A Parliamentary Standing Committee (PSC) came down heavily against ‘criminal’ clinical trials conducted on poor Indian children in the name of ‘observation’ and demonstration. The PSC could reach conclusion that this American commercial experiment was facilitated by the Government officers in Centre and Andhra Pradesh and Gujarat. It all happens in the name of ‘charity’.
Criminal clinical trials kill kids in Khammam
During March, 2010 the deaths of some female children and adolescents in Khammam district of Andhra Pradesh were reported after being administered Human Papilloma Virus (HPV) vaccines, as those were tried by an American agency Programme for Appropriate Technology in Health (PATH), reportedly funded by Bill and Melinda Gates Foundation, an American charity.
Several questions were raised on the role of government agencies including Indian Council of Medical Research (ICMR) and Drugs Controller General of India (DCGI) in approving and facilitating the trials, violating both domestic and international ethical norms and rules; misuse of government funds, man-power, facilities and infrastructure for a private project of dubious nature; use of logo of National Rural Health Mission (NRHM), an official programme of the Union Government during these vaccination drives to give it respectability and official endorsement; and above all the blatant violation by PATH of all regulatory and ethical norms laid down by the Government of India for the purpose as also possible violations of such norms prescribed and very scrupulously enforced in USA.
The Committee on the "Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine" by Programme for Appropriate Technology in Health(PATH) in India was constituted under the chairmanship of Sri Brajesh Pathak in 2010. After studying deaths in Khammam and Vadodra, the Committee found procedural and ethical lapses by Ministry.
In its report in 2011, the PSC brought out startling points. The Secretary of the Department of Health Research and DG, ICMR informed that it was a vaccine against the Human Papilloma Virus which causes cervical cancer in women. The Drugs Controller General, India had given approval for marketing of HPV vaccines in India as per the Drugs and Cosmetics Rules and then for a post-marketing surveillance trial. But it was found that actual trials began two years earlier. The purpose of the trial was to see acceptability of this vaccine on Indian population. These trials were approved by the National Ethical Committee and the State Ethical Committee also.
As per DCGI guidelines Phase III trials cannot be conducted on children until a similar trial was conducted on adults. These norms were violated. Vaccine is given before the sexual activity begins and then it protects against cancer. That was why trials on girls of the age of 10-14 years was conducted. PSC asked clinical trials to be stopped immediately. In its 41st report PSC recommended:
“Taking serious view of procedural and ethical lapses on the part of the Ministry, the Committee sought the matter of allowing trial of the vaccine as also the approval for its marketing in the country to be enquired into by a premier investigating agency and to take further appropriate follow-up action in the matter. It also asked that findings of the investigating agency and the follow-up action taken in this regard may be furnished to the Committee at the earliest. ….recommends to the Department of Health Research that in future all guidelines and norms should be adhered to before allowing trials of any drug including vaccines on Indian population. …. the DCGI should observe optimum precautions while allowing marketing of any drug including the vaccines in the Indian market".
The study utilized both the brands of HPV vaccines available in the market (Gardasil by Merck in Andhra Pradesh; and Cervarix by GSK in Gujarat). In view of certain complaints received, the State Governments have been advised not to carry out further vaccination till further orders.
Noting inaction on its earlier recommendations, the Committee in its Forty eighth Report recommended:
“…. Taken Note given by the Department makes the Committee somewhat apprehensive. Like so many Committees set up by the Government, findings of this Committee, as and when received, may remain on paper only.
The Committee, therefore, recommends that every effort should be made to expedite the Report so that real facts about the HPV Vaccine trial are made known without any further delay and corrective measures not only in respect of this case but for all such ongoing/proposed clinical trials of drugs/vaccines are taken. The Committee also recommended to analyze process of granting permission to these so called research studies.
Considering the enormity of the wrong doing/criminality involved, and the dilly-dallying attitude of the Government in taking exemplary corrective action, the Committee took it up for detailed examination.
Officers represented to the Committee that on June 1, 2006 the American drug regulator, the U. S. Food and Drug Administration (USFDA) approved the first vaccine to prevent HPV virus that is claimed to cause 70% of cervical cancers, under the brand name of Gardasil by a US drug company namely, Merck. In the same month PATH embarked upon a large scale, 5-year long (June 2006 to May 2011) project with “the main objective …..to generate and disseminate evidence for informed public sector introduction of HPV vaccines” in four countries, India, Uganda, Peru and Vietnam. Interestingly these four countries have different ethnic populations: India (Indo-Aryans, Dravidians, Tribals etc.), Uganda (Negroid), Peru (Hispanics) and Vietnam (Mongoloids).
The Committee has been given to understand that ethnicity is relevant in the determination of safety and efficacy of some drugs. What would be of further interest, as per World Health Organization (WHO) is that all these countries have state-funded national vaccine immunization programs, which if expanded to include Gardasil, would mean tremendous financial benefit to the then sole manufacturer.
It was discovered that the Indian Council of Medical Research (ICMR), which is the highest body in the Country for medical research and related matters lent its platform to PATH in an improper and unlawful manner. The State Governments of Andhra Pradesh and Gujarat swayed by the involvement of ICMR followed suit.
PSC finds the entire matter very intriguing and fishy. The choice of countries and population groups; the monopolistic nature, at that point of time, of the product being pushed; the unlimited market potential and opportunities in the universal immunization progammes of the respective countries are all pointers to a well planned scheme to commercially exploit a situation.
Had PATH been successful in getting the HPV vaccine included in the universal immunization programme of the concerned countries, this would have generated windfall profit for the manufacturer(s) by way of automatic sale, year after year, without any promotional or marketing expenses. It is well-known that once introduced into the immunization programme it becomes politically impossible to stop any vaccination. To achieve this end effortlessly without going through the arduous and strictly regulated route of clinical trials, PATH resorted to an element of subterfuge by calling the clinical trials as “Observational Studies” or “Demonstration Project” and various such expressions.
Thus, the interest, safety and well being of subjects were completely jeopardized by PATH by using self-determined and self-servicing nomenclature which is not only highly deplorable but a serious breach of law of the land. The Committee is not aware about the strategy followed by PATH in the remaining three countries viz. Uganda, Vietnam and Peru.
PSC wanted Centre to take up this issue with the other governments through diplomatic channels to know the truth of the matter and take appropriate necessary action. This shows that neither our government nor the officers have any value for human lives.