I’m a software consultant for Pharma companies and have worked on projects that used the same kind of study design as the Pfizer COVID vaccine (Kaplan-Meier).<p>“Raw data” is submitted to the FDA in the CDISC format. This format contains a lot of pretty sensitive medical information, including which diseases a patient has, their medical history, what drugs they take, etc. This is supposed to be anonymized, but if the public were to be able to get this info, I strongly believe there is enough information to re-identify patients. And it’s not as simple as just removing the sensitive medical data because the primary or secondary analyses may be dependent on them.
At this point the original phase 3 trials are pretty much irrelevant, we have so much more data now from the actual use of the vaccines. They really play no role at all now. In terms of effectivness we're three major SARS-CoV2 variants further, and for looking at rare side effects we have billions of doses now compared to tens of thousands in those trials.<p>I'm all for putting pressure on everyone in Science to publish more raw data. This kind of data is likely more complicated because it's really hard if not impossible to anonymize the actual patient-level data. It still should be as accessible as possible to other scientists.
The BMJ seems to be on good form. First publishing the whistle blower account of pfizer [1], and now this call for raw vaccine trial data.<p>I commend them on this approach, and can only hope that the vaccines are as safe and effective as we have been told.<p>[1] <a href="https://www.bmj.com/content/375/bmj.n2635" rel="nofollow">https://www.bmj.com/content/375/bmj.n2635</a> - "Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial"
I remember writing the following about the AstraZeneca vaccine in Nov 2020 when concerns were raised with it.<p>Two things can be both be true:<p>- the vaccine is safe and effective<p>- parts of approach in running studies weren't as good as they should have been<p>Seems to perhaps apply here too.
Ummm… no. In IRB applications and informed consent documents you have to be very clear and specific about who you might share their data with under what circumstances. And these documents tend to be legally binding.<p>So this editorial is kind of nutty. To give you an idea, this is kind of like asking banks to release customer account data to the public.
>The BMJ supports vaccination policies based on sound evidence. As the global vaccine rollout continues, it cannot be justifiable or in the best interests of patients and the public that we are left to just trust “in the system,” with the distant hope that the underlying data may become available for independent scrutiny at some point in the future. The same applies to treatments for covid-19. Transparency is the key to building trust and an important route to answering people’s legitimate questions about the efficacy and safety of vaccines and treatments and the clinical and public health policies established for their use.<p>Serious question: if the raw data could potentially undermine public trust in the US government, can it be classified as a matter of national security?
It seems there has to be some amendments to rules about releasing raw, anonymized trial data when the state is sponsoring development of the drug.
Also, how can Pfizer claim that their "study" ends in 2023? Several hundred million people have already received their vaccine, unaware that it's part of a study where the clinical data is not even accessible to their doctors...
One thing I haven't seen is the "raw data" people being willing to pay for their own government certified consultants to anonymize the data.<p>I presume this would actually be the solution if the "raw data" people were making good faith requests.<p>Is there any reason why this wouldn't be viable?
It’s incredible how quickly pharmaceutical companies rehabbed their deservedly awful reputation by using the pandemic. Years from now, maybe decades, I’m sure we will find out there were very troubling results from the clinical trials that were swept under the rug.
> After a freedom of information request to the agency for Pfizer’s vaccine data, the FDA offered to release 500 pages a month, a process that would take decades to complete<p>75 years, actually.<p>I don't mind trusting what someone says, but I need to be able to verify it.
<a href="https://sciencebasedmedicine.org/what-the-heck-happened-to-the-bmj/" rel="nofollow">https://sciencebasedmedicine.org/what-the-heck-happened-to-t...</a> has some stuff to say about the author (about 2/3 the way down), including signing a petition doubting that HIV causes AIDS.<p>> Indeed, Doshi has history of playing footsie with the antivaccine movement, amplifying antivaccine conspiracy theories, downplaying the severity of influenza and thus feeding antivaccine narratives, using sleight-of-hand to downplay the effectiveness of flu vaccines, and generally playing the role of a false skeptic with respect to vaccines. At this point, I can’t help but note that Doshi also once signed a petition “questioning” whether HIV causes AIDS.