FROM THE PRESS


Vaccine industry an “integral part” of recommended vaccination schedule

A connection has been drawn between the fact that almost every vaccine available in the Indian market – including several that are not listed in the national immunisation programme – features in the schedule drawn up by the Indian Academy of Paediatrics Committee of Immunisation (IAPCOI) and the fact that almost all of the Academy’s funds come from major pharmaceutical companies. However, the IAP feels there is no conflict of interest.

Rs 26.8 lakh of the IAPCOI’s fund of Rs 27.8 lakh is contributed by the industry: pharma major Wyeth contributed Rs 4.9 lakh; Sanofi Pasteur Rs 5.1 lakh; Glaxo SmithKline Rs 5 lakh; Merck Rs 5 lakh; Serum Institute of India Rs 3 lakh; Sanofi Pasteur Rs 1.8 lakh; and Pfizer Rs 2 lakh, according to the IAP’s own Annual Report for 2012.

Dr Sanjiv Lewin of the Department of Paediatrics, Clinical Ethics and Medical Education, St John’s Medical College Hospital, Bangalore, has pointed out that nine out of 10 special invitees to the IAPCOI meeting represented the vaccine industry. To this, the IAPCOI convenor’s defence was that the vaccine industry is “an integral part of the system that affects every aspect related to vaccines”.

Rema Nagarajan, Conflict of interest on recommendation of immunization schedule? Times News Network, January 13, 2013. Available from: http://articles.timesofindia.indiatimes.com/2013-01-13/special-report/36310587_1_sanofi-pasteur-vaccine-schedule-vaccine-manufacturers

Land transfer scandal in ICMR

Several senior serving and former officials of the Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research have been arrested by order of the special fast track court of the Central Bureau of Investigation (CBI) on corruption charges. They include Bela Shah, head of the ICMR’s division of non-communicable diseases; Ashok Kumar Srivastava, executive engineer; and Bhawani Thyagarajan, retired joint secretary in the Ministry of Health. Shah and Srivastava have now been suspended by the ICMR, pending investigation.

After a two-year long investigation, the government’s audit body, the Comptroller and Auditor General (CAG) of India found that between 2002 and 2008, land belonging to the ICMRaffiliated Institute of Cytology and Preventive Oncology (ICPO) had been illegally transferred to a private housing society of employees by the ICMR executive council at far less than the market value, resulting in massive losses to the government exchequer. Originally intended for staff housing for ICPO, the land was taken over by a private housing society, of which the accused were members.

Former Director General, ICMR, NK Ganguly, and former Director, ICPO, BC Das, are also wanted in the case. While Ganguly is said to have claimed that the necessary government permissions for the land transfer were in place, the CAG and the CBI have denied this.

Sanjay Gupta, Indian medical officials charged in land deal case, Nature, March 8, 2013. Available from: http://www.nature.com/news/indian-medical-officials-charged-in-land-deal-case-1.12554

Infamous two-finger test discarded

After repeated protests from women’s organisations and health activists, the infamous and irrelevant two-finger test used to determine whether a rape victim is “accustomed to sexual intercourse” has finally been discarded. The Nagpur bench of the Bombay High Court, while hearing a public interest litigation, Dr Ranjana Pardhi v. Union of India and Others, on sexual assault protocols for investigators and the healthcare response to sexual assault victims, directed the state to implement the recent forensic examination manual prepared by a government-appointed panel, incorporating revisions suggested by Dr Indrajit Khandekar, Associate Professor of Forensic Medicine, Mahatma Gandhi Institute of Medical Sciences, Wardha (See http://ijme.in/211ed02.html and http:// www.cehat.org/go/SexualViolence/Press).

The proforma based on the panel report represents a major shift from the earlier practice, and includes recording patient history, listing specimen collection, opinion writing, and followup check-ups on the rape survivor’s mental and physical condition. “The court told us that we should start implementing their 2011 order. The Directorate of Health Services and the medical colleges will now have to distribute the proforma of the forensic examination in their respective hospitals and centres,” said Bharati Dangre, who appeared for the state.

Menaka Rao, HC asks state to follow new manual, with no twofinger test for rape, Hindustan Times, March 4, 2013 Available from: http://www.hindustantimes.com/India-news/Mumbai/HC-asks-state-to-follow-new-manual-with-notwo-finger-test-for-rape/Article1-1020718.aspx

WB sterilisation camp breaches all norms

Soon after a sterilisation camp in Malda district of West Bengal in February, over 100 women are reported to have been dumped unconscious in an open field. The operations were carried out by two doctors from the Manikchak Rural Hospital and one from the nearby Ratua healthcare centre, who then instructed the helpers to shift the women to the neighbouring field, while some were still under the anaesthetic.

The sterilisation camp was organised in the Manikchak rural hospital and around 103 women underwent the ligation procedure at the camp. They were then moved to a nearby field as the hospital infrastructure could not accommodate more than 30 women patients. The camp was organised in blatant disregard of basic health and safety rules, which include restricting the number of sterilisations to 25 procedures per day and placing patients under observation for a minimum three-hour period.

Many of the patients, dumped in the field, fainted due to the pain. Many others were sent home in cycle vans as the hospital did not have ambulance services. The report says one patient was seriously injured after the cycle van in which she was sent off collided with another vehicle.

The West Bengal chief medical officer has ordered an inquiry and promised to act on the report when it comes out.

Staff Reporter, West Bengal mass sterilisation: over 100 women dumped unconscious in field after operation, International Business Times, February 10, 2013. Available from: http://www.ibtimes.co.in/articles/433424/20130210/westbengal-mass-sterilisation-women-dumped-unconscious-field.htm

Donated hearts going waste

The absence of a well organised programme to retrieve donated hearts recently resulted in the discarding of 250 hearts in Chennai. This occurred in spite of the deaths of thousands of patients in the country due to end stage heart disease, every year. While other organs are harvested from brain dead donors, hearts are often treated as medical waste or left in the donor’s body. Lack of co-ordination among transplant surgeons and low levels of awareness among patients aggravate the situation.

Chennai is said to be foremost in performing heart transplants in the country, yet only 17% of donated hearts were utilised in the state of Tamil Nadu last year. Of the organs from 306 donors received by the state organ transplant registry, 563 kidneys and 280 livers were retrieved, while the figure for hearts is just 52. Part of the problem is the delay, as the heart is the last to be retrieved after other organs, which often makes it unfit for use. Another is that cardiologists don’t spare the time to make patients aware of the fact that they may not survive without a transplant.

Pushpa Narayan, Hearts meant for transplants end up in trash, Times News Network, January 18, 2013 Available from: http://articles.timesofindia.indiatimes.com/2013-01-18/india/36414414_1_heart-transplant-transplant-surgeon-brain-dead-patient

BMC’s killing delays

Twenty children on the waiting list for cardiac surgery at Mumbai’s KEM Hospital died between January 2012 and March 2013 because they could not have the operation. The reason: there were just two antiquated heart-lung machines at the only civic or state-run hospital in Mumbai with a department for paediatric cardiac surgery. And one of these gave up the ghost after 29 years of service. The hospital’s paediatric ward has a waiting list of over 700 children aged between one and five years, waiting breathlessly for life-saving open heart surgery. This dismal situation is simply the result of the municipal corporation’s criminal neglect of the upkeep of the hospital’s equipment. The hospital is said to have approached the BMC for a new machine in 2009, but no replacement has yet been ordered.

The civic body’s four year-long delays over floating and acceptance of tenders have meant that the only such machine has been reserved for “emergencies”. The Additional Municipal Commissioner, BMC, has agreed that this situation has not arisen due to any cash crunch in what press reports call the “world’s richest civic body”, with a budget for healthcare of Rs 27,000 crore. Following the shocked public response to the news, civic officials have said they will send surgeons to the other two civic hospitals to operate in shifts and reduce the backlog of KEM cases; the BMC will also float fresh tenders for purchase of a machine which will take a minimum of three months to arrive. Dr Devi Shetty of Narayan Hrudayalaya, Bangalore, offered to operate on all the children on the waiting list within seven months, and the Bombay High Court admitted a public interest litigation on the matter. Now the BMC has worked out a scheme for surgery on 288 critically ill children at four private Mumbai hospitals under the Rajiv Gandhi Jivandayi Yojana scheme and will bear the cost of surgery and postoperative care.

Lata Mishra, A ray of hope, Mumbai Mirror.com, March 26, 2013 Available from: http://www.mumbaimirror.com/artic le/15/2013032620130326053113465f06facf/Ray-0f-hope. html Lata Mishra, 288 critical kids to be operated upon at city’s top hospitals, Mumbai Mirror.com, March 29, 2013 Available from: http://www.mumbaimirror.com/article/15/ 20130329201303290247329065523ebaf/288-critical-kidsto- be-operated-upon-at-city%E2%80%99s-top-hospitals. html

Dubious autopsy in Bhandara case

The deaths of three sisters aged 11, eight and six, whose bodies were found floating in a well in Bhandara district, Maharashtra, on February 14, shocked the entire state. After initial theories that the children had been raped and then murdered, serious doubts were raised about the reliability of the post mortem which was apparently conducted without doing the basic lung and diatom tests, but included the banned two-finger test on Indian Journal of Medical Ethics Vol X No 2 April-June 2013 [ 84 ] the dead bodies. Further, the bodies had not been kept in cold storage, and were decomposing after being in the water for several hours.

An embarrassed state administration placed the autopsy video recording and findings before a forensic expert, who stated that there was no evidence of rape. The case was again put before a three-member forensic team, which said the deaths were caused by drowning and no rape was indicated. Heads are now set to roll, and the administration has declared certain steps to be taken in future:

  • training programmes at government medical colleges in Mumbai, Pune and Nagpur. for medical officers from every district hospital;
  • for complicated cases, expert opinion will be sought from the forensic medicine department of the nearest government medical college;
  • 19 new posts of medical officers, with special knowledge of forensic science, will be created “in those districts where there are no government medical colleges”.
Santosh Andhale, Bhandara case may be murder, not rape: Reports, DNA.com, March 10, 2013 Available from: http://www.dnaindia.com/mumbai/report_bhandaracase-may-be-murder-not-rape-reports_1809404 Prafulla Marpakwar, Bhandara case: Maharashtra admits goof up in postmortem, Times News Network, March 26, 2013, Available from: http://articles.timesofindia.indiatimes.com/2013-03-26/mumbai/38039875_1_medical-officers-forensic-science-forensic-medicine-department

Drug overdose deaths involve pharmaceuticals

Researchers studying data from the US National Vital Statistics System multiple cause-of-death file found 38,329 drug overdose deaths in the US in 2010, about 58% of which involved pharmaceuticals. They also found that when patients overdose on prescription opioid painkillers, other drugs given for mental health disorders are often part of the problem, These were antidepressants in 13.4% of the deaths, followed by anti-epileptic and anti-Parkinsonism drugs at 6.8%, and then by antipsychotics and neuroleptics at 4.7% . Dr Leonard Paulozzi,, the lead researcher, wrote in a letter to the Journal of the American Medical Association: “This analysis confirms the predominant role opioid analgesics play in pharmaceutical overdose deaths, either alone or in combination with other drugs,”

The researchers emphasised the importance of prescription drug monitoring programmes and electronic health records in order to “identify risky medication use and inform treatment decisions, especially for opioids and benzodiazepines.”

Kristina Fiore, Prescription drugs leading cause of fatal overdoses, medpagetoday.com, February 19, 2013, Available from: http://www.medpagetoday.com/PublicHealthPolicy/PublicHealth/37438

Freebies to doctors will be taxed

The income-tax (IT) department’s decision to tax the amounts that pharmaceutical and other healthcare manufacturers spend on “gifts” for medical practitioners and their professional associations was upheld by the Himachal High Court. The IT department had issued a circular to this effect following the Medical Council of India ban on doctors and their organisations accepting gifts in cash or kind from the medical industry. So far, deductions had been allowed on expenses for business promotion; however, now that regulations expressly prohibit them, this concession will not be made.

C Unnikrishnan, Himachal Pradesh high court upholds tax on freebies for doctors, Times News Network, March 4, 2013 Available from: http://articles.timesofindia.indiatimes.com/2013-03-04/india/37436654_1_freebies-medical-council-pharma-firms

SC issues notice in HPV writ petition

Notice was issued to the Central government on a public interest writ petition filed by health activists Kalpana Mehta and others of the Gramya Resource Centre for Women, Andhra Pradesh, The petition said that Gardasil and Cervarix, the two Human Papilloma Virus vaccines intended to treat cervical cancer, are unlicensed, unproven, and hazardous. It said that the Drugs Controller General of India’s office and the health ministry had granted permission for clinical trials of these vaccines without adequate research on their safety. This was in breach of an order of the relevant Parliamentary Standing Committee of April 2010.

The petition alleged that while Gardasil contained r-DNA as found in samples from different countries including India, this was denied by the manufacturer. It also stated that the production of Cervarix involved insect cells and protein which enter the bloodstream of trial subjects and could cause infections, tumours and cancer. “In addition, the Drugs Controller has not even set standards of acceptable limits for such contamination in vaccines on the basis of which he could have found them safe for licensing,” stated the petitioners.

The petitioners stressed that this project was meant to influence the government to accept these vaccines for introduction in the public health sector.

Legal correspondent, Cervical cancer drug trials risky, says plea in court, The Hindu, January 8, 2013 Available from: http://www.thehindu.com/news/national/cervical-cancerdrug-%20trials-risky-says-plea-in-court/article4284004.ece
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