AdministratorApril 9, 2021 at 1:34 pm
I keep seeing a “fact” in comments that there are no FDA approved treatments because EUAs for vaccines can not be granted if treatments exist. This would shut down the whole vaccine thing, so it’s why Ivermectin et al will never be given the green light.
I am no lawyer, and I haven’t been able to figure out the truth of this from reading what government documents I can find. But the idea doesn’t quite make sense to me. Not only is this an apples and oranges comparison, I can’t see why one type of solution wouldn’t be allowed just because another exists. Nor can I see how, even if such a rule existed, an end-run couldn’t be found by just giving treatments their own EUAs, and avoiding the formal stamp of permanent approval.
Can you lead me towards an answer? Thanks.
MemberApril 16, 2021 at 8:31 pm
<div>While the President in February 2020 moved to protect the USA from a pandemic that was yet abroad – with emergency acts passed by Congress – he could not believe that the USA would ever have the most cases and deaths of any nation or territory in the world. The shifting leadership among the Federal and State health agencies, governors and the Federal branches of government made many people in the USA either hesitant and uncertain about what to do, or, in a life-seeking way, more experimental and innovative, with many possible prophylactic measures coming into conversation and shared on social media and videos.
“…On March 13, standing in the White House Rose Garden, President Trump announced a national emergency in response to the coronavirus outbreak in the United States. That announcement triggered two federal statutes that grant the executive special authorities in times of crisis: the National Emergencies Act and the Stafford Disaster Relief and Emergency Assistance Act. Previously, on Jan. 31, Health and Human Services (HHS) Secretary Alex M. Azar II had determined under the Public Health Service Act that a nationwide public health emergency had existed since Jan. 27.
Since then, Congress has passed multiple bills to address the havoc wreaked by the coronavirus and the president has invoked the Defense Production Act (DPA). While the public waits for further clarity on some of these responses—such as the extent to which the president will utilize the DPA to push companies to manufacture medical equipment—the National Emergencies Act, the Stafford Act and the Public Health Service Act are already available for the president to deploy. The Food, Drug, and Cosmetic Act also gives HHS the authority to use unapproved medical products when the secretary declares that another type of public health emergency exists…”
Many of these preventative measures – “the unapproved medical products” – were sound in principle, having their basis in either being a good idea for remaing healthy anyway (i.e., washing, isolation), or being based on real-world evidence and real-world data (RWE and RWD). An example could be something, some agent, that showed anti-viral properties, or maybe an anti-inflammatory effect, but in different situations with different threats. Also, with an idea of the safety level of the agents considered, there was hope for repurposing these familiar agents for use against infection from this “novel coronavirus”, and possibly getting the FDA, NIH and CDC on board – making preventative treatments “more official”.
There was probably more disagreements among medical personnel – the researchers, physicians, nurses and administrators (who are accustomed to policies restricting their activities and recommendations) – than there were among citizen advocates of health and nutritional products (who cannot, by law, claim to cure, treat or prevent disease).
The policies and process of approval by these agencies were for years, too rigid, but President Trump seemed to motivate anyone who might have a possible solution for emergency use to show and tell about it. However, personality clashes among the President and his detractors seemed to direct corporate media organizations towards reporting Trump ideas an inherently doomed to failure. The combination of that dominance in what could be seen or heard, along with the medical authorities being troubled by the uncertainty of shifting policies and guidelines led to paralysis (some remember when politicians argued about infection vectors, travel restrictions, and whether to mask or not mask because medical frontline personnel needed them more than we did).
So out of all that, the stalling of prophylaxis measures and guidance for the general public became a rather lame “distance, wash and mask”…and stay indoors ORDER…without any support for any use of preventative agents for ingestion. The medical authorities wouldn’t endorse nutrients such as zinc, vitamin D or vitamin C, nor would they encourage us to take any food, nor drink, nor herb, nor any other thing…without asking your doctor.
Some of us did not generally have enough health problems to go to a doctor frequently, so we became really left out of the loop. Protecting ourselves was our own responsibility, and the response to a pandemic became our own experimental experience. We learned how to make our health care choices out of necessity because the nation’s medical authorities were squandering our time to prepare by press-conferencing their shaky ground understanding of the virus.
The Emergency Use Authorization of remdesivir was not rewarded with great success, being less efficacious or available than the demand required. This failure set a precedent for FDA caution, rather than a more widespread gathering of real world data about agents that worked…or seemed beneficial in any way. They failed to be progressive about their own modernize plans.
“…The 21st Century Cures Act, passed in 2016, places additional focus on the use of these types of data to support regulatory decision making, including approval of new indications for approved drugs. Congress defined RWE as data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials. FDA has expanded on this definition as discussed below.
Why is this happening now?
The use of computers, mobile devices, wearables and other biosensors to gather and store huge amounts of health-related data has been rapidly accelerating. This data holds potential to allow us to better design and conduct clinical trials and studies in the health care setting to answer questions previously though infeasible. In addition, with the development of sophisticated, new analytical capabilities, we are better able to analyze these data and apply the results of our analyses to medical product development and approval.
What are RWD and where do they come from?
Real-world data are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. RWD can come from a number of sources, for example:
Electronic health records (EHRs)
Claims and billing activities
Product and disease registries
Patient-generated data including in home-use settings
Data gathered from other sources that can inform on health status, such as mobile devices
What is RWE?
Real-world evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective)…”
Real-world evidence was put aside for DARPA project Operation Warp Speed
“…Since January, America’s scientists and innovators have been working day and night on this national effort. President Trump has refused to accept business-as-usual timelines for vaccines and other essential tools, and instead has insisted that America, and the world, needs answers faster. Under the President’s leadership, his administration and American industry will squeeze every last inefficiency out of the process and pour every resource we can into this effort.”
“In addition to deploying 62,000 military service members in direct support of fighting COVID-19 on frontlines across the globe, the Department of Defense is racing towards a vaccine,” said Defense Secretary Mark T. Esper. “Through our research and development labs such as DARPA and the Defense Health Agency, and our massive logistical knowledge and capacity, we are committed to achieving the goal of Operation Warp Speed for the American people. I am confident that, as with any mission our military undertakes, we will adapt and overcome all obstacles in our path.”
Elements of Operation Warp Speed
Operation Warp Speed is a public-private partnership to facilitate, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures, between components of HHS, including CDC, FDA, NIH, and the Biomedical Advanced Research and Development Authority (BARDA); the Department of Defense; private firms; and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. It will coordinate existing HHS-wide efforts, including the NIH’s ACTIV partnership for vaccine and therapeutic development, NIH’s RADx initiative for diagnostic development, and work by BARDA.
Leadership: In addition to the expertise of Dr.
Slaoui and General Perna, each countermeasure area will be overseen by a
highly qualified and accomplished career HHS scientist:
Vaccines: Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research.
Therapeutics: Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research.
Diagnostics: Bruce Tromberg, Ph.D., Director of the NIH’s National Institute of Biomedical Imaging and Bioengineering.
Commitment to affordability: The Trump
Administration is committed to making these countermeasures affordable
for the American people. As a condition of receiving support from
Operation Warp Speed, companies will provide a donated allocation of
countermeasures developed, including an eventual vaccine.
Financial resources: Congress has directed almost
$10 billion to this effort through supplemental funding, including the
CARES Act, and Congress has appropriated other flexible funding. Over
$6.5 billion has been designated by Congress for countermeasure
development through BARDA, along with $3 billion for NIH research.
Planned updates: Public updates on each step of
Operation Warp Speed will depend on certain scientific milestones, which
depend on the results of clinical trials (e.g., trials are sometimes
halted before completion due to clear results).
Real-World Experiences were not considered outside of clinical trials.
The Cares Act was not used to find cheap natural anti-virals.
Nature provides agents to decompose and terminate some of its (unfriendly-to-human) microbes and vermin. A particular one came from the Streptomyces
Doctors can prescribe Ivermectin without the FDA in the USA.
Be bold, doctors.
MemberApril 18, 2021 at 10:23 am
Here is what I found to point towards an EUA suppression policy in the NIH
The suppression started with hydroxychloroquine.
“July 29th documents from a Food and Drug Administration (FDA) presentation reveal, however, that the “qualifying criteria” for extending EUA to the drug appear to have been met: it “may be effective” and that “no adequate, approved, and available alternative” exists.
The document makes clear that Emergency Use Authorization cannot be used for more than one drug or therapeutic, and the establishment is potentially therefore saving the EUA pre-emptively for vaccines and remdesivir – patently high-value Big Pharma drugs – instead of hydroxychloroquine.”
So the same rigid policy is being applied to Ivermectin.
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