COVID19: Dr Zelenko’s Statement to U.S. Senate Committee, Homeland Security

Written by Vladimir Zelenko MD on December 2, 2020. Posted in Current News

A leading New York medical doctor who has done pioneering work to prove the efficacy of hydroxychloroquine treatment during the pandemic submits his detailed report to the U.S. Senate Committee on Homeland Security.

We have pleasure in re-posting the Statement for the Official Record, by Vladimir Zelenko MD,  Board Certified Physician, New York, below.

Full Committee Hearing, Early Outpatient Treatment: An Essential Part of a  COVID-19 Solution, November 19, 2020  

Statement for the Official Record, by: 

Vladimir Zelenko MD,  

Board Certified Physician, New York 

1540 Route 202 

Pomona, NY10970 

Summary 

Research and development of medicine is now a matter of national  security. Prior to COVID-19, medicine was generally left to the pharmaceutical  industry and a few agencies (“Big Pharma”). Big Pharma relies on an economic  incentive model that prioritizes fiduciary duty to shareholders over public benefit,  resulting in expensive, proprietary, patented drugs that take significantly more  time to develop. This incentive model is leading to a mortality count that may be  greater than the civil war – historically the most deadly war for the USA. 

The cure to COVID-19 is a combination therapy of generic drugs and  supplements that must be administered within the first four (4) days of symptoms. It was the fastest a cure for any disease has ever been developed (months),  using open source Real World Evidence data exchange at global scale, of non patented drugs for public benefit – this is the opposite of the Big Pharma  incentive model. 

The development of new medicines in this way is an elegant solution  which provides extreme value to society, dramatically reduces load to healthcare  system and allows for overall greater production in economy. This can be done  for many other diseases and conditions if the proper resources were allocated – so that a COVID-19 like situation never happens again. There must be an  organization that functions as an intelligence agency for medicine whose  exclusive duty is to the people, not shareholders – building on this solution.  Significant funds must be allocated to implement this – a gap which can filled by  an organization funded by Homeland Security similar to how the TSA was  created in response to 9/11. COVID-19 must be swiftly ended and a situation  like this must never happen again. 

Background 

The 21st Century Cures Act (the “Cures Act”) is a law that was passed in  2016. Section 3022 of the Cures Act is titled Real World Evidence. The Cures  Act defines Real World Evidence as: 

“ data regarding the usage, or the potential benefits or risks, of a drug  derived from sources other than randomized clinical trials … including ongoing safety surveillance, observational studies, registries, claims,  and patient-centered outcomes research activities…” 

The Cures Act goes on to state Real World Evidence may support the approval  of new indications for generic drugs. There is very significant Real World  Evidence that support the approval of using generic drugs to effectively treat  COVID-19 in the outpatient setting. 

While formal clinical trials can provide significant insight into a drug’s  safety and efficacy in a patient population, it may also provide misleading data – as was the case with the opioid clinical trials which resulted in a fatal  epidemic. Reliance on these clinical trials has led to over 200,000 deaths from opioids in the USA – which only started to decrease recently as of 2016 – 2017,  because of use of Real World Evidence. To clarify, the clinical trials for some  opioids did not show how addictive the drugs actually were. These clinical trials  were used to push opioids prescriptions, which has significantly increased the  demand for heroin in the USA. Below is a chart of opioid based deaths over  time.

It was only use of Real World Evidence by physicians in the clinic that  showed their true effect – how dangerous opioids can be. Why? Because  patients in the clinic is an actual real world setting, with real clinicians and  patients whereas clinical trial data is generally paid for by a pharmaceutical  company who has an economic incentive to optimize data presentation for FDA  approval. For example, details from “failed” clinical trials are often not published. 

This has been the case for COVID-19 big pharma drugs. For remdesivir – an alleged COVID-19 drug that was given emergency use authorization, there is clinical trial data which shows no statistically significant benefit in mortality, yet it has received emergency use authorization by the FDA. The World Health  Organization has even stated that remdesivir should not be used to treat COVID 19 due to lack of efficacy in mortality. A significant amount of data has not been  published for remdesivir. This is generally the case with Big Pharma clinical trial  drugs, a significant portion of the data is not published because of economic  incentives. 

Reliance on clinical trials as the only evidence to support the use of  medicines in the market has led to significant problems such as COVID-19 and  the opioid epidemics. 

Incentives – No one can serve two masters 

The financial interests in drug development are significant. Specifically,  pharmaceutical companies and biotech’s are generally publicly traded and  therefore owe a fiduciary duty to their shareholders. This means that the  standard Big Pharma corporation has a special duty to act in the best interest of  the parties that hold their stock. Notably, these Big Pharma companies do NOT  owe a fiduciary duty to patients nor the general public. Big Pharma owes the  same duty to their shareholders that any publicly traded company owes to their  shareholders – make as much legal profit as possible to make the stock price go  up. If a CEO does not do this, he/she will be replaced. Big Pharma’s total  market capitalization is over $2 trillion USD, which is larger than 90% of all  country’s GDP and is approximately 10% of the USA’s GDP. 

In the USA, because of the fiduciary duty, Big Pharma spends significant  funds on lobbying. The pharmaceutical industry as a whole spends more on  lobbying U.S. government agencies and officials than any other industry by over  $100 million USD, per year.

The amount spent on lobbying is directly correlated to deaths by opioids.  A recent 2020 JAMA Internal Medicine article, “analyzed publicly available data  on campaign contributions and lobbying in the US from 1999 to 2018 and found that the pharmaceutical industry spent $4.7 billion, an average of $233 million per  year, on lobbying the US federal government; $414 million on contributions to  presidential and congressional electoral candidates, national party committees,  and outside spending groups; and $877 million on contributions to state  candidates and committees. Contributions were targeted at senior legislators in  Congress involved in drafting health care laws and state committees that  opposed or supported key referenda on drug pricing and regulation.” 

The government agencies that execute the policy, regulations and/or  pricing that flows from this lobbying are Food and Drugs Administration (“FDA”),  the Centers for Disease Control (“CDC”), the National Institutes of Health  (“NIH”). All three (3) of these agencies have significant financial interests aligned with Big Pharma – as outlined below. 

FDA 

The FDA budget for 2019 was approximately $6 billion. Approximately  50% comes from tax payers while the other 50% is paid for by industry user fees.  User fees are paid by industry, e.g. Big Pharma for drug approvals such as a  PDUFA fee. A PDUFA fee is $2 – $10 million USD paid for by a drug sponsor to  the FDA to allow a drug on the market, after the drug has been approved. The  FDA does not receive PDUFA fees when new indications or uses for generic  drugs are discovered or invented. 

Additionally, it is quite customary for FDA employees to go work for  industry. This is the case of former high ranking FDA officials working for Big  Pharma companies after they finish at the FDA. Throughout the COVID-19  epidemic, these former FDA officials regularly go in the media and “update” the  country as to the state of the COVID-19 epidemic. To date, they have generally  not advocated for the use of Hydroxychloroquine or Ivermectin drug  combinations (e.g. Hydroxychloroquine or Ivermectin, Zinc, Doxycycline or  Azithromycin). 

The FDA has warned against the use of Hydroxychloroquine in both the  hospital and outpatient setting. It is unlikely the FDA has received fees for  generic drugs to treat COVID-19 in the outpatient setting. It is very likely the FDA  has received fees for patented Big Pharma drugs and vaccines. 

It is known that the combination therapy of Hydroxychloroquine, Zinc and  antibiotic (azithromycin or doxycycline) is a cure to COVID-19 if administered  within the first 4 days of symptoms. This has been proven with real world  evidence. There is no clinical trial that refutes this. The data is  overwhelming. The FDA has not removed their restrictions on  hydroxychloroquine nor supported the use of this drug combination. 

CDC 

Established by Congress as an independent, nonprofit organization, the  CDC Foundation is the sole entity authorized by Congress to mobilize  philanthropic partners and private-sector resources to support CDC’s critical  health protection mission. Although the CDC Foundation was chartered by  Congress, it is not a government agency nor is it a division of CDC. It is a private,  nonprofit organization classified as a 501(c)(3) public charity. Donors to the CDC Foundation include the top Big Pharma companies. The CDC Foundation then  funds the CDC’s work and becomes a partner. 

NIH 

The NIH budget is approximately $40 billion per year, paid by tax  payers. This is the biggest bio R&D operation in the world. The NIH is financially  involved with almost every Big Pharma company. A significant portion of Big  Pharma drugs originate at the NIH, generating approximately $100 million a year  in royalties paid to the NIH and NIH employees. According to End Points, “from  1988 to 2004, NIH entered into almost 2,500 license agreements and generated  more than $500 million in royalty revenues. More recently, royalties have  amounted to more than $100 million per year.” 

The NIH is paid for by tax payers but is incentivized with Big Pharma’s  fiduciary duty to shareholders. As such this can have a significant effect on  research and markets as support for one drug may increase or decrease sales of  a competing drug therefore affecting economic flow (royalties, relationships,  etc.). Such a model favors research and support to patented drugs over generics  and supplements. The NIH budget allocated towards drug repurposing  (generics) is approximately .015% of the budget. 

A significant amount of NIH research data is generally not publicly  available for collaborative data mining. Notably, from 2013 – 2019, the NIH spent  over $250 billion USD in research and US life expectancy actually  decreased. How can this be? 

During the Covid-19 pandemic, approximately $10 billion was committed  by the federal government to big pharma companies for patented drugs and  vaccines. Less than 1% of this was allocated to researching generic drug  combinations – even after the cure was announced in March 2020. The cure to  COVID-19 is a combination of safe generic drugs and supplements administered  in the outpatient setting. NIH started a clinical trial for a combination outpatient  therapy of hydroxychloroquine and azithromycin – but terminated the clinical trial  after only two (2) months due to “lack of enrollment.” It is known that such trials  can take significantly longer than just two (2) months. 

The NIH funded the development of Remdesivir in a $37.5 million grant to  the University of Alabama at Birmingham – with the grant’s principal investigator  being a board member of Gilead Sciences. Remdesivir is Gilead’s drug. On  April 29 2020, Anthony Fauci MD, the leader of the National Institute for Allergy  and Infectious Disease at the NIH, declared Remdeisivir as the “standard of  care” for COVID-19 treatment. On April 30, 2020 Gilead’s stock reached its  annual high of $84 per share. On November 20, 2020, the World Health  Organization recommended “against the use of remdesivir … regardless of  disease severity, as there is currently no evidence that remdesivir improves  survival and other outcomes in these patients.” As of November 30, 2020,  Gilead’s stock is trading at approximately $60 per share. A drop of 40%, and a  loss of over $20 billion in market capitalization. 

Markets

Stock markets have moved considerably on positive COVID-19 research  news, e.g. advance of treatment, vaccines, etc. In February and March 2020, the  stock market had decreased the most in the shortest period of time, ever, likely  due to COVID-19 fear. This is despite significant injections of capital by  government and institutions. It was only on March 19, 2020 when President  Trump announced the combination therapy of Hydroxychloroquine and  Azithromycin that the trend started to reverse. President Trump even stated that  this combination therapy is expected to provide most benefit early in treatment,  e.g. outpatient, before hospital. On this news, Gilead’s stock went down and the  entire market went up. The exact bottom of Tesla stock was the day before, on  March 18. 

As stated by the hearing witnesses, there is not consensus amongst  medical professionals regarding effective outpatient treatment. This lack of  consensus is due to an incentive model that has led to faulty message  propagation, controlled by shareholder value as opposed to public benefit. If the  generic drug combination therapy was promoted as the cure, it would take profit  away from the patented Big Pharma drugs and likely eliminate the mass panic  and state of emergency, which would reduce funding to Big Pharma. The  economic incentives are misaligned at the expense of tax paying American  citizens. 

The cure to COVID-19 did not come from large pharmaceutical companies  nor the government – it came from private citizens engaged in open source R&D  at global scale. According to Harvey Risch, MD, PhD of Yale University, to date  the generic combination therapy is better than anything that the pharmaceutical  industry or government has put out, including Remdesivir and monoclonal  antibodies. It is clear that generic drug and supplement research can provide  significant benefit. 

The Zelenko Protocol 

I have treated over 3,000 COVID-19 and suspected COVID-19 patients in  a unique orthodox Jewish setting in New York. Additionally, I have consulted  physicians who have treated over 10,000 patients in total. 100% of my patients  that are high risk have fully recovered if they received the triple combination  therapy of Hydroxychloroquine + Zinc + Antibiotic (Azithromycin or Doxycycline)  within the first 4 days of symptoms, and take it for at least 5 days. This triple  combination therapy administered immediately in the outpatient setting has  gained international acclaim and has become known as the Zelenko Protocol.  High risk patients that have been cured include the elderly including Holocaust  survivors that are over 90 years old, cancer patients, diabetics, etc. This group  should have a fatality rate between 5% – 20%. The fatality rate of these patients  that follow the Zelenko Protocol in the first four (4) days of symptoms is 0.00%. 

To my knowledge, I am the first person to publicly integrate a high dose of  Zinc into the combination therapy as of March 2020. Zinc has proven to be  extremely efficacious when used in combination with a zinc ionophore such as  Hydroxychloroquine or Quercetin. These combinations have proven to be very  safe in the outpatient setting. The Zelenko Protocol calls for risk stratifying  patients into high risk and low risk group and treat empirically the high risk group  within the first 4 days of symptoms.

I have published an initial study of my findings with two prominent German  researchers, Dr. Roland Derwand of Alexion Pharma and Dr. Martin Scholz of  Heinrich-Heine University in Dusseldorf Germany, which can be found here:  https://www.sciencedirect.com/science/article/pii/S0924857920304258?via %3Dihub . Further publications are currently in process. 

In addition, patients that have been successfully treated with the Zelenko  Protocol have gone on to develop antibodies to COVID-19. We have provided a  cure and immunity quickly and inexpensively. 

The Zelenko Protocol was developed based on the work of Didier Raoult  MD PhD at the main COVID-19 hospital in Marseille, France – the IHU. Dr.  Raoult is known as one of the top infectious disease doctors in the world and the  most widely cited microbiologist in Europe. 

Incredibly, the French government decided to place a ban on the use of  Hydroxychloroquine to treat COVID-19. Dr. Raoult ignored the ban and  continued to treat his patients with the combination therapy, while the rest of  France abided by the ban. As of July 2020, the case fatality rate of Dr. Raoult’s  patients (3000 +) was less than 1% where as the rest of France had a case  fatality rate of more than 15%. Dr. Raoult has been a strong proponent to early  treatment. 

Any professional who states this combination therapy does not work must  explain the below difference in COVID-19 fatality in France as of July 2020. (Source: Worldometer, IHU website)

Dr. Raoult and his team have been rapidly publishing throughout the pandemic,  for which this recent publication conveys their results from 3,737 COVID-19  patients which is consistent with my  

results: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7315163/ 

The reason why it is so important to engage in early treatment is because  COVID-19 is effectively two different diseases. The first being a replicating virus and the second being respiratory inflammation including pneumonia in the  lungs. If the virus replication is stopped early, the respiratory inflammation can  be limited in which patients can be back to normal quickly. If the virus is not  effectively treated early on, it can be difficult to treat the respiratory inflammation  especially in high risk patients – as their lungs may become severely  infected. This visual was created by Dr. Raoult and his team to illustrate the  stages of COVID-19.

The Zelenko Protocol is a cure to the viral shedding phase, not a cure to  the respiratory inflammation. Once the virus has replicated too much, the  inflammation cascade may not be reversed – hence time is of the essence. This  is why outpatient therapy is so important. 

Additionally, I put my high risk patients on a prevention protocol which  includes use of Zinc and a zinc ionophore (Hydroxychloroquine or Quercetin). To  date, none of my patients using prevention have been hospitalized or died. 

For a list of studies analyzing the effect of hydroxychloroquine and its use  in combination therapy see https://hcqmeta.com/ as well as https://c19study.com/ . The great majority of studies show that when used early, it is very effective in  treating COVID-19. 

This is the Zelenko Protocol for COVID-19 treatment:  

https://www.preprints.org/manuscript/202007.0025/v1

This is the Zelenko Protocol for COVID-19 prevention:  

https://faculty.utrgv.edu/eleftherios.gkioulekas/zelenko/ZelenkoProtocol.pdf

Despite all of this evidence, the FDA and state pharmacy boards have  imposed legal liability on physicians who prescribe these generic drug  combinations. Some states have severely restricted the use of  

hydroxychloroquine – effectively governors telling physicians how to practice  medicine. Incredibly, while the FDA and states have imposed legal liability for  prescribing generic drugs off-label, Big Pharma companies have been  indemnified by the federal government, effectively eliminating their legal liability,  for patented treatments and/or vaccines. 

Due to the media driven hysteria around these generic drugs which  resulted in restrictions, we also use ivermectin in place of hydroxychloroquine which has also provided outstanding results in the combination  therapy. Ivermectin is also a generic drug, safe and inexpensive. 

Conclusion 

Significant funds must be allocated immediately to research and develop  generic medicines under Real World Evidence standard without the influence of  the pharmaceutical industry. Research and development of medicine is now a  matter of national security. There must be an organization that functions as an  intelligence agency for medicine whose exclusive duty is to the people, not  shareholders – building on this solution. Significant funds must be allocated to  implement this – a gap which can filled by an organization funded by Homeland  Security similar to how the TSA was created in response to 9/11. COVID-19  must be swiftly ended and a situation like this must never happen again. 

Without this, the people are reliant on an incentive model that is leading to  a mortality count that may be greater than the civil war – historically the most  deadly war for the USA. Enemies of the USA are standing by observing how a  virus has destabilized the wealthiest nation on the planet.  

There is a cure for COVID-19 as well as effective prevention options. The  Zelenko Protocol could have saved over 200,000 lives. Implement it immediately  for early outpatient use. 

Key Points from the Senate Hearing on COVID-19 Outpatient Treatment and Follow up  correspondence 

Ashish Jha MD stated that he has not treated any COVID-19 patients. Dr. Jha  stated several times during the hearing that Hydroxychloroquine does not work to  treat COVID-19. Dr. Jha did not mention the combination therapy of  Hydroxychloroquine, Zinc and Antibiotic. He also never mentioned Ivermectin.  Dr. Jha wrote an opinion piece in the New York Times following the hearing and  accused the other witnesses from Yale, Harvard and Baylor as snake oil  salesmen.  

George Fareed MD (Harvard), Harvey Risch MD, PhD (Yale) and Peter  McCulloughMD (Baylor) all fully endorsed the combination therapy in the  outpatient setting, combining to have treated over 1,000 patients. 

George Fareed MD stated that he is seeing a 100% success rate with the  combination therapy if it is administered early enough – consistent with my  findings as well as Dr. Raoult’s findings. 

U.S. Senator Ron Johnson, Chairman of the Senate Committee on Homeland  Security stated that we should be pouring billions of USD into outpatient treatment as there are currently no official government approved options for  outpatient treatment. Senator Johnson further stated that the risk reward ratio is  dramatically in favor of the combination therapy and he used a combination of  Zinc and the Zinc ionophore Quercetin to treat his COVID-19 infection. “We can’t  wait for the vaccine, we have to take action now.”

Vladimir Zelenko MD is a board certified physician in the state of New York. He is the inventor of the Zelenko Protocol. He has treated over 3,000 COVID-19 and suspected COVID-19 patients  as well as consulting with peer physicians that have treated over 10,000 COVID-19 patients on four (4) different continents. 100% of Dr. Zelenko’s patients that are high risk have fully recovered if  they received the Zelenko Protocol within the first 4 days of symptoms, and took it for at least 5 days. Dr. Zelenko’s work has been peer reviewed and published. He publishes his findings in real time. 

Please Donate Below To Support Our Ongoing Work To Expose The Lies About COVID19

PRINCIPIA SCIENTIFIC INTERNATIONAL, legally registered in the UK as a company incorporated for charitable purposes. Head Office: 27 Old Gloucester Street, London WC1N 3AX. 

Please DONATE TODAY To Help Our Non-Profit Mission To Defend The Scientific Method

Trackback from your site.