The Indian Academy of Paediatrics (IAP)’s reforms: transformative or cosmetic? #medicalethics


Rema Nagarajan
25 February 2013, 08:14 PM IST, TNN

The Indian Academy of Paediatrics (IAP)’s has dismantled its Committee on Immunisation which recommends vaccines to be included in the annual immunization schedule. It is being reconstituted as IAP Advisory Committee on Vaccines and Immunisation Practices. (ACVIP).

The IAPCOI, which was almost entirely funded by vaccine manufacturers, was under a cloud following criticism about issues of conflict of interest.

In IAP’s new committee on immunization members have to abide by a very strict code of conduct and also have to sign a pretty exhaustive declaration of conflict of interest stating whether they, their employer or their immediate family members have received any money or travel grant or favour from a commercial business, industry association or research association or other enterprises with an interest related to the subject of the meeting or work. The declaration also includes statements about research support including grants, collaborations, sponsorships and other funding the person or his department or research unit might have received. It also includes non-monetary support for research such as equipment, research assistants, facilities, paid travel to meetings, investments such  as stocks, bonds, securities, in a commercial and so on. Plus, the members have to have undergone some training in the field of immunization and vaccines.

The brand name Rotarix is prominently displayed inside the hall of the PEDICON conference held last month, though IAP claims it does not promote brands

The brands Synflorix and Rotarix of GSK, a major sponsor of the conference displayed prominently all over the conference venue

Doctors thronging the stalls put up by various pharma companies especially vaccine manufacturers

Secretary general of IAP Dr Sailesh Gupta pointed out that all doctors’ associations take money, whether it is gynaecology association or the cardiology association of India, as they cannot conduct training without pharma support.

“Why only pharma? There should be concern about us taking funding from WHO or the UNICEF. Even they have an agenda. For example, UNICEF also promotes food products for children. So, even with these international agencies they will want to promote a particular food product they are using in say Africa. So, we need to be careful with them also,” said Dr Gupta. He added that there were very few organisations which were doing something about conflict of interest like the IAP.

Dr Gupta said that Medical Council of India (MCI) was not responsive to doctors’ concerns. “MCI never responds to any letter we send. Sometime back we were organising two conferences which were being funded by pharma companies. We wrote to the MCI seeking clarification regarding this. We got no response from them. Finally, we hired a lawyer specialised in MCI regulations who assured us that there was nothing amiss in conducting the conference. If MCI clarifies that organisations cannot take funds at all from pharma we will abide by that.”

He further explains: “We understand that the public has concerns about conflict of interest in us taking funding from pharma. But when we make recommendations we give an entire armament of medication for a condition and not by brand name. We ensure that pharma does not advertise inside the area where the programme is taking place even when a company is funding a session or workshop or training. We only use generic names and the only credit is to say that the programme is supported by so and so company. We are very careful about conflict of interest.”

While it is true that IAP is making efforts to address conflict of interest in its immunisation committee, it is not entirely true that IAP does not promote brands or that they do not allow advertising inside where programmes take place. A few photos from IAP’s annual conference Pedicon held just last month, show that industry particularly vaccine industry was visible everywhere and even during sessions their advertisements were being projected. Members were also being given gifts by companies at their stalls.

Is this a case of more things change, the more they remain the same? Or, is there a genuine effort to change illegal funding practices and address conflict of interest issues?

How bacteria behind serious childhood disease evolve to evade vaccines


London, Jan 30 (ANI): The study of genetics has provided surprising insights into why vaccines used in both the UK and US to combat serious childhood infections can eventually fail.

The study, which investigates how bacteria change their disguise to evade the vaccines, has implications for how future vaccines can be made more effective.

Pneumococcus (Streptococcus pneumoniae) causes potentially life-threatening diseases including pneumonia and meningitis. Pneumococcal infections are thought to kill around a million young children worldwide each year, though the success of vaccination programmes has led to a dramatic fall in the number of cases in countries such as the UK and US.

These vaccines recognise the bacteria by its polysaccharide, the material found on the outside of the bacterial cell. There are over ninety different kinds or ‘serotypes’ of the bacteria, each with a different polysaccharide coating.

In 2000, the US introduced a pneumococcal vaccine, which targeted seven of the ninety serotypes. This ’7-valent’ vaccine was extremely effective and had a dramatic effect on reducing disease amongst the age groups targeted.

Remarkably, the vaccine has also prevented transmission from young children to adults, resulting in tens of thousands fewer cases of pneumococcal disease each year. The same vaccine was introduced in the UK in 2006 and was similarly successful.

In spite of the success of the vaccine programmes, some pneumococcal strains managed to continue to cause disease by camouflaging themselves from the vaccine.

In research funded by the Wellcome Trust, scientists at the University of Oxford and at the Centers for Disease Control and Prevention in Atlanta studied what happened after the introduction of this vaccine in the US.

They used the latest genomic techniques combined with epidemiology to understand how different serotypes of the pneumococcus bacteria evolve to replace those targeted by the initial vaccine.

The researchers found bacteria that had evaded the vaccine by swapping the region of the genome responsible for making the polysaccharide coating with the same region from a different serotype, not targeted by the vaccine.

This effectively disguised the bacteria, making it invisible to the vaccine. This exchange of genome regions occurred during a process known as recombination, whereby one of the bacteria replaces a piece of its own DNA with a piece from another bacterial type.

“Imagine that each strain of the pneumococcus bacteria is a class of schoolchildren, all wearing the school uniform. If a boy steals from his corner shop, a policeman – in this case the vaccine – can easily identify which school he belongs to by looking at his uniform. But if the boy swaps his sweater with a friend from another school, the policemen will no longer be able to recognise him and he can escape. This is how the pneumococcus bacteria evade detection by the vaccine,” Rory Bowden, from the University of Oxford, said.

Bowden and his colleagues identified a number of recombined serotypes that had managed to evade the vaccine. One in particular grew in frequency and spread across the US from east to west over several years.

They also showed that during recombination, the bacteria also traded a number of other parts of the genome at the same time, a phenomenon never before observed in natural populations of pneumococcus.

This is of particular concern as recombination involving multiple fragments of DNA allows rapid simultaneous exchange of key regions of the genome within the bug, potentially allowing it to quickly develop antibiotic resistance.

The original 7-valent vaccine in the US has now been replaced by a 13-valent vaccine, which targets thirteen different serotypes, including the particular type which had escaped the original vaccine. In the UK, the 7-valent vaccine resulted in a substantial drop in disease overall.

This overall effect was a mixture of a large drop in frequency of the serotypes targeted by the vaccine with some growth in serotypes not targeted by the vaccine. The 13-valent vaccine was introduced in the UK in 2010.

“Childhood vaccines are very effective at reducing disease and death at a stage in our lives when we are susceptible to serious infections. Understanding what makes a vaccine successful and what can cause it to fail is important. We should now be able to understand better what happens when a pneumococcal vaccine is introduced into a new population. Our work suggests that current strategies for developing new vaccines are largely effective but may not have long term effects that are as successful as hoped,” Derrick Crook, Professor of Microbiology at the University of Oxford and Infection Control Doctor at the Oxford University Hospitals NHS Trust, said.

The study has been recently published in Nature Genetics.

Calling all doctors to research into vaccine safety


Dear Dr ___,

Namaskar. Yes I do write against vaccines in general and do not support any vaccination program. This is because of my 27 years of study on the subject, something which I doubt any pediatrician and/or other doctors have done. These doctors do not know anything other than that a few children can get local injection site inflammation, suffer high fevers, even seizures and the cases of anaphylaxis, for which they are requested to be ready with an emergency kit but for which they are rarely prepared against.

I would like you to do some research yourself because nothing less will convince you. There are no safety tests done on vaccines and such tests are avoided. We all know what happened to Dr Wakefield who merely did a case study and suggested more research. Instead of welcoming the much needed advice the medical establishment reacted with alacrity and used the most dubious means possible to disgrace this good doctor, cancel his licence and verily deport him from the UK. His case study was also pulled out by the Lancet, an unprecedented event in the history of medicine.

The FDA has very recently conceded that no toxicity tests are done on vaccines because they are perceived to be safe. The only so called safety tests carried out for usually 14 days by the vaccine manufacturers themselves. They test extremely healthy children against a control group that are given another vaccine. Such tests even do not report serious adverse events as they are perceived to be due to other underlying causes, just as you so assiduously point out. This is a universal excuse that should be condemned rather than being entertained as pregnant mothers, infants and children are the most vulnerable populations.

In my 27 years long campaign for justice I have found that people, medical or non medical, do not wake up unless they or their children are affected. After that they sulk for long periods being affected by guilt, depression and utter helplessness. Rarely do they take up the cudgel to fight as they soon realise what they are up against. Both doctors and other people are threatened to keep quiet. Even I too face threats and there has also been an attempt to bribe me into submission. If vaccines are so sacrosanct and safe, why these highly unethical practices?

Regarding your own research I suggest the following;

1. Study the latest developments in the field of immunology
2. Study if vaccines being manufactured follow the recent findings
3. Collect all available medical literature that point out the dangers of the vaccination process
4. Study the incidence of those dangers pointed out in the child population
5. Study ALL the ingredients of vaccines with the help of a qualified toxicologist
6. Study the incidence of those disorders that come up in point no 5 in the child population
7. Study the presently available attempts that compare vaccinated with non vaccinated populations
8. Go through my articles “Vaccines: The Risk Vs Benefit Argument” and “50 Reasons to Protect Infants from Vaccines”
9. Ask the IAP on what basis they recommend the vaccines they do
10. Ask the Govt of India how they recommended the Oral Polio Vaccine, the BCG Vaccine, the Hep-B vaccine, the most recent Pentavalent and why they still continue with the DPT despite all developed countries discontinuing it.
11. Ask them how Bill Gates, a person with no medical qualification, is allowed to dictate our new Draft Vaccine Policy
12. Study how vaccines work, and whether the effect is prophylactic or anaphylactic
13. Question why the Pentagon is currently undertaking vaccine research
14. Question why known eugenicists like Bill Gates are involved with the vaccination process

After doing all these sincerely and with an open mind, study the history and politics of vaccines, not the doctored history that is now available but the real history and politics.

Regarding the measles vaccine, the recent catch up drive that was undertaken on the basis of a report that talked of 7 deaths, and the drive, as reported by scared doctors, killed 6 healthy children. The matter was ignored till certain persons intervened. And then the vaccine was exonerated and the blame put on program errors. Tell me which parent can be consoled with this semantic foul play.

Regarding the article I sent please get in touch with the authors of this study (after doing the above research), gain their confidence with the new knowledge gained in the process, and know for yourself their views on the matter.

You will also be interested to know that I have sensitized the chief functionaries of the IAP, the people who are directly involved with vaccine schedules and policies, and they have no answers for my questions. In fact many members of the IAP covertly support me and supply me required literature. I am in constant touch with highly reputed doctors and medical scientists in India and abroad on this highly controversial issue.

If you so wish I am willing to humbly help you in your research.

With regards,
Jagannath

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Pentavalent Vaccine Court Case: Govt Says, not we, the petitioners are corrupt


PIL on Pentavalent to aid pvt biz, says govt

TNN Jan 17, 2012,
KOCHI: The public interest litigation challenging implementation of Pentavalent vaccination programme in Kerala citing adverse effects is aimed at helping private companies supplying the vaccine, the central government contended on Monday.
Pentavalent vaccine, including the vaccine against Haemophilus Influenzae Type B (Hib), was rolled out across the State on December 14 last year as part of the Universal Immunization Programme.
National and international experts of World Health Organization investigated the deaths alleged to be due to Pentavalent vaccination in Sri Lanka, Bhutan, and Pakistan but were found to be not related to the vaccine, central government stated in the affidavit.

Pentavalent vaccine is available in Indian private market since 2004 and is being administered by private practitioners at an exorbitant price whereas the same is being given under Universal Immunization Programme of the central government freely, the affidavit said.
Out of a total 1.67 crore doses administered since 2004, 1.56 crore doses have been administered during the period of 2007 to 2011. Indian manufacturers for Pentavalent have increased from one in 2004 to five in 2009 due to the surge in demand, and Rs 6,000 is being charged for a single course of Pentavalent.
The intention of this petition is only to prevent the government from providing the vaccine free of charge so that commercial interests of private sector are protected, the affidavit states.
The central government also stated in the affidavit that more than 41,000 children have been vaccinated with Pentavalent since its introduction in Kerala and Tamil Nadu recently and no adverse event was noted. Pentavalent has been used in Goa since 2008, with more than 28,000 vaccinations until July last year, and no adverse event was noted, the affidavit said.
Countering a petition by a Wayanad-based NGO that the vaccination programme is being implemented without scientific health studies, the central government filed an affidavit at the Kerala High Court that pointed out that Pentavalent has been used for the past seven years by private players and 1.67 crore doses have been sold without any adverse effects

Dr Jagannath Chatterji ‘s response to the TOI article that has not been published ,is below :

THE GOVT OF INDIA HAS BADLY LET US DOWN ON THE PENTAVALENT VACCINE ISSUE

It is a pity that the Govt of India, in tandem with private agencies like the Bill & Melinda Gates Foundation, the GAVI and PATH is misleading the public and ignoring genuine fears and concerns of the public.

It is true that deaths have occurred shortly after administering the vaccine (Pentavalent) in three neighbouring countries and the vaccine consequently pulled out. It has been reintroduced in Sri Lanka after tampering with the adverse effect reporting format which ensures that deaths cannot be linked to the vaccine. The same has been done in India.

Why is an agency like GAVI giving such a costly vaccine free of cost to the GoI? What interest does this private agency have? Is it not true that this is also a temporary arrangement and the GoI will have to spend a huge amount of money to procure the vaccine after the contract is over? What skullduggery is going on here?

Why doesn’t the Govt pull up the IAP for recommending and administering 1.67 crores of doses of a vaccine with highly questionable credentials? What long term follow up has been done on these children? How many of them have died? How many have suffered adverse reactions? Were the informed consent of the parents taken before administering the vaccine? Where are the papers to prove that?

The Nuremberg Code clearly says ALL medical interventions and prescriptions should follow the principle of Informed Consent. The GoI that is a signatory to this act cannot feign ignorance.

Dr Harold Buttram, MD, of the USA in a path breaking book has accused Pentavalent vaccines of causing Sudden Infant Death syndrome and also Shaken Baby Syndrome. The death reported in Kerala strongly resembles the latter.

Why was the press asked for “positive reporting” after a series of genuine negative reports appeared of this vaccine reflecting the genuine doubts of very senior doctors and medical scientists of our country? Is the press being gagged? Are the doctors and health workers free to report deaths and adverse reactions? One sincerely doubts.

I am sure the people of Kerala will not tolerate this chicanery and will give a fitting reply. What a mess we are in! We are having to battle our own Government to fight for the lives and health of our children! Will our Health Minister and his Secretary kindly stand up and upon oath tell us what the ground situation really is?

We are waiting for your explanation Mr Health Minister. Kindly let us know if the facts mentioned in this letter have been considered before the Central Govt replied to the Kerala High Court Enquiry.

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