Wednesday, November 15, 2006

Ouch - 7000 cases and counting...

I almost forgot I had a blog.

Really. Some intereesting things have happened at work, but I forget to record them here. Busy busy busy. My blogshares are suffering terribly.

"King of Torts" comes to life

Yes, we've certainly received legal complaints based on Adverse Events before. But nothing like we're getting this year, for one particular drug.

A law firm in Massachusetts has sent us 7000 complaints, with individual patient identifiers, for one of our psycho-active drugs. Since each patient is named, that means we have to create a case in our safety database for each one. They are overwhelmingly described as having an unspecified illness, so these cases don't get reported anywhere, unless the patient has died. There's a handful of those. We have no idea how many more are coming.

We have a way of marking these cases in our database, so that they don't skew our statistics, which compare a particular instance of an individual event for a drug versus the background rate in the rest of our database. Basically, our database is a universe of patients, that can be used to find safety signals. Adding 7000+ meaningless cases to the database wouldn't help our statistical analyses.

I have absolutely no idea how we are planning to defend these, since no damages are specified, as far as side effect particulars are concerned. Just unspecified illnesses, wreaking havoc on patients' lives. If they named a particular ailment, it's probably on the label anyway. Then you'd be back to the restatement of torts again - unavoidably unsafe products, with warnings provided. They're going to have to provide specifics at some point. The co-morbidities of this patient population are extensive. I don't think this is going anywhere. Just giving our people busy-work.

This drug in particular was a target previously, because we had something listed on our Japanese label that was not listed anywhere else. Oh, the consternation! How dare we not warn the American people about problems that we are warning the Japanese about! Don't we care about Americans?

This went nowhere, because the Japanese label was mandated by the MHW, against our wishes. We didn't believe the Japanese label claim was justified, and we had the data on our side.

Thursday, June 15, 2006

Critical look at Breastfeeding?

My wife sent me a link to this New York Times article on the benefits of breastfeeding, and rather than just replying with a single word like "Interesting!" I sent her the following paragraphs that reflected my views on unfounded claims:

I am glad that there are actual trials underway totest some of the hypotheses that are claimed as benefits of breast feeding.
I'm always reminded of the assumed benefits of hormone replacement therapy, which were assumed to be true fortwo generations, and how shocked everyone was about two years ago, when they were all completely debunkedby a long-term double blind trial.
I'm not trying to downplay breast feeding at all, but so many claims are now being made (like less fussyeaters?!) without solid proof that the public support for breast feeding may come tumbling down if some of them are disproven, if no evidence of benefits hasbeen proven beyond a doubt. Do you get my point?
People love to read an article about something like fat (that a link between fat and certain cancers believed to exist were debunked by study last year) and then say - "See! I knew it all along! Those 'experts' don't really know anything, do they?" It's a profound anti-intellectual streak that runs through Americans. Get the proof, and don't rely on what you think must certainly be true.
My wife said that my reply was "worthy of pharmablogger" so I decided to post it here.

Wednesday, February 22, 2006

The Blogging Irony is Rich!

...And they picked me because of my good looks and charm?!?!

So, here's one of my company's latest initiatives - spinning the blogosphere.

Yes indeedy, my company has hired vendors to monitor disease-related blogs and noticeboards, in order to see what kind of bile is being spewed by consumers, I mean patients!, about our products. And soon, we are hoping to influence some of that discussion. The plan is to hire medical professionals to log on to sites where there is negativity about our products, and try to steer the conversation in a more positive direction. Currently, we are planning to have these hired guns identify themselves as healthcare professionals, but not mention that they are (indirectly) on the company payroll, or connected to us in any way.

This is one of those things that you always suspect is going on in the blogosphere, but it is startling to actually hear that we are going to put it into practice. The net-savvy may catch on to this effort quickly, and identify our guys as company people. I hope so, anyway.

So what's my involvement? I've been asked to help out on a team that will evaluate the regulatory impact of the vendor involvement, specifically from a drug safety perspective. If these vendors are company agents, and one of the medical professionals that we've contracted with reads about an adverse event while participating in a discussion, what should they do? We are choosing to not identify these folks as company agents, at least initially. If they read on a board that product X killed someone's mother, what's the reporting obligation? Does that information constitute a legitimate report, with all of the required elements - identifiable patient, drug, event, and reporter?

The identifiable reporter is the sticking point. An anonymous blogger is arguably not such a reporter, but if I'm chatting with someone, would I have an obligation to ask that blogger to contact me or the company, explaining who I am? That would break the "cover" of our blogger, but good safety reporting should trump, right? If we get an email directed to the company about an adverse event, we record that event in our database, but the report remains "suppressed" unless the reporter also gives us more than just their email address. If we don't get a name or address, we email them back and ask for it. If they reply with that information, the case then becomes part of the database. I believe this is standard industry practice. We need a real name at least.

I'm not sure what our team may recommend. I've certainly browsed websites in the past that discussed my company's products, and even saw people mention what are clearly adverse events, but I never reported them to our safety department. But then, I've never done anything other than read the sites, not participate. Is there a meaningful difference, though? What do you think?