http://healthimpactnews.com/2014/supreme-court-in-india-to-rule-on-merck-fraud-regarding-hpv-vaccine-deaths/
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:
Vaccination was carried out after the Ministry of Health and Family Welfare had ordered all HPV related studies to suspend vaccination. As such then this was a violation of the government orders.
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 Drugs Controller General of India (DCGI), who violated the law that his job specifically asked him to uphold. This 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. 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?
http://healthimpactnews.com/2014/supreme-court-in-india-to-rule-on-merck-fraud-regarding-hpv-vaccine-deaths/#sthash.JejRbeFu.jshcEuV4.dpuf
This is not the only misconduct regarding vaccines that Merck has been accused of. I believe there is a still ongoing hearing about Merck fudging efficacy numbers for their MMR vaccine. Also they’ve been accused, and I believe this is part ongoing hearing, of fudging the stats on supposed links between MMR and autism. There have been articles posted on FR about this.
Of course people love to shove in your face how horrible polio and various other diseases were prior to the vaccines being available. Because the vaccines worked miracles generations ago they all must still be miracles and if you question why a newborn needs a Hep B vaccine then you’re fear mongering.
There must be some common sense middle ground. If you look at the permanent injury rate for diseases like measels, even prior to the vaccine, it was extremely low. The permanent injury rate, though hard to put a number on, from the vaccine is even lower. To some people this is justification for why everyone should be forced to have the vaccine. I maintain that cannot actively force someone to take a medical risk, no matter how small it is.