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    April 10, 2020
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Business Insight Trust science. Trust clinical trials. I cannot express more aggressively how upset I get when non-professional individuals, especially highly opinionated ones, voice their strong words about medical treatments. Watching the recent pandemic events and news daily, I can clearly see and recognize who actually understands the concepts of clinical research and who does not. Politicians do not. First, testing old drugs for new indications does not happen in the lab. That part was already done and a long time ago, before the drug was approved for the first time. Secondly, this is not FDA and doctors who slow the process: they actually protect the process from dangerous opinions, often subjective and lacking all information. FDA and doctors understand that objective trials and testing are done on people, patients like you, and our priority is to balance risk and benefit. A statement 'what do you have to lose' is a very misleading and harmful statement. If the balance of risk and benefit is Do not get fooled if you hear otherwise. The problem is that some drugs, through subjective opinions, might be used extending the concept of compassionate use into thousands of patients who are not dying. This is not an ethical use of the concept. It is actually contrary to the medical ethics and again, can cause more harm than benefit. uneven, yes, you have got a lot to lose. Clinical trials are not just about the effectiveness, efficacy, and treatment. They are also and most of all about patients' protection and safety. Approving trials and studies for patients' new indications must be reviewed for those patients' safety. How about interactions with other drugs? How about individual dispositions and allergies? Would you like to get cured of coronavirus and die from cardiac failure? Hydroxychloroquine like methotrexate is an immunosuppressive drug. This means that it works on some indications through lowering your immune system responses. Coronavirus is an immune system disease, with possible multiple complications also coming from the immune system responses. Yes, it may work for some but it may kill others. Before it is prescribed, there needs to be a careful assessment of individual patients done, which means nothing else but conducting studies and trials, and measuring individual responses and risks. No other way exists to make sure that the drug may be given to a larger population. Period. End of the story. Otherwise, we will be killing people with one medical condition with the treatment for another one. Doctors do not do that. Doctors do no harm. The most of my being upset comes not from medical disputes and discussions. Clearly, we have a lot to discuss and work on as medical professionals, as we always do when the new diseases are occurring or new treatments are proposed. Often, we quickly find out the risks and benefits, and we just keep observing. Any of you who have been a part of the studies we conduct in my practice know exactly what I mean. Many of you benefited hugely from the new drugs and still use them years after they were approved. There are some of you who were discontinued from studies because we discovered new risks or lack of benefits. Thankfully, those represent much smaller group. But the reason for it is such that we, as medical researchers, do our jobs, In a very humble way, we study what is available and exchange our knowledge with others who do the same. My anger goes towards non-medical individuals who lack understanding of clinical research but become arrogant and aggressive promoting their views and opinions. This is not science. This is not about safety. This is about promotions of medical treatments like if they were new brand of apples. Beware of that! Compassionate use concept is not a new development. Compassionate use of some drugs on patients otherwise sentenced to soon death due to a medical condition has been an old concept, used by medical professional for decades. Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net Business Insight Trust science. Trust clinical trials. I cannot express more aggressively how upset I get when non-professional individuals, especially highly opinionated ones, voice their strong words about medical treatments. Watching the recent pandemic events and news daily, I can clearly see and recognize who actually understands the concepts of clinical research and who does not. Politicians do not. First, testing old drugs for new indications does not happen in the lab. That part was already done and a long time ago, before the drug was approved for the first time. Secondly, this is not FDA and doctors who slow the process: they actually protect the process from dangerous opinions, often subjective and lacking all information. FDA and doctors understand that objective trials and testing are done on people, patients like you, and our priority is to balance risk and benefit. A statement 'what do you have to lose' is a very misleading and harmful statement. If the balance of risk and benefit is Do not get fooled if you hear otherwise. The problem is that some drugs, through subjective opinions, might be used extending the concept of compassionate use into thousands of patients who are not dying. This is not an ethical use of the concept. It is actually contrary to the medical ethics and again, can cause more harm than benefit. uneven, yes, you have got a lot to lose. Clinical trials are not just about the effectiveness, efficacy, and treatment. They are also and most of all about patients' protection and safety. Approving trials and studies for patients' new indications must be reviewed for those patients' safety. How about interactions with other drugs? How about individual dispositions and allergies? Would you like to get cured of coronavirus and die from cardiac failure? Hydroxychloroquine like methotrexate is an immunosuppressive drug. This means that it works on some indications through lowering your immune system responses. Coronavirus is an immune system disease, with possible multiple complications also coming from the immune system responses. Yes, it may work for some but it may kill others. Before it is prescribed, there needs to be a careful assessment of individual patients done, which means nothing else but conducting studies and trials, and measuring individual responses and risks. No other way exists to make sure that the drug may be given to a larger population. Period. End of the story. Otherwise, we will be killing people with one medical condition with the treatment for another one. Doctors do not do that. Doctors do no harm. The most of my being upset comes not from medical disputes and discussions. Clearly, we have a lot to discuss and work on as medical professionals, as we always do when the new diseases are occurring or new treatments are proposed. Often, we quickly find out the risks and benefits, and we just keep observing. Any of you who have been a part of the studies we conduct in my practice know exactly what I mean. Many of you benefited hugely from the new drugs and still use them years after they were approved. There are some of you who were discontinued from studies because we discovered new risks or lack of benefits. Thankfully, those represent much smaller group. But the reason for it is such that we, as medical researchers, do our jobs, In a very humble way, we study what is available and exchange our knowledge with others who do the same. My anger goes towards non-medical individuals who lack understanding of clinical research but become arrogant and aggressive promoting their views and opinions. This is not science. This is not about safety. This is about promotions of medical treatments like if they were new brand of apples. Beware of that! Compassionate use concept is not a new development. Compassionate use of some drugs on patients otherwise sentenced to soon death due to a medical condition has been an old concept, used by medical professional for decades. Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net