Sunshine’s getting closer, and we’re not talking sandals and patio seating.

With complete rules scheduled to be out this October, the Centers for Medicare and Medicaid (CMS) are spending the summer writing the whos, whats and whens of the Physician Payment Sunshine provisions, which will require drug and device companies to publicly report payments to doctors and teaching hospitals. And since the devil’s in the details, consumers and industry are weighing in with CMS on how to make Sunshine a source of light, not just heat.

On a recent open door call with the agency, industry and consumers weighed in on aspects they think are important to consider as it builds the Sunshine regulations and system. Representatives from Community Catalyst, Health Care for All (Massachusetts), Minnesota Prescription Coalition and the National Physicians Alliance joined representatives of BIO and PhRMA on the call.

Here are some of the key issues we heard (and were underscored by follow-up letters PhRMA and BIO published this week.)

Payment categories
Categories of reported payments should be adequately detailed, clearly defined and discrete: payment for meals, travel, gifts and entertainment should be reported in separate categories, rather than lumped into broader catch all categories, or collapsed into research or education. This will prevent double-counting, make data comparable across companies and provide more accurate and comprehensive info for researchers and consumers.

In its letter, PhRMA proposes collapsing some payment categories: “some meals and travel could be reported as expenses associated with consulting activities, rather than individual line items.” But CMS should be careful, as collapsing categories could make the data less useful and might assign marketing-based payments –dinner at a nice restaurant, sports tickets—the false legitimacy of bona fide research payments.

Other things it’s important to define:

• Payments reported as “research” should meet the standards, in existing federal law, for systematic investigations, which does not include, for instance, marketing research;
• Payments reported as ‘education’ should refer to participation in an accredited CME program;
• “Consulting” should hew to the definition of bona fide services established in a number of widely accepted industry codes (AdvaMed, PhRMA) and include a written contract, deliverables and clinical research protocol;
• Community Catalyst emphasized that the name of the drug associated with each payment should include both the common name (in addition to the technical name) so consumers will recognize drugs they may be taking.

The Vermont disclosure database and Massachusetts’ databases, though not perfect, provide useful examples for CMS in structuring these definitions and categories.

Accuracy
All parties on the call agreed that industry and CMS should work together to make sure the data is as accurate as possible. Establishing detailed unambiguous guidelines and reporting forms as well as opportunities to correct data will help with that. So would coming up with a list of all potential recipients and assigning unique identifiers, industry and consumers said. Consumer groups also want to see aggressive enforcement to ensure accuracy and full participation by companies.

Speaking of all potential recipients, we’re baffled by a number that keeps coming up. Both on the call and in its letter to CMS, PhRMA cited a mid-size company that estimated it would have to report more than 1 million transactions with 300,000 physicians in the first year of Sunshine. Considering that there are a total of about 660,000 in the whole US (BLS), we are both impressed by the reach of that mid-size company and wide-eyed at its marketing budget. Unless they’re going pen by pen (which the law precludes), that’s a lot of dinners. Or research.

The point they’re making is—we think—is the burden of all this data. A million anything is hard to keep track of! But Vermont’s disclosure law provides some evidence that companies are already managing these data well, because though it is a small state, the Attorney General’s office in Vermont manages to collect comprehensive data from 141 manufacturers of pharmaceuticals, biologics and medical devices. And unless they aren’t complying, this means the companies are managing to get it to them. All that’s good news.

Background info
So why do we need Sunshine? That’s an important question to answer on the Sunshine website, we think, so that consumers and other visitors have both context and rationale to frame what – let’s face it—is going to be a lot of numbers.

The risks associated with financial conflicts of interest are inherent in academic-industry relations, but gone unacknowledged, such COIs have the potential to bias patient care and prescribing. The Institute of Medicine has done excellent work framing the rationale for financial transparency.

Both PhRMA and BIO made a point of asking that the Sunshine website describe the benefits of academic-industry collaboration to patient care; we think such commentary, if included, must be counterweighed with evidence of the risks of financial marketing relationships on clinical care.  Both aspects of the relationship are explored in the IOM research, and its process has included all stakeholders.

So what’s next?

CMS has an open comment period this spring and summer with a goal of having completed regulations up by October 1, 2011 so that companies can begin collecting data in 2012.  The first year data is set to be published by CMS September 30, 2013.

More about Sunshine? Check out the Sunshine Act Guide.

–Kate Petersen, PostScript blogger

(This is the first in a two-part blog. Read tomorrow when we look at how industry and other stakeholders weighed in.)

How clear does risk information need to be in direct-to-consumer drug ads? That’s the question the FDA is getting closer to answering as stakeholders weighed in this week on the agency’s proposed rules for presenting risk in broadcast ads.

Twenty-two members (see end of the blog for a complete list) of Community Catalyst’s Prescription Access Litigation Coalition and other supporting groups joined PAL in submitting comments that support the agency’s new proposal to make risk information clear, conspicuous, and neutral in TV ads. The groups also suggested the FDA require that risks be quantified in ads and that the overly-scientific talk be toned down to match the comprehension of the viewer who would have the most trouble understanding the ad.

Many of the provisions in this year’s proposed rule do reinforce the handling of risk information that FDA proposed in last year’s draft guidance. But they are clearer and more concrete, and would go further than the agency’s current standard of “fair balance,” in which drugmakers are only required to present risk as clearly as they present benefits. Specifically, the proposed rules would require that ads use everyday language that is easily readable when in writing and is presented slow enough and prominent enough, whether in writing or audio form, to be easily understood by a consumer viewing the ad. The FDA also proposed a rule that would ban any distracting sounds or images in broadcast prescription drug advertisements.

A step back on why all this matters: remember that the U.S. is one of only two countries that allows drugs to be advertised on TV at all (New Zealand is the other).  And it’s a relatively recent allowance—only in 1997 did the loosening of an FDA regulation about how the major statement about a drug is presented open the floodgates to the sleep butterflies, allergy bees, and PMS symptom balloons.

As was shown by the PAL cases on Vytorin-Zetia, Nexium, Vioxx and Ketek, those changes came with controversy and human costs. Rofecoxib, or Vioxx, was heavily advertised to consumers and physicians in its first year before it was pulled from market after being linked to between 35,200 to 52,800 deaths and 88,000 to 140,000 heart attacks in the US. This caused the Institute of Medicine and other experts to call for an end to DTCA for new drugs, whose side effects are often not known (or in Vioxx’s case, suppressed) until years after they appear on the market.

The link between DTCA and increased prescribing of newer, less-tested drugs has been well-documented, and policymakers, regulators and academics have all expressed concern that the FDA’s inability to regulate and oversee broadcast ads has put the public’s health at unnecessary risk.

But despite this concern and growing evidence that drug ads carry risks beyond the speed-read ones, drug companies came up short on proving public health benefits to their current ad style or offering new evidence-based ideas for presenting risk info in a clear and neutral way. We’ll take a look at what they said tomorrow. Short of all out banning DTCA, the FDA must determine the appropriate standards to best protect the public.

What else could the FDA do?
In addition to offering support to the proposed rules, PAL suggested additional steps that could further enhance the clarity of ads and thus further protect consumers. PAL urged the FDA to address the widely-held myths that the FDA approves all TV ads, and that the government only lets drugs that are “really safe” be advertised on TV, by requiring a disclaimer that “FDA has not approved this ad” for all ads that have not been pre-approved, and including the adverse event hot-line “Medwatch” number in all TV ads.

Though PAL fully supports FDA’s increased vigilance in regulating prescription drug ads, we noted in our comments that there are far more new ads being produced than there are FDA staff members to review these ads. It’s a big imbalance, and though increased funding and staffing of the FDA would help, delayed warning letters that appear long after an ad-buy—such as this Lunesta one–will probably still happen.

To address this issue, the FDA should start using their authority to fine drug companies for ads that violate FDA regulations. Though fining will not increase the speed at which the FDA is able to review ads, it could potentially increase pharma’s compliance with these regulations and exact a price from noncompliant companies, even if the ad in question is no longer being aired.

Those joining Community Catalyst’s and PAL’s comments were:

The Alliance for Retired Americans
The American Federation of State, County and Municipal Employees (AFSCME)
The American Medical Student Association (AMSA)
Breast Cancer Action
California Alliance for Retired Americans (CARA)
CALPIRG
The Coalition of Wisconsin Aging Groups
Connecticut Center for Patient Safety
Connecticut Citizen Action Group
Consumers Advancing Patient Safety (CAPS)
Health Care for All
IUOE Local 4 Funds
Long Island Health Access Monitoring Project
MASSPIRG
New England Carpenters Health Fund
National Legislative Association on Prescription Drug Prices (NLARx)VPIRG
National Women’s Health Network
Oregon Health Action Campaign
Prescription Policy Choices
TeamstersCare
US PIRG

–Emily Cutrell, Prescription Access Litigation

It’s a week of catch up at PostScript – here’s a little link-love before the weekend hits:

A great opinion column appeared in yesterday’s Eugene Register-Guard. The author Gail Hacker M.D., medical director at Lane Community College Health Clinic, does an eloquent job of explaining why drug samples aren’t a solution for her and her underserved patients – and why she feels it’s incumbent on her fellow physicians to turn back pharma’s advances, not the other way around. She writes:

Physicians can afford office supplies and food. Physicians can read journals to get unbiased updates on medications. And if physicians choose to get medical information from a representative of a pharmaceutical company, they can certainly do so without being fed.

Former drug rep talks to docs to Beantown

As we posted earlier this week, former Eli Lilly rep Shahram Ahari was in town talking to medical students and trainees at Boston University, Harvard, Tufts, and Mass General Hospital.  Joe Shortsleeve of WBZ-TV reported on one of his talks and legislation in Massachusetts that would ban gifts to doctors. Watch here.

Congressional clips

Cleveland Plain-Dealer columnist Diane Suchetka takes a look at the proposed federal academic detailing initiative in Congress right now, and talks about the bill with RxP member Allan Coukell, who testified about the practice before the Senate this month.

Coukell also spoke with Pharma Executive about the Physician Payments Sunshine Act, which has been introduced in both houses of Congress.

Business Journal features chief of UMass

John O’Brien, president and CEO of UMass Memorial Medical Center in Worcester, penned this column in the Worcester Business Journal about the process his medical center used to build new, top-tier confict-of-interest policies.

Aussies, AMSA, and Academe

Pharmalot’s been busy, as usual. Here are some recent posts that caught our eye:

Australian Rx is spending big bucks on doctors, too 

AMSA’s how-to on holding pharm-free meetings and conferences

Two MIT researchers’ big idea for restructuring the drug pipeline

Lit review: a false positive?

UC Davis Professor of Medicine Michael Wilkes has this caveat emptor in the Sacramento Bee for those trying to make sense of recent study that found antidepressants little better than placebos in most cases.  Wilkes reads the PLoS Medicine paper as both a case study and cautionary tale about how much we – patients, doctors, even journal editors -  can trust ‘the literature’ in a scientific culture where pharmaceutical companies own the studies and the data they produce.

“Even the process of getting research published in a major medical journal is subject to bias,” Wilkes writes.  “For example, in one recent report, 8 percent of research with a negative result was published in medical journals, compared with 97 percent of research with a positive result.”

This education brought to you by Merck: OK with IOM?

This article from Medical Marketing & Media says the Institute on Medicine is halfway through its slate of meetings on commercial funding of CME, and reports that attitudes on the committee against industry CME may be thawing, but warns that “conflict hawks” like the Josiah Macy Foundation and the Association of American Medical Colleges could still change the status quo.

In recent weeks, two communications to-dos at federal agencies illustrate the good, the bad, and the ugly when government tries to talk to its people about less-than-ideal stuff.

The good: The formation of an FDA risk communications panel by recommendation of the Institute of Medicine and provision of the FDA Amendments Act of 2007.
The bad (and ugly): A fake press conference held by the Federal Emergency Management Association during the California wildfires to promote the fact that it’s handling of the fires was not at all the botched job it became famous for in the aftermath of Hurricane Katrina.

But the FEMA news briefing — to which reporters were invited only 15 minutes in advance and then allowed only to listen to questions asked by what turned out to be FEMA staff — was evidence of the contrary, and just one more foible for the much-maligned agency, which found itself right back in the public stockades.

Unlike the fake news conference, the risk communications panel seems an earnest effort by the Food and Drug Administration to better inform the public of drug safety risks in a post-Vioxx world, where more drugs are coming from more sources than ever before and risks associated with widely-prescribed drugs are being discovered too late in the game.

William Vaughan, a committee appointee and senior policy analyst at Consumers Union, said that the advisory committee, which is scheduled to meet first in 2008, has a full plate.

“Between the new law’s requirements for how to convey adverse events in clinical trials, and the ‘study’ of how to add 1-800 number information to DTC ads (due in March 2008), I think the first year will be busy,” said Vaughan by email.

Self-declared fake news (a la The Daily Show and Colbert Report) has its place, but fake news-making paraded as real inquiry and open forum does not. Risk communication, on the other hand, is a crucial component of a good public health program. We’re all for it.

But recent reports – that the FDA reviews a small percentage of imported drugs, that it’s oversight of clinical trials is in shambles, and that post-market surveillance is hardly systematic — leave one wondering if the FDA knows enough about the risks it’s encountering to communicate them effectively.

Regardless, both announcements — one promising, one farcical — point to a serious effort to get the sound bytes right.  The prickly side of public relations — how the government talks to the people its charged with protecting about things it can’t necessarily protect them from — has taken on great importance in the Information Age and seemed recently to sometimes supersede the securing of the protections themselves.

One hopes that the advisory committee can develop ways to do both – effectively communicate food and drug risks to the public as the agency builds better safeguards and systems of surveillance and regulation. But one note of caution: Section 917 of the FDA Amendments Act, which outlines the purview of the risk communications advisory committee, calls on it to “partner with professional medical societies, medical schools, academic medical centers, and other stakeholders to develop robust and multi-faceted systems for communications to health care providers about emerging postmarket risks.”

And this could turn out good: those listed stakeholders have the potential to be valuable contributors to a better communication of drug and food risks.

Or it could be bad and ugly, since recent reports have shown many of those institutions to be rife with corporate dollars — especially dollars that come from drug and device makers.

By explicitly involving academic medical centers and medical specialty societies in this communication process about drugs that pose risks, the FDA should also be explicit about requiring full disclosure of the conflicts of interest those contributors bring to the table, or better yet, do its homework and only consult med schools and societies that have strong conflicts-of-interest guidelines in place.

As for “other stakeholders,” one can only wonder whether that’s a euphemism for industry.