On June 1, 2007, Reed Elsevier, owner of The Lancet, announced its decision to exit the defence exhibitions sector. Its chief executive officer said: “…it has become increasingly clear that growing numbers of important customers and authors have very real concerns about our involvement in the defence exhibitions business… this has led us to conclude that the defence shows are no longer compatible with Reed Elsevier’s position as a leading publisher of scientific, medical, legal, and business content.”
The decision was welcomed by the editors of The Lancet who had been part of the campaign opposing the company’s stake in the arms business.
The British government has approved a plan to allow women to donate eggs for research and be compensated. Women getting fertility treatments will receive a discount if they donate eggs for research. Others will receive money to cover costs such as travel or lost work time.
Some researchers argue that patients are often paid for medical experiments. Others worry that poor women will be exploited, donating eggs just for money. Authorities have been accused of downplaying the health risks.
The first trials of new drugs in humans should be planned much more carefully, recommends a report by a working party of the Royal Statistical Society, UK. The report was prompted by the TGN1412 drug trial in 2006 in which six healthy volunteers experienced severe immune reactions. The report found that “the trial design was not well suited to its objectives of testing the safety and tolerability of the drug.”
The working party recommended that phase I, “first in man,” studies should include justification of the starting dose, assessment of its risk level and appraisal of the uncertainties. This should be given to the ethics committee, study participants, and insurers. Researchers should take a precautionary approach to study design for any experimental medicine that is “first in class” (and therefore high in risk) or which has a high dose specific risk.
The report is available at www.rss.org.uk/first-in-man-report.
Thirty-six-year old Jolee Mohr died from bleeding and organ failure on July 24 after her knee was injected with an experimental genetically engineered drug. Questions are being about why she was recruited into a gene therapy experiment whose chief goal was to test the safety of a novel arthritis treatment. The events leading to Mohr’s death suggest failures in the safety net to protect people from the risks of medical experimentation. Breaches of clinical research standards and a federal oversight system that allowed key decisions to be made behind closed doors may have helped draw Mohr into an experiment that was not what she thought it was.
Company officials say they were upfront about risks, adhered to regulations and were terribly saddened by the loss.
The Delhi-based Society For Scientific Values (SSV) said that a research team at the National Centre for Cell Sciences (NCCS) in Pune was “guilty of misconduct for falsification/fabrication of data” in two papers published in the Journal of Biological Chemistry in 2004 and 2005. The journal withdrew the papers in February 2007 amid allegations of data manipulation. The SSV noted that the department of biotechnology, which is responsible for NCCS, had ignored requests for information, and also withheld the first committee’s findings.
The Lifeline Institute of Stem Cell Therapy and Research (LISCTR) in collaboration with a Japanese organisation held a press conference to announce its results with stem cell therapy. Paraplegic patients – who paid Rs 1 lakh each for the treatment — spoke on their recovery. Dr Rajkumar of LISCTR said: “This is the largest series of successful treatment of spinal cord documented in the scientific world,” and added that the findings would be presented at an international stem cell conference shortly.
The Supreme Court overruled its 2005 direction and said that an MBBS is competent to perform sterilisation operations, waiving the five years of gynaecological experience it had mandated for this purpose. The government had pleaded that its family planning efforst were affected due to the ruling following a public interest litigation giving criteria for permitting doctors to do the procedure.
Five Bulgarian nurses and a Palestinian-born doctor were released after eight years of imprisonment, torture and maltreatment in Libya for allegedly infecting more than 400 children with HIV. They have repeatedly denied the charges. Results of two international reports, filed respectively by the WHO and a scientific duo hired by the Libyan government, confirmed that the outbreak was nosocomial. The release came with a price tag. The European Union promised medical support and US$426 million for the families of the infected children.
Rais Abbas has claimed that he was forced to perform the delivery of his son at the Meerut Medical College. Doctors, who refused to touch his pregnant wife on learning that she was HIV positive, instructed him from a distance. A report of the National AIDS Control Organisation states that the delivery was conducted by doctors.
Two HIV-positive patients died in Gandhidham in Bhuj district after they were denied treatment in hospitals there. Maheshwari, 35, a mason, died following complications of tuberculosis after being refused treatment at the General hospital in Bhuj. Two-year-old Khushbu died of respiratory problems after being denied treatment in two local hospitals.
A recent UNICEF survey found rampant discrimination against children with HIV, particularly in the six high prevalence states in the country. In hospitals they were not allowed in the wards but put up in corridors. The research was based on focused group discussions among affected children, their adult caretakers as well as teachers and healthcare workers.
A search by local police in Orissa’s Nayagarh district unearthed 132 polythene bags with medical waste, aborted foetuses and newborns. The district police raided six nursing homes that have ultrasound facilities. The Indian government has sought a report from the Orissa government.
Haryana police say AK Singh, who is not a qualified doctor, has confessed to aborting female foetuses. Locals say they have complained about his activities several times to the health authorities but nothing was done. Following a tip-off that Singh was conducting sex tests, a decoy was sent to his hospital and an unlicensed ultrasound machine was seized.
The Bombay High Court upheld an amendment to the law banning sex-determination or sex-preselection tests.
The court was ruling on a petition filed by Vinod and Kirti Sharma to allow parents with one or more children of the same sex to select the sex of the child before it was conceived.
The couple had argued that the Pre-Conception and Pre-Natal Diagnostic Techniques Act, 2002, violates the fundamental rights to life and the couple’s liberty to choose the sex of their child before it is conceived
A survey of 40 clinics offering sonographies in Chembur, Mumbai, found that none of them followed the rules in the Pre-Conceptual and Prenatal Diagnostic Techniques (PCPNDT) Act, 2002. Most did not display a board stating that ‘determination of the sex of the foetus is banned and illegal’. Only one maintained records of Form F containing details on the patients scanned, reason for scan, etc. The survey was conducted by an alliance of 10 non-governmental organisations, Laadli.
Bombay Municipal Corporation authorities admitted that they had neglected the PCPNDT Act. They stated that only 501 of the 1,164 registered clinics had renewed their licenses in the past year. They promised to start checking clinics and act against those who have not complied with the law.
The national consumer disputes redressal commission directed Delhi’s Ganga Ram hospital and one of its senior gynaecologists SK Bhandari to pay Rs 5 lakh to a 57-year-old woman whose right kidney and both ovaries were removed during a hysterectomy in 1993. The commission also held that hospitals should give patients complete information before surgery.
The Delhi State consumer commission has asked the All India Institute of Medical Sciences to pay Rs 4 lakh as compensation to a woman for surgically removing her right breast after wrongly diagnosing that it was affected by cancer. Histopathology tests after the tumour’s removal found that it was not cancerous. The commission rejected AIIMS’ contention that every tumour, whether benign or malignant, had to be removed as part of treatment.
A Delhi court has sentenced a Dr Kumar to five year’s rigorous imprisonment for causing the death of a woman who came to her for an abortion. A post-mortem report found that the woman died from multiple organ failure due to an adverse drug reaction. Kumar claimed he did not practise medicine but the court accepted the woman’s dying declaration holding him responsible.
The Mumbai police arrested Dr Ramzan Hawaldar for issuing a death certificate stating that 23-year-old Kavita Shevale died of natural causes though she died of strangulation. He did this apparently on the request of Kavita’s father and stepmother who are suspected of committing the murder.
The Delhi high court asked the government and Safdarjung hospital authorities why compensation should not be paid to the parents of a child whose foot had to be amputated after a tightly applied plaster cut off circulation to the foot.
When his patient died following uterine perforation during a medical termination of pregnancy, Dr Pradyot Naskar in Kolkata lodged a police complaint against his own negligence. The woman’s family has not filed a complaint. The police stated that they have initiated investigations and sought the opinion of medical experts but are perplexed on how to take action against the doctor.
The Bombay high court ordered the Maharashtra Food and Drugs Administration to test drug samples from all government hospitals in the state for adulteration. It was hearing a writ petition filed by a Pune resident whose son died allegedly after being administered spurious medicines. The court dismissed the government’s statement that there were no cases of spurious drugs, and that it regularly conducted raids for this purpose.
The National Commission ruled that a doctor qualified in one system of medicine may not practise another system.
The ruling, on August 16, 2007, was in the complaint filed by the parents of Jai Dev Kumar who died in 1996. The complaint alleged negligence on four counts: the patient was attended to by a junior resident with a degree in Unani medicine; no senior doctor attended until very late by which time the patient’s condition was critical; no proper steps were taken to clear the patient’s blocked airways, and the post-mortem report stated that aspiration in this situation should have been foreseen and prevented. The commission stated that the hospital was liable for the doctor and directed that the complainants be paid a compensation of Rs 8 lakh.
Mumbai police arrested five persons including an ayurvedic doctor for allegedly causing the death of a 20-year-old woman during delivery. The police are checking whether Shailaja Patwardhan, Bachelor of Ayurvedic Medicine and Surgery, is allowed to run a nursing home and conduct deliveries.
The gangrape of a 17-year-old patient inside the intensive care unit of a leading private hospital in Meerut led to district-wide protests. Three hospital wardboys were arrested on charges of rape and the hospital was sealed under the district magistrate’s directives.
A mob attacked Vivek nursing home in Mumbai after the death of Manas Agine, who was brought there with breathing problems. The Agines had been directed by the nursing home to go elsewhere to put the child on ventilatory support but the child died before this could happen. Hospital authorities told the police that the child’s death was from natural causes.
There is no drinking water in the Dube municipal state hospital in Badlapur, Thane. The fans don’t work, and the doctor and X-ray technician are missing. Dr PM Chapalgaonkar, civil surgeon in charge of government hospitals in the district, explained, “It is not the duty of the state health department to take care of (such) problems… (but) of the municipal corporation which owns the hospital.” The head of the municipal corporation said he had not been informed of the situation.