058. Open Letter To WHO On Pentavalent Vaccine Related Deaths In India

Open letter To WHO On Pentavalent Vaccine-Related Deaths In India

Pentavalent vaccine was introduced in two states of India last year by the World Health Organization (WHO). Several alleged deaths occurring due to the vaccine, prompted the All India Drug Action Network to write to WHO asking for a re-evaluation of the introduction of the vaccine.

By All-India Drug Action Network

To: 

Dr. Margaret Chan,
The Director General,
World Health Organization, 

Geneva

Dear Dr Margaret Chan,

All India Drug Action Network (AIDAN) is a network of not-for-profit civil society organizations 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 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 de-listed a number of brands of pre-qualified 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 Global Alliance on Vaccines and Immunization (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

March 12, 2012.


Republished here on public interest by courtesy of All-India Drug Action Network

Links:

Pentavalent Vaccines Promoted by WHO Despite Deaths of Healthy Children – Part I, Asia

http://www.dadychery.org/2012/05/01/pentavalent-vaccines-promoted-by-who-despite-deaths/

Tags:

Kerala Health News, Health Research Online, Public Health Kerala, Health News, Kerala Health Service, India Health, Health Department, pentavalent vaccines, Antigen, Paediatric disease, Infant death,

057. Kerala’s Everyday Drink Of Vaccine Cocktails

Kerala’s Everyday Drink Of Vaccine Cocktails

India serves up costly cocktail of vaccines

By Ranjit Devraj

Source: Inter Press Service News Agency,
New Delhi, India.
Saturday, November 9, 2013.

Ignoring widespread concern over the safety, efficacy and cost of pentavalent vaccines, India’s central health ministry has, this month, approved inclusion of the prophylactic cocktail in the universal immunization programme in seven of its provinces.

Pentavalent vaccine doses, a cocktail of five antigens in a single shot, confers immunity against five paediatric diseases – diphtheria, pertussis, tetanus, hepatitis B and haemophilus influenza type b (Hib), with the last one considered particularly problematic by some experts.

Pentavalents, produced by several manufacturers and promoted by the Global Alliance on Vaccines and Immunization (GAVI), has had a history of causing adverse reactions and deaths in India’s neighbouring countries like Bhutan, Sri Lanka and Pakistan.

In 2010, the National Technical Advisory Group on Immunization (NTAGI), a body of experts selected by the Indian government, recommended limited introduction of pentavalents in southern Kerala and Tamil Nadu and evaluation of results over a year before extension to other states.

Pentavalents were launched in Kerala and Tamil Nadu in December 2011, but the results were not encouraging. Kerala recorded four infant deaths following vaccination, with symptoms similar to what were seen in other South Asian countries.

Public health activists in Kerala, a state with 100 percent literacy and human development indices similar to those of advanced Western countries, quickly filed a public interest litigation (PIL) in the Kerala High Court asking for intervention in having the programme called off and a return to the existing health plan.

But despite infant deaths and two pending PILs (with yet another being heard in the Delhi High Court) against pentavalents, the health ministry announced on Apr. 16 that pentavalents would be introduced in five more states – Gujarat, Haryana, Karnataka, Goa, Jammu and Kashmir and Puducherry in October.

In making the decision, the government overlooked the NTAGI, which has not even been convened since August 2010 when the body suggested limited introduction to Kerala and Tamil Nadu as the two states have good adverse event following immunization systems.

“Going by what we have seen in the neighbouring countries and now in the state of Kerala, pentavalents can, without warning, cause children (to suffer) hypersensitivity reactions and death,”

Jacob Puliyel, an eminent paediatrician at St. Stephen’s hospital in New Delhi and member of the NTAGI, told IPS. Puliyel likened the situation to penicillin sensitivity and said it bordered on criminality to be administering pentavalents without first testing a child for hypersensitivity. “Every child that is being given a dose of pentavalent vaccine is a potential victim of the adverse reaction,” he said.

Puliyel was among the many eminent physicians and public health activists in India who wrote to World Health Organization (WHO) director-general Margaret Chan on Apr. 3 asking the health body to “re-evaluate” its recommendation of pentavalent vaccines on the grounds of safety.

Another signatory, Dr Meera Shiva, an expert on pharmaceutical drugs attached to the voluntary Medico Friends Circle, told IPS that WHO had to de-list a number of brands of ‘pre-qualified’ pentavalent vaccine, “but adverse reactions persist and we have surely not heard the last of them.”

The letter to Chan, written under the aegis of the All-India Drug Action Network, an umbrella of public health activist groups, suggested that the cause of the vaccination- related deaths was likely to be “hypersensitivity reaction as described in the post mortem report on one of the children (who died) in Kerala.”

“Unlike conventional drug treatments meant for the management of existing diseases, in prophylaxis with vaccines, safety is of paramount importance. Vaccines that frequently and unpredictably cause the death of healthy children cannot be recommended,” the letter to Chan said.

Policy analysts specializing in vaccines said they were dismayed at the move to approve pentavalents in as many as seven of India’s states, which account for 340 million of India’s 1.2 billion people.

“Pentavalents are a test case for India’s new policy on vaccines that is in keeping with liberalization and openly favours pharmaceutical majors at the cost of India’s public sector vaccine units,” said Madhavi Yennapu, a scientist who specializes in vaccines at the central government’s National Institute of Science, Technology and Development Studies.

Twenty of India’s 23 public sector vaccination units, once the mainstay of the country’s immunization programme, have been shut down one after another over the last four years on the grounds that the quality of their products was suspect.

Yennapu pointed to the draft National Vaccination Policy, released last year, for clues on why the government has not made any serious attempt to revive the vaccine- manufacturing units by enforcing quality standards, for instance.

The new policy demands that the “risk of manufacturing vaccines by private manufacturers must be cushioned by assistance from (the) government” and suggests that it be made mandatory for the government to support vaccine producers with advance market commitments (AMCs).

Madhavi explained that AMCs provide guaranteed markets for a vaccine even before trials are conducted, with the government committed to paying a supporting minimum price.

“Even if the vaccine turns out to be less efficacious than the existing one the government must honour the AMC by buying the new vaccine at the agreed price.

“This means that AMC funds must be deposited with the World Bank ahead of vaccine delivery by countries that GAVI is supposed to be helping with the introduction of new vaccines,”

Madhavi told IPS:

“Naturally, GAVI would be looking at large countries like India, Brazil and China to provide the AMCs.” For a country like India, what is important is to “see how many vaccines are needed to prevent how many deaths and at what cost, rather than throw out tried and tested vaccines in favour of a cocktail (pentavalent) which not only has doubtful advantages but has been shown to cause adverse reactions,” Madhavi said. According to Madhavi, there is no hard scientific evidence to show that India needs the Hib vaccine .“It is clearly piggybacking on other vaccines and the public made to pay for it.” The existing diphtheria, tetanus, pertussis (DPT) vaccine costs about 30 cents for all the doses needed to immunize a child, while immunization with pentavalents will cost more than 10 dollars. “We need to ask ourselves if introducing the new vaccine is really worth all the public money being spent on it,” Madhavi said.

Republished here on public interest by courtesy of Inter Press Services

Source: INTER PRESS SERVICE News Agency
Saturday, November 9, 2013

Tags: Kerala Health News, Health Research Online, Public Health Kerala, Health News, Kerala Health Service, India Health, Health Department, pentavalent vaccines, Antigen, Paediatric disease, Infant death,

056. Kerala Health Department Severely Accused By CAG On Account Of Sickle Cell Anaemia

Kerala Health Department Severely Accused By CAG On Account Of Sickle Cell Anaemia

Comptroller and Auditor General of India raps Kerala health department

Sickle Cell Anaemia is an inherited disease characterized by red blood cells that assuming a sickle shape making normal life difficult in later stages of the sickness

Press Trust Of India, Thiruvananthapuram
June 22, 2014

The Comptroller and Auditor General (CAG) has expressed concern over the failure of the public health system in Kerala to tackle the prevalence of sickle cell anaemia among the tribal population in Wayanad, home to nearly 31 per cent of Adivasi communities in the state.

According to a recent CAG report, out of the 85 per cent of tribal population screened by health authorities in the district, a total of 706 persons were found to be affected with the disease while 6,992 showed its traits.

Quoting a survey by the National Rural Health Mission (NRHM) from 2007-08 to 2012-13, it said as many as 312 of those suffering from the "life-long inherited disease" were in the age group of 18-40 and 262 in the school-going age of 5-17.

Sickle Cell Anaemia is an inherited disease characterized by red blood cells that assuming a sickle shape making normal life difficult in later stages of the sickness.

The NRHM had recommended grant of incentives to the school going students to continue their studies and for preferential treatment and temporary and contract jobs to those patients in the age group of 18-40, it said. However, the government and district administration did not initiate steps to implement this, the report said. The report also found fault with the state health department for not completing the disease screening to cover the entire tribal population in the region.

"No special efforts have been made by the Health Department to extend help to the identified patients to lead a normal life," it added.

Republished here on public interest by courtesy of Business Standard Dot Com

Link: http://www.business-standard.com/article/economy-policy/cag-raps-kerala-health-department-114062200709_1.html

Tags: Kerala Health News, Health Research Online, Public Health Kerala, Health News, Kerala Health Service, India Health, Health Department, Sickle Cell Anaemia, CAG, NRHM, Adivasi, Wayanad, Tribal

055. Who Will Catch Fake DMOs Who Catch Fake Doctors?

Who Will Catch Fake DMOs Who Catch Fake Doctors?

By Special Correspondent
Kerala Health Research Online

A District Medical Officer of Kerala caught a fake doctor in the private sector. But who will catch fake DMOs in the Kerala State Health Services Department? Justice M P Menon Commission that enquired into the fake mark list and MBBS certificate cases in the 1980s concluded its report by saying that the Commission, with its limited resources, time and staff, could only catch and expose a few fake doctors and the majority of them might still be working in the Health Services Department as Assistant Surgeons and Civil Surgeons. No follow up action was ever ordered and undertaken by the Chief Ministers, Health Ministers, Health Secretaries or the Directors of Health Services of Kerala. Most of them were duly promoted and some may have eventually become DMOs and other key Programme Officers. And it is, was, not the end of faking certificates and bribing for appointments. Things became only easier since then with the advent of computers, laser printers and other advancements available to those who want to fake things. Where do they actually verify the certificates a person claiming to be a doctor produces? There are three major recruiters in government sector- the Kerala Health Services Department, the Kerala Medical Education Department and the new, free, liberal and open route, National Rural Health Mission. In the last, anything is possible with its non-accountability. In the first two, there is no initial verification before appointment; everything is taken as gentleman’s word. After appointment, when the supposed doctor goes to the concerned institution to join is the SSLC Certificate and MBBS Certificate physically verified for proof of age and entry qualification, by a lowly clerk. They rarely hand over these to the clerks but just ask them to prepare a covering letter to the Accountant General without seeing them. A clerk in Trivandrum District once reported this to his superintendent and the superintendent said: ‘this person, from Sooranad, did not show them to even me, then how would to you? Anyway, give him the covering letter.’ SSLC Book of another doctor from Karunagappalli revealed that she secured 5 marks for English I Paper and 8 marks for English II Paper in Eighth standard. How will she ever become a doctor? When these facts were reported to higher authorities, the then Deputy DMO, DMO and DHS were very, very, very eager to suppress news; after decades, they sent this clerk away without four higher grades, promotion as UD Clerk on attainment of 50 years age, gratuity or even a pension, even though he had a corruption-less service of 32 years and was recruited through PSC. (Documentations are available online). They are such long-remembering and spiteful. So, before arresting others for faking, every doctor in the Kerala Health Services Department in Kerala, including the Director, has to prove before the public that they are not fakes. Let them put relevant details with scan copies of certificates in their official website and let people verify. Let IMA and KGMOA officials do it first.

Link to news article:

കൊച്ചിയില്‍ 20 വര്‍ഷമായി ചികിത്സ നടത്തുന്ന വ്യാജ ഡോക്ടര്‍ അറസ്റ്റില്‍

http://www.indiavisiontv.com/2014/09/18/353814.html?fb_action_ids=531725000290925&fb_action_types=og.comments&fb_source=aggregation&fb_aggregation_id=288381481237582


Tags: Kerala, Kerala Health News, Health Research Online, Kerala Public Health, Health News, Health Corruption, Fake Doctors, Illegal Medical Practice, Kerala Health Department, DMO, DHS, IMA, KGMOA, MBBS,

054. Kasaragode Hospital Spends Lavishly For Artists, Not For Pediatric Equipments.

Kasaragode Hospital Spends Lavishly For Artists, Not For Pediatric Equipments

'Kasaragode General Hospital spent 50,000 rupees for drawing 30 pictures of Micky Mouse, Tom & Jerry and Donald Duck in the walls of the children’s ward. The hospital superintendent Dr. Narayana Naik told Indian Vision Channel that this was made possible with the help of Hospital Development Committee, and as the next step, every wall in the hospital would be painted and filled with colourful pictures.' (News reported by India Vision Channel Live on 14th September 2014)

Special Correspondent
Kerala Health Research Online

According to health and revenue authorities, Hospital Development Committees in Kerala are outdated and long due for reconstitution. No one cared to regularize and develop them as societies fit enough to hold enormous sums in custody. Kasaragode District Hospital’s HDC is no exception. The District Collector of Kasaragode has full responsibility for the money-spending of this HDC which seems to have unlimited funds accumulated through years but no sense of destination. The politicians in this retired committee are spending money lavishly and foolishly. Indian hospital rooms have their long-approved colour patterns- green below and white above- to create pacifying, soothing effect. Nobody will paint them in red, pink and violet- angry colours. Normal stay for a child in hospital is three days. On the first and second days, the children won’t see practically anything for they would be in pains. On the third day, the day of their discharge, they do not need see anything; they just wish to go home. If they have to stay for more than three days in Kasaragode District Hospital, this hospital is bad in administration, cross-infectious, useless and risky. Because there is money, we cannot spend it; it is our reserves. When large amounts of money needed for a pediatric ward cannot be obtained from government, then, and then alone, can we spend HDC funds. Somebody must tell the Hospital Superintendent and the District Collector of this truth. Does this hospital have enough Pediatric Exam Tables and Scale Tables? Do they have Neonatal Infant Care Infant Warmers? How many working Transportable Infant Incubators do they have? How many Portable Vital Signs Monitors, Hand-Held Pediatric Vital Signs Monitors and Oximeters? How many Baby Finger Print Pulse Oximeters? Do they have Automated External Defibrillators, Fetal Monitors and Fiber-optic Phototherapy Systems? Have they ever demanded these from the Director of Health Services or Medical Services Corporation or have ever written to government requesting these. Have this committee ever discussed these basic necessities of children’s ward in meetings and recorded in minutes? There is a limit to ignorance, negligence and incompetence. Either leave decisions to doctors and other medically-qualified professionals or resign decently from this ornamental committee. Only in hospitals would this cheap political power play become possible. Will Kasaragode District Collector allow and tolerate a politically constituted Collectorate Development Committee imposed upon him, making him a puppet in taking decisions? If this committee, which knows nothing about children’s treatment other than how to make children, want to know about what are needed in pediatric wards, come down from the skies and ask the B.Sc. and M.Sc. Nursing-qualified staff who will tell them to purchase Electric Cots, Mobile Aneroid Stand With Cuffs (Rs.20000/-), Hand-Held Oximeters (Rs.60000/-), Portable Pulse Oximeters With Finger Sensors (Rs.80000/-), Gamma XL Patient Monitor (Rs.300000/-) or even a Da Vinci Robotic Surgical System which will cost only £500,000. Let this HDC prove their mettle.

Mobile Aneroid Stand With Cuffs is a Blood Pressure Machine with reusable blood pressure cuffs of varying sizes to suit any child. Hand-Held Oximeters are used to monitor oxygen levels in babies to prevent damage to vital organs due to lack of oxygen. Portable Pulse Oximeters With Finger Sensors are hand-held devises to monitor pulse and oxygen level while child patients are moved from place to place. Respiratory Humidifiers heat and moisturize the oxygen that is being delivered to children during mechanical ventilation, to prevent them from becoming cold, thick airway secretions from building up, breathing tubes from blocking up and the little lungs from collapsing, based on the principle that humidified and heated oxygen will make children recover faster. Vital Signs Monitors in pediatric and neo natal wards and emergency wards reads, registers and provides all necessary vital signs of the sick child. Gamma XL Patient Monitor can be purchased for Rs.300000/- which will watch all vital signs including Pulse Rate, Temperature, Blood Pressure and Cardiac and Pulmonary functions, replace all other equipments and prevent children from being moved to different monitoring levels, floors or rooms. The latest thing to present a children’s ward in a hospital with is the Da-Vinci Robotic Surgical System which ensures more accuracy in surgery, lesser pain, smaller scars and quicker discharge. The surgeon at the console sees 3D images of internal organs, makes tiny incisions, manipulates miniature instruments and performs surgery. These are becoming popular now- U.S. has 300 0f them and U.K. 1. Why don’t Kasaragode try? Anything is possible, and do not tighten purses where children are concerned. Also take care of a few other things. How many High Dependency Unit Beds, Electric Cots, Pediatric Nurses, Consultant Pediatricians and Anesthetists trained in Pediatric Care are there? Is there a Children’s Ambulatory Care Ward, so that children needn’t stay even a day for surgery? Are cots, waiting room chairs, and equipments including thermometers and birthing-baths beyond or with in Accepted Infection Control Parameters and Standards? Are all beds provided with oxygen space and access to oxygen outlets? What about prevention of cross-infection? Are medical and surgical patients separated? What about cleanliness in children’s baths, toilets and closets?

Link to News Article:

ചികിത്സക്കെത്തുന്ന കുരുന്നുകള്‍ക്ക് കൂട്ടായി കാര്‍ട്ടൂണ്‍ കഥാപാത്രങ്ങളും

http://www.indiavisiontv.com/2014/09/13/352453.html?fb_action_ids=530039403792818&fb_action_types=og.comments&fb_source=aggregation&fb_aggregation_id=288381481237582


Tags: Kerala, Kerala Health News, Health Research Online, Kerala Public Health, Health News, Health Corruption, Kasaragode, Pediatric Equipments, Pediatric Wards, District Hospitals, Hospital Funds, HDC