Now that
150,000 people have died from the Covid-19 pandemic within the US even the
non-compliant are concerned at last. This article explores the dangers of “warp
speed” production techniques when it comes to science and human subjects. First, the pharmaceutical industry loves to
get an accelerated pathway from the Food and Drug Administration (FDA), because
it allows them to spend less money conducting expensive human subject studies
and proceed to money making with an approved product. Accelerated approvals
have become commonplace at the FDA, with minimal push-back, especially from the
science-suppressing Trump Administration.
Here are the
steps a drug developer ideally undertakes before a new drug is approved in the
US
1. Scientific research is conducted on a hypothesis
to determine if the intervention produced statistically significant results
2. Results are subject to peer review, by a panel
of experts, whom hopefully are not conflicted by pharma grants, compensation,
or appointments
3. Once a finding clears these steps, the next
phase is to undergo testing with human subjects, which is initially conducted
in a small study, probably populated with targeted or idealized patients, and this
study is often observational and not a randomized control study, as a means to save money.
4. The next step, after a successful human-subjects
phase is clinical testing, where the treatment or intervention is deployed with
patients. Again, this phase may be observational and not the gold-standard of randomized
controlled study which eliminates bias by double-blinding and other techniques.
5. If the intervention is going to have a
significant risk for a large population, the next step should be large scale
population testing on a broad cross section of the society which is to receive
the drug. It is this latter phase that the pharmaceutical industry is loathe to
do, because it takes more time and money and, in many cases, mutes the benefits
of the drug they are touting.
Malignant-How
Bad Policy and Bad Evidence Harm People with Cancer, by Vinayak Prasad, MD,
MPH, brilliantly explains the use of surrogate endpoints to accelerate drug
approvals, which only reach level 3 in the drug development scale in some cases,
before approval by the FDA. (Vinayak K.Prasad, 2020, pp.
23-50)
To call this a rush to judgement of drug efficacy is an understatement. An accelerated
approval is basically a provisional drug approval for a drug which hasn’t fully
met the standards of the regular process. A surrogate endpoint is basically a
substitution by pharma to shorten the approval process for a drug which has
shown a statistically significant result, but which may have minimal value when
applied to a real world patient population. In other words, if it only works on
a few idealized patients without other comorbidities what is the value to
society?
Most of the
drug development in the US is paid for by the federal government through grants
from Health and Human Services and citizens have a right to thoroughly
researched drugs which are not merely approved by conflict-ridden FDA staffers
who are ex-pharmaceutical employees. The current individual in charge of the “warp
speed Covid-19 vaccination”, Moucef Slaoui, of GlaxoSmithKline is in fact so
conflicted that he would be unable to obtain Congressional approval for the
job, so instead the Trump Administration waived that requirement and allowed
him to consult with the government without divesting of any of his pharma stock.
Of real
concern with Operation Warp Speed is that important steps in the safety of an
immunization will be minimized or eliminated because of the accelerated
approval provision. This means that people who are less healthy may experience adverse
side affects and could result in deaths. In other words,
with the Covid-19 immunization Americans are the guinea pigs under accelerated
approval.
In 2016, Dr.
Prasad and Chul Kim reviewed all FDA cancer drug approvals and 66% were based
on the jujitsu of surrogate endpoints. (Vinayak K.Prasad, 2020) They reviewed the use
of surrogate endpoints through systematic review of available literature on
scientific studies and found that 56% of the studies used to justify accelerated
approvals did not even document the strength of the correlation they were using
for surrogate endpoint justification. And 37% of the regular drug approvals did
not document the strength of study correlation either. If statistical
validation is not used then perhaps the findings are weak.
The FDA uses
surrogate endpoints and other work arounds to justify “unmet needs” in
healthcare, which is certainly the case for a Covid-19 vaccine. The goal in
vaccine development is to eliminate susceptibility of disease, but corona
viruses are notoriously difficult to development immunities. For example, the
annual influenza vaccine is only partially effective in preventing influenza,
and the vaccine has to be redeveloped annually because the virus evolves. This
is essentially the situation the world is facing now with Covid-19. Of concern
are the gladiator stakes the Trump Administration has created for several drug
companies to compete to develop a vaccine. Being first for a vaccine would seem
to be less important than providing the most effective vaccine for our
population. And of course, a measure of efficaciousness is cost, which is born
by US taxpayers and patients.
This is the
healthpolicymaven signing off encouraging you not to sign blanket release forms
when submitting to a medical procedure, do indicate that for which you agree
and which you decline. It is after all your health, and that is no surrogate
endpoint.
3 comments:
Almost every post finds me in complete agreement with the Healthpolicymaven. This post is an exception because several statements are not accurate. No FDA submission is being allowed which doesn't include large-scale population testing. Also, vaccine development has commonly not been profitable, which is of deep concern to many of us who have conducted clinical trials. We absolutely must accelerate the process when faced with a pandemic such as Covid-19. I agree we should be concerned about Moucef Slaoui having a conflict of interest, but he's also very qualified to potentially get the job done. The FDA has often conducted assessments with conflicts of interest before, so this is not unusual when the US definitely doesn't have the best drug approval system in the world. For a review of the 165+ vaccine candidate trials with human subjects, I recommend reading the NY Times review of each program published this past week. We should be praising the great scientific achievements to have brought development this far, which is exactly what Dr. Tony Fauci has done recently. I stand with Fauci, and Johns Hopkins University, as should all of us in this time of misinformation out of Washington.
The purpose of this article was to highlight the FDA process that informs accelerated review, which is widely used by big pharma to get provisional drug approvals, without completing follow-up testing.I cite Prasad's latest book with evidence gathered from his research and meta-analysis. I chose to use Operation Warp Speed to illustrate how the process works with the FDA. Of concern with the Trump Administration are science suppression and the political appointees who inhabit the FDA and other agencies. Yes, Dr. Fauci is doing a great job, but he has been silenced and minimized by Trump. If the current administration really cared about disease prevention it would have done something in January or February when the pandemic was already here. The latest initiative is a political ploy for Trump to gain re-election.
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