Drugs and Cosmetics Acts Archives - Mother on the Tower Blog

By Alicia Capilla (President of AAVP)

AAVP, together with law firm Almodóvar & Jara, filed the first of a long series of lawsuits for damages caused by HPV vaccines. The complaint is filed in the High Court against health authorities and vaccine manufacturers.

The process of trying to find justice now begins for one of the Valencian girls who suffered an adverse reaction after the second shot of Gardasil in 2009. Spanish families whose lives have been adversely impacted by HPV vaccines have organized as the Association of Affected People by HPV Vaccine (AAVP www.aavp.es) to assist others in similar circumstances.

The well documented lawsuit is based on violations of the fundamental right to informed consent prior to medical interventions which all citizens have.

Parents whose daughters are vaccinated with Gardasil are not informed beforehand of the possible risks their daughters may suffer, despite the fact there are numerous reports in Spanish, European and American databases. Furthermore, most of the adverse reactions these girls suffered are included in the brochure/leaflet of the product.

The introduction of HPV vaccines into the market without their real effectiveness being known is another issue. The effectiveness has not sufficiently been proven and will not be demonstrated for decades.

Much of the damage these vaccines are producing is being hidden, despite the fact that pharmacovigilance systems around the world are collecting numerous reports of similar reactions.

Moreover, the Spanish Health Ministry withheld information from affected families by denying that the damage the girls suffered was legitimate and previously known via similar cases being reported to health authorities in various countries.

The Spanish Ministry of Health, Sanofi Pasteur, and Merck, Sharp and Dohme (MSD), producers of Gardasil®, human papillomavirus vaccine, have a responsibility to report accurately and in a timely manner all data available at the time.

Health authorities around the world are trying to deny any causal relationship between HPV vaccines and adverse events occurring after vaccine use. In some cases, authorities say that the new medical conditions are psychological. This is a paradox because if people in different times and different places suffer a similar adverse reaction, it is undeniable that the cause is the vaccine.

The damage these girls have suffered and many continue to suffer were not all included in the leaflet at the time of injection. Some of them were included later. Others continue without being warned.

Based on data that the AAVP has examined, the number of suspected deaths and serious sequelae left behind after human papillomavirus vaccines is completely unacceptable.

As stated in the case filed, health authorities do not investigate the facts and their attitude is favoring manufacturers. They even accused the victims of suffering psychological disorders, which is not true.

This first case will be followed by another four within two months. The firm will continue to file additional cases, not only against Gardasil® but also Cervarix®, the other brand of the HPV vaccinemanufactured by GlaxoSmithKline.

www.aavp.es

This article, in it’s entirety, is compliments of SaneVax.org.

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. (Link to report)

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.

Article in it’s entirety, compliments of SaneVax.org