I'm Back! Now Let's Talk Sunshine.

Hi readers. Yesterday was my last day at The Pew Charitable Trusts--timed to coincide with the launch of the Open Payments website.

Before commenting on the website, here are some quick impressions about my last 2 1/2 years in Washington: fascinating, sometimes frustrating, often exhilerating, and overall just a great introduction to the arena of politics. Pew is amazing--work there if you can.

But now, let's talk Sunshine.

When I said my goodbyes to you in March of 2012, the Open Payments website was already delayed, and much of my work at Pew was aimed toward preventing that delay from stretching to infinity and beyond.  The site was finally launched yesterday, one year behind schedule--not too bad.

The website is not what most people were originally anticipating. Most of us were expecting a big search box where you could type in your doctor's name. Instead, what we have are downloadable spreadsheets of varying complexity. CMS--the agency in charge of the site--plans to make it more user-friendly within a month or so.

At this point, the best way to begin to peer through that complexity is by going to Propublica's website, where you can benefit from the wisdon of the undisputed guru of physician payment data-mining, Charles Ornstein.

The main headline is that companies have spent $3.5 billion on various "transfers of value" to physicians and teaching hospitals during the last five months of 2013. That sounds like a lot of money. It is. For fun, I did a back-of-the-envelope calculation and determined that companies spent $23 million/day, or roughly $1 million/hour over that period.

But let's not go overboard. Of that $3.5 billion, about $1.45 billion was for research, and roughly $1 billion was equity that physician-investors have in drug or device companies. That leaves about $1 billion in other payments to doctors and teaching hospitals. These are the potentially dubious payments.

So what do we make of these amounts? How do we judge them? Because ultimately, the reason the Sunshine Act was passed in 2010 was that not all drug company payments are morally equivalent. We must look at the data and judge which payments appropriate and which are not. 

Next post, we'll go through each category of business activity listed in the website and start to assign some moral valence to the payments.  

Preview: The Open Payments website makes companies look better than I would have thought. Stay tuned.

The Gig is Up: The Sunshine Act Will Include CME Payments to Doctors

Those of us who have followed the progress of the implementation of the Physician Payment Sunshine Act have been acutely aware of one potential loophole: drug companies might try to hide payments to doctors for industry-supported CME activities. That’s because these payments are not "direct" payments to doctors, but rather indirect payments.

In a 2007 op/ed piece for the New York Times, I referred to this arrangement as a money laundering scheme: “Essentially, this is a new twist on that well-known instrument of corruption, money laundering. Drug companies don’t directly pay doctors to teach courses. Instead, they pay someone else to cut the checks. Similarly, the drug companies don’t explicitly tell doctors to say good things about their products. Instead, they hire a company to write good things about their products and to pay doctors to deliver the messages.” 

Nothing substantial has changed about this cloak and dagger payment process since 2007—other than the fact that the total amount of commercial support for CME has dropped substantially, from a high water mark of $1.2 billion in 2007 to $830 million in 2010—a decrease of  37%. But $830 million is still a chunk of change, and some unknown portion of that sum is paid directly to physicians by the CME provider.

Therefore, those of us in favor of transparency were able to breathe a sigh of relief when CMS recently unveiled its proposed regulations. Drug companies will, in fact, be required to report payments that flow through third party entities and end up in doctors’ pockets, as long as the company is aware of the identity of the doctor. And how could they not be aware? ACCME requires all CME programs to publically disclose the identities of both the industry supporter and the faculty—meaning that companies will eventually always know which doctors end up partaking of their “educational grants.”

In closing this loophole, CMS officials were hardly acting on their own—they were simply implementing the Sunshine Act as it was approved by Congress. In fact, if you look at the text of the Act, it is hard to imagine any reasonable interpretation other than CMS's. Here’s the crucial opening paragraph of the law, which sets the context for the entire Act:

“On March 31, 2013, and on the 90th day of each calendar year beginning thereafter, any applicable manufacturer that provides a payment or other transfer of value to a covered recipient (or to an entity or individual at the request of or designated on behalf of a covered recipient), shall submit to the Secretary, in such electronic form as the Secretary shall require, the following information with respect to the preceding calendar year….” (my italics).

The language is technical, so let's unpack it a bit. “Applicable manufacturer” means a drug or device company. “Transfer of value” means giving a doctor anything of value, including cash, meals, and gifts.  “Covered recipient” means a physician, dentist, podiatrist, optometrist, or chiropractor—all of which are professionals covered by the law. So far, the law is saying, in common parlance, “Any drug company that gives money or something else of value to a doctor…will have to report this to the government.”

But the framers of the Act went out of their way to acknowledge that sometimes these payments are indirect, and that such indirect payments should be reported as well. How else could you interpret all the language in parentheses: “ …Or to an entity or individual at the request of or designated on behalf of a covered recipient.”  To translate again: the Act is saying here that drug companies must report payments to any “entity” (eg., a MECC, a medical society, a non-profit organization) that takes payments from drug companies when those payments are actually “designated” for a “covered recipient”, ie., a doctor.

It seems quite clear, but of course both drug companies and those MECCs dependent on drug company grants are viewing this issue differently--see, for example, Tom Sullivan's take in this article on his blog Policy and Medicine. So stay tuned. Hopefully CMS will stick to its guns and issue final regulations that will not allow drug companies to cast a shadow on a major source of physician payments. Let the sun shine in!

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.

Big Troubles at Mass General

The blogosphere is buzzing with the Sunday New York Times article by Gardiner Harris and Benedict Carey in which we learn that three child psychiatrists at MGH did not report most of the payments they received from drug companies on conflict of interest disclosures.

I have been reading the pertinent documents in the Congressional Record in order to figure out whether these three psychiatrists, all of whom I know from my training days at MGH, behaved very badly or just a little badly. All three are highly intelligent and committed researchers. During my residency days, I received a few lectures from Dr. Wilens, and he is a good, solid person. I didn’t have as much contact with Dr. Biederman or Dr. Spencer.

The issue at hand is a little complicated, but here’s my understanding. Whenever a researcher is awarded money from the NIH (National Institutes of Health) to conduct research, the employing institution (in this case, Harvard) must obtain detailed conflict of interest disclosures from these researchers. After all, this is public money, and the NIH wants to make sure that our hard-earned tax dollars are being spent responsibly. There are two big rules that are relevant to this controversy. Rule One is that researchers cannot accept more than $20,000 in payments from a drug company whose drug they are funded by NIH to research. Rule Two is that they must disclose any payments of $10,000 or more that they have received from any drug company.

The most serious of Senator Grassley’s allegations (Grassley being the ranking member of the Senate Finance Committee) is that all three doctors broke Rule One. They all conducted NIH-funded studies of Eli Lilly’s Strattera (atomoxetine) for ADHD during years that they also received payments from Lilly—payments that exceeded the maximal payments permitted. If this is true, it represents a pretty significant breach in the integrity of the NIH funding process.

The other allegation is that the doctors chose to reveal only a fraction of all the money they actually received from drug companies. When Grassley and his aides looked over each doctor’s yearly disclosures, it appeared that they received no more than a combined few hundred thousand dollars over a seven year period. However, when the doctors were asked to look back over their financial records for the Senate Finance Committee, they suddenly discovered quite a few overlooked checks, to the tune of $1.6 million each for both Biederman and Wilens, and $1 million for Spencer.

I am inclined to give them the benefit of the doubt on this issue. I don’t think they hid these payments out of greed, sneakiness, or the thrill of getting away with something. They probably simply didn’t believe these earnings were relevant to the NIH funding they received. If you look at the charts detailing each doctor’s income in the Congressional Record, you can get a sense of why this might have occurred. Many of the large payments were not from drug companies directly but from third party medical education companies, with vague and uninformative names such as “Phase 5,” “MedLearning,” “Strategic Implications,” and “Primedia.”

For example, in 2005, Dr. Wilens received only $9500 directly from Eli Lilly, but $70,000 from “Promedix,” and $37,750 from “Advanced Health Media.” A little googling reveals that Promedix is a division of Advanced Health Media, which in turn is a company that does “speaker program management.” So Wilens received a total of $107,750 for speaking programs, but the disclosure does not allow us to track things any more specifically. Who was he speaking for? Was this CME or promotional? How did this relate to his NIH funded research?

I’m willing to bet that most of this money came from Shire, because I have seen Wilens, Biederman, and Spencer headlining many Shire-supported CME programs on ADHD. (See here for some background).

So the psychology of non-disclosure may have gone something like this: “I’m doing NIH-funded research on an Eli Lilly drug, so I’d better be scrupulous about disclosing payments from Lilly. But the marketing work I’m doing for Shire is not relevant to my NIH research, and it’s indirect CME money anyway, so I won’t disclose that.”

A little sleazy? Maybe. Malevolent? I don’t think so.

The big lesson here is that Congress must pass the Physician Payment Sunshine Act, because we will never be able to grasp the extent of the complex financial relationships between companies and thought leaders without this legislation.

PhRMA Endorses Transparency Bill; CME Loophole Persists

The drug industry’s main trade group, PhRMA, just announced that it will support a congressional bill that would publicly post all drug company payments to physicians. The bill, the Physician Payments Sunshine Act, was initially resisted by drug companies, but recently Eli Lilly announced its support of the legislation, and both Merck and AstraZeneca have followed suit. Given these developments, and given that the bill has substantial support in the House and Senate, it is virtually certain of passage.

What would this bill actually do, and what are the implications in terms of scaling down the extent of corruption in industry-supported medical education?

You can view The Prescription Project’s fact sheet on the bill here, and coverage of the latest developments from the excellent Politico website here. Essentially, the bill forces drug companies to report any payments or gifts to physicians, as long as they are valued at more than $500. This would include payments for speaking, consulting, travel reimbursement, and various other activities. Payments for clinical research and the value of drug samples would be exempt from disclosure requirements.

It's a great start, but unfortunately, the bill misses one of the largest sources of industry payments to physicians: payments to third party medical education communication companies (MECCs). This is the money laundering scheme used by industry to make drug advertising look like objective continuing medical education. A drug company awards a MECC an “unrestricted educational grant” for a conference on, say, antipsychotics. The MECC then hires physicians as faculty members who can be counted upon to say good things about the sponsor’s drug. The checks to these physicians are then nominally written by the MECC, although the drug company is the actual source of the money. These payments typically begin at $1000 and head skyward from there. And this doesn’t include additional thousands for reimbursement of lavish travel expenses. In 2006, drug companies funneled $1.2 billion into this sleazy shell game. In its current form, the Physician Payments Sunshine Act will allow these payments to go completely unreported, because it focuses only on direct financial transfers between drug companies and doctors.

On the positive side, all non-CME, explicitly “promotional” talks will be subject to the bill’s provisions. This means that patients will be able to look up their doctors on the Physician Payments website, and find out exactly how much money they accepted from which companies, to do what. I predict a rapid depleting of the speakers bureaus of drug companies, because most doctors will be too ashamed to have this information made public. Only the most mercenary of the hired guns will remain, and they will rapidly lose their credibility as their audience members connect the dots between their financial incentives and the promotional content of their talks.

But in what could well become a case study for the Freakonomics column in the New York Times, the bill actually creates strong financial incentives to further distort medical education, precisely the opposite of what is intended. This is because hired guns who do not want to be exposed will simply shift from promotional talks to CME talks, where the third party MECC umbrella will continue to hide them from the “sunshine” of the bill’s requirements. The drug companies will follow the speakers, and we will see commercial support of CME mushroom. Good news for the MECCs. Bad news for medical education.

Luckily, the bill’s language is still being tweaked, and I hear rumors that Senator Claire McCaskill, one of the co-sponsors, is pushing for inclusion of a provision requiring disclosure of CME payments.

Stay tuned.