PIs on Pharma’s Payroll

Who is being paid to conduct clinical trials? A review of Investigator Payments and Sunshine Act buzz
[box style=”2″ close_btn=”true”]

Money Matters: It is payday again, so this topic falls under the theme of trial fiscal management. Like a steady paycheck, you can look for blog updates on financial topics in this semi-monthly series.
[/box]

Which Clinical Investigator’s are on Pharma’s Payroll?

Yeah, I’ve Heard of the Sunshine Act. What is it again?

For today’s installment of Money Matters, let’s review some of the Sunshine Act buzz.  Just in case you missed the memo on this one, In March of 2010, the Patient Protection Affordable Care Act passed the house and the senate. The “Physician Payment Sunshine Provision” is part of the act and the whole thing kicks in August 1, 2013.  This consumer protection legislation is built around a call for transparency; patients need to know about payments to their physicians from drug manufacturers (15 categories of payments, in fact, including consulting fees, grants, honoraria, equity, royalties, food, etc.).

Some of the big pharma have already started voluntarily reporting direct and indirect payments to physicians and institutions.  Failure to report moving forward can result in penalties of up to $10,000 per infraction not to exceed $150K annually; the loss of face and perceived lack of transparency with consumers will predictably have greater consequence than these nominal monetary fines.  If the manufacturer knowingly fails to submit, the penalty can be up to $1m.  For further reading on The Physician Payment Sunshine Act, I can recommend this balanced Deloitte presentation report featured by Forbes.

But I only bought the doctor a bagel?

buying the doctor a coffee

Well, there are some provisions in the act that do not require reporting payments of sorts that are less than $10 (to be increased each year in accordance with the consumer price index). One caveat here is that the total amount of payments within a calendar year cannot exceed $100 otherwise all of the small non-reportable payments do become reportable.

So, no more Free Prescription Drug Samples?

The drug samples are not governed under this act (but are part of a separate provision so they are tracked and reported, just not considered part of reportable physician payments) nor are brochures or other educational materials produced exclusively for patient education and hence not reportable.  Pens, mugs, notepads, etc. are reportable so there will likely be (and we have already seen in the last few years) less swag lying around at the doctor’s office.

Getting Paid is a Bad Bad Thing. Yeah, not so much.

When I am reviewing potential investigators for a trial, I need to assess whether or not they will be good advisors, whether or not they will provide appropriate oversight and strictly follow the protocol design, and also predict whether they will recruit adequate and appropriate subjects.

So as a Clinical Operations Manager, should I be excluding physicians who have accepted payments from pharmaceutical manufacturers?  Absolutely not.  If anything, having deep relationships with pharma may be a predictor of better trial compliance and proof of trust.  I like getting paid for my contributions to clinical research and so do our sites.  Higher payments can correlate with higher quality.  This isn’t a hard and fast rule so it is up to my team to objectively review all the details in a proper site qualification. Knowing a Principal Investigator’s history of cash and other sorts of payments is just one data point in evaluating them as a potential investigator.  Having and processing the information about which physicians have accepted payments and what amount gives me a competitive advantage.

Would it be Better to Work With an Investigator who is Unknown to Industry?

It is unlikely that I would have better outcomes with a new Principal Investigator (PI), one who has never accepted any payments from any other drug companies.  At my current company, we are evaluating new medications for severely ill patients.  I want to work with experienced and compliant investigators to reduce statistical noise in my trials.  A PI with no recorded payments of any sort may also have no documented training in clinical trial conduct (There is an exemption that states that payments for clinical investigators don’t have to be disclosed until the date of FDA approval or clearance so we still need to ask about previous clinical trials in our qualification of new PIs).  I’m not opposed to working with new investigators but I am also absolutely not ruling out investigators who have recorded payments from pharma.

Is my Doctor on Pharma’s Payroll?

There is a lot of publicly available information for researching your own physicians; just Google them.  Here are a few of the resources I return to again and again when looking for background information on my physicians.  Have fun but don’t jump to conclusions; payments to physicians are not necessarily bad:

Dollars for Docs Interpret the data as you will, but the site is slanted towards misrepresentation
National Provider Identifier Registry
FDA Clinical Investigator Inspection Search
ClinicalTrials.gov search under ‘Sponsor/Collaborators’ or ‘Locations’ for the Last Name
PubMed US National Library of Medicine Journal Articles Search
Annals.org Annals of Internal Medicine Journal Search

Your thoughts?

I’d love to have your thoughts in the comments here or to continue the conversation via email.

You may also likeFrom the Lead CRA Blog

Please follow me on the Clinical Operations Toolkit Facebook page

Decluttering my Desktop
Find Files Faster
About The Author

Nadia

Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.

2 Comments

  • Ray-ray

    March 20, 2014

    I don’t see the link between big payments and good performance! This is clinical research and Money corrupts everything here!

    • Nadia

      Nadia

      March 21, 2014

      Hi Ray-ray, thanks for stopping by and weighing in. I don’t agree that money corrupts research. The endeavor of advancing an investigational product to market is expensive and the costs along the way need to be reimbursed. I am completely in favor of reasonable payments and making investigators whole for their major contributions to clinical trials and drug development.

      I do absolutely agree that big payments to not necessarily beget good performance. In clinical operations, we oversee the selection of qualified clinical investigators, establish appropriate milestones, and measure/adjust performance along the way. Clinical research is not a transaction and the relationships with investigators have to be managed and developed throughout a trial lifecycle; many touchpoints translate to good performance.

Leave A Response