The most recent large-scale study from the World Health Organization shows remdesivir does not produce promised results. As I've covered in the past, there are numerous scientists who question the official story about the COVID-19 pandemic and the baseless fearmongering driving changes to worldwide behavior.
Recently I shared a video interview in which British journalist Anna Brees spoke with Michael Yeadon, Ph.D., who is a past vice-president and chief scientific adviser of the drug company Pfizer and founder and CEO of the biotech company Ziarco, now owned by Novartis.
Yeadon has over 25 years of experience working in the pharmaceutical industry and has consulted with over 20 biotechnology companies.1 In the interview, he talks about his concerns that widespread PCR testing is creating the false idea the pandemic is resurging, as the total mortality rate is completely normal. He also discusses his concerns with COVID-19 vaccine mandates.
PCR testing is generating needless fear, and likely helping to fuel a Big Pharma push for antiviral drugs governments may seek to stockpile, thus driving financial gain. One antiviral drug that proved disappointing in 2014, and again in 2020, is remdesivir. The path this drug is taking is eerily similar to that of another failed drug, Tamiflu.
To Know Tamiflu Is to Understand Remdesivir
In this video, Dr. Tom Jefferson is speaking at The Symposium about Scientific Freedom in Copenhagen. He describes the journey he and his team took to publish the only Cochrane review based solely on raw unpublished regulatory data.2 Ultimately, the results of the review showed Tamiflu shortened the duration of symptoms from flu by less than one day.
The struggle to get the data was nearly as eye-opening as the results. According to Jefferson, the journey began in 2009 when the team received what Jefferson characterized as a "HUGE amount of money — £5,000 — to commission a rapid update of our existing review of the drugs."3 In his depiction of the funding that amounted to $6,675, his arms were spread wide as if he were unable to hold it.
In October 2009, Jefferson received a phone call from Melanie Sinclair, Ph.D., claiming to be a ghostwriter for Adis and responsible for writing the Kaiser meta-analysis. In other words, the study research that found Tamiflu could reduce the effects of pneumonia from flu was not penned by the scientists, but instead by a global publisher of over 30 medical journals.4
"This is vital to understand because it formed the major part of the rationale for stockpiling huge amounts of oseltamivir (Tamiflu)," Jefferson explained. During the process, the team also received a challenge from a pediatrician in Osaka who pointed out the key piece of evidence underpinning the Kaiser conclusions that Tamiflu had an impact on complications from influenza came from a study funded by Roche.
Four of the six authors were employed by the pharmaceutical company and a fifth was a paid consultant. The bulk of the data analyzing the effectiveness were unpublished. Jefferson described the climate of the time, saying:5
"So we were in the middle of a situation where there was an unfolding pandemic that everybody said would kill just about half the population on the planet, we had a HUGE pot of money — £5,000 — to update the review and we had this criticism, which under Cochrane rules we had to answer within six months."
The team requested the unseen trial data but came up against many obstacles that took several years to overcome. In the meantime, a 2009 BMJ investigation by Deborah Cohen6 that is behind a paywall, uncovered interesting details from the lead researchers on two of the pivotal trials included in the Kaiser review:7
"John Treanor, lead author of a pivotal Tamiflu treatment trial, told The BMJ: 'I did not perform an independent analysis of the primary data, which was not required or requested by JAMA at the time of submission, and I do not have access to the primary data, which I also never requested.'
When asked a similar question, [Karl] Nicholson, lead author of the other pivotal Tamiflu treatment trial, 'said he did not recall seeing the primary data. He said that the statistical analysis had been conducted by Roche and he analysed the summary data.'"
Roche Protected Data That Showed Tamiflu Not Effective
By 2012, Jefferson and the team had not received the raw data from any of the researchers or from Roche, which had sent an open letter promising to send it. Jefferson then published open letters to:
- World Health Organization
- Centers for Disease Control and Prevention
- European Medicines Agency (EMA)
"These organizations had promoted the drug. They had pushed the drug in any way. And we were asking them how did you reach your conclusions? How did you support your policy?"
What Jefferson found was:8
"WHO was recommending Tamiflu use, but they'd never vetted the data. EMA had approved Tamiflu; they'd never vetted the full data set. CDC was promoting the use of the drug. They had never seen the data set.
CDC's promotion was taking place despite the fact that the FDA — which HAD vetted the data — required Roche to add a statement on the label saying serious bacterial infections may begin with influenza-like symptoms or may co-exist with or without complications during the course of influenza.
Here comes the punch. Tamiflu has not been shown to prevent such complications. FDA was saying, this business about complications: no evidence of that."
Four years after Roche promised the data, 150,000 pages were delivered to Jefferson's team from which they determined "there was no convincing trial evidence that Tamiflu affected influenza complications and treatment or influenza infections in prophylaxis."9
FDA Knew of Negative Trial Results but Approved Drug Anyway
Remdesivir is an antiviral drug that was evaluated during the Ebola breakout in 2014. The development used at least $70.5 million in taxpayer money, and that number may be higher.10 After analysis showed disappointing results for treating Ebola, it was once again tested in the early months of 2020 during the COVID-19 pandemic.11
A few of the remdesivir trials were stopped early after participants experienced significant side effects. Yet, some scientists believed the data suggested the drug could shorten recovery time.12 However, the drug has not produced adequate results and has not been proven to reduce the potential for death in those with severe disease. Worse, treatment comes with an added price tag of potential kidney damage.13
It seems remdesivir is following in the footsteps of Tamiflu. The story exploded when Dr. Anthony Fauci, head of the President's Coronavirus Task Force and NIAID, made a promotional announcement from the White House, in which he called results that had not been peer-reviewed from a pharmaceutical-sponsored clinical trial "highly significant" and remdesivir to be the new "standard of care."14
WHO recently revealed the results from the SOLIDARITY trial15 showing remdesivir has little to no positive effect on mortality, length of stay or the need for ventilation.16
This supports what some doctors have been reporting and other studies have found, which I discuss in greater detail in the past article, "The New COVID-19 Medication Isn't Backed by Results." Gilead, makers of remdesivir and the developer of Tamiflu, attempted to cast doubt on the results of the SOLIDARITY trial, writing:17
"The SOLIDARITY Trial is a multi-center, open-label global trial that provided early access to Veklury [remdesivir], among other investigational COVID-19 treatments, to patients around the world — particularly in countries where ongoing trials of investigational treatments were not available.
The trial design prioritized broad access, resulting in significant heterogeneity in trial adoption, implementation, controls and patient populations and consequently, it is unclear if any conclusive findings can be drawn from the study results."
However, the endpoint measurements in the trial included mortality, length of hospitalization and ventilation requirements. These are more objective than most open-label clinical trials. As Dr. Srinivas Murthy from British Columbia Children's Hospital in Vancouver, pointed out:18
"Mortality should not be affected by whether a study is open label or closed or placebo blinded for obvious reasons: you or your doctors can't will yourself into staying alive by knowing you had the drug."
Gilead also questioned the use of a heterogeneous group of patients from 405 hospitals across 30 countries. Yet, the SOLIDARITY team says this is a strength of the study as it demonstrates "how remdesivir performs in complex real-world environments beyond the controlled settings of the smaller clinical trials that came before."19
October 22, 2020, one week after the trial results were made public, the FDA officially approved the drug as treatment for any hospitalized person over age 12. A press officer at the FDA acknowledged they were aware of the trial data, but based their decision largely on the two Gilead sponsored trials.
Gilead to Make Cheaper, Generic Version of a $10 Drug
Dr. Derek Angus, chief health care innovation officer at the University of Pittsburgh Medical Center, believes this approval may slow or stop further trials that may help identify the populations of people in which remdesivir may possibly have a potential positive effect.
The cost of treatment is another stumbling block since one five-day course costs the government $2,340 and private insurers $3,120. As more hospitals are looking to purchase remdesivir, Gilead reached agreements to develop a generic version that would be cheaper. This move was to help low- and middle-income countries.
However, according to a review by the Institute for Clinical and Economic Review (ICER) published in May 2020, a cheaper version may not be necessary. ICER is a nonprofit group that evaluates drug pricing. Initial estimates showed the total cost of producing a "finished product" at $10.20 This included packaging and a small profit margin and was based on the cost of the active pharmaceutical ingredients in the drug.
The cost estimate was based on research published in the Journal of Virus Eradication analyzing the cost of repurposing drugs for use with COVID-19 and included remdesivir. The data used global shipment record "costs of active pharmaceutical ingredients using established methodology, which had good predictive accuracy for medicines for hepatitis C and HIV amongst others."
After three producers in Bangladesh and India reported a price range of $590 to $710 for a 10-day course of treatment,21 ICER revised their cost range, writing: "Given the $10 estimate from Hill et al, and the new information on early generic pricing in developing countries, we have chosen in this update to frame the cost recovery pricing for remdesivir as a range between $10 and a rough mid-point generic pricing figure of $600 per 10-day course."
This means in order to lower the price from $3,120 for other countries, Gilead must make the drug cheaper than a range of $10 (estimated based on the known costs of the active ingredient) to $600 (estimated cost of manufacture in Bangladesh and India, when these prices already include a small profit margin).
Ultimately, the full story behind the clinical trials and use of the antiviral drug will likely not be known until Gilead releases the raw data from their clinical studies.
The Tamiflu Cochrane review began in 2009, but it was not until 2013 that Roche finally released the full clinical data. Jefferson said that it was only after analyzing the raw data that the team found Tamiflu could shorten influenza by only a few hours.22
Steps to Reduce the Risk of Severe Disease
Some health experts and the media are using the rising number of cases of COVID-19 diagnosed each day as a way of encouraging people to stay in place and wait for a vaccination. As I've written several times in the past months, PCR testing does not accurately diagnose an active infection.
I recommend that you proactively work to support your immune system using strategies evidence has demonstrated reduces your risk of severe disease. You'll find several simple, yet significant strategies on my Coronavirus Resource Page.
As I have written, it has become apparent that optimizing your vitamin D level may be the least expensive, easiest and most beneficial strategy to minimize your risk.
It is also important to make simple lifestyle changes that have an impact on normalizing your blood sugar levels as this can reduce your risk of heart disease, Type 2 diabetes and severe disease from SARS-CoV-2 and other viral infections like flu.23,24
You may lower your risk of heart disease by following suggestions that affect your lifestyle and exposure to environmental toxins. In my article, "Cholesterol Managers Want to Double Statin Prescriptions," I share a list to help minimize your toxic exposure and improve your body's ability to maintain good heart health.
Additionally, in "Nearly Half of American Adults Have Cardiovascular Disease," I summarize further strategies to improve microcirculation in your heart. I also talk about mitochondrial function and insulin resistance, which are related to strong heart health.
It is difficult to control Type 2 diabetes when you rely strictly on medication and do not change the underlying lifestyle factors that have caused the problem. If properly addressed, Type 2 diabetes can be entirely reversible in most people.
The reason is that Type 2 diabetes is a diet-derived condition rooted in insulin resistance and faulty leptin signaling. This means it can effectively be treated and reversed through dietary and lifestyle choices. I discuss this further, with suggestions for changes, in "Diabetes Can Increase Complications of COVID-19."
Source: mercola rss