Healthy Skepticism Library item: 17552

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
Allan Coukell On Payments To Doctors & Disclosure
Pharmalot 2010 Apr 5
http://www.pharmalot.com/2010/04/allan-coukell-on-payments-to-doctors-disclosure/

Full text:

Last week, Pfizer began posting payments to doctors for consulting, speaking and clinical trial work, as well as meals and other goodies worth more than $25 (more details). In doing so, the drug giant joins Merck, Eli Lilly and GlaxoSmithKline in publishing such lists, as well as Cephalon (which like Pfizer, did so to satisfy a Corporate Integrity Agreement).
The move also comes just after passage of the health care reform bill, which includes a provision known as Physician Payments Sunshine, which requires drugmakers each year to record – starting 2012 – all gifts and payments to docs and teaching hospitals. Posting begins in 2013 (see more here and here). We spoke with Allan Coukell, director of the Pew Prescription Project, which worked for passage of the provision and pushes safety issues concerning prescription drugs, about these developments.
Pharmalot: What do you like about the Sunshine provision?
Coukell: Well, first, the provision requires comprehensive disclosure of gifts and payments to physicians and teaching hospitals. And there’s a low threshold for reporting $10, which we support. If an individual receives cumulative amounts of more than $100 in a year, everything must be reported. The payments are broadly defined as all transfers of value with a couple of exceptions. Discounts and rebates, for instance.
An example would be payments alleged to have been used to incentivize doctors to increase a dose of epogen would not be required…the law also allows delayed reporting of payments for clinical research or product development. And we think that’s legitimate for bona fide work to protect commercial sensitivity. We would, of course, be concerned if companies started to use that provision as a way to delay reporting more broadly – if all of a sudden all their consulting activites were called product development arrangements.
Pharmalot: What don’t you like?
Coukell: There was a House counterpart (to the Senate version that was incorporate into the health care reform bill) that covered more recipients – payments to other heath care providers, nurse practitioners and pharmacists, who can either write prescripions or influence choice of products and covered payments to disease advocacy groups. Still, what’s passed now is a tremendous advance over what we had before – the industry transparency is a huge step forward. Maybe down the road they’ll turn to these other things I mentioned.
Pharmalot: So do you think this will achieve the transparency that was sought?
Coukell: The law is well written and comprehensive and if the industry complies in good faith then I think we will have achieved most of what we’ve been hoping to achieve with a national transparncy standard. If they start looking for walkarounds or loopholes we’d support Congress going back and tightening it futher…
Pharmalot: Does the Pfizer site achieve these same goals?
Coukell: We welcome any steps toward transparency, whether they’re voluntary or required by a legal settlement. And I think there are a number of companies making disclosures on their web sites and that’s good, but none of these replace a need for a single national database as established by the Sunshine act. One of the things Pfizer is doing that others aren’t doing is reporting payments for clinical research and we welcome that. There’s been concern about a whole array physician and industry financial ties, and while reaearch collaboration is beneficial, we think we need transparency.
Now contrast the Pifzer site with the Merck site. Merck is only disclosing payments for speaking, which leaves a lot of other financial relationships undisclosed. We like the fact you can search the Pfizer site by an individual name, but on the other hand, from the point of view of someone researching this information, you’d like to be able to download a spreadsheet or access a database….so you can understand financial ties and prescribing trend. You want to be able match that up against another database and you can’t do that here, because you can only use their search to find one provider at a time. The Pfizer site is sorted by name, but not by state. As an example, it makes it hard to match payments Pfizer made to doctors in Massachusetts with payment data in the Massachusetts Medicaid database.
But it’s as good or better as what the other companies have done. It includes all licensed healrth professionals and there’s a pretty broad set of payments. It’s also clear what they’re disclosing and there’s a pretty broad set of disclosures. So it’s good, but it’s not perfect. We think the Sunshine provision is a stronger standard with $10 threshold. And with Pfizer, only once (payments to an individual) get past $500 cumulatively does it get reported.
Pharmalot: Just the same, these sites are largely voluntarily. To what extent can this process be relied upon to provide the kind of transparency you and others talk about?
Coukell: We welcome what Pfizer is doing and it’s great they’re doing it and have done it reasonably well. So now, we have four big pharmas reporting and all reporting different info in a different format and that’s still represents a tiny minority out there. Clearly, the Sunshine provision will only work if companies comply with the spirit of the law. The intent is very clear. My hope is that companies have seen this is now the new expectation – Congress wants it and the public wants it and eventually, reporting will be full and complete. But we’re not there yet.