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NEJM; Flush it!

The once prestigious New England Journal of Medicine recent publication on July 23, 2020 is misleading to say the least. “Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19 from study in Brazil resulted in news reports that this medication was not effective in mild to moderate cases of Covid-19. The news reporter likely read the title and not the manuscript. A reader of the news article would justifiably presume these were early cases of mild to moderated magnitude. However, the news report read by more people than the manuscript was misleading to say the least. There was no mention about the patient cohort studied in this news publication. The inclusion criteria for the patient population in the NEJM study was a magnitude of infection such that it required hospitalization. Furthermore, some of the hospitalized patient’s conditions were such they required supplemental oxygen. Then the NEJM accepted the hospitalized patient as designated; mild to moderate classification. I read the news report as mild to moderate condition of the patients studied being early cases. If I read only the NEJM title I would have come to a similar conclusion. The patients studied had mild to moderate condition, presumptively of early onset and not a group reported upon that were so sick they were hospitalized and some on oxygen. In addition, follow up reports on clinical studies by reputable journals require at least a one to two years. The term of this study was just 15 days before gaining headlines. It is unlikely to find a competing world record short term report published by NEJM citing information to the contrary. I am not privileged to the NEJM’s publication policies, bias or political agenda. I do not know if the news reporter read beyond the journal headline. I do not know their policies or agenda. Whatever the reality, this is an all-time low in medical and news journalism. Flush it! 7/26/2020

Coronavirus in perspective.

7/9/2020: To date there have been 544,739 deaths due to the coronavirus. covid19.who.int/?gclid=Cj0KCQjwgJv4BRCrARIsAB17JI59AtdDLhLPtxu0fad1zakLXArmfNrNmzXCXrFRxomaayLunQbmhlgaAvMgEALw_wcB To put this in perspective see the following from: www.ncbi.nlm.nih.gov/pmc/articles/PMC6747855/#bibr6-1176934319876938 Influenza A is one of the deadliest infectious diseases in human history, and it can be ranked equally with the bubonic plague in the ability to create large-scale fear and terror despite the great effort of humans to control it.1-3 From the first outbreak in 1918, called the “Spanish flu” and caused by the H1N1 strain, influenza A has killed 4 to 5 times more people than the number of casualties in World War I. The following site estimated 50 million died, one-third of the world’s population at that time. www.livescience.com/spanish-flu.html In 1957, the Asian flu, caused by influenza A H2N2, began in China and spread around the world, killing 1.1 million people in total.3 Ten years later, a new strain of H3N2 lead to the eruption of a new pandemic called the “Hong Kong flu” that caused the death of 1 million people.3 In 2009, the strain that caused a deadly pandemic in World War I returned with a new type called H1N1pdm09; the result was approximately 575,000 deaths.3 Along with the deadly strains that infect humans, other strains, like H5N1, cause problems that can indirectly and catastrophically effect humans.4 The H5N1 outbreak appeared in Vietnam in 2003 when a massive avian infection led to the forcible killing of poultries, crippling the agriculture industry.4 Le KP, Do PC, Amaro RE, Le L. Molecular Docking of Broad-Spectrum Antibodies on Hemagglutinins of Influenza A Virus. Evol Bioinform Online. 2019;15:1176934319876938. Published 2019 Sep 16. doi:10.1177/1176934319876938.

Jerry Sloan; one of my first famous athlete patients

5/22/2020: I saw in the press that Jerry Sloan, famous basketball player passed away. www.msn.com/en-us/sports/nba/hall-of-fame-nba-coach-jerry-sloan-dies-at-78-he-led-utah-jazz-for-23-seasons/ar-BB14sWMI He was one of my first famous athlete patients to undergo arthroscopy in the mid 70’s. I remember it well as I was lecturing at a meeting in Chicago suburb and his agent arranged for me to come down town and perform a diagnostic arthroscopy under local anesthesia. I did not tell anyone where I went and as my custom I created no publicity. I forgot about it until today.

Incomplete data analysis on Coronavirus Incidence

5/20/2020: The incidence of coronavirus cases are increasing because the frequency of testing is increasing. That should not be surprising nor unexpected. The magnitude of the condition is not reported; asymptomatic or symptomatic patient, just positive or negative test. The incidence of coronavirus cases with hospital admissions are high perhaps for this contributing reason. Reimbursement has always been the name of the game in medical economics. Now there is bonus money for coding as COVID-19 for billing purposes. Medicare will pay hospitals a 20% “add-on” to the regular DRG payment for a billing coding of a patient with the new government COVID-19 billing codes. Medicare has determined that a hospital gets paid $13,000 more if a COVID-19 patient on Medicare is admitted and $39,000 more if the patient goes on a ventilator with the coronavirus diagnosis. www.statesman.com/news/20200422/fact-check-do-hospitals-get-paid-more-to-list-patients-as-having-coronavirus This is in addition to the base reimbursement. What you incentivize you will get more of. Ever wonder why the high incidence of COVID-19 patients? The real numbers may never be known.

Malaria drug evaluation: some facts

5/8/2020: There are many factors to be considered in evaluation of a drug. The first issue is safety. Hydroxychloroquine has met that standard for 50 years in treatment of malaria, lupus and rheumatoid arthritis. The main potential side effect is adverse effect on the heart and that is infrequent. A prescription for any treatment selects the intended patient based upon certain criteria. Is the patient without the disease? In this case the treatment is called preventative or prophylactic. The treatment should be disease specific and in this case the physicians considering the use of hydroxychlorquine for the coronavirus symptoms is called “off label (not FDA approved for this use). It is not being proposed as virilcidal for SARS CoV 2. There is no such certified drug at present. It is being prescribed to affect the symptoms of a specific patient. The next consideration for a use of a drug is for those presently affected by the disease is the disease stage at time of onset. Did it just start or is the disease progressive? The magnitude of the disease in the patient is the next factor. So why all the controversy concerning reports of hydroxychloroquine? So far the answer appears simple and logical. There is a difference in severity of the condition and the amount of the drug given. The success reports have a patient population that are at the early stage of the disease and treated with low dose. The failure reports are the use of those advanced to hospitalization and/or very high doses known to be toxic. The complication in the negative reports are related to the amount of the dose. Those taking 200 mg twice day are not as sick and have fewer complications than those taking greater amounts. There also is the caveat that those getting the higher dose are those most severely effected and with other conditions. For emphasis, the patients not likely to get a benefit are those in the hospitalized group. They are those (recent New England Journal Medicine) who are the sickest and those with most comorbidity (other disease conditions) and on the highest doses. This is not unexpected adverse result. The two opposing views, may be agenda driven, but both have credible logical medical rationale. However, but each is based upon different patient selection and treatment parameters. Bottom Line: It is legal for a patient and their doctor to decide on the individual’s treatment and/or prescription. You may decide with the advice of your physician.

Dr. Fauci’s argument critique

4/14/2020: Dr. Fauci’s argument discrediting the malaria drug for coronavirus patients is somewhat misleading. It is true that the randomized double blinded studies are the gold standard in medical science research. It is also true the hydroxychloroquine has been used for more than 50 years in other conditions with minimal complications. There are published studies in peer reviewed journals from France of the successful use in COVID-19 patients. However, Fauci knows better, but ignores the fact that historical controls are a valid means of producing valid reliable data. For example, if it is known that a given condition results in 100% mortality in 6 weeks even with the present treatments. This forms a historical control. The result is that everyone dies. With his historical control, a known medicine is given according to law where the doctor patient relationship allows a licensed doctor to prescribe an “off label” drug. An “off label” drug is one approved for another condition. In the best judgement of the doctor and the informed consent of the patient the medicine is given. This is legal and medically ethical. That is what is being done with hydroxychloroquine for COVID-19. Back to my example. When a series of medically well-defined patients have been followed for 6 weeks with the “off label” drug and 50% live it is accepted as valid research based upon the historical control. Only bureaucratic doctors who do not or perhaps never went face to face with a patient would withhold a potential safe reasonable treatment waiting for FDA approval. What is being done in practice and benefiting patients with “off label” drug is legal, ethical and scientifically sound.

Medical Technology New to Me.

9/11/2019: Medical Technology New to Me. Yesterday I was asked by two different professional athletes to give my opinion on two different medical treatments previously unknown to me. You must remember I concluded by clinical practice 24 years ago. The first one was about ARP wave therapy. My Internet search learned it is primarily a commercial entity. See www.arpwave.com/ It is based upon an electrical input that reduces the “charge of injury”. I could not readily find a definition for this term. There is before and after MRI evidence on the Internet promotion showing rapid repair of torn anterior cruciate ligament. It is advocated for nerve and muscle treatment in a wide variety of conditions. The second one was ozone injection therapy for spinal disc degeneration. See www.ijssurgery.com/content/8/17 They both appeared to be safe. The ARP lacks histological evidence, but search for such from the promoter results in opportunity to purchase the equipment. There is more supporting literature for the ozone treatments. The general effectiveness although promoted, the specific uses and outcomes remain unclear.