CAMPAIGN AGAINST DEPO PROVERA

January 1995

It is extremely important that the women who undertake the test are seen as victims of existing power arrangements and prejudice in society rather than be damned as criminals. The proliferation of commercial and professional interests in the sphere of pre-natal diagnostic techniques too needs to be checked. Without providing for effective mechanisms for local vigilance, the possibility of making a difference to the situation will remain remote. The problems on account of selective child birth cannot be taken care of under the provisions of the present Bill. The necessary amendments must therefore be carried out and Bill be implemented at the earliest.

To argue for legislation, however, is not to suggest that law by itself can resolve the problem of discrimination in matter of births. No less than a comprehensive review of state policies and programmes which themselves contribute to devaluation of the female gender and privileging of the male in the society needs to be undertaken and correctives introduced. The conditions which perpetuate gender bias, and hence son-preference, also need to be changed with a sense of urgency. For nothing short of a more egalitarian and less exploitative social order can make a difference to the problem. Yet, appropriate legislation is the first requisite in the direction.

In 1992, we read in the newspapers that without conducting any research, the Indian government was gearing itself to approve the entry of Depo Provera a long acting progestogen injectable contraceptive. We made enquiries in writing from the Indian Council of Medical Research (lCMR) and requested the National Commission for Women to enquire into the case. Since 1991, the campaign against hazardous contraceptives had been carried out jointly with other Delhi based local and national women's and health groups. There was also a joint petition. But it did not even bring a reply in its wake.

Later we discovered that this letter at least had the impact of delaying approval by nearly a year because Up John Ltd., the manufacturer of Depa Provera, was asked to submit data based on Indian research. Though this was in the nature of a ritualistic exercise and the data submitted by Up John totalled five studies, none of these had even carried out dose determination which would be appropriate for Indian women. They had been carried out independently and one of them was not even a study of contraceptive effect but more a study of Vitamin status relative to oral pill use while one was a Depo Provera plus Diethyl Stibestoral study (Yes! of the DES tragedy fame). These studies had been carried on nearly 20 years back! It must be mentioned that ICMR had found Depo Provera to be even less acceptable than Net-En (the injectable against which we have a case in the Supreme Court where the ICMR has not been able to contest even the basic issue of drug safety). And the study on vitamin status, though started by ICMR researchers, had to be abandoned because, according to the authors, Depo Provera was banned in India.

As many of you are aware, in the health and population circles it is becoming increasingly fashionable to hold consultations with women's groups, and even as the news of Depo Provera social marketing hit the newspapers, the government of India also decided to hold consultation with women's organisations in June 1993. For this consultation, some papers were floated- one of which contained a reference to NET-EN, DEPO-PROVERA, CYCLOFEM, and NORPLANT as available methods of contraception. All the injectable contraceptives were hailed as being easy to administer (on account of the existing Universal Programme of Immunization which had taught all health workers everything about giving injections) and better than IUDS because of the existing rate of Reproductive Tract Infections. Another booklet was produced at the meeting itself which was a reprint of an "Answer to some queries about injectables" by Population Services International.

The interesting thing was that despite two years of joint protests most of the protesting organizations had not been invited to this meeting. This was not a conspiracy, but the fact that the consultation was a ritualistic exercise and to the Department it made no difference which organizations turned up so long as it could say that it had held a consultation with women's organisations. So our demand for additional invitations was met without any resistance. By this time we were aware that on account of the IMF dictated Structural Adjustment Programme, the proponents of Population Control had been granted powers that transcended the existing checks and balances in new contraceptive introduction and agencies like the ICMR responsible for research were themselves ready to circumvent trial requirements. Similarly, the rules of the Drugs and Cosmetics Act had been modified to give the Drugs Controller of India (DCI) the discretion to waive Phase III and IV trials after the NET-EN petition had been filed by us in 1986. At Saheli we felt that this meeting with the government had to be different than the encounters so far where Saheli seemed to be the gang leader with only a passive support of other organisations. Hence before the meeting, we organized a day long seminar to give information on various technologies to sister organisations.

At the meeting, the government was taking a very peculiar stand. It claimed that the mention of various methods including the injectables was no indication of the government's decision to introduce these methods into the Family Planning Programme and as such these would only be available in the market against prescriptions. But in the changing context of the government handing over various schemes to "voluntary agencies” and "private practitioners", this claim had no meaning. When cornered, even on the question of Depo Provera, the Secretary Dept. of Family Welfare admitted that only in the current year there were no plans for its introduction into the Family Planning Programme which really amounted to nothing.

Therefore, we made a joint representation to the Minister not only on the question of injectables, but also about the vaccine, NORPLANT, and schemes of social marketing in August 1993. In the meanwhile, we found that injectables had become a regular feature in the governmental literature. In November 1993, we confronted the Director General (DG), ICMR, who had earlier in writing stated that Indian trials were a must before the introduction of any new contraceptive, how had he advised going ahead with Depo Provera on which ICMR had not conducted adequate research. While he admitted that the ICMR had recommended that Depo Provera be licensed, this had not been accepted by the technical advisory committee to the government. This was a misleading statement as we found out later because Depo had been granted approval way back in July 1993. As these assertions had been made in a public meeting, we were really misled and no activity really took place right till April 1994. At that time we got to know from women's groups in Bombay that Depo Provera was to be launched in early April.

The launch took place in Bombay and the groups there attended the launch and protested. This was also the launch of the present campaign against Depo Provera. A similar launch was, we were told, scheduled to take place in Delhi in mid April. We called for a meeting of women's organisations. The response to this meeting was rather lukewarm a disappointment because Up John had indeed taken a very aggressive stance. At the meeting we also learnt that German Remedies had also launched Net-En though somewhat discreetly. As it turned out, even the Drugs Controller had been caught unaware, by NET-EN launch as per his own admission to us in writing.

Given the level of response we decided to launch our all India campaign against injectables through a chain letter. (This letter is reproduced in this newsletter for you to carry out the campaign), Max Pharma Ltd., who was to market this drug, also did its best to mislead us. It sent its publicity firm Mudra Diversified to meet us and carry out a dialogue while the company went ahead with press meetings while we waited for a public meeting. Though corporate responsibility was an issue we felt that our government had to tackle first. Hence we took a delegation to meet the Minister. The Minister showed complete ignorance and directed us to the Secretary. Secretary, Department of Health, also showed complete ignorance, while the Secretary, Family Welfare said that he really had nothing to do with launches in the open market. Of course he had no logical explanation for promotional literature printed with government money to support launch of the products of private companies.

The Health Secretary was more responsive and agreed to get the explanation of the DCI on this issue. We did discover, that he kept his word and is probably, single handedly responsible for the meeting the Drugs Controller held with us later. We were, however not content to let this be and pressed forward with endless telephone calls to the DCI which were never returned and definitely not answered. To force a dialogue, the only way out seemed to be to gherao the DCI. Fifty women thus marched into his office, defying security arrangements in the Ministry and parked themselves to await his arrival. When he did come, he tried to be very tough but agreed to provide us with the data which had formed the basis for his approval. A meeting was scheduled for May 13th, 1994.

In the meanwhile we were tipped off by our friends in the press about a press conference by Max Pharma Ltd. to dispel doubts about Depo Provera following the press publicity of the events on 12th May 1994. We decided to use this opportunity to really inform the press about what was happening, i.e. complete subversion of the laws of the land and profiteering at the expense of women's health. We were barred entry by Mudra Diversified to this meeting and had to scale the walls in order to gain entry. We had tipped off Press Photographers to be present because we did not expect the going to be smooth, It was their presence that gained entry for us as otherwise women from Mudra Diversified were blocking us physically.

After entering the Press Conference we raised a series of technical questions. In their aggressive bid to convince us, Mudra Diversified had unwittingly passed us the information of the U.S. package insert and from Parivar Sewa Sanstha (who has publicly announced the plans to market Depo) we had received information in Hindi which was meant for unsuspecting Asian women. Our press release focused on the contrast lack of information for us and the so called "complete" picture presented to the American women.

The contrast was an eye opener. Max Pharma representatives tried to depict us as a bunch of rabble rousers and hence showed extreme willingness to answer our queries right then and there. Their confidence was of course short lived. We raised a list of 13 questions ranging from dose determination, to long term effects which had to be answered to justify their claims of product safety and efficacy. Needless to say that they could not answer anyone of them satisfactorily. We asked them for the Indian data, they referred to it but failed to provide it because only they knew how meaningless and incomplete it was, we had not even seen it. While this sparring was going on, the press realized that we were not just arguing meaninglessly and emotionally but were asking relevant questions for which there were no answers. This day won us new allies in the press. And the issue gained a front page status. Max Pharma representatives tried to hide behind WHO study on cancer but we said that cancer was only one of the concerns. They tried to hide behind the Drugs Controller but we pointed out the specific problems in the Indian context. Ultimately, 4 1/2 hours later, Max Pharma representatives threw up their hands and stated "there is very little we can do if you are not ready to accept the authority of WHO or the DCI”. We then drew their attention to corporate social responsibility which meant that if they had no ease for defending the introduction of Depo Provera in India they should voluntarily suspend its marketing. We also asked for information they were to provide to the Indian user, but they failed to give it to us. However, they did give us the Indian Studies, because we were raising questions about content and methodology which they could not answer because they had submitted these studies without having read and evaluated them. By passing them on to us they thought that they would appear to be transparent and they could bring the meeting to an abrupt end as every minute was becoming more and more embarrassing for them. The event received excellent coverage in the press. The criticism was also there -not on the content of our arguments but over our ungracious conduct of scaling walls and violating the "right" of the corporate sector to "whitewash" its misdeeds and hence, for having engaged in a very unfeminine conduct. In their criticism the Press forgot that this very Corporation was trying to play with the "right" of Indian women to lead a "healthy" life. And if we had indeed taken Mudra Diversified at its face value we would have kept on waiting for a democratic open debate while the company went ahead with press publicity. Similarly, if we had gone on writing letters to the DCI and not staged a sit in, he would have avoided answering us altogether as he has done even to the Supreme Court in the Net -En and EP drugs case earlier, for eight years and more.

The meeting with the DCI was scheduled for the following day. But he was in close communication with Max Pharma and he called off the meeting at the last minute without so much as cancelling it on telephone. Obviously, he had been ready to meet women's groups who knew nothing but was not prepared for a confrontation with women who knew what they were talking about. We wrote a letter to him to schedule the meeting later. His office even refused to receive this letter. Ultimately, we had to address a letter to him via the Health Secretary because the Private Secretary to the Health Secretary had the courtesy to send a messenger to the reception desk to receive this letter. Sympathizing with our difficulty, an official of another Ministry tried to help us by taking the letter to the DCI's office. Not only was he misbehaved with, but the functionaries at the Reception desk were hauled up for allowing this messenger of ours to go in (notwithstanding the fact that he had a pass to enter the Ministry whenever he wanted to and the Reception had no mandate to prevent his entry). While this has only anecdotal value in the happenings in the campaign it shows the resistance of public servants to respond to the most vocal groups of people's representatives (who have a high visibility and belong to the same class). One does not have to stretch one's imagination to see how far they would go to keep the "real" women out of decision -making. So much for women's informed choice and empowerment which the government does not tire of pronouncing in every document.

The response to us followed two weeks later. A meeting was scheduled in the Ministry -due to paucity of time we had been unable to inform all participating organizations to join the sit in, and only six organizations had been able to participate in the event. The letter of invitation stated that of these only five women's organizations should attend the meeting and each organization should send only one representative. At a joint meeting it was decided to agree to this conditionality but to protest about it during the course of the meeting. But when we arrived we were shocked to find that the other side had more than 20 representatives, not only from the Ministry and the Drugs Controller's office, but also from ICMR and various expert committees. Strangely enough, many private doctors were also present, not only from Delhi hut also from Bombay.

While the Government had called the meeting, it had not made any preparations to provide us with information on the basis of which a discussion could take place. It had not even decided what our locus standi was in the matter. We were however, very clear that Depo Provera had been introduced in violation of all norms and had to be banned and we had no reason to compromise on this stand. The Doctors started to assert themselves from the very beginning, hoping to cow us down with their "expertise", little realizing that we had studied the drug more than they had and had a better knowledge of research procedures, ethics and requirements than they had. Anyway, one must say that they are smart if not knowledgeable and kept quiet when their remarks were shown to be unethical and unscientific, when they started comparing injectables to oral pills, or narrating unpublished studies of their own patients.

We had informed the press about the meeting. The Health Secretary had also asked the press to be present but the other officials had not invited the press keeping in view the Max Pharma press conference. This was remedied during the meeting but the non-officially informed press reporters, were not allowed entry easily.

The DCI continued to show a non cooperative attitude. He tried to give an impression that he really had no role in importing new drugs under the new liberalized import policy where all drugs, except a banned list of six, could be imported by any Doctor or a health institution in any quantity. This in itself is an alarming situation. But we persisted to find out whether be had, in fact, granted marketing permission and if that was not his role. He had to admit this. We also asked him about misuse of drugs and whether it was not his role to regulate the use of drugs and to regulate claims of manufacturers about these. When thus cornered, he was forced to admit that if there was misuse then it was his role to remedy it. At this point we flashed before him ampules of Depo Provera bought from leading chemist shops in the capital without a prescription. He immediately piped up to say that, "But this is not the fault of Max Pharma”. We told him not to be so quick in reaching this conclusion without investigation. He also said that if we gave him the bills he would take stern action against the erring chemists. We told him that this was not our priority for the time being. We had clearly demonstrated that the drug was already being misused within weeks of coming into the market and now it was up to him to ban it. It is worth noting that Prof Ranjit Roy Choudhury of National Institute of Immunology (NII) who is the Chairman of the Technical Advisory Committee of the G.O.I. on new contraceptives agreed with us. But instead of taking the ethical stand of Dr Roy Choudhury, we were told by others that "it is his opinion not the governments".

Next we questioned the DCI, P. Das Gupta, on his role in deciding the package insert and who the information was meant for. He asserted categorically that he approved the dummy and the information was meant for the Doctors. He then had no explanation for the limited information available on the Depo insert in India as compared to the U.S. Even the bills we had with us, to show that over-the-counter counter sale had taken place he had tried to shrug aside, by saying how was he to believe that there was no other Dr P. Das Gupta whose name the bill carried who had not actually prescribed the drug. (We had done this on purpose.) But in so far as the package insert was concerned he did not even have this lame excuse. We in fact dared any of the representatives of the Government to accompany us to visit chemists and buy the drug without prescription and get proof right then and there. But we were believed and no one challenged us. This moved Dr. Satyawati, DG, ICMR, to say that all of us were working for women and that the Government must answer our list of written questions one by one. Dr. Mukherjee. Director General of Health Services (DGHS), who at this moment was chairing the meeting, assured us that he taken cognizance of the complaints made by us and he would take remedial action. We also re-asserted that our demand was to ban the drug in its present status and not merely to make these small changes –i.e. the package insert, or selling OTC. Therefore, we would like to have a full meeting to discuss safety and use issues relating to Depo Provera after we had been provided complete information which we had asked for. We also raised the question of why a Post Marketing Surveillance (PMS) had been ordered but not started given the fact that the product had already been in the market for three months.

While questions regarding Depo Provera were at least discussed, the DCI took the plea that he will not discuss NET-EN because it was sub-judice. While he did not feel the need to restrain German remedies from marketing a sub-judice product, he was ready to hide behind law to prevent a discussion on his own actions.

Dr. Mukherjee the DGHS was more forthright in responding to the issues raised by us and our demand for a thorough discussion on the subject but was a bit wary of giving us a locus standing beyond being complainants. He, therefore, agreed only reluctantly to even write the official minutes of the meeting.

He assured us that all our questions will be answered within ten days and a full meeting held within a month. Needless to say, that most answers were not provided. Yet the Drugs Controller was forced to agree to a few remedial measures in writing these are:

1.Ordering a post marketing surveillance for NET-EN.

2.Changing the package insert for Depo Provera.

3.Monitoring sales without prescription.

4.Providing information to users.

5.Considering restricting sales to limited outlets.

But the practical steps to ensure the above had not been outlined in his letter. He also made it clear that these contraceptives are not even claimed to be superior to existing contraceptives. He has admitted that he does not have information on volume of import and sale. Nevertheless he made many claims of the safety of Depo Provera which are unsupported even by the manufacturers. All in all, his attitude is extremely biased. We publicized these measures, hoping that some chemists may be thus restrained into behaving themselves, we are planning to move the court for ensuring other reliefs.

Our attempt has been to broaden the base of the agitation. This is not a women's issue. Dangerous long acting contraceptives are a tool in the hands of the population control establishment. Entry of multinationals, wrenching open the third world market and enforcing population control are the tenets of Structural Adjustment Programme. We are happy that other groups have started responding and the information update on Depo been printed by Public Interest Research Group and not by a women's organisation.

The planned meeting with the government did not take place. Our reminders were ignored systematically. We even went to the extent of asking for a limited meeting to consider the practical issues accepted by the DCI in writing. Tired of waiting, we called a public meeting on 17th August 1994. This meeting was attended only by representatives of ICMR and the DCI, though we had extended the invitation also to others like Max Pharma, Mudra Diversified etc.

At this meeting, we were informed that the DCI had no powers or mechanisms to monitor or for that matter take any action against errant chemists. This was the task of the State Drugs Controllers. This is-most unacceptable, should the potential for misuse and the consequent misuse not be made a ground for cancelling the licence of a non essential drug which is not even superior to existing alternatives?

DCIs assurance on the question of providing informed choice for users, based on dos and don'ts was as non serious as anything. Despite more than two months having passed since his written assurance in this regard, all he had to show for this safeguard was a one page sheet of some typed information in English which is grossly inadequate, dated 16.8.1994, obviously prepared in a hurry just one day before the meeting.

In so far as the question of the protocol for the Post Marketing Surveillance was concerned, the representative of the DCI again insisted on maintaining the confidentiality of Up John/Max Pharma. This is really ironic, why should a research protocol be kept confidential from the very people who will be affected by this research. Is it the job of the DCI to safeguard the interests of companies? Is he not expected to do just the contrary, i.e., protect the public from drug companies?

The only success till date has been a change in the package insert. Now the Indian package is the same as in U.S.A.

Since we failed to get any satisfactory answers from the DCI, we are moving to the Court for this purpose. The struggle thus goes on. As we write this article a country wide signature campaign is being launched to ask for a ban on Depo Provera. The text of which is reproduced below, so that you too can join the campaign.

BOX

The Minister,

Ministry of Health and Family Welfare

Nirman Bhawan, New Delhi

We are alarmed at the rate at which hazardous, long acting, invasive contraceptions like Depo Provera are being introduced in the country, without adequate testing or any consideration for the implications they have for the health and welfare of the women of India. The manufacturers of Depo Provera themselves have admitted to 78 adverse effects some of which are life threatening and for most there is no treatment. Despite protests by health groups and women’s organisations this prescription drug continues to be sold over the counter. In fact at a public meeting a representative from the office of the Drugs Controller of India has openly admitted complete inability to monitor and control the sales of Depo Provera.

IN VIEW OF THIS WE DEMAND AN IMMEDIATE BAN ON DEPO PROVERA