By Norma Erickson
3 July 2014: As a result of continued investigations regarding clinical trials involving HPV vaccines in India, more allegations of unethical conduct have been lodged against Merck. These allegations pertain to Merck’s recent trials of the new V503 HPV vaccine, a proposed nine valent HPV vaccine. A complete report of the investigation results written by Dr. Anand Rai, Kelly O’Connor, Amoli Tuli, and Anisha Bhattacharya is now a matter of public record.
The additional allegations of multiple ethics violations were added to a currently ongoing Supreme Court Case via an affidavit added as an addendum to the brief previously prepared regarding the ’demonstration projects’ conducted by a U.S NGO PATH in India beginning in 2009. The deaths of subjects during the ’demonstration projects’ resulted in a government-ordered enquiry and suspension of all HPV vaccine trials in India pending further investigation. This suspension was effective as of April 2010 and is still in effect.
Ultimately, the suspension and subsequent investigations allowed advocates in India to take their case all the way to the Supreme Court. The petition for the case was formally admitted by the judges on January 7, 2013. By September 2013, the court had issued notices to all participants involved while the Indian Parliament issued a scathing comment condemning all organizations involved in the so-called ’demonstration projects’ calling them a case of child abuse expressly carried out to create a market for the two companies – Merck and GlaxoSmithKline.
According to new allegations, Merck ignored the suspension of HPV-related clinical trials and continued with a phase III trial of the yet-to-be-approved investigational HPV vaccine called V503, which theoretically adds protection against 5 types of HPV to the ones already included in their current HPV vaccine, Gardasil.
Allegations of Merck’s Misconduct
The supplemental affidavit submitted to the Supreme Court of India states that Merck and/or their representatives committed the following violations of basic human rights:
1. Respondent No. 8, MSD Pharmaceuticals Pvt. Ltd. and its affiliate companies in respect of pre-licensure trials with investigational HPV vaccine V-503.
2. Pre-licensure Phase III trials were carried out at many centres in India. One of these centres was Indore. In Indore this vaccine was administered to 44 children, boys and girls. A field study with the participants was carried out by Dr. Anand Rai and others and is detailed in the Annexure.
3. The timing of this trial was such that vaccination was carried out during the same period when Respondent no. 1, The Ministry of Health and Family Welfare, had asked all HPV related studies to suspend vaccination. As such then this was a violation of the government orders.
4. The Annexure also lists in detail all the problems with this trial on a case by case basis, some of them are summarized below:
a) This clinical trial was not preceded by any trial among adults thereby violating the Drugs and Cosmetics Act. This trial had the approval of the Respondent No. 2, The Drugs Controller General of India (DCGI), who violated the law that his job specifically asked him to uphold. The petitioners have complained to the court that is the second time regarding HPV vaccines the DCGI bestowed this favour on Merck and its associates.
b) The trial used middle men and women acting as agents of the investigator who went around residential areas recruiting subjects in complete violation of all national and international guidelines.
c) The trial was carried out at a government hospital using government stationery and seal even though this was a privately sponsored trial of the company thereby misusing the trust parents place in the governmental vaccination programmes.
d) The parents and children were told that they were getting a successful vaccine from abroad free which would otherwise cost Rs 10,000. This was a blatant lie as this vaccine was not approved for marketing anywhere in the world. Also this constituted undue inducement to recruit children to this trial.
e) None of the participants were informed that they were participating in a clinical trial.
f) Economically vulnerable sections and those from scheduled castes and minorities were recruited for the trial, those who would not be able to afford the vaccine if and when it is marketed; thereby the trial further violated all laws and guidelines in this regard.
g) Merck listed history of allergic reaction that required medical intervention, currently enrolled in another clinical trial, subject is pregnant, subject is immunocompromised or has taken immunosuppressants in the last year, subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial and subject has history of positive test for HPV as exclusion criteria for this clinical trial. No examinations of the children who were selected for participation were undertaken prior to administration of the V503 vaccine.
h) There was no placebo involved in this trial, simply three different lots of V503, despite the fact that one purpose of the trials was to detect potential safety issues.
i) From the beginning to end, there was no examination of the children for their health status, and even though the trial was supposedly carried out to determine the safety of the vaccine not even fever post vaccination was recorded.
j) No medical care was provided for the health problems of the children nor were they provided any compensation. The study found many children who continue to suffer new medical problems even as late as 2013. Out of the 12 individuals interviewed, 4 have experienced health problems after the vaccine, such as mood swings, persistent stomach aches, dizziness, late onset of periods and severe anaemia. One boy whose family was interviewed has suffered extreme weight loss.
k) Though the investigation covered only the trial centre at Indore the entire list of trial centres is placed in the supplemental affidavit for information. In all hundreds of children have been affected in India.
One would think all of the complaints filed against PATH and Merck during the ’demonstration projects’ for Gardasil would have caused them to be on their best behavior. But apparently, when the government officials in India called a halt to any trials relating to HPV, Merck thought the decree did not apply to them. Either that, or they believed themselves powerful enough to be above the law.
Whatever the motivation, it appears hundreds more economically disadvantaged children and their families were put at risk by their participation in a clinical trial they were not told they were taking part in.
Compound this disregard for informed consent with participants being told they were priviledged to receive a successful and very expensive vaccine from overseas. Nevermind the fact that this ’successful vaccine’ had not been approved for use in any country in the world.
The people of India are not the only ones who may suffer the effects of this particular set of clinical trials. What ’results’ will Merck report to the rest of the world on this set of trials where the exclusion criteria was apparently ignored?
What ’results’ will Merck report to the rest of the world when no adverse events were recorded? One can certainly assume the adverse events which apparently were not recorded will no longer exist.
Will pretending these new medical conditions did not happen allow Merck to report their new V503 HPV vaccine is safe?
Is Merck above the law?
Will Merck be allowed to ignore the international laws protecting the basic right of informed consent prior to participation in clinical trials? Will Merck be allowed to continue to exploit economically disadvantaged people then extrapolate the resulting ’conclusions’ to the entire population of the world?
One can only hope the Supreme Court in India decides to protect the health and well-being of their young people by responding to the complaints of the organizations who put forth the allegations in a manner which will stop these types of abuses from ever happening in their country again.
By doing so, India’s Supreme Court Judges could help protect all of the world’s young people.
The Supreme Court of India has scheduled the final hearing of this case for August 12, 2014. The Court’s decision should be rendered on that date.
Whatever the ultimate outcome, advocates around the world will be watching.
Tragically, India may be added to the growing list of countries where countless inhabitants are suffering permanently damaged health and even deaths caused by HPV vaccines.
There are many grave concerns about this new HPV vaccine including:
– The culture of corruption and indeed criminality which is once again exhibited by Merck.
– Damaged health and deaths of many poor victims of the unethical trials.
– Manipulated trials where reactions were only registered for a short period of time, when autoimmune conditions may appear up to years after vaccination.
– Trials arranged with exclusion criteria which make the vaccine appear to be less dangerous than it is in reality.
– Lack of a true placebo in the trials, which also make the vaccine appear to be less dangerous than it is in reality.
– Multi-dose formulation which necessitates an antimicrobial preservative, the choice being a toxic combination of m-cresol, phenol and benzyl alcohol.
– Adjuvants, being in addition to neurotoxic aluminium (which is also an ingredient in Gardasil), a saponin, cholesterol, and a phospholipid.
Saponins are irritants and potent immune stimulators. Their applicability as vaccine adjuvants is controversial due to associated toxicity.
Phospholipids, cholesterol or any fatty substances when injected may cause the immune system to see them as invaders and increase risk of autoimmune disorders.
There is serious reason to believe that this new vaccine may be even more dangerous than the predecessor Gardasil which already has permanently damaged the health of many thousands across the world and is the cause of countless deaths.
So the final case was due to be heard on 28th October 2014.
What happened?
I assume from the lack of hysteria that it was quashed?
The ‘lack of hysteria’ as you put it comes from multiple postponements primarily resulting from last minute submissions by vaccine stakeholders. The case is still very much alive and pending final outcome.