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There have been 76 deaths till August 2014 from Pentavalent vaccination. This is unacceptable and the PMO must intervene and stop this unwarranted vaccination, instead of promoting it, says a letter sent by a group of academicians, practitioners and teachers of pediatrics and public health
Several eminent doctors and scientists have requested Prime Minister Narendra Modi's immediate intervention to stop unwarranted vaccination in public interest.
Highlighting the recent deaths of young children following Pentavalent vaccination (76 deaths till August 2014), the letter sent to the PM says, "We request this note from us may please be taken on record since the Prime Minister's Office (PMO) has itself been involved in pronouncements of vaccine initiatives in the past few months. We feel it is our responsibility to place these scientific facts before the PMO so that it is aware of the facts and so that urgent and appropriate action may be initiated by you to direct the Ministry of Health to act in public interest and in accordance with basic precautionary principles. We hope we will receive an action taken report in the next two weeks".
The letter is signed by Prof Dr BM Hegde, former Vice Chancellor of Manipal University, Dr Vikas Bajpai from the Centre of Social Medicine and Community Health, Jawaharlal Nehru University, Prof Amitav Banerjee, Professor for Community Medicine at Dr DY Patil Medical College, Dr JP Dadhich, Consultant Paediatrician, Dr Arun Gupta, Paediatrician and Member of the PM's Council on India's Nutrition Challenges, Prof SK Mittal, former Professor of Pediatrics, MAMC and Head of Paediatrics at Pushapanjali Crosslay Hospital, Prof Ritu Priya, Prof at Centre of Social Medicine and Community Health, Dr Jacon Puliyel, Head of Pediatrics at St Stephens Hospital, Prof S Srinivasan, former Director-Professor of Pediatrics, JIPMER and Prof KP Kushwaha, Principal and Dean of BRD Medical College.
"Expensive vaccines that have little utility are being rolled out without monitoring benefits or harms and which are causing deaths and serious adverse effects. As a result, in spite of official attempts at denial, the public are losing trust in the entire immunization programme. We, a group of academicians, practitioners and teachers of pediatrics and public health would like to draw your attention to the pattern of adverse events and deaths from the newly introduced Pentavalent Vaccine (DPT+ Hib + Hep B vaccine) which is proposed to be rolled out nationwide as a government policy," the letter says.
Alleging global pressure to roll out vaccination drives, the letter says, "We are aware that there is global pressure from international organisations and donors. These very international organisations have ensured that even the protocol used to investigate the deaths have now been changed so the deaths can be ignored."
According to the letter, every few days one more child dies after receiving the Pentavalent vaccine.
The Deccan Herald of 22 August 2014 reported two more deaths from Haryana with the Pentavalent vaccine. Last week it was a death in Ujjain. Today’s newspaper (Nai Dunia, Indore) reports a death in Shivpuri (MP). Yet as these deaths mount, it has been announced that Pentavalent vaccine is to be introduced in three more states. Already as per RTI reply there have been 76 deaths in India till August 2014 from Pentavalent adverse events following immunization (AEFI).
It says vaccines are a public health measure to prevent serious disease and deaths. That is how a common man perceives the role of a vaccine. Therefore, deaths in healthy children from vaccines are not acceptable. These deaths have become so frequent that in Tamil Nadu, in spite of official denials, people have stopped going for vaccination and the immunization uptake has fallen by 25% in the last 4 years. According to the District Level Household Survey – DLHS 4: 2012-13 (https://nrhm-mis.nic.in/SitePages/DLHS-4.aspx) immunization coverage across districts in Tamil Nadu, with over 85% full immunization (DLHS–3:2007-08) has fallen to 56%. At the same time, a study on Hepatitis B vaccine (now included in the Pentavalent vaccine) published in the latest issue of the journal of the Indian Academy of Pediatrics – Indian Pediatrics shows the vaccine does not protect babies from infection, it added.
Here is the letter sent to the PMO...
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US Fed sent a joint warning letter to marketers of dietary supplement over unapproved Ebola treatment claims
A dietary supplement advertised online as a defense against Ebola — as well as a featured item on TMZ Live (!) — has drawn the censure of federal agencies for making unapproved treatment claims for the deadly disease that has ravaged West Africa.
The FTC and FDA write in a joint warning letter to the marketers of Ebola-C:
The marketing and sale of unapproved or uncleared Ebola Virus-related products is a potentially significant threat to the public health. Therefore, FDA is taking urgent measures to protect consumer from products that, without approval or clearance by FDA, claim to diagnose, mitigate, prevent, treat or cure Ebola Virus in people.
The letter cites the name of the product and the phrase, “DEFEND YOURSELF NOW!!!!! EBOLA-C®,” as examples of the dietary supplements being marketed as a drug, which is illegal without FDA approval.
For more of our coverage on Ebola treatment claims, click here.
Kickback allegations against its former editor prompted the Journal of Patient Safety to review his writings and adopt new standards for disclosing commercial conflicts of interest
This story was co-published with NPR's Shots blog.
The aftershocks of what's been called "patient safety's first scandal" continue to reverberate in the medical community, most recently in the current issue of the Journal of Patient Safety.
The Journal's editorial team reviewed 10 articles by Dr. Chuck Denham, the publication's previous editor, and said nine had potential conflicts of interest, five of them undisclosed. Though it's unlikely the articles resulted in patient harm, the editorial said, they may have hurt the journal's credibility.
The review is the latest turn in a rapid fall from grace for Denham, whose business dealings and patient advocacy came under scrutiny this year after a Justice Department kickback settlement.
A year ago, Denham was a golden figure in the burgeoning patient safety movement, a smooth-talking advocate who brought Hollywood pizzazz to the cause with his connection to actor Dennis Quaid and commitment to filmmaking.
As ProPublica reported, Denham also served in other prominent patient safety posts – most notably as co-chairman of a committee that set guidelines for the National Quality Forum, a nonprofit group that endorses best practices that are widely adopted throughout the healthcare community.
He ran a nonprofit patient safety organization and a for-profit consulting business, but Denham wasn't a practicing physician and didn't have strong academic credentials.
The scandal started when the Justice Department accused Denham of taking $11.6 million in kickbacks from CareFusion, a pharmaceutical company that makes the surgical antiseptic ChloraPrep. Denham was not a defendant in the civil case, which the company settled for $40 million. But prosecutors claimed he was paid to influence recommendations of the Quality Forum in favor of the drug.
Denham has denied the allegations. He did not return a call for comment about this story.
On Jan. 28, ProPublica reported that Denham had not disclosed that his for-profit company had been paid by CareFusion while he led the Quality Forum's Safe Practices committee and advocated for ChloraPrep's formulation. The Quality Forum ended up endorsing the formulation, excluding other antiseptics, in its guidelines. Other experts on the panel told ProPublica that had not been their intent.
The Quality Forum cut its ties with Denham, as did the Journal of Patient Safety.
A new editorial board was appointed in Denham's wake. The editors wrote in their review that they were surprised when Denham was named editor in February 2011. They hadn't been consulted, there was no formal search process and Denham had previously published only 17 academic articles.
A spokeswoman for Wolters Kluwer Health, the company that publishes the Journal of Patient Safety, told ProPublica that Denham was appointed because he was a prominent member of the editorial board who had been recommended by the previous editor.
The Denham articles that editors reviewed included no direct references to ChloraPrep.
But the articles contained numerous references to the Quality Forum's Safe Practices guidelines. That was a potential conflict-of-interest given that the company that could have benefitted from Denham's control of the guidelines, the editors concluded.
"This is a clear violation of the standards of the Journal," the editors wrote.
Dr. Albert Wu, an associate editor with the journal and a professor in the Johns Hopkins Bloomberg School of Public Health, said it was clear when Denham's ties to CareFusion became public that a review of his published work would be necessary.
Wu said the Denham controversy has helped the patient safety movement grow up by showing that the world of quality improvement presents opportunities for industry to corrupt medical practice.
People are becoming as wary and aware of the influence of money on patient safety as they have been in the world of medical devices and pharmaceuticals, he said.
"We're now much more aware that we need to be more vigilant," Wu said.
The Journal of Patient Safety launched in 2005 and hadn't adopted some of the conflict-of-interest standards of the International Council of Medical Journal Editors. Now conflict-of-interest forms will be published with articles, and editors will publish disclosure statements and recuse themselves from decisions where they have conflicts.
The new editors should be commended for airing their dirty laundry because the openness will build trust, said Eric Campbell, a professor of medicine at Harvard Medical School.
"The reputation of a journal is all it has," said Campbell, who studies conflicts of interest.
Campbell said the controversy opened the eyes of many in the patient safety field to the notion that money could corrupt, "even something as awesome and great for society as patient safety."
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