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

While physicians may be more wary of marketing relationships with industry, a new national survey of nurse practitioners shows that the group, who outnumber family docs, still has extensive ties with the industry and holds favorable views toward marketing tactics such as drug samples, sponsored lunches and dinners, and industry-backed continuing medical education. Considering nurses’ expanding role as primary prescribers in the U.S. health care system and the way the Sunshine provisions in the health reform law require reporting of only physician payments, these data may presage a turn in the industry’s promotional efforts away from physicians and toward nurses.

In the survey of nurse practitioners, “Under the Radar,” conducted in 2007-2008 by Elissa Ladd et al and published in the latest issue of the American Journal of Managed Care, 96 percent of respondents reported having regular interaction with the pharmaceutical industry, and the same number attended an industry-sponsored CME program over the prior five years. Forty-nine percent of nurse practitioners reported that they regularly attended pharma-backed lunches or dinners in the previous six months, and 48 percent said they’d be more likely to prescribe a drug that was highlighted at such a lunch or dinner event.

While the nurses’ survey does not give us trends, it does suggest an openness to industry marketing that may be waning, if slightly, among physicians. In a widely-cited 2004 survey by Eric Campbell et al in the New England Journal of Medicine, 94 percent of physicians reported having a relationship with the pharmaceutical industry. According to a November 2010 follow-up survey in the Archives of Internal Medicine by the same authors, fewer physicians (about 84 percent) reported relationships with pharmaceutical companies and involvement in all domains—samples, gifts, payments, and reimbursement—had decreased over the previous five years. Still lots of ties, but less of them.

Take samples. The number of physicians accepting samples went from 78 percent in 2004 to 64 percent in 2009; that reduced percentage nearly matches the proportion of nurses—66 percent—who reported taking samples between 2007-2008. So while we can’t see trends in the nursing data, we can surmise that policies around physician-industry relationships, coupled with nursing’s favorable attitudes toward promotional activities and its growing prominence (there are now more prescribing nurses in the U.S. than family physicians) could push both exposure and marketing attention toward the nurses’ corner.

If there is a salt-grain alert, it could be that the nurse survey represented a much smaller pool of respondents (263) than the 2009 AIM physician follow-up (1,891). And as they were independently designed and conducted, the surveys are necessarily snapshots, and not designed for perfect comparison.

Still, a few general lessons are worth noting here. While the spotlight has been trained on physician-industry relations in the last six years, the fact that prescribing nurses still hold a very positive attitude toward and active engagement with pharma marketing is an important signal for the nursing profession and those concerned with the influence of marketing to look more closely at the industry’s interaction with prescribing nurses.

State and federal policymakers moving to curb the influence of marketing on prescribing should keep in mind the implications of a group of prescribers whose numbers and prescribing power in the health care industry is growing, but whose involvement with the industry has largely flown “under the radar,” and make sure that policies don’t make a loophole of the nursing profession, and undercut the regulations that seek to protect the integrity of the patient-prescriber relationship.

–Kate Petersen, PostScript blogger

An investigative outfit’s consolidation and analysis of payments that drug companies made to doctors has refocused attention on state efforts to shine light on the financial ties between doctors and drugmakers.

Currently three states—Minnesota, Massachusetts, and Vermont—require drug companies to disclose payments to prescribers and make some of that data public. While each of these states takes a different approach to collecting and making the payment data available to the public (more on that here), information from all three have been extremely valuable in demonstrating the dimensions and scope of these marketing relationships. And now a new value to the state data has emerged: demonstrating that pharma isn’t keeping very good track of who it’s been paying what.

The ProPublica report in Monday’s Minnesota Star Tribune and here online found a series of big discrepancies between what a company said it paid a doctor on its website and what it told the state of Minnesota it paid the same person. Right now, ProPublica can only crosscheck the seven companies that have posted payments on their own websites.

Big pharma has been caught off-guard again. Like the reports earlier this fall that hundreds of sanctioned doctors were still making cash on the side with speaking gigs, some companies seem not to know who they are paying what. Despite spending billions of dollars to develop and manufacture drugs, and spending other billions to market them to prescribers and armchair prescribers (i.e. consumers), the folks who brought you Lipitor, Effexor, Zyprexa and that one that will send this to your spam folder, don’t seem to know what they paid docs to give PowerPoint presentations.

The report also gave some doctors the opportunity to say strange things:

Dr. Randy Shapiro, one of the doctors whose take was under-reported to Minnesota told ProPublica that if anything, patients should want to see their physician among the speakers on these payment lists. “If their doctor is not on the list,” he said, “maybe they should look for a different doctor.”

That’s…an interesting take. We’re not aware of any links between participation on speakers bureaus and clinical excellence or bedside manner. Based on some earlier findings (we’re thinking of the Risperdal, Biederman, and all these folks) we’re not sure that would be our prescription. (In fact, based on the mounds of evidence about the influence of even small gifts, we tend to think finding a pharm-free physician or one who is engaged on clinical projects she’s happy to tell you about, and not just the PowerPoint circuit, is the way to go).

And the top-paid physician in Minnesota, Dr. Todd Hess, a pain specialist in St. Paul who made over $364,000 last year, told ProPublica that the media is unfairly lumping these educational talks with the old pharma ways.

“This is a mountain-molehill thing,” Hess told ProPublica. “I know the problems of the past. I know what pharma has done to change those. People just can’t get over the past.”

Maybe he knows something that we don’t know, but it might not be a problem of a press corps with a too-long memory. Recently, awkward chuckles went up through the pharma news sphere when word of Abbott’s celebratory pig roast for a Maryland doc who managed to implant 30 stents in one day showed up in a Senate Finance report.

That wasn’t back in the high-flying, anything-goes 90s depicted in the recent pharma-flick “Love and Other Drugs.” It was two years ago. Teachers are warned not to grade 30 papers in one day (and this blogger can vouch for that advice). We’re pretty sure, like the Senate Finance Committee, that 30 stent operations in a day is an even worse idea.

Despite what headlined docs and pharma spokespeople say, there is still a lot of money changing hands for things of questionable clinical value. The thing about the ProPublica data is: it’s current. The stories about hundreds of millions of dollars going to sanctioned docs, the Massachusetts reports that just came out–those payments are all from 2009-present. And now we see it isn’t being recorded very well. Maybe some of these companies really did believe no one would bother to look.

“If all the reports are true I’m outraged,” Maryland delegate and physician Dan Morhaim told the Baltimore Sun.

According to the Sun, “Maryland’s General Assembly has explored limiting financial relationships between doctors and drug or device makers, but no laws have come from it,” but Morhaim said ‘it’s a continuing topic of interest’ in the next legislative session.”

While there are real and beneficial relationships between academic medicine and industry, Pew Prescription Project Allan Coukell told a Memphis paper this week that “patients deserve to know if their doctors are receiving money from drug companies.”

And patients and state lawmakers are right to be concerned about what add up to significant financial exchanges between industry and doctors willing to pitch drugs to their colleagues. We wouldn’t be surprised to see more states explore ways to keep track of or limit the types of payments industry makes to doctors. Regardless, pharma should take this opportunity to get its house in order so everyone’s on the same—accurate—reporting page by the time Physician Payments Sunshine kicks in.

–Kate Petersen, PostScript blogger

Three headlines that caught our eye over the weekend:

FDA report suggests it’s not quite time for J&J to cut the ribbon on its brand-recovery campaign. The New York Times looks at the most recent inspection report the agency filed on J&J’s troubled Puerto Rico plant, which documents “distribution of drugs that failed quality requirements, a failure to identify product defects during routine testing, failure to detect incorrect expiration dates on drug labels, failure to adequately investigate product problems, failure to follow laboratory controls and inadequate training of lab staff.” The report goes through early November; earlier this month, more manufacturing problems led the company to make another huge wholesale recall of more than 9 million bottles of liquid Tylenol, 4 million packages of Benadryl, as well as Motrin and Rolaids products.

As concerns of nationwide counterfeiting problems grow, India commissions a feasibility study on a federal computerized distribution system to better track drugs through the supply chain. In addition to this survey of stakeholders, India’s drug regulatory agency, DCGI, is also encouraging smaller drug companies to use national subsidies to help with set-up costs of a barcoding system. “Both developments tie in with recent initiatives by the Indian government to try to improve the transparency of India’s pharmaceutical sector – a critical supplier of essential generic medicines for countries around the world – and shake off its image as a hub for counterfeit and substandard drugs,” Securing Pharma writes.

And American Medical News, the online news arm of the American Medical Association, sees a significant drop in doctors’ financial ties to drugmakers. Using follow-up survey data on commercial CME, meals, and samples in a recent Annals of Internal Medicine article, the AMN suggests the last five years have seen a sea-change in the way industry markets to doctors (or conversely, the way doctors accept industry’s advances.)

But though there may be a trend here, recent payment data from Massachusetts’ disclosure law and aggregators like PharmaShine and ProPublica suggest that hundreds of millions of dollars are still going from industry marketing budgets to physicians’ pockets each year.

The future federal sunshine law, as well as state and other AMC public disclosure regs (which barely got a paragraph here) are key: not only as potential driving factors in the trends that AMN is pointing to, but as sources of data that suggest the drop off of physician-industry coziness may not be quite as simple as the AMN suggests.

The article also gives a lot of space to the voluntary PhRMA conduct code and AMA’s own code, both of which are relatively weak and unenforceable compared to many academic medical center policies, and which were, chronologically, responses to pressure for system reform rather than drivers of such change, as the AMN article implies.

–Kate Petersen, PostScript blogger

Drug and device companies paid Massachusetts physicians more than $16 million in the second half of 2009, the Bay State’s newly-unveiled disclosure database shows (for those of you ready to bookmark: http://mass.gov/dph/pharmamed/). Health Care for All’s got first impressions over at A Healthy Blog:

“While other states have come out with data,” they write, “Massachusetts’ is the first database that is fully searchable by provider name, company name, or payment category, and is the nation’s most comprehensive.”

Massachusetts joins Vermont and Minnesota among states that publish pharma payments made to doctors, and as researchers, journalists and consumers begin to comb the data, more pieces of the picture about industry marketing payments to health care providers will fall into place. The data and, importantly, the database itself–its organization, user-friendliness, design and maintenance–offers one working draft for the designers of the federal Physician Payments Sunshine database to copy, improve on, or tweak as they build the federal version, and we’ll be looking at the database with an eye toward its blueprint-ness in the coming weeks and months.

On your mark, get set, download…

–Kate Petersen, PostScript blogger

Having revealed that more than 250 physicians with serious sanctions against their medical licenses are on the speaking circuit of some of the nation’s top drug companies, ProPublica and a series of news outlets around the country have put the question to the companies: When it comes to speakers bureaus, who’s keeping the gate?

One company said that they had a previous plan for gatekeeping.  So what happened to it?

These are not nitpicky violations we’re talking about—a CME credit here or there, unpaid dues. One doctor listed in the ProPublica database, Kenneth Fisher, is paid by GlaxoSmithKline and two other companies despite having been on probation for nine years in the state of Arizona for a series of serious misconduct charges, including sexually violating HIV patients.

This is the sort of thing that makes landlords do background checks. And if landlords can do them, why not drug companies spending millions to have certain doctors talk about their finely-tuned brands?

“Let’s be honest, they do a lot of very complicated things very well,” Hastings Center bioethicist Josephine Johnston told ProPublica. “These are the people who have figured out how to get prescription data for individual doctors so they can send drug reps to target particular doctors in particular ways.”

Good point. Data-mining isn’t exactly a simple (or transparent) marketing strategy, but the industry has it down, spending millions each year to buy individual prescriber records and pairing them with prescribers’ names so that they can tell how much Lipitor Dr. Doe is writing, and how many more scrips she’s likely to write (more on data-mining here). But complicated things in service of marketing that works, and complicated things that might make effective marketing harder are two different matters (although one wonders if there aren’t easily 250+ blemish-free docs willing to step in to fill vacancies on the speaking circuit).

Perhaps the failure to do background checks—the casualness it conveys—underscores just how big these marketing budgets are. That the $7.1 million these seven companies gave the sanctioned docs in the last two years isn’t enough to inspire thorough background checks suggests the sums don’t make industry’s reputation radar. Pharma has been cutting sales rep jobs for awhile now, but let’s not mistake that for cutting marketing spending—doctor-to-doctor talks work, and they are still going strong: The ProPublica aggregator totaled up $282 million in speaking fees from seven companies between 2009 and 2010.  And there are more than 70 drug companies in marketing in the U.S., meaning there’s potentially a lot more money on the table that we will learn of when state disclosure laws and the federal Sunshine laws kick into effect.

None of the seven companies whose payment data was reported offered an official to speak with ProPublica (a sign as a reporter that you’re on to something). But among the general statements they did make, we couldn’t help our jaw from dropping a little as we read the range of reasons companies gave for not doing background checks on their speakers:

Pfizer and Glaxo noted that some of the physicians listed no longer speak for them.

Pfizer also noted that none of its doctors had been banned from participating in federal health programs.

Merck & Co. said it had “previously initiated” plans to conduct more frequent background checks and “is exploring additional capabilities.” The firm would not be more specific.

Johnson & Johnson, Glaxo and Cephalon each said that they are always looking for ways to enhance their selection of speakers.

In an e-mail, Glaxo spokesman Kevin Colgan added that disciplinary actions alone shouldn’t be the basis for excluding a potential speaker or consultant.”

Glaxo and Lilly each made payments to more than 100 of the 292 sanctioned docs ProPublica identified.

After reading about Dr. Fisher’s record, we’d be interested to see the criteria GSK does use to exclude a potential speaker or consultant.

–Kate Petersen, PostScript blogger

Using public reports from seven drug companies about their payments to doctors, a wide-ranging investigative report by ProPublica revealed this week that tens of thousands of U.S. doctors and health practitioners were paid over $250 million by pharmaceutical companies since 2009, much of it to give promotional talks for the companies. Among them, ProPublica found that hundreds have been cited for serious sanctions and misconduct, lack expertise such as publications or even board certification, or are in violation of their medical institution’s or hospital’s conflict-of-interest policies.

This report, in cooperation with the Boston Globe, the Chicago Tribune, NPR, PBS Nightly Business Report and Consumer Reports, suggests that when it comes to selecting opinion leaders, drug companies have often created their own from sheer volume of talks a doctor is hired for. The report also suggests a eye-opening failure to perform due diligence in investigating the records of those speaking to other physicians about their products. ProPublica reports:

A review of physician licensing records in the 15 most-populous states and three others found sanctions against more than 250 speakers, including some of the highest paid. Their misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients. Some of the doctors had even lost their licenses.

More than 40 have received FDA warnings for research misconduct, lost hospital privileges or been convicted of crimes. And at least 20 more have had two or more malpractice judgments or settlements. This accounting is by no means complete; many state regulators don’t post these actions on their web sites.

Only two of the seven companies said they looked routinely into state licensing boards before hiring doctors to speak for them.

These frightening findings—made possible by the fraction of payment data currently available from companies–remind us that complete and mandatory disclosure of payments made to doctors is a critical crosscheck for consumers who want to know whether their doctor has been paid by industry, and for public and private payers and institutions interested in the compliance of health practitioners with state or institutional policies. ProPublica collected the data from the seven companies that publicly report some physician payments—AstraZeneca, Cephalon, GlaxoSmithKline, Eli Lilly, Johnson & Johnson, Merck and Pfizer—in a database that consumers and medical school compliance officers can use to make these searches.

That’s a good thing, but these companies represent just over a third of prescription drug sales in the U.S.; extrapolating, significantly more money trading hands isn’t being captured. That’s why the Physician Payments Sunshine law, which will require all U.S. drug, device and biotech companies to disclose all payments over $10 to physicians beginning in 2013, is so critical to completing the picture.

Despite the hundreds of millions of dollars that doctors are being paid to give drug talks—many making the equivalent of a second salary to do so—a survey done by Consumer Reports as part of the series suggests that consumers are clearly fed up and understand the dangers of bias that attend marketing relationships between industry and physicians: Nearly three-quarters of Americans are concerned that taking pharma money affects patient care, and more than two-thirds think that their doctor should tell them if he or she has been paid by a company whose drug they plan to prescribe.

The survey underscores a 2008 Pew Prescription Project consumer survey (pdf) that showed the public was similarly concerned that being paid to talk about a company’s drug could bias their health provider.  In the absence of professionwide self-regulation by physicians, many of whom continue to take these large sums, medical schools, hospitals, and states have stepped forward, creating new policies and regulations that put distance between doctors and drug marketing departments.

The American Medical Student Association Scorecard, which assesses the conflict-of-interest policies of every U.S. medical school each year, is a powerful tool that consumers and administrators can use alongside ProPublica’s database to check compliance of their doctor with his or her school’s policy, and to get ideas for how some medical centers have gone about strengthening their policies.

One example is Harvard Medical School’s new policy banning faculty from doing industry speaking gigs, which goes into effect early next year. Using the 2009-2010 data, the Boston Globe found that nearly half of the $6.3 million paid to Massachusetts physicians went to those affiliated with Harvard, and several doctors told the Globe they had stopped the speaking arrangements in order to comply with Harvard’s new rules.

But the Globe story also showed that just having a rule or strong policy isn’t enough. The Globe found that numerous clinicians whose Massachusetts hospitals had rules against giving promotional talks, including Beth Israel Deaconess Medical Center and Boston Medical Center, continued to perform such talks for drug companies.  These institutional policies and state laws need diligent and rigorous enforcement.  Having good intra-institutional compliance structures and information-sharing among medical schools about implementation are key to the success of these policies. Disclosure tools like Sunshine database, when it is complete, and others like ProPublica will reveal health providers who violate these rules.

One final point: the fact that the news outlets here found so much misconduct connected to drug company money in the incomplete records they have suggests there may be much more that remains undiscovered. Rigorous enforcement of existing policies and laws, and comprehensive disclosure from good work like ProPublica’s database and the future Sunshine Act, have never been more important in making sure that patients are getting the best medicine from their doctors, and that physicians are getting the best unbiased information about drugs.

Find the full series and searchable database at: http://www.propublica.org/topic/dollars-for-doctor

–Kate Petersen, PostScript blogger

Are the muckrakers moving more slowly than their subjects in the medical field when it comes to pharmaceutical conflicts of interest? That’s one way to look at two recent stories that indicate that the press establishment may be increasingly confronted with the same questions that it’s been pressing physician and medical groups to answer for years.

Eyebrows were raised recently over the news that Pfizer endowed $80,000 worth of fellowships through the National Press Foundation for 15 journalists to attend a four-day conference on cancer in October. According to Pharmalot, this is the second year of the conference.

On her blog at Politics Daily, Alison Fairbrother asks: Just how big a conflict is this?

Well, plenty of people (journalists included) readily answered: Big. Pfizer makes a handful of incredibly expensive cancer drugs. (Probably not on the conference program is Forbes columnist Robert Langreth’s “Why Pfizer can’t cure cancer.”) There is now wide consensus that industry-backed education for doctors (CME) creates the potential for bias, and many medical schools, specialty societies and physicians groups have moved accordingly, restricting ways that industry can support CME or banning such support entirely, as the University of Michigan did earlier this year.

This week, in fact, a Harvard neurologist launched an industry-free CME company that will draw on expertise of non-conflicted Harvard physicians to create the curriculum modules. It’s encouraging to see the move toward industry-free continuing medical education move beyond regulation and back into the private market.

And as for the journalists? A Pfizer spokesman told Pharmalot this:  “With the 24/7 news cycle now, my concern continues to be the ability of journalists to have enough time to understand the material and have the knowledge to do the analytic work they need to do. I can complain or be part of the solution. We believe we’re doing this the right way.”

That’s not surprising. And it sounds a whole lot like the pharma industry’s pitch for detailing and CME sponsorship: How else, they say, are busy doctors going to get this information?

Well, there are beginning to be more alternatives for doctors. And we would posit that that’s precisely journalists’ job: to figure out the right unbiased way to get the information, also known as reporting. That’s what they are: professional information-getters.

But as newsrooms cut and cut further, they will be scanning ever-wider circles for someone willing to foot the bill, as Gary Schwitzer of Health News Review told Pharmalot and Fairbrother.  And pharmaceutical companies are great at footing the bill, especially when the ROI looks good.

And when you have the President of the National Press Foundation saying things like this—“I evolved a way of using a strict set of guidelines which basically say we’ll take money from anybody as long as they follow certain rules”—how could pharmaceutical companies not see an open door? They have whole divisions devoted to following rules.

Arguably, awareness of the potentially problematic financial ties between physicians and industry has never been higher, and the new federal Physician Payments Sunshine law will further illuminate the scope and prevalence of those ties. It’s perhaps ironic, then, that the industry that played such a big role in raising that awareness may be next to confront its own vulnerability to Rx influence.

–Kate Petersen, PostScript blogger

Last week the Association of American Medical Colleges and three other university associations took aim at the NIH’s proposed rule to tighten disclosure and reporting requirements, departing from their initial support of tightened regs last summer.

Like the AAMC and Association of American Universities (AAU), who joined AAMC in its comments, we voiced our support for reform and suggested ways to strengthen reporting and transparency when the NIH solicited public comment last summer on ways to shore up rules aimed at promoting objectivity in research.

This May, the Institutes issued a proposed rule with many strong reforms (you can read about that here on PostScript.) The rule was amended and the comment period extended after it came to light that an National Institutes for Mental Health director Thomas Insel had recommended psychiatrist Charles Nemeroff for a job at University of Miami, despite Nemeroff’s failure to report large sums he received from GlaxoSmithKline while working on an NIH–backed grant on a GSK drug. That violated NIH rules and led to his resignation from Emory University, but Insel apparently assured Miami administrators that Nemeroff would be eligible for NIH funds at a different university. (Carlat Psychiatry Blog and Pharmalot have the backstory.)

In its newest comments, AAMC asks for reporting exclusions that would significantly weaken the proposal.  As currently written, NIH would exempt disclosures only for seminars at institutes of higher ed and government agencies. AAMC suggests exempting all speaking gigs, lectures and seminars at academic teaching hospitals, medical centers, research institutes affiliated with an institute of higher education, and other non-profits involved in research.

They also suggest that travel funds be exempted from reporting requirements, as well as any funding for CME presentations that meet ACCME standards. However, in this compliance-savvy climate, most industry-backed CME presentations in which NIH investigators participate are ACCME accredited – and such accreditation does not eliminate inherent bias in such programs.

Unfortunately, those are pretty big slices of the pie. A lot of research-related dollars are flowing through third parties at this point—including the non-profits and other third parties that AAMC asks to be exempted. Most patient organizations and professional medical associations are non-profits, and the grants money they receive is often passed on to individuals for fellowships, participation in research symposia, or education. As you can see on Pfizer and Lilly’s websites, most grant recipients from the two drug companies listed here are non-profits, and many of those grants seem to be for these research-related purposes.  
Just because they are issued through a non-profit does not mean these funds cannot somehow influence how an investigator conducts his research.

The AAMC and its cosigners also suggest that NIH should rely first on investigators to decide what to report, based on their judgment of the relatedness of a financial interest to their research.

Well, this is how much of this started – Sen. Grassley and others found that investigators, who decide under current regs what they do and don’t report to their institution, weren’t reporting some pretty big industry payments related to their research. See Nemeroff, Schatzberg, Biederman, et al. In most cases, the medical schools that AAMC represents were the ones to get the bad press and in hot water for these omissions. The NIH proposed rule change would help protect these institutions by taking the evaluative reporting decision away from the investigator. With the Sunshine Act providing a national database of company payments to physicians and teaching hospitals, we don’t want institutions that are accountable to NIH to be caught out if they aren’t aware of a payment to an investigator that shows up in the Sunshine database.

The AAMC also proposes that if undisclosed conduct is discovered, an investigation could be waived.  But we support NIH’s proposed mandatory investigation if someone fails to report a Financial Conflict of Interest (FCOI). The new regs were proposed and will be implemented for good reason. There is no current mechanism for NIH or an institution to judge whether an investigator failed to report a FCOI “in bad faith” or whether the unreported interest affected research. Unless you investigate, there is almost no way to uncover intentional and problematic non-disclosures. We can’t count on whistleblowers to enforce this.

Worryingly, the groups frame their comments by calling into question the very need for the reforms.

There is a paucity of evidence that the disclosure and management of financial conflicts of interest affect objectivity and integrity. In the absence of such evidence, onerous regulations are not only unwarranted, but could create a glut of policies that increase activity without adding protections and at the same time erode the trust between the regulators and those being regulated.

We think this is a tough claim to make, since the rule was proposed and amended in large part because of Congressional investigations and media stories that revealed millions of dollars of undisclosed industry funds in the hands of publicly-funded researchers.

While there may be no study yet that links disclosure of FCOIs to research integrity, there is increasing evidence of bias in research and disclosure is one step we can take to try to reduce this bias.

–Kate Petersen and Ian Reynolds, PostScript

New proposed rules from the NIH yesterday on preventing conflicts of interest in biomedical research improve public disclosure but leave the decision about what constitutes a financial conflict with an investigator’s institution. The rule lines up with much of Community Catalyst and Pew Prescription Project’s recommendation to the agency in July 2009. The Institutes are again seeking public comment for 60 days.

The proposed rules require investigators – that is, anyone involved with the design, conduct or reporting of publicly-funded research – to disclose to their institution all payments greater than $5000. Those payments include consulting, honoraria, speaking or travel funds, or paid authorship. The institution – commonly an academic medical center or university—must then determine what is a potential conflict and report those payments and a management plan to the NIH.

This is a shift from the current rules, which require an investigator to disclose payments to her institution only if she believes it conflicts with her research – a system, it seems, that left too much room for interpretation. News reports have documented millions of drug company dollars that went to investigators running trials on drugs made by those companies. (GoozNews has about a complete a list of news clips as one could want.)

The proposed rule also requires each institution seeking NIH funding to establish a publicly accessible website on which it would post its conflict of interest policy and all financial conflicts of interest held by investigators, updated at least annually. This is a great step toward better transparency that is meaningful to patients and consumers, as it will provide an important crosscheck to the Sunshine database and other disclosure websites for assessing conflicts and compliance.

We’d still like to see payments below $5000 be disclosed to institutions – the number is arbitrary, and studies suggest gifts and payments much lower than that can create bias.  Though the NIH cited concern over administrative burden, many institutions and companies have already begun requiring disclosure at a much lower threshold, suggesting it’s important, and doable.

And the big increments that NIH set for public disclosure on the websites (less than $20,000, less than $50,000, less than $100,000 or more than $250,000) leave too much guesswork. There is a difference between a $250K relationship and one in the millions, but the public won’t be able to see that if the proposed rule stands as is.

The nature of academic-industry relations has changed dramatically in recent years, and it’s encouraging to see that the NIH rules get that—and account for it. For instance, the NIH addressed the shift in industry-backed CME by making explicit that payments for lectures, seminars, and speaking gigs sponsored by non-profits are not exempt from disclosure, acknowledging that for-profit companies often create non-profit arms to fund talks and execute programming. And they added “paid authorship” and “travel reimbursement” to the list of examples of payments to acknowledge industry’s heavy reliance on speakers’ bureaus, backing researchers to attend or present at conferences, and ghostwriting – or soliciting an academic to sign an article that was not written by her/him in full:

With regard to “paid authorship”, in particular, although there should be little question that receipt of payment from an entity in exchange for the drafting of a publication constitutes payment for services, we believe it is important to reference this form of payment specifically in the regulations.

Read more about our original comments to the NIH here, or read the proposed rule at the Federal Register.

–Kate Petersen, PostScript blogger