Hacker News Reader

Comment by cnorthwood | Hacker News Reader

I don't think it's unreasonable to keep the personal details of trial participants secret, for example

Apparently this is not what has been breached. From the article:

> no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware that any study participants have been identified through the data being accessed

Those are never, ever stored with the pharma companies. If FDA finds out they are you can close shop.

Where they are stored? At the investigator of the trial?

Yeah, wherever they are usually stored.

As I said in another comment - the only data the pharma company gets to "take home" is anonymized (partially, ie. a number instead of a name) and blinded (you don't know if they received drug or placebo)

The company must reconcile the patient data with the trial data (on premise), in a scenario like: "liver enzymes abnormal after administration of vaccine, is there anything in the patient data that could clarify that (apart from the vaccine itself)". Someone has to painstakingly go through all that data.

Source: this was my job

After the study is concluded, won't they get the non-blinded (still anonymous) version?

During efficacy/side-effect analysis you should definitely use only blinded data. After confirmatory statistical analysis, it seems reasonable to go over the data in an exploratory pass to possibly discover/hypothesize why/when/how the medicine works/fails/interacts. Or do they just get the aggregate report?

It looks like this was an attack on the EMA, so that data could have been present there

if by close shop you mean, pay a token fine as the cost of doing business and move on, the yeah.

if it were useful to big pharma to have that info, they’d have it.

It's not useful to them.

And even if it was, they'd be breaking half a dozen rules at the risk of getting the whole study trashed and billions lost, for almost no benefit.

Getting a study invalidated is the nightmare scenario of every pharma company. And it's not just the FDA or EMEA but also scientific journals that go through this stuff.

Not only is it reasonable, it's required by law (HIPAA).

Do they need to collect this information in the first place?

Yes, you want to contact them if some issue comes up which was not immediately clear.

Pfizer should not have this data, normally it doesn't leave the investigation site. Pfizer has only coded data (pseudoanonymous) that does have subject names replaced with numbers.

edit: note that subjects can still be identified with this data, just not directly.

CROs handle that data. Also adverse effects are strictly handled by third parties.

This is likely an attempt at IP theft. Probably a second rate state actor.

CROs act as an agent of the Pharma company, so shouldn’t have it either. Patient identifiable information shouldn’t leave the investigator’s site.

No, there should be no reason for Pfizer to collect this data. This could be done by a third party.

Is it being collected?

I find it interesting that you argued for hiding this kind of information, while not knowing what was stolen.

Yes, your argument is trivially true, how does it help us move forward?

The grand-parent commenter wrote "If they have secret data, that really ought to be a reason to withdraw their patent.".

The parent commenter helpfully explained how such statement is trivially false, in that there is value in keeping some data secret even though patents are involved.

I see it - there is something there. Ill read it again and inspect my own reactions to it.

Thank you! I mean that

Reply on news.ycombinator.com