16, Number 94, December 2013/January 2014 Knowledge Gain in Train? by Jayalakshmi Ramanna
“New experiment? Do they think that we are guinea pigs? Rats? Cruel ... unethical ... inhumane ....”
And the worst thing was “You kill people? Aaaaaa ....”
This is the common expression we generally notice when someone talks about clinical trials.
I happened to come across a pleasant lady on Friday evening, who sat in the seat next to me on the subway. She was charming and apparently seemed to be in a happy-go-lucky-mood. After
exchanging several looks and smiles, she decided to break the ice.
“I like the way you manage to read a novel and play on your phone simultaneously,” she said.
I laughed. “Ha ha. Yes, kinda addicted to both.”
“Oh! So you read a lot?”
“Aaah, not as much as it may seem, but yes, enough that the story I read appears in my dreams.”
“Wow. Are you a student?”
“No, I work in clinical research at a cancer care unit.”
“Sounds interesting. My mother-inlaw passed away due to cancer. I hate cancer.”
I smiled. “I am sorry about your MIL. However, for that matter any disease is bad.”
“So, you work in a lab and look under that sco...p ...sorry ...microscope for something that people have been trying to figure out for decades?”
“Ha ha. No, I am not into lab research. You are referring to the preliminary stage of research.”
“So you are into advanced research? Do you use telescopes?”
She sounded funny. Enthusiastic though. “Not telescope; we do ‘human research’. I can say drug development. The chemical entities are discovered using a microscope, and are then passed on for tests on animals. If they are proven to be safe, we test them on humans.”
“Oh My God!! Jeeeeezz!!! So you kill animals and then come to humans?”
Oh man!! She was tough!! I tried to remain calm. “Not really, we actually test the compound in animals with utmost care, concern and scientifically proven standards. It might take years, cost millions of dollars for studying a compound’s safety and effectiveness without any assurance of a positive outcome!! We ultimately aim not to cause harm or death to the animals. But you know, the tested drug may save millions of lives in the future, so we have to study it at some stage. We
choose animals for preclinical testing which is accepted as a most reasonable option at this stage of human evolution and available technology.”
“Is it because that they can’t speak?”
“No, because many animals have physical and psychological similarities to that of humans. So exposing these animal models initially to these drugs provides a lot of insight for further human studies.”
“Oh!! Whatever. I am not for this!! I see in the newspaper these ads on trials. They say ‘Need healthy men and women for research’. So they think we are some kind of cheap experimental models? I remember that my mother-in-law was approached for a trial, when she was diagnosed with cancer. My husband and I refused to send her for it. She managed to survive for a year on some drugs.”
Ufff!! She knew about trials? That too, all information that made no sense. “So may I know your name?” I asked.
“Annie Woo. You can call me Annie. Actually it is Annie Woo Windsor. ‘Windsor’ comes from my husband’s family. I don’t like to use that name!! And you...?”
“Jaya”... I smiled.
“Zaaya. Can you please tell me why the government agrees to conduct such inhumane tests? Why on earth do people agree to participate in research? Who convinces them to do this? Who pushes them to such dangerous wells?”
I had no idea as to why she sounded so concerned. Was it because her motherin-law was asked to participate in a trial? Did she hate science? Did she know that many trial participants actually survive longer than other patients?
Okay, I thought. I was constantly trying to think of convincing answers in my mind while talking to this lady. Talking about a very interesting topic in my area of expertise to a stranger while travelling was not a bad way to pass time.
“You sound scary!! You all are dangerous people,” she said as she looked for something in her bag. Phone, I guessed. I was wrong. She took out a tablet. “Tylenol.”
Ha ha. Did sitting next to me give her a headache? Wow, I can induce “aches” in people!!
Well, something strikes my mind.
“Wait,” I said. She narrowed her eyebrows, which probably meant to ask me “whyyy?”
“What is this tablet for?”
“Well, I have had a fever since this morning.”
“So you are having Tylenol. You know if it is safe? Are you sure it is for fever? What if it reacts with some part on your body and ends up making you more ill?”
“What? This simple and most common tablet Tylenol? Nooooo. It won’t. I have used this before. It reduces my temperature and helps relieve headaches after every fight I have with my husband!!”
“So, how did you know that this was for a headache? Who told you?” I asked.
“Yes, my physician prescribes it. Before that, my mom also had given me on her own instincts.”
“So who told her and your physician about Tylenol and that it reduces fever? Did your physician invent this drug?”
“Well her mom, or some source where she or my physician had an opportunity to learn about it. Why?”
“So why not try other brands? Like L..N, P... L etc.?”
“Nooooooo. I don’t want to take risks. I am very sensitive. Last week I had Italian ... something. I had itching for a week. Can you see redness all over the body?” She projected her hands towards me.
“So, let me understand. You take Tylenol because you feel it is safe. You started taking it based on someone’s prescription or information. You had allergic reactions after eating Italian food. Isn’t all of this giving you an instinct that there is a necessity for established data? People only consume something when they feel they know how safe or effective it is. Am I right?”
“Yes, of course. It’s the same way I chose this subway because I am scared to drive, in spite of having two cars at home.”
“True, so how do we obtain this data? By conducting in depth studies. How do we conduct studies? In live models. Only then, we can understand the mechanism of these drugs, their actions on cells and the body, their effect on other organs or if they are unsafe and could lead to serious injury or death.”
“So, we conduct these tests to obtain a specific profile of drugs known as the safety and efficacy profiles. We cannot expose each and every human to such risks, so we conduct these tests in animals at a very safe dose. We alleviate the dose later once the tests are done in animals. Just because animals cannot speak, they are not subjected to unsafe trials. There are committees overseeing tests performed in animals too. They may hold trials, suspend or even close animal units in case of misconduct. If there were no studies done, no research conducted, there would have been no Tylenol now. You would have to wait for your fever to disappear on its own. Or your headaches would have persisted or gotten worse after fights with your husband. Had the government not approved the research, there would have been no data saying Tylenol was safe, Tylenol is for fever. Had there been no data, there would have been nothing. So trials are not to kill people, in fact to save the lives of millions while few of our patients take the risk of participating in research. They are medical heroes!! Trust me, there are trial participants who were expected to survive for only two to three years, amazingly showed improvements and have survived for much longer than these periods. Not all experiments have successful outcomes though, an experiment is an experiment!!
“However, I must agree with you on the point of misuse of clinical trials. This is an inherent and perpetuating issue with any system, something similar to misuse of loop holes in laws. But the bottom line is we have to accept this and keep correcting our mistakes in the process due to the sole reason that there is no alternative to clinical trials to get better drugs to the patients.”
“Ok, I am with you on this. I understand that it is good for mankind!! A series of tests in a small population which benefit a greater population you say!! Okay... got you!!”
“Yes,” I said with relief. I don’t know if I could ever convince everyone, but her, yes, I could.
Lastly, I left the last arrow with a hard core fact. “Annie, do you know what the greatest discovery in the 20th century is? It’s not penicillin, or the iPhone or a space shuttle. It is the RCT, which stands for randomized controlled trial. It’s a short clinical trial which may increase the average human life expectancy throughout the world by 20 years.”
I could sense that she was thinking, although, her happy-go-lucky mood could no longer be seen.
She then said she should have enrolled her mother-in-law for the trial. I said, “It depends, chances of her survival would be due to both the drug and to luck as well!!”
She smiled. We had a few more conversations on other various general topics for a few more minutes. As her stop approached, she hugged me which probably meant ‘bye’.
“Have a great weekend,” she said, smiling.
“Thanks Annie, you too. Have a lovely weekend. Nice meeting you.” And our train stopped. The subway door opened.
“Same here dear!! See you again, bye,” she said stepping out of doors.