Q: How can you tell when a lawyer is lying?

A: His lips are moving.

That’s just one of about a zillion lawyer jokes I’ve heard in my life*.

But I guess I’m in the minority since most of my interactions with lawyers have been positive. My philosophy is that you do everything possible – in life and in business - to avoid ever having to use a lawyer. But when you do, you make sure to hire the best.

That said, I understand most people’s dislike and distrust of lawyers, especially those who litigate drug and medical liability cases. At the best of times, those attorneys are acting to protect and champion people who have suffered serious side effects from their medications. But a lot of times, they seem to be only a small step up from ambulance chasers.

How does this all relate to drug safety and AdverseEvents? One of the things we’ve become well aware of is the increasing use of FAERS reporting by lawyers. Lawyers have long contributed to FAERS, but it seems of late that the volume of targeted reporting has increased significantly – especially for cases that are in active litigation.

 

Related Read: FAERS - Myths vs. Realities

 

This issue came to light again over the past few weeks as our analyst team worked on their recently released safety review of the Statins drug class. We received and processed tens of thousands of new FAERS case reports from a Freedom of Information Act request with the FDA, but ended up having to discount or discard a number of them from our analysis due to questionable origins. This was especially true with cases of Statins being linked to diabetes.

As Dr. Keith Hoffman, our lead author noted in the report:

"*The large number of type II diabetes reports for Lipitor needs clarification. 4,271 of the 4,488 primary suspect reports linking Lipitor to type II diabetes were just received via our latest FOIA request. Curiously, non-healthcare professionals filed almost all those new reports. This influx of cases should be viewed with caution as it could be related to ongoing litigation. The results prior to the recent FOIA data, however, still showed an elevated association as there were 217 reports listing Lipitor as the primary suspect for type II diabetes with an ROR (disproportionality) of 2.8."

Now, just because a case report is submitted by a lawyer, doesn’t make it wrong or untrue. In fact, lawyer-derived case reports can actually help to identify certain adverse events that take longer to develop, as in the case of Breast Cancer with the drug Prempro. Additionally, while I’m not a legal expert, I assume that any false reports filed by lawyers would be among the first items a pharmaceutical company's defense team would try to have thrown out in active litigation. One could even argue that no prudent lawyer would want to be caught red handed filing falsified or exaggerated reports. So, in some cases, lawyer-submitted reports might even be more reliable than an average FAERS report.

All that said, it is still hard to totally ignore the inherent conflict of interest that may exist by an attorney submitting a report (or, in a lot of cases, many, many reports) for side effect cases that he or she may be actively litigating. It becomes especially troubling when some of those same lawyers then turn around and put out a press release trumpeting the high number of case reports being reported into FAERS for a specific drug-adverse event link without bothering to mention that they and their cohorts are likely the ones responsible for those high volumes of FAERS filings

And the problem isn’t just restricted to the case of Lipitor and diabetes. Here are a few examples of cases where the reporting by lawyers far outpaces the reporting by healthcare professionals:

Drug

Adverse Event

Healthcare Pro Cases

Lawyer Cases

For Calendar Quarter

ACCUTANE

Depression

18

254

Q3 2012

CHANTIX

Anxiety

20

256

Q1 2012

FOSAMAX

Femur fracture

172

919

Q2 2012

NEXIUM

Osteoporosis

21

401

Q2 2012

NUVARING

Pulmonary embolism

17

98

Q2 2012

PROPECIA

Erectile dysfunction

17

102

Q2 2012


You’ll note that all of these are situations with large former or active litigation.

Unfortunately, this type of ‘report padding’ contributes to the ongoing belief that FAERS as a whole can be influenced by outside factors and therefore should not be fully relied upon. We, of course, dispute this on the basis that these situations are few and far between and that due to the large volume of reporting, the overall potential for influence is inconsequential. In fact, we have a paper forthcoming on just this specific issue.

 

Published Research: Stimulated Reporting - The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS)

 

Still, we take steps to mitigate any undue report influencing. In all of our analytic tools, we discount the impact of reports from lawyers. That isn’t a decision we’ve reached lightly, but we’ve ultimately come to believe that the best reporting originates from front-line healthcare professionals and so we emphasize our findings from those reporters. In our written analysis, we always take care to look for and note those rare situations where we think that reporting is influenced by a small group of reporters, as we did in the Statins report.

A couple of weeks ago I wrote about the OpenFDA effort and my concern that letting raw data out into the wild without proper analysis, clean-up, and user understanding of those data could be counter-productive or even dangerous. Report padding by lawyers is just one of those areas of concern – and one of many situations where our team of highly skilled and well trained analysts is invaluable to help unlock the limits and possibilities of the FAERS database.

*On the off chance that you still haven’t yet heard zillions of lawyer jokes, here’s a pretty good list.

 

Related Read: 3 Ways to Increase Adverse Event Reporting

 


Stimulated Reporting Research - Download

Brian Overstreet

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Topics: FAERS

Brian Overstreet

Written by Brian Overstreet