be exposed. Unlike conventional drug treatments meant for the management of existing disease, in prophylaxis with vaccines, safety is of paramount importance. Vaccines that frequently and unpredictably cause death of healthy children cannot be recommended.

Pentavalent vaccine is at present recommended by WHO and its introduction is supported by GAVI funds. Given these circumstances the WHO needs to re-evaluate the recommendations. We propose to copy this letter to countries supporting the GAVI initiative so that they may be able to initiate action in a responsible manner.

Looking forward to your early action in the regard.

1. Dr Jacob Puliyel, Drug Action Forum – Karnataka (DAF-K), New Delhi

2. Dr Mira Shiva, Medico Friend Circle, New Delhi

3. Dr Gopal Dabade, DAF-K, Dharwad

4. Mr Srinivasan. S, LOCOST, Vadodara

5. Mr Naveen Thomas, Headstreams, Bangalore

6. Mr Prasanna Saligram, AID India, Bangalore

7. Dr Anurag Bhargava, JSS, Chattisagarh

ALSO READ: Vaccine woes continue, Down To Earth, March 12, 2012

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NGO asks WHO not to support Wyeth’s anti-pneumonia vaccine

The Economic Times, Delhi edition dated Sep 18, 2008 (Page Number 26) carried news about Drug Action Forum of Karnataka (DAF-K) open letter to World Health Organisation (WHO) regarding the pneumococcal conjugate vaccine.

GLOBAL pharma major Wyeth’s vaccine Prevenar is caught in dispute as the Drug Action Forum of Karnataka (DAF-K), a member of All India Drug Action Network (AIDAN), has asked the World Health Organisation (WHO) to withdraw its support for the pneumococcal conjugate vaccine.

NGO asks WHO not to support Wyeth’s anti-pneumonia vaccine

In an open letter to WHO, the Karnataka-based forum said a recent study revealed that the vaccine does not reduce clinical pneumonia and is likely to cause asthma in children. “It has been found through studies that the vaccine reduces a rare type of pneumonia called radiological pneumonia and only about 4 cases are prevented for every 1,000 children immunised and what is even more dangerous is that for every four in whom pneumonia is prevented, two children develop asthma because of the vaccine,” DAF-K president Dr Gopal Dabade said. Prevenar is the only licensed…. To read more, click here

To read the open letter sent by DAF-K, click here

Price Control Move Hailed (AIDAN Press Release 2006)

Press Release: 27 July 2006

MOVE TO BRING ESSENTIAL MEDICINES UNDER PRICE CONTROL HAILED

– All India Drug Action Network (AIDAN) calls for a comprehensive, balanced and rational drug policy

The All India Drug Action Network (AIDAN), which is a national network of a number of organisations who have been working on pharmaceutical policy issues since the early eighties, has hailed the decision of the Union Chemicals and Fertilisers Ministry to bring all the medicines in the National List of Essential Medicines under price control.

RATIONALE FOR PRICE CONTROL

We point out that there is a strong rationale for price control of the essential drugs

·    Medicines are the only commodity in which the payer (the patient) does not decide what to buy and at what cost. The doctor prescribes and the patient pays.

·    Unlike other commodities, the purchaser of medicines is extremely vulnerable as they are seeking immediate relief from suffering. Hence even in so-called market economies (except USA) medicine prices are regulated.

·    In India, unlike in the developed countries, expenditure on medicines constitutes a large proportion (>50%) of total medical expenditure. 90% of this expenditure is out-of-pocket expenditure by the people, since the government spends a very small proportion on medicine procurement

·    Unlike in the developed countries, most Indian patients face the drug industry as hapless individuals because most are not covered by insurance or social security mechanisms.

·    Majority of Indians are below or near poverty-line, yet they are forced to spend on unnecessarily costly medicines. This unnecessary expenditure on medicines is a very important cause for indebtedness after hospitalization.

·    The track record of the drug industry in India as regards to pricing is extremely reprehensible. The following example would illustrate this point –

The same drug in the same strength manufactured by two trusted companies can vary from 2 times to 20 times in their prices, which has no credible explanation other than overpricing. Levofloxacin used in infections is sold by CIPLA at Rs. 7 per tablet, while Aventis sells it at Rs. 95 per tablet. What is worse is that costlier drugs most often sell more because of more aggressive promotion.

·    Lastly, the prices of drugs outside price control are marked by anarchy and price deregulation in the past has increased the prices of drugs. Committees constituted by the Government have clearly documented abnormal rises in prices of drugs after they were taken off the list of price-controlled drugs. For instance –

After price deregulation in 1995, the price of some TB drugs rose by 250%. Yet no action has been taken.

Successive governments had brought down the number of drugs under price control from 347 in 1977 to a projected 25 or so in 2002, due to industry pressure. And it took the Supreme Court of India to take note of the situation and rule that, this would make them out of the reach of ordinary people.

PROFITABILITY vs. PROFITEERING

We believe that ‘price regulation is fully compatible with profitability’, as the real cost of manufacturing a drug is often a very small fraction of the retail price. For instance, Cadila Pharmaceuticals bid for supply of a medicine for worms, Albendazole 400 mg tablets, at a mere 22 paise, while its ZYBEND brand sells for Rs. 11.90 in the market. A drug for hypertension like Atenolol is procured at 12 paise by Delhi State while in the market, the same drug is sold for as much as Rs. 2.50, i.e. over 20 times the cost.

Currently drug prices are unnecessarily high also because the pharma trade too is indulging in profiteering. The trade margins in pharmaceuticals can be astronomical. A study done by VOICE, a consumer education organisation, and supported by the National Pharmaceutical Pricing Authority had shown that the difference in price to the retailer and that to the patient could well be over 400%. For instance, Nimesulide was available at Rs.24 for 10 tablets, while the price to the retailer was just Rs.6 for the same. The trade margin should also be regulated.

Pharmaceutical sector needed to explain to the public how it could afford to sell drugs at even 10% of their MRP to wholesalers and not suffer from loss of profitability and yet complain bitterly whenever the MRP was sought to be lowered by the government? The proposed pricing policy talks of a 150-200% margin on the post-manufacturing expenses for drugs under price control. Surely such a profit margin was adequate for profitability of any manufacturing enterprise,

RESEARCH vs. MARKETING

We disagree with the claims of the drug industry that research would be hit due to price control. In India, pharma companies spend 2% of sales on research and ten times on sales promotion! Pharma industry should divert its expenses from unnecessary sales promotion to research. It has been a part of the pharma policy that any drug developed by indigenous R&D shall be exempt from price control for a period of up to 15 years. But, here have been no claimants!

MORE ACTION REQUIRED

Past experience suggests that in the light of price regulation, the companies switch to production and promotion of alternative drugs, which are often irrational or higher priced alternatives which are outside the list. The government should pre-empt this by bringing all alternative drugs also under price control, if not, at the very least, under a scheme of price monitoring. And with over 649 million people in India lacking regular access to essential medicines (World Medicines Situation Report, 2004; WHO), there is an urgent need to go beyond just price control and to institute a comprehensive, balanced and rational drug policy in the country.