Double-blind COVID-19 Testing should be Stopped Immediately!

End of the Road 550

3,000 first responders, health care professionals, and bus drivers in Detroit, MI were invited to volunteer for a placebo-based double-blind study of hydroxychloroquine to see if it is effective in preventing infection by the COVID-19 virus.  All of these volunteers were at risk of contracting the disease.  The protocol description is provided by a Henry Ford Health System document.  Henry Ford Hospital Systems is proud to be chosen to test this drug using its staff and facilities.

“The study, titled WHIP COVID-19 Study, is a 3,000+ subject look at whether the drug prevents front-line workers from contracting the virus. Once they provide a blood sample, the study subjects will receive vials with unidentified, specific pills to take over the next eight weeks: a once-a-week dose of hydroxychloroquine, a once-a-day dose, or a placebo (a pill that looks like the medication, but does not contain any medication or other active ingredients). The study medication was specially procured for this study and will not impact the supply of medication for people who already take the medication for other conditions.

Participants will not know what group they are in. They will then be contacted weekly and in person at week 4 and week 8 of the study to see if they are exhibiting any symptoms of COVID-19, including dry cough, fever, or breathing issues, as well as any medication side effects. At eight weeks, they will be checked again for symptoms, medication side effects, and have blood drawn. Results will be compared among the three groups to see if the medication had any effect.

Despite no approved application of hydroxychloroquine to treat COVID-19 by the FDA, President Trump has consistently pushed the CDC and FDA to approve this drug as a treatment or preventative drug for COVID-19.  There is now evidence that the side effects of this drug include potentially fatal heart damage.  These side-effects have now caused the withdrawal of prescribing instructions for this drug as a preventative measure for COVID-19 infection.

The World Health Organization has placed a temporary halting of studies testing of hydroxychloroquine for use in the prevention of COVID-19 infection.  WHO quoted a study reported in the British medical publication, the Lancet that showed no effective reduction in COVID-19 infections while causing serious heart issues leading to death.

“Researchers examining data from nearly 15,000 COVID-19 patients have found no evidence that taking hydroxychloroquine or chloroquine provides any treatment benefits and may be linked to an increased risk of serious heart complications, a study published in The Lancet says.“

There is a serious ethical question involved in running a placebo-based double-blind study of any drug that is being evaluated for its efficacy in treating COVID-19.  Since COVID-19 deaths in the US have now exceeded 100,000 patients, why would persons at risk be given a placebo that has been deliberately formulated to have no impact on preventing or treating COVID-19.

A far more useful comparison would be to compare the infections and deaths of half of the study participants using another treatment protocol instead of a placebo.  One possible alternate treatment is to expand on a protocol being followed in Shanghai and New York City that involves administration of large doses of IV-vitamin C.  Paul Marik, MD has used a protocol to significantly reduce sepsis deaths in an ICU that he manages by combining IV-vitamin C with IV-vitamin B1, and IV-steroids.  The dosage for the protocol to treat sepsis in Marik’s ICU is well defined.  You can watch the complete explanation from Dr. Marik about how he first tried this protocol, and the results of that procedure on reducing deaths from sepsis in his ICU.

The two major causes of deaths from COVID-19 in ICUs has been sepsis and blood clotting in the lungs.  Dr. Marik is in charge of the ICU at a hospital in Virginia.  He compared the recovery and deaths patients with medically confirmed sepsis infections of 47 patients before and 47 patients after utilizing the above-mentioned protocol.  It may be useful to do a comprehensive study of the Marik sepsis protocol in treating COVID-19 patients in the ICU.

With the evaluation of any drug or other treatment protocol to determine effects against COVID-19, a complete medical exam and extensive testing needs to be instituted.  With a thorough database established for each patient, the before and after results can be accurately compared.  The database should include chest x-rays, comprehensive blood work on measurements related to the kidneys, liver, and inflammation markers.  Accurate testing of the presence of the COVID-19 virus is absolutely required.

There are far more qualified experts on what is necessary to document the results of a drug or procedure, but comparing results against a placebo group when the disease is known to be potentially lethal is unconscionable.  The group of volunteers that participated in the Henry Ford System trials and subsequently given a placebo were put at risk of contracting COVID-19.  They could have had a legitimate alternative that would have provided comparative data on the test drug versus Marik’s protocol.

Note:
There was a study that purported to duplicate Dr. Marik’s protocol that concluded that his protocol was no better than standard Medicare procedures.  It failed to do that, and a real test should be set up that follows the defined protocol precisely.

The Summary of Results show that the study did not follow Marik’s protocol for treatment.  Summary Results are copied below without alteration other than bolding the areas where the study failed to follow Marik’s protocols and standard procedures.  You can examine the whole study by accessing the link above.

3. Results

While our power analysis required 54 patients, we enrolled 94 patients (47 patients in each group) in an attempt to replicate the methods and results by Marik et al. [6]. However, twenty-seven patients (57.4%) did not complete TT treatment for a full four days or until ICU discharge due to following reasons: therapy discontinuation by primary team (n = 9 (33.3%)), patient death (n = 9 (33.3%)), missed doses due to medication delivery issues, line access issues, operations (n = 5 (18.5%)), insufficient number of doses ordered (n = 3 (11.1%)), and thiamine shortage (n = 1 (3.7%)). Baseline characteristics were well-matched between the two groups (Table 1). The most common infection in both groups was pneumonia (TT 46.8% vs. SC 38.3%; p = 0.404), followed by gastrointestinal and biliary infection (TT 21.3% vs. SC 31.9%; p = 0.243). Sixteen patients (34%) in the treatment group and 18 patients (38.3%) in the SC group had positive blood cultures (p = 0.668).

If validated by independent testing, Marik’s protocol may substantially reduce COVID-19 fatalities in the ICU, shorten recovery times, reduce recuperation times, and drastically reduce the costs of treatments.  The testing should not utilize a placebo-based double-blind protocol because the patients are already know to have COVID-19 infections.  There are vast amounts of data available regarding the current time in the ICU, time to recovery, and deaths from COVID-19.

For readers that take an active role in encouraging action by federal regulatory agencies, e.g. the FDA, CDC, NIH and NIAID, you might send a copy of this article with a request that Dr. Marik’s protocol be completely tested as a substitute for the placebo portion of studies of other COVID-19 treatment protocols.  Communication with your senators and your representative is also encouraged.

Dr. Marik does not necessarily endorse this promotional effort, but his protocol deserves to be evaluated on a fair and professional basis using real data and strict compliance to the Marik protocol.

 

 

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