Substitution Therapy: Harm Minimization or Harm Maximization
By Namaram Kishalaya
In coping with the ever-growing menace of drug addiction, different strategies and approaches have been adopted on trial bases. Harm Minimization based programs are a recent strategy adopted by different Agencies in the control and prevention of drug abuse in the State, although such programs have been implemented in various parts of the world, especially in the Western Countries. The concept of Harm Minimization came to Manipur with the outbreak of HIV/AIDS in the State. Non-Governmental Organizations working with the Injecting Drug Users or IDUs are the pioneers. During the earlier part of the epidemic that occurred in the mid 1990s, most of the programs were mainly confined to Needle and Syringe exchange, Bleach and Teach program, etc. Lately, Maintenance or Substitution Therapy, a part of Harm Minimization program was introduced in Manipur on an experimental basis at Thoubal district by a Government Agency. Due to a lack of success, it was discontinued thereafter. Spasmo-proxyvon capsules were used as the substitute drug for Heroin in that pilot project. Since 1999, an NGO called the Social Awareness Services Organization, SASO in collaboration with a Delhi-based NGO; SHARAN once again started the Maintenance Therapy in the state as a two-year pilot project. Basically the program attempted to switch people over from using/injecting illicit drugs like Heroin to other legal drugs, which are "less harmful and less addictive". This allowed the individual to function normally without the withdrawal pains. This time Buprenorphine hydrochloride sublingual tablets 0.4/2 mg branded as Addnok and manufactured by Rusan Pharma Ltd. was being experimented as the substitute drug by these NGOs. Substitution/Maintenance Therapy is still a controversial program, especially in Manipur and a wide and intense debate is going on around the world. The writer made a study on how this controversial experimentation is being carried out in the state by interviewing and taking opinions of the Experts, Service Providers and the Service Receivers (clients) as well. Prof Ahanthem Dwijamani Singh, Superintendent, Regional Institute of Medical Sciences, RIMS at Imphal expressed that, Substitute Therapy is one of the method used to reduce the craving for dangerous addictive drugs like Heroin besides detoxifying the users. Buprenorphine tabs are used in this therapy but they are neither legalized nor approved by the government and apparently this mode of therapy is not "advisable". Prof AD Singh further stressed that there are no proper protocol or any scientific study that has been done regarding Buprenorphine Maintenance Therapy. Yet a Non-Governmental Organization is conducting the therapy as a pilot project. Prof AD Singh questioned the accountability on how far it is being implemented scientifically since no official feedback has been reported about its assets and liabilities. Prof AD Singh further pointed out the need to address the root problem in the first place. Stating that since any form of addiction is essentially related to human psychology and behavior, one should address the core issue of changing the behavioral and psychological aspects of the person, which is very tricky. By substituting one drug with another does not necessarily mean that a person is free from the problem of addiction. The most important part, which is "psychological dependency" - would still persist. Prof AD Singh preferred to use the word "trial" even though the drug (Buprenorphine) is not available in the market legally. The writer also met Prof Gyaneshore Sharma, head of the Department of Psychiatry, RIMS at Imphal and sought more input regarding Drug Detoxification and Substitution/Maintenance therapy. According to Prof Gyaneshore, Buprenorphine is basically a painkiller. It also has some properties to help addicts overcome their withdrawal symptoms. Of late, this drug is being used by some NGOs to treat chronic users to maintain their habit since the danger of overdose is non-existent with its use. The financial factor comes into play here as well as this drug is distributed freely, besides freedom from the usual dangers associated with injecting drugs like Heroin. He also expressed that, compared to Heroin powder, Buprenorphine tablets have a lesser addictive potential and is much easier to give up in terms of physical withdrawal symptoms by tapering their doses though it defers with each individual. However, the clients who are taking Buprenorphine as a substitute drug found it more difficult and painful to withdraw or give up Buprenorphine than Heroin. Prof Gyaneshore also readily admitted that Buprenorphine tablets are yet to be legalized. He also stated that Buprenorphine is being used as a substitute to Heroin on a trial basis, with a view to minimize the harm related to IDUs. However, if Buprenorphine is to be used in a Maintenance Therapy, the Service Providers (the NGOs) need to have a clear-cut policy and an understanding with the clients, he added. Regarding Maintenance Therapy, there are several factors to be considered including the feasibility beforehand. The clients must be informed about the duration and mode of the therapy and the Service Providers must be clear as to how the clients would cope with their new addiction until the substitute drug is made available legally in the market. The second point is the issue of whether the clients would be able to afford the drug after the project ends even if the drug is legalized. In addition, there are no proper guidelines about Maintenance therapy in terms of its duration in any of the existing medical books, admitted Prof Gyaneshore. He also recalled having tried very hard through various platforms to prevent introduction of Maintenance Therapy in the state long ago. Dr K Shantibala, Psychiatrist at JN Hospital, Imphal who is also a Consultant to SASO, said once a Heroin addict becomes a Client, the chances of the Client staying free from Heroin is high and the risk of any harm involved while injecting Heroin is minimized. The therapy also helps clients to perform their duties and other activities at home and at work without the hassles they had to face in the process of scoring and injecting Heroin from the black market. However she too admitted that she did not have any answer on what will happen to those users who are already dependent on Buprenorphine in the event that the project is withdrawn or not extended by the funding agency. The writer met some of the clients who are undergoing substitution therapy at SASO and they shared their experiences. Lagijao (not his real name), a client who has been taking Buprenorphine as a substitute drug to his Heroin addiction for the past year (on and off) expressed his fear if he would ever be able to stop using Buprenorphine (maintenance drug). He said he had tried to stop using Buprenorphine several times but the withdrawal symptoms were much greater than Heroin. He further said that he was confused as to the course of action he would have to take if current stock of the drug runs out or if the project is withdrawn. He said he became suspicious about the stock issue when SASO officials refused to enroll one of his friends in the program. Another regular client who also spoke to this writer sounded a different tone. He was happy with the therapy and admitted that he no longer had to spend money or become exposed to the risks of injecting. He also said he has seen improvement in his appetite and have developed a healthy relationship with his family. According to SASO, the Service Provider, a total of 441 clients has been enrolled so far, out of which 110 are regulars. Among them 385 are IDUs and the rest comprises of oral and occasional IDUs. SASO's Project Manager, Mr.Hidungmayum Umesh Sharma and its secretary Mr.Lamabam Birendrajit (Wawa) refused to be interviewed and declined to comment specifically on Buprenorphine for reasons best known to them. The officials also restricted entry and denied giving further information to this writer when visited for the second time at one of their drop-in-center. Earlier, the Project Manager had requested this writer not to put in print certain management-related issues regarding the therapy program. The Project Manager wanted to erase the fact that a qualified doctor did not strictly monitor drug doses prescribed to the clients. Visits by the doctor at SASO number about 3-4 times a week and they stay at the Center for about four hours, usually from 1 pm to 4 pm, while the clients are required to visit the drop-in-center twice a day to get their doses. Surprisingly, the State Health Directorate is not aware of this "experimental project" and does not have any idea about the drug (Buprenorphine) that is being used by the concerned NGO, when enquired by this writer. The question now is whether Maintenance Therapy with Buprenorphine as a substitute drug should be allowed to continue or not. Experts have already identified the pros and cons. What the authority needs to do is to clarify how such a trial project is allowed to proceed without any proper monitoring and knowledge of the concerned Government Department! What will happen to the clients who are already dependent on Buprenorphine when and after the project is withdrawn from the State as the duration of the Pilot Project is only for two years and a year has already been completed. It can be noted as well that regardless of the success of the therapy, there are clients who have been already introduced to the new drug and dependency on it has been developed as mentioned earlier by a client. One cannot foretell at what rate these Buprenorphine tablets are going to retail in the market if and when it is legalized. The black market scenario is not any better. Even legalized drug like Spasmo-proxyvon is sold in the black market five times higher than its original price. The price is exorbitant, but more important and valuable is the life of the person who is led from one addiction to another.