The views stated here are those of the author and do not necessarily reflect those of the editors of this newspaper.
I have just returned from taking my Cairn Terrier Hershey for a walk at Haddam Meadows where I could not help but notice the sounds and signs of spring. There were a couple of flowering trees decked out in all their splendor and a willow tree which had those first light green leaves that are a sure sign of warmer weather around the corner in spite of today’s gray sky.
Since Hershey rarely speaks, the walk at the Meadows gave me a chance to do some uninterrupted thinking and as a result I have a few random rambling thoughts I will share.
The question of whether doctors should use hydroxychloroquine in combination with or without azithromycin to treat Corona Virus has been the subject of many conversations in the media. While I am not a physician I have had experience dealing with the U.S. Food and Drug Administration in a previous life. FDA is a very conservative bureaucratic organization and does not approve drugs or make decisions quickly. They need to be careful when approving new drugs for all the obvious reasons.
The first step in the approval of any new drug is to understand the safety profile of the drug. The initial tests in humans generally start with clinical trials in healthy young males to determine if the drug is safe enough. Once there is reasonable assurance that the drug safety is understood then randomized double-blind clinical trials are conducted under careful surveillance in people who have the disease for which the drug is hoped to help. The process usually takes years before a drug is approved for use in a specific disease.
Hydroxychloroquine and azithromycin have been around for decades and their safety profiles are well known but they have not been tested in the U.S. against the Corona Virus which has only around for a few months. We have heard that there have been lots of anecdotal reports of the drug combination being successful against this virus and reports of studies in France and China but the experts do not all agree on the results. The FDA has always been reluctant to approve drugs on the basis of studies done outside of the U.S. so do not expect the FDA to give its approval anytime soon.
On the other hand doctors have given drugs off-label at their discretion for years. Off-label simply means that the doctor prescribes the drug for a reason/disease which is not on the approval list from FDA. The drug manufacturer cannot market the drug for off-label reasons so this is a thin line which doctors walk. I hope that this helps explain the reasons why the health professionals at the highest levels whom we hear from on the news are reluctant to give their approval on a national broadcast.
Now if I were to have a definitive diagnosis of Corona Virus I would want to get this drug combination as quickly as possible because I believe that the drugs are reasonably safe and that early intervention would be best.
Ed Munster
Haddam, CT
Note: Ed Munster is President of the Haddam Civic League, the parent company of Haddam-KillingworthNow.com.
I agree. My sister has lupus and is very compromised due to this disease. She has lived on and off with this combination. She has COPD and had COVID. She is doing well as her doctor kept her on this combination and she survived. I believe it works and I too would want to be on it immediately before COVID starts to seriously effect the lungs.