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“ A Parliamentary Standing Committee (PSC) used dignified language to explain the criminality of an American company and support to it by corrupt Indian officials. “They are murders. But we call ‘deaths’ before enquiry and ‘killings’ in conclusion.  Most surprising is we do not even give exact number of children killed, we simply say some deaths. This is trivialisation of corporate murder of Khammam children with support of corrupt bureaucrats.” 

–says Prof Madabhushi Sridhar, in a series of three recent articles published in July, 2018, in  www.thehansindia.com, daily newspaper from Hyderabad.

We are notoriously corrupt! People are poor and ignorant also. They do not even try to know.  Multinational companies (MNCs) are clever. Doctors are either compelled to be silent or actively involved.  As the main motive of the young doctors is to recover the cost of their education and make quick money they are simply toeing the ambitious and unethical profit maximization plans of corporate businessmen.

The silence or criminality of doctors is an important facilitating factor behind converting Indian poor into gullible victims of injurious clinical trials. Human life has no value for them. They do not mind causing slow deaths. They do not intend killing a specific person, but do not care if some poor is either severely injured with diseases or even succumbs. Deliberately the pharma companies do not disclose what and why they are trying and consequences of clinical tests.

The consent of the people is extracted without full disclosure of all relevant facts about clinical trials. Even if the people die of those trials, none cares, neither the government, nor the companies. The clever corporate companies secure permits from corrupt officials of the state and execute dubious trials with silent doctors.

They made India rendezvous for clinical trials and Indians, the gullible guinea pigs! There are no strong regulatory laws.  No disclosure is insisted. In the absence of factual disclosure informed consent is impossible.

Colin Gonsalves, the founder of the Human Rights Law Network, says in a report that on account of all clinical trials conducted by various pharmaceutical companies, nearly 2,800 patients were said to have died between 2005 and 2012 in India. A parliamentary panel report found all parties involved of gross ethical violations — the ministry, Drugs Controller General of India (DCGI), Indian Council of Medical Research (ICMR) and those who conducted the clinical trials.

The Drugs and the Cosmetics Act was amended in 2005 only to permit multinational pharmaceutical companies to conduct tests called Phase II clinical trials on Indians in India. This is for the first time that such permission was given. Those companies breach their duty to provide needed reports from their countries.

Colin Gonslaves says: “…clinical trials in India have been accompanied by large-scale criminality as doctors, officials and pharmaceutical companies understand well enough that India is a cesspool of corruption where clearances can be had for a pittance.

While there have been many cases since, the underbelly of India’s clinical trial industry came to the spotlight in 2005 when 3,300 patients were subjected to 90 clinical trials that followed no protocols at a hospital in Indore, Madhya Pradesh. In American law, such violations automatically attract the criminal charge of battery. In India, the poor don’t count at all”.

Non-disclosure angle is the worrying factor as the subjects/victims of these tests are not fully informed.  Once they concede to the tests, no individual has a right to withdraw. There is no comprehensive medical insurance or meticulous monitoring after the drug was administered on them.

These are the serious crimes being perpetuated against them. They die. But nothing happens. None notices. Media does not bother, nor highlight. Mostly corporate media is paid to be friendly with corporate pharmaceuticals. For political parties, it is no issue.

Gonsalves pointed out that 16,000 tribal girls in Andhra Pradesh and Gujarat were used for these trials without consent from the girls’ parents. $3.6 million worth human papilomavirus (HPV) vaccines were tested on these poor girls. There were allegations of adverse effects.

The 72nd Parliamentary Standing Committee Report, in a scathing indictment of India’s then booming clinical trial industry, implicated the DCGI for licensing the vaccines without adequate research on safety and efficacy; the Health Ministry for not questioning violations in the licensing process; the ICMR for promoting a drug even before it was approved and the NGO for setting up a trial without following basic protocol.

The parliamentary committee found commercial interests were influencing government policy, and that authorities were “overenthusiastic to act as willing facilitators to the machinations” of foreign institutions.

The committee recommended that henceforth, trials ought to be conducted only in the 330 medical colleges that have emergency facilities. It also sought — among other things — an investigation into the illegal approval of drugs and of doctors who submitted “ghost” letters recommending drugs for approval.

A book published by National Academy of Sciences Safety Testing, in 2004 wrote: Laboratory animals are not only crucial in understanding diseases; they are also essential in evaluating the safety of drugs, vaccines, food additives, household products, workplace chemicals, cosmetics, water and air pollutants, and many other substances.

The Food and Drug Administration (FDA) oversees this process for drug, vaccine, food additive, and cosmetic safety testing. Other agencies like the Consumer Product Safety Commission, the Environmental Protection Agency, and the Occupational Safety and Health Administration regulate other types of testing .

The book further noted: In 1933, more than a dozen women were blinded and one woman died from using a permanent mascara called Lash Lure. Lash Lure contained p-phenylenediamine, an untested chemical. At the time, there were no regulations to ensure the safety of products.

Explaining the need for drug safety testing with higher standards the book narrated another tragedy: A few years after the Lash Lure incident, another tragedy involving untested products occurred. A drug company in Tennessee decided to develop a liquid form of a sulfa drug (antibacterial) that would appeal to children. This drug company took a well-tested sulfa drug, mixed it with a sweet-tasting liquid that children would like, and sold it as “Elixir Sulfanilamide.”

Unfortunately, the drug company did not test the safety of Elixir Sulfanilamide before putting it on store shelves. The pleasant-tasting liquid in Elixir Sulfanilamide contained ethylene glycol, a sweet-tasting poison that is the main ingredient in antifreeze. Ethylene glycol poisoning causes the kidneys to fail so that toxins and fluid are not excreted from the body.

Eventually, the amount of toxin build-up is so great that it over-whelms the body and causes death. Elixir Sulfanilamide killed 107 people, mostly children, before it was pulled from store shelves. Source: https://www.ncbi.nlm.nih.gov/books/NBK24645/

There is a lack of awareness about the guidelines for standardized and transparent reporting of biomedical research, among the medical professionals. To ensure transparency in bio medical research, several guidelines are established world over, such as:

 

  1.  The “Enhancing the Quality And Transparency of health Research” (EQUATOR) network has published more than 350 guidelines for Health Research Reporting;

 

  1.  With respect to generic formats of study designs, the common ones are the “Consolidated Standards for Reporting Trials” (CONSORT) for randomized trials;

 

  1. “Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)” for observational studies;
    4. “Standards for Reporting of Diagnostic” (STARD) for diagnostic studies;

 

  1. “Preferred Reporting Items for Systematic Reviews and Meta-Analyses” (PRISMA) for systematic reviews and meta-analyses; and

 

6.“Standard Protocol Items: Recommendations for Interventional Trials” (SPIRIT) for defining protocol items for clinical trials;

 

  1. More and more specialised guidelines have been developed such as CONSORT non-inferiority for reporting of non-inferiority and equivalence trials;

 

  1. The RECORD statement for the reporting of studies conducted using observational routinely collected health data , and so on;

 

  1. Apart from these, there are other guidelines too that deserve a mention such as “Statistical Analyses and Methods in the Published Literature” or SAMPL guidelines for reporting statistical analyses;

 

  1. “Strengthening Analytical Thinking for Observational Studies” (STRATOS) for reporting observational studies.

Criminal clinical trials kill kids in Khammam

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’. 

The PSC used dignified language to explain the criminality of an American company and support to it by corrupt Indian officials. “They are murders. But we call ‘deaths’ before enquiry and ‘killings’ in conclusion.  Most surprising is we do not even give exact number of children killed, we simply say some deaths. This is trivialisation of corporate murder of Khammam children with support of corrupt bureaucrats.” 

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.

No transparency in clinical trials

There is a need for strong regulatory mechanism to supervise, review and restrict clinical trials and that should be transparent. The regulator should insist on obtaining well-informed consent from the families or persons on whom the clinical tests are intended to be conducted.

Professor of University College of Medical Sciences, Delhi UCMS with expertise in Quantitative Social Research, Amir Maroof Khan, in his research article on “Guidelines for standardizing and increasing the transparency in the reporting of biomedical research” published in international Journal of Thoracic Disease (JTD), Vol 9, No 8 (August 2017) a peer reviewed open access journal for high quality research on Thoracic Disease” wrote (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5594115/): Comprehensive and transparent reporting makes research credible, reproducible and help reduce research wastage. Standardized guidelines give directions towards achieving this objective. More and more specialized biomedical research reporting guidelines are being developed which can serve the varied interests of the medical researchers to make research transparent.

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.

There is a need to generate interest among the medical researchers and make them aware towards using these guidelines. The Clinical Trials Registry encourages the registration of all clinical trials conducted in India before the enrolment of the first participant. “The registry is meant to bring transparency to clinical trials conducted in India” explains Kapoor, who is all too aware of the shortcomings of current trial publication practices, including a tendency to publish trial results only when they are positive.

“Trials done earlier where the drug has not been found to be effective are sometimes not publicized,” she says, adding that information about failures should also be put in a publicly searchable database. Working together with the Indian Journal of Medical Research, the Clinical Trial Registry also brought together the editors of 12 Indian biomedical journals at the beginning of the year to develop policy covering the publication of clinical trials.

The editors issued a statement urging all those conducting and/or planning to conduct clinical trials involving human subjects to register their trials in the Clinical Trials Registry or any other primary clinical trial register. From January 2010, these journals will consider publication of a trial started in or after June 2008 only if it has been previously registered.

Bulletin of the World Health Organization of August 2008 reported: “Dr Chandra Gulhati, editor of the Monthly Index of Medical Specialities, for example, would like to see more teeth in the clinical registration process in the country.” “The first step should be the Drugs Controller General of India making it obligatory for all trials to be registered on the Clinical Trials Registry site before permission is granted to conduct them,” Gulhati says. “The failure to do so should carry a penalty. In addition, while registering trials, the composition of hospital ethics committees, which approved the trial, should be disclosed.”

Gulhati is particularly concerned about ethics committees lacking independence. “Fewer than 40 Ethics Committees in India are properly constituted and functioning, which means that the safety of the subjects of clinical trials is on the back burner,” he says, adding that it is also worrying that there is no legal requirement for investigators or members of the Ethics Committees to declare a conflict of interest. He considers this a particularly serious problem given the increasing number of hospitals now owned by drug companies.

“Clinical trials at such hospitals should carry a statement of disclosure about the relationship,” Gulhati says in a past issue of Bulletin of the World Health Organizations. Using animals in clinical trials raise several ethical issues relating to PETA and might provoke RTI requests, which need to be answered.

If clinical trials extend to human beings, it involves more serious issues and transparency at every stage should be made mandatory. The Indian Council of Medical Research brought out the ‘Policy Statement on Ethical Considerations involved in Research on Human Subjects’ in 1980 and revised these guidelines in 2000 as the ‘Ethical guidelines for Biomedical Research on Human Subjects’.

This was revised in 2005. Some of the points in the international guidelines for biomedical research on human participants, which have relevance to international collaborative research initiatives, have been included in this version. General policy statements says: Such research is CONDUCTED under conditions that no person or persons become a mere means for the betterment of others and that human beings who are subject to any medical research or scientific experimentation are dealt with Statement of General Principles in Biomedical Research Involving Human Participants in a manner conducive to and consistent with their dignity and well-being, under conditions of professional fair treatment and transparency; and after ensuring that the participant is placed at no greater risk other than such risk commensurate with the well-being of the participant in question in the light of the object to the achieved.  Principles of voluntariness, informed consent and community agreement, principles of accountability and transparency were incorporated (Bulletin of the World Health Organizations).

M S Valiathan,  Chairman, Central Ethics Committee on Human Research,  ICMR, New Delhi, stated: “India is being projected as a global hub for clinical trials and the number of corporate hospitals with state-of-the-art facilities is growing, visits by foreign specialists using newer techniques or devices is increasing…..  Due to globalization rapid techniques of diagnosis and therapy are now available through R&D.

The advances in the area of genetics, genomics and molecular biology have grown by leaps and bounds with the resultant need to rein in these advances with sufficient safeguards to protect the rights and welfare of human participants subjected to biomedical research.

Globally international agencies have been bringing out guidelines for researchers in their countries with relevance to developing countries. Considering the recent advances in the field of Assisted Reproductive Technologies, separate guidelines have been brought out by the Indian Council of Medical Research as “National Guidelines for Accreditation, Supervision and Regulation of ART Clinics in India”(2005)”.

A separate document has been made for regulating the medical devices under Indian Medical Devices Regulatory Authority (IMDRA).  The guidelines for the important biotechnology areas like stem cell research and stored tissue including DNA banking have been added in the revision of guidelines in 2005.

The revision has taken into consideration the changing dimensions of ethical issues in the context of new technologies and evolving universal guidelines and revised the existing chapters on Clinical trials, Organ Transplantation, Human Genetics, Epidemiology and Assisted Reproductive Technologies.

If the Ministry of Health passes the legislation, a Biomedical Research Authority will be set up under Ethical Review Procedures as per the proposed Bill on Biomedical Research on Human Participants (Promotion and Regulation) which would require that all IECs register with this Authority. It will also evaluate and monitor functioning of the IECs, and develop mechanisms for enforcing accountability and transparency by the institutions.

Medical devices is a flourishing business in India, which can convert the corporate hospitals to extortionists and patients gullible victims, unless there is strong regulatory with compulsory disclosures at regular intervals. We are seeing the scandals involving implantation of stents and similar other medical devices at high cost than the original value.

Author Amir Maroof Khan concluded that: Comprehensive and transparent reporting makes research credible, reproducible and help reduce research wastage. Standardized guidelines give directions towards achieving this objective. More and more specialized biomedical research reporting guidelines are being developed which can serve the varied interests of the medical researchers to make research transparent.

There is a need to generate interest among the medical researchers and make them aware towards using these guidelines. The public health-related information referred above, has to be in public domain, and should be given on request otherwise. Transparency can prevent corruption in public health schemes and save the lives.

(Madabhushi Sridhar Acharyulu is an Indian academic and Central Information Commissioner. He was a Professor at Nalsar University of Law in Hyderabad. Email:professorsridhar@gmail.com)

See also Darker side of private hospitals

by Dr Madabhushi Sridhar — July 1, 2018

https://countercurrents.org/2018/07/01/darker-side-of-private-hospitals/

 

 

 

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