Hello, and welcome to my channel Medicine with Dr. Moran.
Transparency is extremely important in medicine. Do you think big pharma is transparent? Today
I have an interesting editorial published in the esteemed British Medical Journal. It was published
this week and it called for data transparency from the Covid-19 vaccine manufacturers.
There's a link below if you'd like to read all of it. I must say it's an interesting read.
It's written by the editor-in-chief, former editor-in-chief, and senior editor of the
journal. The editorial points out that a decade ago during an influenza pandemic it came to
light that the governments around the world spent billions stockpiling antivirals that had not been
shown to reduce the risk of complications hospital admissions or death. It's a story you may not know
the majority of the medical trials that underpinned regulatory approval
of the drug Tamiflu which were sponsored by the manufacturer. Most were unpublished and those
that were published were ghost written by writers paid by the manufacturer. The people listed as
principal officers lacked access to the raw data and academics who requested access to the data for
independent analysis were actually denied. Due to this and the uproar that it caused a number of
changes were made to promise better accessibility to the data with more transparency. Unfortunately
the same kind of thing is happening with this particular pandemic the Covid-19 pandemic.
The anonymized participant level data underlying the trials remain inaccessible
to physicians researchers and the public and they may remain that way for years to come.
As has been reported by the media Pfizer has said it will not begin entertaining requests for trial
data until May 2025. Pfizer's pivotal Covid-19 vaccine trial was of course funded by itself.
The employees of Pfizer designed carried out and authored their own study. The company and
any research organizations that they contracted assistance with their trial have all the raw data.
The situation is similar with other manufacturers. Moderna has indicated that data can be seen upon
request and subject to review once the trial is complete which is the end of October, 2022.
AstraZeneca has indicated that it could take up to a full year upon its full submission
of a request for someone to obtain its data. Now data for Covid-19 therapeutics is similar.
The editorialist mentioned Remdesivir which was funded by the U.S. National Institutes of Health
does have a portal to share data but the data set on offer is actually quite limited.
So ultimately physicians and researchers are left with publications and journals
for the vaccines and therapeutics but limited or no access to the actual data.
The journals that did ultimately publish the primary studies on these vaccines and therapeutics
did so without the anonymized participant data in the clinical trials. Now I'm not a research
physician but I do know that journal editors physician reviewers and those physicians that
write clinical guidelines generally only see what's in the journal publication.
It is important that we as physicians know whether the researchers followed their clinical trial
structure , their methodology and did exactly what they stated in the methods section of the study
that they produced. It's also important that the database be accurate and free from bias.
Last year papers were published in the Lancet and New England Journal of Medicine based
on the Surgis Sphere database which involved studies with Ivermectin and Hydroxychloroquine.
Now the studies were ultimately retracted why because the data set was found to be unreliable.
This is something that we don't want to see in medicine.
It takes away trust. Now the regulatory agencies that review Covid therapeutics and vaccines do
ask for additional data as part of their review process. The FDA in response to a freedom of
information request for Pfizer's vaccine data offered to release 500 pages per month which is a
tiny fraction of the number of pages that they actually have. Now in court Pfizer argued that
publicly releasing this data was slow due to the need to first redact sensitive information.
This month in the news a judge you may have heard rejected the FDA's offer and ordered the data to
be released at a rate of 55,000 pages a month. It remains to be seen how the FDA will respond
to this court order. Other U.S. manufacturers data such as Moderna and Johnson & Johnson
cannot be released until the vaccines are formally approved which they have not been.
The manufacturers which actually have the raw data are not legally required to honor requests for
access from independent researchers. Many people don't trust the big pharmaceutical companies.
Some of the companies making Covid vaccines have settled criminal and civil settlements costing
them billions of dollars. The pandemic of course has made many in the pharmaceutical business
extremely wealthy. The manufacturers have reported tens of billions of dollars
in revenue. Tansparency with respect to their underlying data and decision-making is important.
In an ideal world the Covid-19 vaccines of course would do two things one it would
prevent severe disease and death and secondly it would prevent transmission and stop infections.
The clinical trials were not set up to answer these two questions.
It's only our real world data that shows a reduction in severe disease and death.
Unfortunately the vaccines do not prevent mild infection in many people as you know
and transmission from vaccinated individuals to others occurs also. It would have been nice to
know that much earlier. That would have affected health policy. So it's important that doctors and
researchers have transparency to see all the data so that ultimately vaccination policies are based
on evidence-based medicine. They conclude their editorial by stating the following.
"The public has paid for Covid-19 vaccines through vast public funding of research and
it's the public that takes on the balance of the benefits and harms that accompany vaccination.
The public therefore has a right and entitlement to those data as well as to the interrogation of
the data by experts. Pharmaceutical companies are reaping vast profits without adequate independent
scrutiny of their scientific claims. The purpose of regulators is not to dance to the tune of
rich global corporations and enrich them further it's to protect the health of their populations.
We need complete data transparency for all studies. We need it in the public interest and we
need it now." That was the end of the editorial. Now I couldn't agree more. In my opinion honesty,
integrity, and transparency are important in medicine. It's what we strive for as physicians.
People need to have trust in the process or the whole process starts to break down.
Lastly today I have an announcement. Starting this week I'm going to try to devote more time
and streamline how I make my videos so I can provide more videos faster succinctly in order
to provide the most accurate up-to-date Covid developments. If you like my channel and this is
what you're interested in please subscribe. Feel free to share with your family and friends. Most
of the videos on my channel are actually about Covid primarily because I started my channel when
the pandemic began. There are quite a few videos on other medical topics on the channel. Thank you
for joining me today on Medicine with Dr. Moran I'm Dr. Keith Moran get healthy and stay healthy.