The question whether all human clinical trials undertaken in India are conducted ethically has been answered. The final report of the three-member committee appointed by the central government to go into the alleged irregularities in the conduct of the human papilloma virus (HPV) vaccine trial reveals gross ethical violations. The trial, suspended since March 2010, was carried out by the Program for Appropriate Technology and Health (PATH), an NGO, in collaboration with the Andhra Pradesh and Gujarat governments and the Indian Council of Medical Research. It was conducted on nearly 23,500 girls in the 10-14 years age group in Khammam district (Andhra Pradesh) and Vadodra (Gujarat). The “casual approach,” which saw the informed consent forms, the most sacrosanct trial documents, being filled “very carelessly” with “incomplete and probably inaccurate” information is shocking. In Andhra Pradesh, nearly 2,800 consent forms were signed by a hostel warden or headmaster, as the ‘guardian'. The justification: the parents were not easily reachable! That being the case, and since it was a research study and not an emergency, should such children have been enrolled at all? What ethical justification can there be for the warden or headmaster acting as a “legally acceptable representative” to meet the requirements of the 1945 Schedule Y of Drugs and Cosmetics Rules? Since students have “reduced autonomy,” the fact that teachers played a “primary role” in explaining and “obtaining consent” meant that the consent was obtained under duress, in a legally untenable way.
The trial came under scrutiny following a public outcry over the death of seven children. Although the cause of the deaths was found to be unrelated to vaccination, the incident revealed a total failure of the mechanism to monitor the ‘volunteers' for both serious and non-serious adverse events following vaccination. There was a five-month delay in reporting a death, while two deaths in Khammam district went unreported. Ironically, while measuring and reporting the adverse events after vaccination were the “primary end points of the study,” the Principal and Co-Principal investigators failed to report all such events to the sponsor within a day, as required under the Drugs and Cosmetics Rules. That widespread transgressions of prescribed procedures and norms have been detected in conducting the trial, despite the apex medical body being a part of it, and that the investigating committee has done little by way of fixing responsibility, sends out a highly damaging message.
Comments:
It is common knowledge that pharmaceutical and biotechnology therapeutic firms seek to introduce new drugs, vaccines and increase their profitability. However over the last 10 years a variety of global firms conduct their 'clinical trials' in India where a vast poorly educated and poorly informed population give these firms, 'favorable' results. It is high time, we the people demand accountability: Ban these clinical trials, appoint physicians of integrity to oversee them.
This is extremely sad. NGOs in India are indulging in questionable activities and we are encouraging them. We need to have legislation that forces NGOs to be transparent. The NGOs need to be forced to clearly document everything they do. We need to have a complete list of NGOs and their day to day activities on the net so that ordinary citizens can monitor them. What is most troubling about this episode is that many educated Indians were probably involved with this NGO and probably helped it to carry out this dastardly act. We need to hold those Indians accountable and see if we can file cases against them.
If this was the case in US or Europe, there would have been lawsuits against the NGO as well as the respective governments. Unfortunately these poor, and illiterate Indians are not at all aware that they were being turned into guinea pigs.
This is indeed a complete shocking unethical trial concerning Human papilloma virus on masses without the proper test in the Labs.How can a person become a guardian of thousands.Is this not a complete violation of Drug and cosmetic rules,moreover a complete failure of system. And culprits should be put behind the bars so that it can become good lesson for the future for conducting such a trial before the medicine can pass out in the market.
HPV is primarily a sexually transmitted disease - a western cultural problem among teenagers hence not applicable to the Indian context. The Andhra girls were used as guinea pigs so that the drugs could be approved for the US market. This is criminal case not another negligence lawsuit. Folks from the NGO need to be tried and sent to jail.
The history of Clinical trails on Human subjects is replete with unethical and coercion. Historical facts starting with Nuremberg Doctors Trail, The Milgram Study(Stanely Milgram 1963), Thalidomide tragedy, study of untreated syphilis in The Negro Male etc.Following that there are stringent regulations in most countries for the Human trials.The three key elements of which are Review of research by an Institutional Review Board which amongst it members have non physicians, Second An Informed consent of subject which is the most important of all. The question is if the subject had the comprehension of the consent as to what was being proposed,in USA it is sort of a legal document and lastly Institutional assurance of compliance.I am afraid that India has lagged behind developing these essential components of structure where safe clinical trails can be conducted.You editorial points out the most fundamental violation in which an unknown guardian signs of on behalf of unsuspecting subjects.That is truly shameful and probably illegal.
It shows that a thought process is required over the process at which the informed consent forms are being signed by wardens. Most surprisingly they were approved and trial is conducted.. It clearly shows the poor validation status.Accountability is more required in such cases prior to start of trails itself..
It shows, how many miles we have to travel to bring a simple awareness about personal health. The gullibility of innocent people is helping people to make easy money. Who is to blame, God or Govt.?
There is an all round failure. There are systems in place right from the protocol stage to see that the ethical guidelines are followed. Obviously, there has been no overseeing of the trial by the monitoring and auditing agencies including the DCGI. Good that 'The Hindu' has brought this out succinctly.
It is an inhuman thing authorities did to poor human society. I have heard about unethical trials like nazi expt, thalidomide tragedy etc happened long back. It is very hard to believe that this type of trials are happening now a days also.
"Nobody in this story, and no outfit or corporation, thank God, is based upon an actual person or outfit in the real world. But I can tell you this; as my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with the reality, my story was as tame as a holiday postcard." --John Le Carre
I am sorry that you feel that patients were not given appropriate consent etc, While this may be true (I am not sure what is happening in INDIA). Most times people do not want to know the medical issues at all. I agree that consent is very important but unfortunately in India everything is corrupt (even small things.Most people cant get medical care in a timely or early fashion. While the end result does not justify the means,I think a lot of lives can be saved by using the vaccine since there is no means of having preventive medicine done in India. It is amazing that the educated public does not want to change even and have preventive measures done. people in India do not have any access to medical care so I feel that what you say may be true - more people will be harmed by your comments.
Cervical cancer is an important cause of death in India that can be very easily prevented. Are you willing to sue the govt for its atrocities and incapacity to take care of the people who are suffering? Are you willing to get the money from the 2G scam and give it to the poor? The Govt does not even give Morphine ( not available in a lot of states)
This is very sad for Indians poor people. Normally people are not aware about clinical trials and Govt. also not stepping in to it. Mediators are making money. Mostly pharmaceutical companies are forget their ethics.
Shame on our leaders !
It is common in India that such surveys are conducted only when something terrible and unjustified occurs.Instead of this it should be made mandatory that whenever any experimental procedures are done the proper analysis should be followed and should be open to debate also.But no one takes care regarding this.thanks to large population and illiteracy and public unawareness .I strongly recommend stringent laws and proper implimentation of rules otherwise there will be more such incidents will be followed by public outcries.
The apex body (DCGI) should make clear and strict guidelines for the conduct of Clinical trials. Also should have vigilance and hold on the firms doind clinical research. No drug is safe by its nature. Unless you do the clinical research, you may not know the good effects or bad effects. Today's modern medicine is based on the evidence of the clinical trials. Preventing clinical research may hamper the process of developing new and safe drugs. Preventing clinical research is not a good idea rather making strict guidelines.
There is no transparency in the NGOs - be it for any purpose. The NGO is promoted by group or groups as a lobbying point too. No regulator for establishment and following of the money trial of the NGOs.
It is saddening that an extremely valuable vaccine is being rendered questionable because of the unethical trials. However, 'Informed Consent'; is a big joke in India. An example follows. Some 25 years ago, a so-called contraceptive vaccine (based on Human Chorionic Gonadotrophin, HCG) 'developed' by a biochemist at the AIIMS, was being tested on a national scale. The very concept of the vaccine had been severely criticized by internationally reputed scientists, because it would interfere in a big way with female hormones and physiology, including the menstrual cycle. However, the said biochemist had powerful Indian and foreign connections. The then minister of health, for example, pooh-poohed all criticism and declared that the biochemist was going to win a Nobel prize. I saw some scenes of the trial of the 'vaccine' broadcast on Doordardhan ('Durdarshanam', as it was called by a journalist at that time), and I was aghast to see and hear the doctors telling the recipients of the trial 'vaccine' -- mostly uneducated village women -- that it was 'just like any other injection that your doctor will give you when you fall ill'. It may be mentioned that the WHO stopped funds for the 'vaccine' project of the said biochemist because he allegedly indulged in unethical practices. He was also exposed for misconduct in a different matter, viz, anti-leprosy vaccine. Nevertheless, he continued to wield enormous power till his retirement and even after that.
If what TSR says in his above comments is true, it is a good case for a class action suit. Some reliable and honest NGO should take the initiative of collecting petitions from the affected ladies. In cases like these that are of grave public importance, it is advisable to disclose the name of the scientist and the name of the Minister and others responsible so that the affected people and others who are interested have the necessary information.
Since the committee was appointed by the Government of India, one should expect the government to initiate prosecution against the organisations and personnel who were responsible for this unethical and illegal practice. The professional bodies of the various professionals involved in this trial also have a responsibility to take disciplinary action. If the government and professional bodies do not act, collective legal action by the victims should happen.
"HPV is primarily a sexually transmitted disease - a western cultural problem among teenagers hence not applicable to the Indian context." Not to condone these unethical and cruel trials, but -although it's been 30 years since the advent of HIV, it appears that the mindset displayed by the above statement still persists. Until we realize that HPV and all other sexually transmitted diseases can affect all sexually-active people everywhere, regardless of the cultural context, we are binding ourselves to the extremely negative outcomes consequent to this ostrich-like mentality. Also, since 'the Indian context' encompasses a wide range of social and economic circumstances (including some which might not allow for any other means of employment except the sex-trader industry), such a mindset automatically stigmatizes the work of NGOs working to reduce the incidence of STDs in the most vulnerable populations.