Three Women in India Slay the Goliath
Holy Hormones Journal: Three women activists in India – have brought the attention of 24,000 girls in their country suffering from potential adverse reactions to the Supreme Court. They have proved that illegal and unethical PATH trials pandered Gardasil and Cervarix without informed consent of either parent or child – and without any follow up management and care. They are demanding justice.
The women in India worked hand in hand with other activists around the world who provided them with information, research – and of course non-compliance by the U.S. government as noted by Judicial Watch when they filed a FOA to get government records on how many were compensated in Vaccine Court for Gardasil and Cervarix injury.
The women researched, spent years organizing papers and data – went into the states of Andhra Pradesh and Gujarat at risk to their lives – and saw first-hand the lack of management and care of adversely injured girls.
Nalini Bhanot, Kalpana Mehta and Dr. V. Rukmini Rao have brought PATH and the GATES Foundation to its knees. Talk about David slaying the Goliath. They have accomplished what no others have ever down before. They did not appear before the court as ‘anti-vaccine’. They did appear demanding the right to information about the vaccines so that Indian patients, girls, and women who can then make a rational choice and take timely decision to seek medical care if they choose to get vaccinated. They asked for the same right that girls get in the U.S. And why should they not have them?
Supreme Court issues notice to PATH while Indian Parliamentary committee calls PATH led trial with Gardasil and Cervarix “a sordid incident”
A trial done by PATH with HPV vaccines on 24000 girls in Andhra Pradesh and Gujarat has been termed a “sordid incident” by the Parliamentary Standing Committee for Health and Family Welfare that found the entire matter “very intriguing and fishy”. This trial has left in its trail at least 1200 girls in the two states with chronic health problems. A writ petition was filed before the Supreme Court praying for the identification of the health problems of these girls and provision of treatment, along with other prayers.
Notices were issued to the Government of India and the Drugs Controller by the Supreme Court in January 2013 but neither has bothered to file a reply. In this callous delay in court proceedings, the 72ndreport of the Standing Committee released last week has proved to be a boon in disguise. The concerned officials from the ministry, ICMR and the DCGI, and also from PATH appeared before the Standing Committee but their explanations cut no ice.
This report was placed before the judges today and senior advocate Colin Gonsalves representing the petitioners reiterated the misery of the girls who are likely to be afflicted with serious conditions like convulsions, asthma, central demyelinating diseases, acute disseminated encephalomyelitis, idiopathic thrombopenia purpura, etc.; autoimmune conditions like thyroiditis and rheumatoid arthritis; and also by mental ailments that are serious enough to lead to suicides. The Standing committee has also stated that HPV vaccine as a possible, if not probable, cause of suicidal ideation cannot be ruled out.
Since the filing of the main petition many new facts about these vaccines and their serious health implications have come to light. Tomljenovic and Shaw examined post-mortem brain tissue specimens from two young women who suffered from cerebral vasculitis-type symptoms following vaccination with the HPV vaccine Gardasil and concluded “Our study suggests that HPV vaccines containing HPV-16L1 antigens pose an inherent risk for triggering potentially fatal autoimmune vasculopathies.” It should be known that cerebral vasculitis is a serious disease which typically results in fatal outcomes when undiagnosed and left untreated. Many of the symptoms following HPV vaccination are indicative of cerebral vasculitis such as intense persistent migraines, syncope, seizures, tremors and tingling, myalgia, locomotor abnormalities, psychotic symptoms and cognitive defects.
On 20 March 2013, the United States based Judicial Watch announced that, it has received documents from the Department of Health and Human Services (HHS) revealing that its National Vaccine Injury Compensation Program (VICP) has awarded $5,877,710 (US dollars) to 49 victims including two deaths in claims made against the highly controversial HPV (human papillomavirus) vaccines.
Meanwhile a fact finding mission undertaken by NGO’s in the project areas in Gujarat in June 2013 indicated that many of the girls have already got married and moved away making it difficult to trace and treat them.
The petitioners had therefore asked by way of interim relief that all the vaccinated girls be examined by qualified medical practitioners to ascertain their health status and provide appropriate medical care.
Beyond these 24000 girls the other consumers of the two vaccines Gardasil and Cervarix are also at risk because the two companies have not bothered to update their product information to include serious side effects as they are emerging and being included in the inserts of other countries.
Also in countries abroad both companies provide information to the patients/users that informs them of the effectiveness, potential problems and symptoms for which the users should approach a medical facility. The petitioners felt that this information is also the right of Indian patients, girls, and women who can then make a rational choice and take timely decision to seek medical care if they choose to get vaccinated.
Based on these arguments the judges have asked that notice be served on PATH to respond to the petition and on the rest of the respondents to give their responses within four weeks.
Nalini Bhanot, Kalpana Mehta and Dr. V. Rukmini Rao
IN THE SUPREME COURT OF INDIA
CIVIL ORIGINAL JURISDICTION
I.A.NO. OF 2013
WRIT PETITION (CIVIL) NO. 558 OF 2012 (UNDER ARTICLE 32 OF THE CONSTITUTION OF INDIA)
|In the matter of:|
|KALPANA MEHTA & ORS.||…Petitioners|
|UNION OF INDIA AND OTHERS||…Respondents|
APPLICATION FOR DIRECTIONS
(FOR INDEX KINDLY SEE INSIDE)
ADVOCATE FOR THE PETITIONER: JYOTI MENDIRATTA
|Sl. No.||Particulars||Court Fee||Page No.|
||Application for directions|
||Annexure P-1A True Copy of the Department Related Parliamentary Standing Committee on Health and Family Welfare Sixty Sixth Report, issued by the Parliament of India, dated 26 April 2013.|
||Annexure P-2:True copy of the fact-finding report, PATH HPV Vaccine Demonstration Project Test Districts – Vadodara District, Shinor, Dabhoi, and Kawant Blocks, Gujarat, dated June 2013.|
||Annexure P-3:True copy of Cervix vaccine issues trigger health notice, issued by Japan Times, dated 15 June 2013.|
IN THE SUPREME COURT OF INDIA
CIVIL ORIGINAL JURISDICTION
|WRIT PETITION (CIVIL) NO. 558 OF 2012|
|IN THE MATTER OF:|
|KALPANA MEHTA & ORS.||…Petitioners|
|UNION OF INDIA & ORS.||…Respondents|
APPLICATION FOR DIRECTIONS
The Chief Justice of India and his Companion Justices Supreme Court of India
Humble Application of the
Petitioner above mentioned
Most respectfully showeth:
- In 2012, health activists filed a writ petition before this Hon’ble Court pointing out violations in Respondent No. 2’s approval and licensing process, Respondents No. 7 & 8’s marketing strategies, and Respondents No. 3 and 6’s unethical studies with two HPV vaccines, Gardasil and Cervarix. The PIL (WP (C) 558/2012) was admitted on 7th January 2013 and this Hon’ble Court issued notices to the Government of India (Respondent No.1) and the Drugs Controller General of India (Respondent No.2) to respond. New information from the Parliamentary Standing Committee on Health and Family Welfare, a fact-finding in Gujarat, recent international developments, and the continued failure of the Respondents to reply or take action has prompted the Petitioners to file this request for directions. (A true copy of the Department Related Standing Committee on Health and Family Welfare Sixty Sixth Report, issued by the Parliament of India, dated 26 April 2013 is herein marked and annexed as Annexure P-1; A true copy of the fact-finding report, PATH HPV Vaccine Demonstration Project Test Districts – Vadodara District, Shinor, Dabhoi, and Kavant Blocks, Gujarat, dated June 2013 is herein marked and annexured as Annexure P-2.)
- As of date the Respondents have not replied. The vaccines were licensed for use in 2008, only in the private sector, but the sale and distribution of these vaccines in the public sector and private markets using underhand methods continues unabated. The petition has already mentioned such instances. Since the filing of this petition the petitioners have come to know of private camps for promotion of the vaccine in Punjab and of attempts to introduce it in the governmental programme in the state of Rajasthan.
- As has been pointed out in the petition there are at least 1200 girls who would be suffering from debility or new autoimmune conditions requiring continuing medical support. We have dealt with this matter in detail in the main petition paras 9 – 9.5, 10 – 10.8, 24.2, 24.3, 244 onwards. It is important that these girls are examined and a medical survey be conducted to determine the extent of possible damage in the vaccinated population.
- The side effects of these vaccines are not speculative, but real. On 20 March 2013, the United States based Judicial Watch announced that, “it has received documents from the Department of Health and Human Services (HHS) revealing that its National Vaccine Injury Compensation Program (VICP) has awarded $5,877,710 (US dollars) to 49 victims in claims made against the highly controversial HPV (human papillomavirus) vaccines. To date 200 claims have been filed with VICP, with barely half adjudicated.” (Judicialwatch.org, March 20, 2013).
- On 15 June 2013, The Japan Times reported, “The health ministry has issued a nationwide notice that cervical cancer vaccinations should no longer be recommended for girls aged 12 to 16 because several adverse reactions to the medicines have been reported.” Mariko Momoi, the chair of the Health, Labor and Welfare Ministry panel that decided to suspend the recommendation said, “It is necessary to gather information immediately to accurately grasp how often [the side effects] are occurring.” A true copy of Cervix vaccine issues trigger health notice, issued by The Japan Times, dated 15 June 2013, is herein marked and annexed as Annexure P-3.
- According to The Asahi Shimbun, dated 18 June 2013, “The [Japanese] health ministry suspended its recommendation [for the cervical cancer vaccine] on 14 June after nearly 2,000 complaints of side effects, such as prolonged pain and numbness. The figure includes 357 serious cases, such as difficulties in breathing or walking and convulsions.” (Analysis: Experts at a loss over pain from cervical cancer vaccination, The Asahi Shimbun, 18 June 2013).
- Since the filing of the petition, Tomljenovic and Shaw published an article, “Death after Quadrivalent Human Papillomavirus (HPV) Vaccination: Causal or Coincidental?” in Pharmaceutical Regulatory Affairs: Open Access Journal. In their study, “they examined post-mortem brain tissue specimens from two young women who suffered from cerebral vasculitis-type symptoms following vaccination with the HPV vaccine Gardasil. They conclude, “Our study suggests that HPV vaccines containing HPV-16L1 antigens pose an inherent risk for triggering potentially fatal autoimmune vasculopathies.” They state the practice implications of their findings as: “Cerebral vasculitis is a serious disease which typically results in fatal outcomes when undiagnosed and left untreated. The fact that many of the symptoms reported to vaccine safety surveillance databases following HPV vaccination are indicative of cerebral vasculitis, but are unrecognized as such (i.e., intense persistent migraines, syncope, seizures, tremors and tingling, myalgia, locomotor abnormalities, psychotic symptoms and cognitive deficits), is a serious concern in light of the present findings. It thus appears that in some cases vaccination may be the triggering factor of fatal autoimmune/neurological events. Physicians should be aware of this association.” (Tomljenovic and Shaw, Pharmaceut Reg Affairs 2012, S12:001)
- Many of the girls who received this vaccine in 2009 will have married or migrated to new villages or states further complicating this follow up study and driving the urgent need for this Hon’ble Court to act. The June 2013 fact-finding report found that in Gujarat, a substantial number of families with HPV vaccinated daughters had left their villages for seasonal work and many girls have been married and moved away (See Annexure P-2). It will become increasingly difficult to locate the girls for proper checkups, to compensate the girls or to provide continuing medical care. It must also be stressed at this point that after all the adverse publicity that the PATH project drew it is not possible to do a meaningful survey in the area unless it is mandated by an authority such as this Hon’ble Court.
- As has already been brought out in the petition before the Hon’ble Court, the two manufacturers have not updated their product information thereby keeping doctors and users alike in the dark about the potential hazards of Gardasil and Cervarix. As was stated in the petition, every six months new updates about field data come in and are submitted to the regulatory authorities and new conditions are added to the list of side effects. This updation has not been done in India. So the prescribing physicians as well as the potential vaccine recipients are in the dark about this growing list of side effects many of which are life threatening.
- Also with rampant advertising and holding seminars in the school to promote the two vaccines the two companies have spread myths about safety and effectiveness of these vaccines unsubstantiated by facts. In countries abroad both companies provide information to the patients/users that informs them of the effectiveness, potential problems and symptoms for which the users should approach a medical facility. This information is also the right of Indian patients, girls, and women. Since there is precedence of this information being provided in other countries there is no reason why they should deprive Indians of this benefit that has tremendous potential for making a rational choice and timely decision to seek medical care.
- The dearth of information is apparent in the 2009 HPV experiment villages. The June 2013 fact finding found, “many girls reported that the vaccine would help with ‘problems after marriage’ or ‘problems related to menstruation’ demonstrating a widely uninformed perception of the vaccine they received….to this day, the girls, their families, and the ASHA workers who administered the vaccine cannot accurately articulate the purpose of the vaccine they received.” (Annexure P-2)
- It should also be noted that the governmental enquiry (set up in April 2010) itself pointed out grave violations of informed consent in the study. This violation should be immediately addressed as this violation is happening with impunity in almost all clinical trials in the country and compensation provided in this case may be exemplary and prevent such violation in other cases as well. The June 2013 report found, “The fact-finding team can unequivocally conclude that health workers did not obtain full and informed consent for this clinical trial. None of the families understood that their daughters were to be vaccinated as part of an experimental programme. In schools, headmasters and teachers signed on behalf of the girls. Neither the girls nor their parents can read and understand the information cum vaccination cards given to the girls. Although the cards included the term “HPV,” not one girl, parent, or health worker mentioned the virus during interviews.” (Annexure P-2)
- The enquiry committee had also recommended compensation in case of girls who died during the project. This should also be done at least on an ex gratia basis till the liability is determined. PATH and state governments should provide this support to families. The June 2013 fact-finding team spoke with the parents of Manjula Laxman Vasava. Manjula died shortly after her second dose of Cervarix. Today, almost four years later, her parents do not have a cause of death for their daughter’s death. They understand that they have been used in a vaccine test and they are waiting for justice and accountability. (Annexure P-2). Petition paras 329-336
- The third major recommendation of the enquiry committee was in respect of ongoing studies with the HPV vaccines, which had been put on hold with the setting up of this committee. The enquiry committee asked that these HPV vaccine studies be re-reviewed scientifically and ethically before restarting them. These included a study with an octavalent HPV vaccine which was also to be administered to boys. This review is of paramount importance as some newer studies are aiming at another vulnerable population – namely HIV patients – and are being carried out in an unscientific haphazard fashion as pointed out in our petition para 59, para 96 of the petition. Because the Respondents have clearly failed to uphold their duty, is necessary for this Hon’ble Court to issue directions to protect vulnerable participants in these and in future trials.
- Since each passing day brings new damaging information about the two vaccines and every delay compounds the pain and suffering to the girls who were unwittingly included in the PATH study, we feel that the delay on part of the Ministry and the DCGI in responding to the writ is creating further damage. Families know that they have been used, but they do not understand the justice process or why the government cannot provide clear answers. Many families told the June 2013 Gujarat fact-finding team that they would “never accept another injection from government health workers.” (Annexure P-2).
- The June 2013 fact-finding confirmed that
•16.a The girls, health workers, and parents believed that the vaccine was mandatory and a component of the National Rural Health Mission (NRHM). The information cards provided to families contain the NRHM logo and NRHM workers including ASHAs and ANMs administered the vaccine.
•16.b All the girls, health workers, and parents knew that the vaccine was very expensive and were made to believe that they were lucky to receive it for free.
•16.c In violation of the project protocol, health workers did not ask each girl for her age, and most girls do not know their ages. Standards in school do not correspond to age. For example, the team spoke to 17 year olds who are in second standard.
•16.d Health workers gave the girls a vaccination card in Gujrati. None of the parents interviewed can read and very few of girls know how to read. The information card includes the NRHM logo.
•16.e Girls vaccinated in schools did not sign consent forms; their teachers or hostel wardens signed the consent sheets.
•16.f Most girls could not explain what the vaccine is for; a few girls incorrectly told the team that the vaccine prevented “uterus cancer.” ASHA workers who administered the vaccine also incorrectly identified the shot as a vaccine to prevent “uterus cancer.”
•16.g In Segva village ASHA workers administered just two of the three required doses of the vaccine. The ASHA workers did not know that the vaccine requires three injections and in fact were not supposed to administer the vaccine and were only to assist the ANM as she administered it.
- The Government’s complete unwillingness to act in the face of clear drug-approval deficiencies is underscored in the April 2013 Parliamentary Standing Committee on Health and Family Welfare’s Sixty Sixth Report on Action taken by the Government on the Recommendations/Observations contained in the Fifty Ninth Report on the Functioning of Central Drugs Standards Control Organization (CDSCO). The Fifty ninth report outlined 69 recommendations to the government to ensure fundamental rights and safe, ethical drug practices in India.
- The 66th report of the Parliamentary Standing Committee found the “Government’s response to be “evasive, inconclusive, dilatory, and vague. Most importantly, the replies were without any firm commitment about the implementation of Recommendations” (para B). The Committee also found:
18.a. No action from the Government: “The Government has done nothing concrete or conclusive even for the Recommendations and findings of the Committee, which directly concern the safety, and health of crores of our countrymen.” (Annexure P-1, para 6).
18.b. Gross human rights abuses as a result of collusion and cover-ups: The Committee also expressed its astonishment at the Government’s inaction in the face of clear delinquency and acts of omission and commission: “The continued inaction on the part of the Ministry on this serious matter almost borders on collusion with an intention to save the guilty. Committee after committee are being constituted to postpone the day of reckoning of guilty people. On another plane this inaction has led to unhindered marketing of these drugs with unknown and unspecified risks to the unsuspecting people who are consuming them amounts to a serious violation of human rights of the hapless patients.” (Annexure P-1, para 3.39).
18.c Grave concerns about the competence and qualifications of the Drugs Controller General of India, the head of the CDSCO (see para 487 of the petition): “The Committee derives no solace from this very open-ended response of the Government. Nothing tangible has been done by the Government in the direction of implementing this Recommendation.” (Annexure P-1, para 3.17)
18.d Failure to order Phase III clinical trials in India for newly approved drugs. The HPV vaccines Gardasil and Cervarix were also approved by the DCGI without a complete Phase III clinical trial. (para 488 of the petition). In the 66th report, the Committee concluded, “Even after a lapse of more than seven months and with virtually nothing concrete having been suggested by the three-member expert committee on this contentious matter, the Government intends to delay a decision by referring it to yet another committee.” (Annexure P-1, para 3.42)
18.e Failure to ensure ethnic diversity and an adequate number of participants in Phase III trials (petition para 488h, 488j): The 66th report states, “The Committee notes with trepidation, its instant Recommendation of considerable import for the health sector in the country, also getting lost in the maze of inactivity which is all pervading in the final action taken notes of the Ministry. The systemic improvements suggested by the Committee for pre-approval trials are easily doable, if the government has a will to carry them out.” (Annexure P-1, para 3.50)
18.f Inadequate post-marketing surveillance: Para. 490 of the petition outlines the findings of the 59th report regarding the ineffective system of identifying and reporting side effects. In the 66th report the committee found, “Even after spending more than six months, the Ministry is almost directionless on several vital aspects of drug regulation in the country and has, therefore, chosen to prolong decisions by the mechanism of establishing committees even on matters where decision making is not only within its competence but can be arrived at right away.” (Annexure P-1, para. 3.169)
18.g Failure to maintain current and accurate product information (see para 491 of the petition): “CDSCO is supposed to approve monographs/labels on all formulations and amend/update them periodically as new information becomes available. The Committee found that changes pertaining to approved drugs are not being incorporated and hence monographs remain outdated had recommended that changes in monographs should be made from time to time. At the same time manufacturers need to be penalized for not keeping CDSCO informed on changes taking place globally as the manufacturers are generally the first to get information on products in their portfolio. Besides they are legally obliged to keep CDSCO informed on all changes. Instead of responding to the Committee’s concern the Ministry has given evasive and irrelevant information.” (Annexure P-1, para 3.176).
18.h Unethical advertising: The 59th Report asked the Ministry to take appropriate action against companies that advertised Schedule H drugs in the lay press. Both Gardasil and Cervarix have been heavily promoted through newspaper and TV ads, direct SMS to students, school workshops, and billboards (petition, para. 489). The 66th report finds: “The Committee notes that the Ministry has proposed an amendment to prohibit advertisement of Schedule H drugs. The said amendment has been deliberated and approved by the Drugs Consultative Committee on 20 July, 2012 and by the DTAB four days later on 24 July, 2012. The Committee is, however, pained to note that the matter instead of being brought to its logical conclusion at the earliest is still under process. Deprecating this laissez-faire attitude of the Ministry, the Committee desires that all necessary formalities to formalize the proposed amendment be completed forthwith so that its proper implementation starts in right earnest without any further delay.” (Annexure P-1, para. 3.199)
19. The Government’s failure to adequately respond to 46 of 69 Standing Committee recommendations reflects a culture of passivity that will cost Indian citizens their lives. The 66th Committee report concludes, “In case of 46 Recommendations the action taken by Government is only with the intent to delay, obfuscate, stagger implementation or not implement at all with a view to delay/negate action in proven cases of wrongdoing. This inspite of the fact that the Government took not the stipulated three months to take action on Recommendations of Committee but more than six months and they were afforded not one but an unprecedented two opportunities by the Committee to implement the Recommendations contained in the Fifty-ninth Report. All this has been done when CDSCO, which is mandated with the onerous task of directly ensuring health safety of more than one-sixth of the population of the world has, most unfortunately, not acquitted itself well, both, at professional and ethical planes. The Committee considers this highly regrettable and with extreme pain and anguish is constrained to bring these facts on record.” (Annexure P-1, 3.200 )
We therefore pray before the court to pass the following interim orders to control the damage.
In light of the facts and circumstances of this case, the Petitioner prays as under:
- For an order directing the CMC Vellore (Respondent No. 9) or any other independent medical team to immediately carry out medical camps for girls between 12-18 years of age to assess the health status of girls who received either Gardasil or Cervarix and to start providing continuing care for chronic problems, in the six project affected blocks in Vadodara and Khammam Districts after well publicizing these medical camps in schools and villages. This should be done in a time bound manne
- For an order prohibiting DCGI, Respondent No. 2 from approving any new studies/clinical trials or restarting stalled studies on the HPV prophylactic vaccines till such time as their essentiality is established in the Indian context and the validity of their licensing is decided upon by this Hon’ble Court.
- For an order prohibiting DCGI Respondent No 2 from approving any biological (recombinant) vaccines or drugs till such time as the technical capability of the CDSCO is developed to properly evaluate them.
- For an order directing Respondent No. 1 to direct the state governments not to purchase or use HPV vaccines in vaccination programmes.
- Direct the Respondents No. 7 and 8 to provide all girls and women availing of the HPV vaccines comprehensive information in the local languages about (1) The possible adverse effects and what needs to be done on experiencing an adverse effect, (2) The efficacy of the vaccine, (3) The potential need for recurring booster shots (4) The alternative available including the pap smear and VIA, and all other information relevant from the point of view of illiterate, malnourished and poor women and girls providing at the minimum all the information provided to girls in the U.S.
AND FOR THIS ACT OF KINDNESS, THE PETITIONER AS IN DUTY BOUND SHALL EVER BE GREATFUL.
(Jyoti Mendiratta) Advocate for Petitioners
Filed On: . 07 .2013
IN THE SUPREME COURT OF INDIA
CIVIL ORIGINAL JURISDICTION
I.A.NO. OF 2013
WRIT PETITION (CIVIL) NO. 558 OF 2012 (UNDER ARTICLE 32 OF THE CONSTITUTION OF INDIA)
In the matter of:
KALPANA MEHTA & ORS. …Petitioners
UNION OF INDIA AND OTHERS …Respondents
I, Kalpana Mehta D/o Anand Singh Mehta, age about 59, R/o 43 Saket, Indore 452018, M.P. presently at New Delhi and is competent to swear this Affidavit,:
- That I am the petitioner no. 1 in the above mentioned matter and therefore well conversant with the facts and circumstances of e case.
- I have read and understood the contents of this application for directions as shown to me and I say that the contents thereof are true and correct to the best of my knowledge and belief.
- That the annexures to the application are true and
correct copies of the respective originals.
- That the Petitioner has not filed any other or similar petition/ application before this Hon’ble Court or before any other court/ tribunal.
Verified at New Delhi on this the ___ day of 2013 that the contents of the above affidavit are true and correct to my knowledge, that no part of it is false and that nothing material has been concealed there from.