Friday, March 26, 2010

The Physician Sunshine Act: Time for Hired Guns to Scatter

Obama's healthcare reform package was finally signed into law on March 23. And while Obamacare will have a huge impact (in my view, a positive one) on health care in the U.S. over the next few decades, one component, the Physician Payments Sunshine provisions, may improve medicine even more profoundly.

You might recall that the Sunshine Act was first introduced almost three years ago by Senator Charles Grassley. I've blogged about it several times before, here for example.

The Sunshine act is the culmination of a Herculean effort by Grassley, his staffer Paul Thacker, and many others to disinfect the culture of corruption and commercial influence that has permeated medicine. Click here for a series of links on Grassley's website offering a meandering trip down a memory lane of conflicts of interests. Almost all of the sights along the way pertain to my own field of psychiatry, which consistently provided the lowest-hanging fruit among ethically challenged researchers.

At any rate, now that the Sunshine Act is officially the law of the land, what, exactly, are its provisions, and how might it affect medicine? You can download a concise fact sheet on the act from the Pew Prescription Project website here. Essentially, the law requires that all drug and device companies report all payments made to physicians and teaching hospitals. This includes money for marketing activities, such as promotional talks and consultation, but also includes research grants, "charitable" contributions (which usually come with some promotional strings attached), and funding for conferences, whether CME or otherwise.

Given that so many drug companies have already published registries of physician payments, one might reasonably ask whether this act was actually needed, and whether it will really accomplish anything new. It was, and it will, and here's why.

As noted by Eric Milgram on his Pharma Conduct Blog, the existing company sponsored disclosures provide few details and are formatted in such a way that they are "translucent" rather than "transparent." As a patient, physician payment registries are important because they would presumably allow me to easily look up my doctor, and find out if he or she has been paid to push that new and expensive drug that was just prescribed for me. The current registries don't provide that level of detail, and they make it hard or impossible to conduct efficient searches.

The Sunshine Act fixes this problem. Companies will be required to report names, addresses, the amount of the payment, the date of the payment, and the precise nature of the "service" provided by the doctor. Not only that, but if the payment was for a promotional talk, the company will have to disclose the name of the drug the doctor was pushing. Thus, for example, Eli Lilly's current registry would allow you to find out that a doctor made $50,000 in 2009 performing what is vaguely (translucently) described as "healthcare professional education programs." But the Sunshine Act registry will tell you that your doctor made $50,000 for marketing Zyprexa in 2009. In fact, the Zyprexa speaker's payments will be broken down by date, so you might be able to discover that your doctor got a fat check exceeding your annual salary on the day before he wrote out a Zyprexa prescription for you.

It is this kind of granularity of information that will truly make doctors think twice before pursuing careers as hired guns.


SteveM said...


I have to disagree on the potential effectiveness of the Sunshine Act. The government maintains tons of consumer info data bases. Most consumers never consult them.

And how many sick consumers are actually going to play beat reporter and track down their doctor's pharma relationship history prior to an appointment or getting a script filled?

A better solution would be to mandate that the physician hand out a printout of his/her pharma relationship history to every new patient when they enroll in his/her practice. I.e., attach it to the clip-board as a take-away.

That would impinge on the doctor/patient relationship, i.e., it makes it businesslike. But maybe that's the way it has to be.

Unfortunately, the Act will probably be just a toothless facade. Look at a guy like Nemeroff. He got pounded in the media, but he's probably practicing exactly the same way as he always has. Like Nemeroff, most docs who take money won't care because their patients won't pay attention.

CL Psych said...

Seriously? I knew it was possibly going to be part of healthcare reform, but I figured it would get killed long before the final votes were tallied. Looks like Pharma got almost everything they wanted in this bill, but this is a rare gem of transparency. But we'll see if this works out as planned. There's always a chance something like this will get scuttled.

Chris said...

I never knew such a registry existed. I looked through the list and was quite surprised to see some of my colleagues' names on the chart. I asked them, and they shrugged...
Does anyone know the sites for the other Pharma registries? We beat up on Eli Lilly so much, but I would like to see what other companies have on their payrolls.

Debra said...

This looks good. On paper.
But I agree with SteveM.
This is MAYBE going to make SOME people feel more virtuous, and others possibly guilty.
When I was falling apart three years ago, and my GP prescribed for me (while my shrink pursed his lips...), the last thing that was going through my mind was whether he was in the pocket of the laboratories.
I"ve already said that transparency is not the answer.
How do you build trust and faith in physicians in a society that basically doesn't have faith in... ANYTHING OR ANYONE any more ?
I know this sounds hopeless.
But... I think that as individuals we can LEARN which people to trust (maybe). And I think that most of us desperately WANT to be able to trust other people.
Putting lots of emphasis on illicit behavior, and PUBLICIZING how much you're doing to control illicit behavior encourages people to BELIEVE that illicit behavior is EVERYWHERE.
Is THIS what we want ?
What if "transparency" has gone.. TOO FAR ?

Dr John said...

I don't think psychiatry, organized medicine or pharma runs the risk of being damaged by too much transparency let alone pts, Debra. Leave faith at the church door. Illicit behavior IS all around us.It always has been. It is human nature. It always will be. Shine some light on it.

Debra said...

Na, Doctor John. Another example of the famous glass half empty, glass half full phenomenon.

Debra said...

Oops, my comment about the glass half full/half empty got disappeared.
The continual call for more and more transparency is the symptom of a faithless, "depressed" society.
Careful, you can go to church and.. not have faith in your fellow man.

Virginia S. Wood, Psy.D., Instructor said...

I'm all for the law on general principle, but I don't think it's going to slow anybody down much.

SteveM said...

Re: Virginia S. Wood, PsyD said...

I suppose there' some value to the Act. However, nominally trivial responses by government to systemically hard problems allow the affected stakeholders to continue business as usual through different administrative mechanisms. So the window dressing effectively enables evasion. Which nets systemically negative. Like campaign finance reform, passive oversight is really just stepping on a half-filled balloon.

I've said this several times before, but I guess no one believes me. The root cause of psycho-pharm overuse is no longer the money. The reason is that the immediate psycho-pharm solution has become psychiatry's "Best Practice".

Money may influence what brand of a particular drug class is prescribed but that's it. If a kid is diagnosed with ADHD, (in all of it's elastic descriptions), he's getting a stimulant. Whether it's Adderall or Concerta is a side issue. Most doctors need no monetary inducements to make or concur with the diagnostic and therapeutic determination.

Nah, the database and labeling the "hired gun" docs are well intended, but mostly a diversion from the necessary hard thinking required to modify psychiatry's normative practice. Glom inertia and money together in any domain, and you have a pretty significant change management challenge on your hands.

BTW, the other (mostly pointless) diversion from psychiatry's "Couch in Crisis" is DSM V. An exercise in false precision. That's Titantic deck chairs stuff. Confusing activity with progress. (It's amazing how psychiatric group think is just like everybody else's.)

The APA should suspend DSM 5 and redirect the study efforts toward a reconfiguration of psychiatric practice guidelines with an objective of a more holistic standard of care.

P.S. a significant, distressing irony is that many of psychiatry's ablest change agents probably withdrew from the APA because they got fed up with the status quo. So their voices are not captured and incorporated.

David M. Allen, M.D. said...

The pharmaceutical companies may eventually be forced to divulge which "experts" they pay and how much they pay them. However, the names and payouts are actually of lessor importance for distorting both science and clinical practice than the tricks that the people who are paid use to fool the practitioners whom they influence. Through promotional talks, control of supplements to journals and through "throw away journals," these paid experts are masters of deception. They use a number of tricks to make it sound like mere conjecture is established fact, and they twist the science in a very subtle manner. Of course the companies also influence the methodology of studies that they pay for or promote through the use of deceptive outcome measures and hidden attributes of the patients in the study samples.

Scream said...

I like it! I'll find out just how much Risperdal branded popcorn my shrink ate last year.

Joseph Arpaia, MD said...

I agree with SteveM. The pharma companies have very willing clients, and their clients are not just psychiatrists. Most psychotropics are not prescribed by psychiatrists. Many patients come in wanting the medications, especially the new ones they see advertised (It took me 40 minutes to explain to a patient doing well on Effexor that she did not need Pristiq). Therapists also send patients to physicians for meds if the therapy is not going well, which may be needed, but maybe the therapy needs to be different.

I think the fundamental flaw in the medical model is that it proposes a "neurochemical" balance as the basis for health and ignores the fact that the brain is constantly and dynamically adjusting its neurochemistry and structure in response to the body's internal and external environments.

I try to figure out what kind of learning has created a destructive and self-reinforcing response pattern in my patient. The process of exploring goes in tandem with the therapy, CBT, psychodynamic, hypnosis, biofeedback, as well as medications, which may not be the usual psychotropics (alpha and beta blockers can really help reduce autonomic reactivity).

This perspective makes psychiatry fascinating though sometimes mind-bendingly complex. Look at all the neuropeptide research in the last few years and tell me a monoamine imbalance is THE cause of anything. The brain, body, and mind all work together in an awe inspiring manner and it is a privilege when a patient allows me to look into those processes they are undergoing and attempt to influence them. I just wish the paperwork were less.

David Behar, M.D., E.J.D. said...

Dan: How would this registry change doctor behavior?

Patient says, "Doctor, thank you for the Zyprexa script. I looked up your name. You speak on behalf of Zyprexa, and made $50,000 last year. Did that influence your decision?"

Doctor says, "It is the reverse. I use a lot of Zyprexa because I feel it is the best. Because of my experience, I was selected as a Zyprexa speaker."

Or else, doctor says, "If you have time to research me, you are not sick enough for me. Find another doctor."

Elissa Ladd, PhD, RN said...

I applaud the inclusion of the Sunshine Act provisions in the new health reform law. However, I am also deeply concerned. The law as it is currently written is not applicable to all prescribers and only includes physician specific language. Similar state laws such as in Massachussets, Vermont and Minnesota have language that is inclusive of all prescribers - ie nurse practitioners and physicans assistants.
Currently, there are almost 149,000advanced practice nurse prescribers in the US, a number that it is 50% larger than family physicians. I am deeply worried, that, because of the lack of more inclusive language, marketing efforts directed toward advanced practice nurse prescribers are going to accelerate as pharma will not have to report payments made to this group.
We worked very hard in Massachusetts to pass the Gift Ban law that requires transparency for all prescribers. It is unclear now whether federal law will trump more progressive state statutes.

Pharma Conduct Guy said...

Thanks for the mention and the comment on my blog. I've really enjoyed reading your posts. For the latest update on Pfizer's payments to physicians, check out Pharma Conduct: Which Doctors Received the Highest Compensation from Pfizer During the Second Half of 2009? Keep up the great work!

Anonymous said...

Dear SteveM,
I am a patient. I look. I check all of my doctors, but am particularly vigilant about checking up on my psychiatrist since it is clear the specialty has trouble controlling itself when it comes to taking drug money. I am nothing but a patient. I look. And I send the links to the registries to all of my friends and family members and suggest that they check, as well. Of course, it takes forever since the "search boxes" that these companies add to the registries DON'T FRICKIN' WORK. Nice try, pharma. When you put the name of the first doctor shown on the list into the search box and he doesn't pop up as a search result, and in fact, NO ONE pops up as a search result, it's not too difficult to figure out that the search box is a farce.

Anonymous said...

I had to ask my psychiatrist 3 times on separate occasions whether he was on any speakers' bureaus before he would answer me (about 4 years ago). I'm sure he considered it some kind of invasion of privacy... but you know what? When he finally replied (by email), he listed each company for which he had spoken and the names of the drugs he presented on if I had taken them at some point. At that point, I think he finally got it. I have a right to know what is factoring into his decisions to give me pills that I am going to put in my body and which may cause dangerous side effects. Funny, he doesn't do those talks anymore...

Anonymous said...

"a Herculean disinfect the culture of corruption and commercial influence that has permeated medicine."

Change the words "medicine" with "politics" and this might be a good bill. In my personal opinion, physicians are much more honest, accountable, and resistant to being "bought" than are politicians. How often do government officials literally sell their vote to special interests for monetary benefit in exchange for favorable legislation? Moreover, what's the different between lobbying and handing over suitcases of money to receive favorable legislation and, by definition, a bribe? This is a hypocritical bill. Yes, there are areas of medicine that need to be more honest and accountable. But these pale in comparison to the blatant corruption and morally repugnant behavior demonstrated by Washington and our politicians.