This week, I talked by email with physician and researcher Dr. Joseph Ross about the importance of using unique identifiers in pharma disclosure data, and other ways to take the guess work out of the Physician Payments Sunshine database.

PS: Last week, a commentary in JAMA (Carpenter/Joffe) suggested that unique investigator identifiers should be used in the Physician Payments Sunshine database to make the data most usable, accurate, and suitable for cross-reference with other databases.

You’ve spent a lot of time with data collected under similar disclosure laws in Minnesota and Vermont. From your point of view as a researcher, what aspects of an identifier are important or helpful to looking at these data?

JR: From our experience examining the data in Minnesota and Vermont, I can only say that some unique identifier is necessary. Neither the Minnesota or Vermont data that we used included a unique identifier, just the name of a physician, clinician, or hospital/clinic that accepted the payment from the pharmaceutical company.

We found that trying to determine exactly who accepted which payment was virtually impossible, because one could not be sure whether a “Dan Smith” in Minneapolis was the same or a different “Dan Smith” in St. Paul, for example. Without a unique identifier, doing research to examine which physicians or clinicians are accepting payments can only be done in the aggregate, not at the individual level.

However, what is most interesting about Carpenter and Joffe’s proposal is not the unique identifier in itself, but the development of an identifier that could be used across databases, linking payment disclosure data, to grant applicants, to manuscript submissions and publications, to service on NIH or FDA committees. I could imagine this identifier being an expanded use of the NPI (national provider identifier), or another number, but it would certainly make identifying potential conflicts of interest far simpler.

PS: One of the reasons these authors suggest a unique identifier is to capture payments made to non-physician investigators. Did you deal with this issue in your work with the Minnesota and Vermont data?

JR: Yes, examining the data in Minnesota and Vermont, there were a substantial number of payments made to non-physicians, although these clinicians were not necessarily investigators. I agree that if the PPSA is broadened to include payments made to non-physicians, an alternative identifier to the NPI might be necessary. NPIs are required by all health care providers, including non-physicians who bill insurance companies or write prescriptions. But some non-physicians who receive payments from industry may not fall into this category.

However, to me, the real issue is a shortcoming of the PPSA, which requires companies to include physicians’ NPIs in their annual submissions, but prevents these numbers from being made publicly available.

PS: Why is that a problem?

JR: This is a problem because, as it stands, the payment disclosure data cannot be confidently attributed to an individual without using the NPI as a unique identifier. Our prior experience suggests that individual physicians will appear in the disclosure data multiple times, potentially with different spellings of their names, different practice addresses and so forth. It becomes a bit of guess work to determine if a payment to Daniel Smith from Lilly in September should be combined with the payment to Dan Smith from Lilly in April.

PS: In your 2007 JAMA article, you wrote about difficulty you had obtaining the Vermont/Minnesota data, and the poor quality of the information once you received it. Out of this experience, what should some of the priorities be in developing Sunshine systems and payment categories to produce a meaningful public disclosure scheme?

JR: Well, we’re still more than two years away from seeing how the PPSA plays out in practice. The legislation was fairly specific in terms of what information is to be collected.

Of all the categories pre-specified, the “nature” of the payment is most subject to interpretation.

My hope is that they interpret it as specifically as possible, so that, for instance, its disclosed when a payment is for a) speaking at a ACCME accredited educational event, b) speaking at a non-ACCME accredited educational event, c) attending a ACCME accredited educational event, or d) attending a non-ACCME accredited educational event. If the “nature” of a payment is disclosed vaguely, all four of those activities could be listed under the umbrella of “education.”

Otherwise, I agree with the Carpenter/Joffe commentary: Something needs to be done to ensure that a unique identifier is required for disclosure by companies and made available to the public. Without this, these payments may be misattributed, particularly within larger markets, limiting the effectiveness of this law within those communities.

Joseph S. Ross, MD, MHS, is an Assistant Professor in the Section of General Internal Medicine at the Yale University School of Medicine in New Haven, CT. He holds a medical degree from the Albert Einstein College of Medicine, Bronx, NY, and completed his post-graduate training in primary care internal medicine at Montefiore Medical Center in Bronx. As a fellow in the Robert Wood Johnson Clinical Scholars program at Yale University, Dr. Ross earned a Master’s degree in health sciences research. Using health services research methods, Dr. Ross’s research focuses on examining factors which affect the use or delivery of recommended ambulatory care services for older adults and other vulnerable populations, evaluating the impact of state and federal policies on the delivery of appropriate and higher quality care, and issues related to conflicts of interest, medical professionalism, and drug safety.

Interviewed by Kate Petersen, PostScript blogger

The 2010 American Medical Student Association (AMSA) Scorecard is out today, and for the first time since the student group began assessing conflict-of-interest policies four years ago, one half of all U.S. medical schools received an A or B (78 out 152).

That’s up from approximately one in three schools last year, and just 20 percent in that range just two years ago, suggesting that we really are engaged in a nationwide project to figure out what the proper role of the industry in  medical education should be.

About one-fifth of medical schools improved their scores over last year, the same improvement rate as we saw in 2009 over the previous year’s Scorecard. We think that’s really good. Let’s remember that these are giant, slow-moving academic institutions – not exactly the hares of the system-change race. That makes such steady and significant shifts even more impressive.

As for “most improved” candidates for the we-wish-it-existed AMSA Scorecard Yearbook, Tufts University would have to be up there, moving from D to an A and to the top of the class this year among medical schools in Massachusetts, as would University of South Dakota Sanford School of Medicine and Des Moines College of Osteopathic Medicine, who also jumped from Ds to As in a year.

We should point out here that the room between A and B is somewhat complex. The scorecard is composed of 11 domains:
-acceptance of gifts and meals from industry;
-consulting relationships;
-speaking relationships;
-disclosure of financial conflicts;
-pharmaceutical samples;
-individuals with financial conflicts participating in university purchasing decisions;
-financial support for educational events (on- and off-campus);
-industry support for scholarships and trainee funds;
-access of industry sales personnel to medical school or hospital personnel;
-and inclusion of education about conflict of interest within the academic curriculum.

Each year, AMSA asks all medical schools, early and often, for their policies in each of these domains and then using methodology developed with the help of the Pew Prescription Project, independent blinded assessors evaluate the policy out of a possible three points.

The needle’s been harder to move in certain domains than in others.

Unsurprisingly, very few—10 percent of schools—got a perfect score on their on-campus continuing medical education policy. Drug company sponsorship of grand rounds and other on campus co-hosted educational activities is a big money maker for medical schools, and can give a company talk the imprimatur it craves. The Accreditation Council for Continuing Medical Education gets this, and its policy recommendations have lagged behind many rule-making bodies and medical groups on decoupling industry-physician marketing relationships.

More surprisingly, perhaps, even fewer schools – just two – got a perfect score on limiting access to sales reps. A score of “3″ on industry access, according to AMSA’s scorecard site, is given to policies in which “pharmaceutical and device representatives are not allowed to meet with faculty regardless of location, or are not permitted to market their products anywhere inside the medical center and associated clinics and offices. (Exceptions may be made for non-marketing purposes, such as training on devices or equipment.)”

Schools that limit faculty and student interaction with sales reps, or where sales reps can go, but do not ban them, received a 2.

Still, the fact that no more than two schools banned sales reps outright is surprising to us because:

A) allowing sales reps on campus seems like the easiest, clearest example of letting industry inappropriately infiltrate your medical school. It’s in the name: they are there to sell stuff. Cutting out sales reps doesn’t get into questions of patient access to drugs or doctor access to education programs.

B)There are just less of them than two years ago. The last half of this decade hasn’t been a good one for sales reps, as pharma companies with trickling pipelines have slashed traditional marketing budgets in favor of … well, doctor-to-doctor CME, for one, and online campaigns. It seems that this would make it even easier for schools to put together great policies to keep the sales reps at bay. Maybe people need pens more than we thought.

For more, visit the 2010 scorecard at http://amsascorecard.org or check out the Pew Prescription Project resources on marketing and conflicts of interest.

–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

We heard the Early Reader gets the Bookworm, but whether that’s fact or fable, the Reader gets an early start this week with news that Stanford University School of Medicine will be decoupling pharmaceutical industry funding from its continuing medical education programs, effective Monday. The move comes in the wake of Congressional inquiries into a Stanford psychiatrist’s financial interests and research post earlier this year, as well as growing calls for limits on industry involvement with doctors’ continuing education.

According to the San Jose Mercury-News, the new policy mandates that “companies will no longer be able to designate that their contributions be used for specific types of medical training, to limit the companies’ ability to tailor those sessions around their products.”  These restrictions make Stanford’s CME policy among the strongest in the nation.

“It’s a good plan, and it’s a big deal that a place like Stanford has adopted it,” Dr. Murray Kopelow told the New York Times.  Kopelow heads the Accreditation Council for Continuing Medical Education. “When this is all over, medical education will not be the same as what it’s been.”

All-you-ever-wanted-to-know at:

Wall Street Journal Health Blog

San Francisco Chronicle

Chronicle of Higher Education

Speaking of CME, this historical look at industry involvement in continuing medical education in last week’s Journal of the American Medical Association demonstrates just what a ‘therapeutic jungle’ it is out there. According to authors Scott Podolsky and Jeremy Greene, concerns about industry involvement in medical education are much the same now as they were 50 years ago, though they argue the stakes are higher now.

“Technological and regulatory solutions intended to defend professional control over knowledge circulation—such as CME—have instead provided novel sites of intersection between pharmaceutical marketing and physician education,” they write.

Label liability?

And now to Washington, where this week the FDA finalized a rule that will make it tougher to update a drug label to reflect warnings and side effects.

According to the BNA Health Care Daily Report:

“The final rule published in the Aug. 22 Federal Register (73 Fed. Reg. 49603) allows manufacturers to submit a supplemental application to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the product.

‘Expressly requiring that a CBE supplement reflect newly acquired information and be based on sufficient evidence of a causal association will help to ensure that scientifically accurate information appears in the approved labeling for such products,’ the FDA said.

Critics are saying that the rule adds up to immunity for drug makers, who would no longer have to warn consumers about drug risks or new side effects without proof of causation and newly acquired information. The American Association for Justice, which holds the new rule protects drug manufacturers, told the BNA the FDA’s decision “leaves the drug and device companies too much discretion in determining when to include safety hazards on warning labels.”

Baby steps

In other FDA news, the agency signaled it would be revising rules on over-the-counter cough and cold medications for children, according to the Washington Post. Last fall, an advisory panel convened to look at the safety and efficacy of the drugs, which have been linked to children’s deaths and have not been put to effectiveness tests.

Now, a year on, the agency has scheduled a meeting on Oct. 2 to consider questions about whether the products should be proven effective or safe to remain on the market, and if so, how. Baby steps? Maybe. But experts say this is how it gets done.

“This is how the agency can take these products off the market,” Baltimore Commissioner Joshua Sharfstein told the Post.  “I think this signals the agency is going to apply a modern standard of safety and efficacy to these products, and that is a standard these products cannot pass.”

Sharfstein organized the citizens’ petition filed in March 2007 requesting that the FDA review the safety of these drugs.

And the midyear update from the National Conference of State Legislatures says that prescription drugs continue to be a hot topic in state houses everywhere; 540 pharmaceutical-related bills have been filed this year, to date.

If you don’t already know about it, these topical legislative reports on the NCSL website are a dynamite resource: You can read description of all prescription drug bills filed so far this year by state, topic, or status of bill.  Find clusters of states where similar legislation has been introduced, or just see things that make you go ‘Hmm.’  Like how earlier this year Florida House members passed H.9065, a non-binding resolution honoring PhRMA on the anniversary of its program…honoring pharma.

According to a recent post at Pharma Marketing Blog, online CME has taken a toll on the standard powerpoint and folding chair affairs.  Continuing medical education (CME), which are the credits required for a physician to maintain her medical license, comes in many forms: hospital grand rounds, symposia at annual meetings, correspondence courses offered through universities, medical associations, and journals, or online courses among them. Blogger John Mack did the numbers on the Accreditation Council for Continuing Medical Education annual trends and found that pharmaceutical investment in traditional CME has leveled off, and doctors are doing more and more CME online—a trend that Mack argues allows less opportunity for ‘collateral marketing,’ by which he must mean handouts, tchotchkes, and location, location, location.

But though these data show traditional pamphlet and slideshow courses may be on the wane, the same isn’t true of pharma’s influence.  Just look at the web ads above Mack’s blog post:
“7th Annual ePharma Summit” for “Pharma-marketing in the Web 2.0 World” at the Ritz-Carlton in Philly, www.freecme.com, www.cmedownload.com. And it’s anyone’s guess how many more online CME brokers advertise on this page and others like it. 

Mack argues that “pharma’s return on online CME investment may be much less than for live events such as symposia at medical conferences,” but don’t be so sure.  As with online shopping—or online anything—the nature of the web makes it easier to pass something off as something else: in this case, to hide sources, support, and credentials, at less cost to those doing the fleecing.

Though in broad strokes, Big Pharma’s trickling R&D pipeline, shrinking profit margins and multi-front regulatory war make it look like a lumbering and antiquated machine, the industry in other ways moves with the deftness of a biological organism, adapting to and manipulating a quickly changing environment in real time.

The number of third-party CME companies proliferating in the brochures of annual meetings and online medical journals are evidence of the latter. 

Take the CME shop featured in Dr. Daniel Carlat’s blog post this week: a company that will provide ‘independent content validation’ for your industry CME courses. Responding to a heightened regulatory atmosphere, the service on offer, “CME Peer Review,” pledges to verify the science and “truthiness” of your CME—via a pool of other industry-backed experts.  Dr. Carlat, who has made it his mission to expose industry-backed CME—a challenge not for lack of material, but for its myriad disguises and tendency to shapeshift—flips through the materials with equal parts incredulity and admiration of the deft corporate evolution on display.  

But for every Superbacteria that crops up, the world uses more hand sanitizer: as pharmaceutical companies get more sophisticated in their methods of influencing CME, so too do those who are calling for the profession to take back the textbooks…and the seminars, and web curricula, and annual meeting symposia.

Recently, PostScript talked with a physician who regularly attends the CME series at University of California San Francisco. Last month, a course called “Marketing Medicines: Critical Skills for Physicians” caught her eye.  The course is supported through the Consumer and Prescriber Grant Program that grew out of the $430 million Neurontin off-labeling marketing settlement in 2004.  The UCSF course is just one of a series of projects intended to re-educate doctors and prescribers about the influence of pharmaceutical companies on medical practice; Dr. Jerry Avorn’s academic detailing work in Pennsylvania and Elissa Ladd’s nurse education program at MGH are others familiar to the Prescription Project.

As universities, government leaders and payers tighten their belts and restrict physician gifts and inducements from pharmaceutical companies, less overt influencing—i.e. marketing disguised as education—will undoubtedly become the locus for more and more industry attention. 

And as industry adapts to an increasingly aware medical community and skeptical public, count on the ways it gets its message into docs’ homework pile to multiply.