[SaneVax: In India during 2010-11, there were 1106 people who died during clinical trials. Only 37 families were compensated for their loss. In 2010, clinical trials of Gardasil and Cervarix were halted after allegations of unethical conduct were raised by local consumer advocates and medical professionals. What is wrong with this picture?]
Trial by error
By Sushi Dey
A few years ago, Renuka, a social worker in the Khammam district of Andhra Pradesh, discovered that around 14,000 girls, between 10 and 14 years of age, living in various hostels across the district, were enrolled in a study for a cervical cancer vaccine. “In most cases we found that the consent forms were signed by the hostel warden without any permission or knowledge of parents of those young girls,” says Jyoti who heads the All India Democratic Women’s Association in Khammam and under whom Renuka works.
The matter came to notice only when the vaccine allegedly led to the death of a few girls and various others developed new illnesses like epilepsy, headaches, depressions, stomach disorders, irritations and early menarche or irregular menstrual cycles. “We took up the matter with various authorities, even filed complaints with the police and district collector, but everything fell on deaf ears,” say Jyoti and Renuka.
It is only now that there is outrage over the methods used by drug makers, hospitals and doctors in clinical trials. According to government data, as many as 2,242 people have died during clinical trials in the country since 2008. Data also shows that most of the deaths have happened during studies conducted by multinational pharmaceutical companies. Recently, the Supreme Court expressed concerns over illegal clinical trials of drugs in the country, saying it’s “unfortunate” that humans were being treated as “guinea pigs”. A recent report of the Parliamentary Committee on Health and Family Welfare, tabled in the Rajya Sabha, said the Drug Controller General’s office doesn’t have the wherewithal to keep such activities under check. Now, at long last, the Union health ministry and the Drug Controller General’s office have started drafting legislative guidelines to regulate the sector. The issues under discussion include compensation to the families of those who die during the trials or suffer after-effects, inspection of trial sites and ethical best practices.
Yet more tragic cases due to the pharmaceutical industry’s lack of ethics, greed and corruption. The industry may be described in one word: criminal.
The whole issue of clinical trials is an utter disgrace. The protocols are written by the pharmaceutical industry who manipulate so that results are favorable for themselves.
Investigators are not required to register planned group and sub-group analyses.
If a protocol is discontinued the results don’t have to be passed on to the regulatory authorities.
But why are trials stopped? Because “there are difficulties”. One “difficulty” may be because some patients die.