Dr Nandini Kumar, former Deputy Director General of IMCR , has worked extensively in the fields of Ethical Guidelines in Biomedical Research and Traditional Medicine Research. She has been closely involved in finalizing the ICMR Ethical Guidelines of 2000 and 2006, especially the section on Traditional Medical Research, and of the Draft Guidelines on Bio-banking and Stem Cell Research and Therapy, Mental Health Research, Data Set Protection and Disaster Related Research. Dr Kumar is an Adjunct Professor in the Department of Hospital Administration, Kasturba Medical College, Manipal. She is also a Fogarty Fellow graduate in Bioethics (International Stream) from the University of Toronto.
On traditional systems of medicine:
The traditional medical system takes care of the mind as well as the body. The underlying fiber was that the physicians who were taking care of patients should also be spiritual. This is not present in modern medicine. Modern medicine is reductionist, it treats the individual part and not the whole body.
On informed consent:
In the traditional system of medicine, the physician had to do what the state dictates. For example, if the physician knew that a treatment is experimental, he had to seek the permission of the king. If you look at history, the Indian system matched with that of ancient Greece. Plato also says that in such a case, the consent of the patient is not important, the physician makes the decision; it is a paternal decision. Further down history, Alexander the Great became very ill. No physician wanted to go near him. In two occasions Alexander had to declare to the public that he permitted the physicians to treat him in his best interest. This is informed consent. When you are enrolling a patient in a study, you have to inform the patient of the procedure and possible side effects. The informed consent of that time is different from the informed consent of today. In the past, the doctor, the ruler and the family overruled the will of the patient.
The material the volunteer is supposed to read is about 25 pages long. The physician will not have the time to explain everything to the patient. Instead, there will be a research co-ordinator who is expected to explain everything to the volunteer. But even in the case of educated patients, the patient will still usually leave the decision to the doctor. What, then, is the point of making these explanations? It is largely a legal procedure. The patient is expected to be informed of what is happening and compensation is due if something goes wrong.
Regarding the Novartis patent case:
There is another process called ‘evergreening’, where you tweak the product a little bit, change a few molecules, and extend the patent. Because of this, the generic (and cheaper) version of the drug will have to wait longer to come to the market. In the Novartis case, the argument by which it lost its case was that there was not enough proof that the drug improved bioavailability. Also, the court ruled that the molecule should be proven to increase efficacy. Since there was not enough proof of this, the drug was rejected. Several of these companies were waiting to extend the patents, others had entered into deal with the generic drug companies, so that they could continue making money from these drugs. But the FDA has now stopped these deals.
In drug development, man is supposed to be the superior most animal. First, a drug has to be tested on non-animals (cultures, etc), then animals (in vivo) and if the results are found to be beneficial, it is then tested on humans. There are several phases to these trials. In Phase 1, the drug is tried on health volunteers. You must have heard stories about people selling their kidneys for money. In the same way, drug testing is a way of making money. People sell their bodies. In the US it is also a trade; they sign a contract, these are taxable incomes. By participating in these trials, homeless people can get food and shelter for a couple of months, especially in the case of Phase I trials that pay better. Is there any harm in this?
Sharvari: It depends on what is being tested. They may be healthy volunteers! The question is whether they go out as healthy?
Response: Suppose I am a healthy volunteer, and I enrol in a trial for a disease I do not have. I am not going to gain anything from it. I will just be tested for various things, to see where the drug is, etc, and I let them use my body to generate knowledge for both humanity and the company. In Phase II, I may be a patient who has run out of treatment options. During the time I am on the experimental drug, I may get some relief. Is this wrong?
Raj: I find your view to be a little too optimistic. What if something goes wrong in Phase I?
Response: You’re right. In John Hopkins University there was a trial for a drug for asthma and the patient died. There are a number of similar studies that have gone wrong. And say something does go wrong, what is the solution? This remains a serious issue in our field, and there are no obvious alternatives today.
On medical research ethics:
Aivin: I have a problem with two things. First, there is a socio-cultural connotation to testing. Would we send our children for testing? Second, I am a little uncomfortable with the way we are putting animals and poor people on the same plane.
Response: There are three key-terms in the ethics of our profession: respect for persons, beneficence, justice. There has to be a justified spread of burden and benefits.
There are some diseases that people believe affect only tribals. In particular, there are certain diseases that can be studied only in certain belts in India. In such cases, the drugs can be tested only in those populations. But what about diabetes? We should technically take in people from all stratas of society. The question then you have to ask yourself when you see a consent form is: would I enrol myself in this trial? Then we can talk about risk and benefits.
Aivin: Don’t you think it is the onus or the medical practice or the company to make the material easy to understand for the volunteer?
Response: Definitely. Officially, a seventh grader should be able to understand the language. In fact, the target of 15 or 25 pages-long documents came through the FDA requirements, following law suits in the US. There was a study on syphilis that was conducted in 1948 in Guatemala. A doctor had conducted trials on vulnerable populations to research the spread of syphilis. This was brought to light in 2010 by a researcher who accidentally found the documents. Obama had to take stance and he apologised for the trials. The US had created rules in 1990 for bioethics, and after that had never changed it. One of the duties that Obama gave the bioethics committee was to amend the rules. An important question they are dealing with is about reducing the length of this informative material.
Who bears the burden of the disease?
In the States they found that a particular drug became the standard treatment for HIV. However, this was an expensive drug, not everyone could pay for it. So, the State had to pay for the treatment. The burden of the disease fell on the State. There were studies conducted in Uganda to see if reduced dosage (at a lesser cost) could slow the progress of the disease as well. There was a huge hue-and-cry in the United States: it was an outrageous double standard, as the full dosages were used in the United States but not in Uganda. But according to the people of Uganda, when there is a general shortage of drugs, some drugs are better than nothing.
The ethics of testing and medicine itself:
Sometimes unforeseen side effects may take place, which may have been undocumented. Trials should be conducted in environments that are capable of handling adverse events. But sometimes patients are sent home and then something happens. It is up to the investigator to take care of the situation and to the sponsor to provide compensation. How do you decide the amount of the compensation, in terms of death and for injury? And if something does happen, the question is the following: whom should it be paid to? Say there are three children, and there is only one child who has been looking after the parent, then how do you decide who is the nominee? There are sometimes no answers to these questions.
Asim: When you have an unequal power position, for example, like that between doctor and tribal, you always have things happening in one direction. We feel we have to go the tribal, or the US has to help developing countries; rarely is the movement in the other direction. The tribes don’t come to the city and ‘offer to help us’. This is the question of the ethics of help. What about local knowledge systems? How does one decide whether these drugs are going to beneficial to them or not? Would we not rather they seek help actively, rather than be forced into it? In a power structure like that, is it even possible to have a dialogue?
On integrated approaches to medicine:
Sundar: Even with even the best-intentioned doctors, there are terrible things happening in both private and public practise. The larger question is: how do we deal with things called modern medicine in a society which has other methods of dealing with disease in culture? How do we make sense of a completely different system of knowledge, and legitimize it, and engage in this dialogue?
Response: There are in India integrated approaches of medicine. The animated arguments against local systems in the 80s has faded, now. What the patient needs is some sort of cure, whichever system it comes from. But there remain some problems with these local tradition of cure. In Ayurveda there are no regulatory systems: no way to know the efficacy of a particular medicine, since it is the whole body and its regulation that is inspected. In the contrary, in alopathy, because it has a reductionist approach, it is possible to point out where it has gone wrong. In Ayurveda, the practitioners must keep in mind the whole body. Only very few specialists can do that.
On ethics committees:
Every institution is supposed to have an ethics constitution, made of people from different disciplines, scientists and non-scientists. People in the private clinics do not have the set up to have an ethics committee of their own. That is how the idea of independent ethics committees came up. Some of them were good, but most were not at all… ethical. If one ethics committee rejects something, some other committee will pick it up. It’s like window shopping. This is how Madhya Pradesh became a center for such bad practises.
Nikhil: Why is it that academic syllabi of medicine are so dry and so unpolitical? It is almost as though these students are desensitized and intentionally made apolitical. Is a detailed rehauling of the syllabi possible, to situate them within a larger cultural and political background?