UPDATE ON EP DRUGS CAMPAIGN REPORT OF PUBLIC HEARING

UPTODATE ON EP DRUGS CAMPAIGN

REPORT OF PUBLIC HEARING

Newsletter Oct 1987

History of the campaign

High dose combinations of oestrogen and progesterones (EP drugs as they are commonly called) were developed in the fifties and sixties. As oestrogen, if for some time and then withdrawn, produces bleeding, this combination was recommended for pregnancy testing. The drug had to be given for three days and then stopped. If the woman had bleeding after a week, she was supposed not to be pregnant.

However, further research showed that this test was not reliable, as a pregnant woman could have withdrawal bleeding and continue to be pregnant. In some cases, even if the woman was not pregnant, she would not have any withdrawal bleeding.

In 1976, reports started coming in relating the use of hormonal pregnancy tests with congenital birth defects. Australia banned these drugs; later the World Health Organization recommended to its member countries that EP drugs should not be used for pregnancy tests. The Drug Controller of India issued a notice to the manufacturers to put a warning on the packet to this effect; and drug companies complied. However, they had sold the drug so well earlier that these printed warnings had little effect, and EP drugs continued to be used as pregnancy tests.

In 1982 various women’s organizations, health groups and consumer movements came together to ask for a ban on EP drugs as they were continuously being misused. The Drug Controller banned them in June 1982. However, he left a lot of loopholes, of which the chief ones were that the manufacturers had six months to stop manufacture and one year to stop sales of EP drugs. Three drug companies—Organon (Infar), Nicholas and Unichem went to the High Courts of Calcutta and Bombay and obtained stay orders against the ban.

In December of the same year, Vincent Panikulangara, a Cochin-based lawyer filed a case in the Supreme Court against the continuing availability of numerous banned drugs. EP drugs were on this list. In November 1986, the Supreme Court, refusing to take any decision on the case on the grounds of it being a technical issue, charged the Drug Controller of India to hold public hearings and decide whether the ban should be lifted or not.

The first public hearing was held at Madras. As there was not enough prior notice given through national and regional newspapers, consumer participation was negligible. In Delhi, where the second hearing was held, it was a little better. But the fact that this was to be the last hearing was not communicated to the consumer and health groups, while drug companies had managed to bring in experts from all over India.

Under public pressure, which protested against this sort of bias towards the manufacturers, hearings at Calcutta and Bombay were fixed. At Calcutta, numerous doctors, medical representatives and Women’s groups were very vocal about the misuse of the drug. The Bombay hearing was fixed for the 14th of July.

In the extremely short time available before the hearings, (July 10th and July 14th) we therefore pre-pared a submission to the Drugs Controller stating the following:

1.      That all evidence by voluntary agencies/persons in favour of the ban, whether presented orally, by post or at the time of the hearing, should be taken cognizance of, and that failure to submit 40 copies of evidence should not be held against us.

2.      Minutes of the hearings should be circulated to all the people who attended the hearings.

3.      Minutes of the letters given by doctors in Delhi in favour of the EP drugs. We pointed out how many of these doctors admitted to using EP drugs for testing pregnancy; how many had not specified which drugs they were talking about (high dose or low dose); and how several doctors were in favour of the drugs but did not state what they used them for.

4.      Our submission also included two affidavits and prescriptions from doctors who had given evidence in favour of the drug, showing how even these doctors prescribed EP for pregnancy testing.

5.      A few letters from doctors who believe EP drugs are not essential and agree to their misuse and consequent danger, were also included.

One of us attended the Bombay hearing and found it a very educative experience. About a 100 people were present. Those in favour of the ban included doctors, women’s organizations, consumer groups, science groups and a lawyer. Aside from representatives of drug companies, there were doctors against the ban, and some members of the workers union from Unichem were also present. A few reporters had come to cover the hearing.

The Drug Controller started the meeting by defining the purpose of the hearing and significantly saw the matter as an entirely technical one: were EP drugs useful in the treatment of secondary amenorrhoea or not; what alternatives existed to their use for treating secondary amenorrhoea; which countries had banned EP drugs and why, etc. The entire aspect of misuse of the drugs for pregnancy testing and as an abortificient was not considered in laying out the framework of the enquiry.

All those present and wanting to speak were called to do so in the order in which they had registered. Each person was allowed 4 minutes, which was obviously not enough to present even the gist of one’s argument, however, no attempt was made to extend the duration of the hearing, in spite of the fact that almost two hours were lost in the morning in getting the hall equipped with microphones.

While waiting for the actual hearing to start, it soon became apparent that several doctors, including gynaecologists present were not clear that the hearing was regarding high dose combination EP drugs and thought all EP drugs were to be discussed, which would include oral contraceptives. Many of them said that infact they were not in favour of high dose EP drugs either. The public notice issued by the Drug Controller in the press had not clarified this point. Clearly this confusion goes in favour of the drug companies, and though the matter was clarified in Bombay, it is left to the Drug Controller to screen the hundreds of letters written by doctors which are in favour of the drug but utterly ambiguous about which combination they mean (high dose or low dose). This ambiguity is compounded by the fact that many doctors have not mentioned what they use the drug for.

Since every speaker could talk for 4 minutes on any aspect of the matter, the discussion did not proceed in any logical sequence. Each aspect could therefore not be discussed thoroughly by both sides and on several occasions people got really angry because they were not allowed to refute the statements being made by the speaker. The testimonies of various people, the truth or falsity of the same, the arguments and counter arguments—there is no way of knowing how these matters will be decided unless minutes of the meeting are circulated, especially since several valuable points were made in the course of the hearings and have not been put down in writing by the speakers.

The following is a gist of the kind of issues discussed.

Several doctors testified both in favour of and against the use of EP drugs, in the treatment of secondary amenorrhoea. However, secondary amenorrhoea itself is a term which can be loosely interpreted, with some doctors labelling any woman who stops getting her period as having secondary amenorrhoea, when infact the term is supposed to technically apply only to those women who have missed their periods for atleast three cycles or six months. Several letters written by doctors in favour of EP drugs clearly indicated this confusion in terminology, and once again there is no way of knowing what precisely doctors were testifying about at the hearing because the terminology was not clarified. At any rate, it became a question of one doctor’s word against the other.

Whether EP drugs cause congenital malformation if taken during pregnancy was another issue that was hotly debated. For the drug companies, nothing short of water tight proof based on Indian studies was adequate. Such water proof evidence is of course almost impossible to get, and those who were in favour of the drug kept finding fault with all the evidence which was presented, based on studies done in several countries.

Women’s groups and consumer groups largely focussed on the wide-scale misuse of these drugs. Women presented evidence of being prescribed EP drugs for pregnancy testing and cash memos showing that these drugs were still being sold over the counter by chemists, inspite of the fact that public hearings were going on. They pointed out the fact that there is no monitoring of prescription practices of doctors, or of over the counter sales; that most women do not question what they are prescribed by their doctor and are hardly in a position to change their prescription practices. The high cost of urine tests for pregnancy was also pointed out as a reason for widespread misuse of EP drugs since they are much cheaper.

In the course of the hearings, some important questions regarding drug licensing and approval were also raised. For instance, if secondary amenorrhoea can be treated in other countries by drugs other than high dose combination EP drugs, then why are Indian women special? What is the estimated need of these drugs for the limited purpose of treating secondary amenorrhoea rationally and how does this compare with the quantity of the drug presently being produced?

The drug companies were of the view that misuse was not their problem. On their part, they said, they had complied with the notifications of the Drug Controller and placed warnings on the product sheets and packing as required. According to them, there was no technical ground to ban their product, and if there was such a ground, then the Drug Controller had not thus far stated it.

The labour union of Unichem presented the view that workers would lose their jobs if EP drugs were banned. This can be taken as an indication of the scale of production and profits from EP drugs on the one hand and on the other an indication of how the social consciousness of workers can be misused.

After hearing all the participants, the Drug Controller summed up the day‘s proceedings, and once again his remarks were most revealing. According to him, while the technical issues as well as the questions of misuse could not be ignored, issues related to misuse had to be dealt with at another level, by different measures.

Some lessons from the EP drugs controversy

Given that women are exposed to a number of hazardous drugs, specially meant for them in treating Gynaecological disorders, during pregnancy, as contraceptives, the EP drugs case raises important issues for future campaigns.

1.      Technically speaking, it is incumbent upon the drug company to prove that a drug is safe. However, if we dispute the safety, then it is for us to provide evidence of hazard.

2.      Since most studies are done by drug companies or research institutions which are not always unbiased, we have no scope of generating alternative information which will provide conclusive proof.

3.      If the debate of safety is thrown open to the medical community, it becomes the word of one expert vs. the other and decisions can be hard to reach.

4.      The Court considers such matters to be too technical in nature for it to intervene.

5.      The Drug Controller, the drug companies and the law do not consider misuse sufficient ground for banning a drug, because everything has the potential for being misused.

6.      There is no way in which doctors can be sued for malpractice at present in our country because doctors, specially private practitioners, do not maintain patient records. Prescriptions do not state the diagnosis, and patients themselves are often unaware that a subsequent health problem could be drug related.

7.      The medical community does not regulate itself in any way.

8.      There is no mechanism by which drugs sold over the counter can be regulated.

In such a situation, thousands of people are victims of drug abuse and misuse, and yet they have no recourse to remedial action. With drugs used for contraception, the potential for misuse is on an even larger scale.

Since there are very few instances of litigation against harmful drugs, the EP drug case and its out-come will set an important precedent for all time to come. It is doubtful whether the Drug Controller will infact ban EP drugs. He may or may not come out with any suggestions on how to tackle misuse even though everyone (including those in favour of the drug) agree that something should be done to stop misuse and have asked the Drug Controller to take the necessary steps.

On our part, it is clear that we cannot let the matter rest. We have to continue campaigning against the hazard of such drugs and their wide scale misuse.

We feel it is important to contact and share information with groups which have not yet participated in the campaign, and to devise strategies with all those who are in interested. Some ideas are as follows.

1.      Identify and write to the concerned ministries to take action in preventing misuse of EP drugs, e.g. the women’s ministry, which also has links with the ministry of health and family welfare.

2.      Explore the possibility of demanding that the Medical Council of India take the responsibility of regulating prescription practices of doctors as the Press Council does for the press. The Medical Council did recently de-recognise Dr. Sreeram Lagoo.

3.      Demand cheaper and safe urine tests be made available so that atleast the demand for EP drugs is no longer there on account of financial reasons.

4.      Find out what pregnancy test is routinely recommended in General hospitals.

5.      Try and find out the licensing policy with regard to production of such drugs and see whether any changes were made after the drug was banned as a pregnancy test.

We hope that you will send us your comments and suggestions for future action.