The commentary included in the law echoes industry concern that more clarity is needed to ensure that preemption is not applied ‘too narrowly’. While the law may not be the best news for pharma, “it’s better to have one burdensome statute than to have 50 different ones with variable impacts; a statute that at least imposes  uniformity across states has value,” as John Kamp, Executive Director for the Coalition for Healthcare Communication put it to Pharm Exec. CMS responded to the issue by promising guidelines to clarify the preemption requirements, while at the same time adding a confusing caveat that state preemptions would be evaluated on a case-by-case basis. Kamp warns, “This case-by-case clause is a flag to industry that says, ‘This may not be over’.” Such a contingency gives the CMS the flexibility to gauge how Federal Reporting actually works and then to adjust its actions accordingly, versus simply living with the reality of what States currently do in their own reporting.

Alternatively, The Sunshine Act may have the effect of doing away with the clash that state laws present against the status quo in Washington. In January, Minnesota repealed its physician payment disclosure laws in anticipation of the Sunshine Act’s release. “There’s an element of logic that dictates states will fall back on the federal statute and reinforce the complexity of Sunshine as it is,” says Saul B. Helman MD, Managing Director and Life Sciences segment leader at Navigant Consulting, a company that advises life science companies on issues of compliance.

“On the other hand,” he counters, “states may realize that they require disclosure for payments that are not included in the federal Act, or that they may require different thresholds and additional areas of reporting.” For instance, if a state decides that CMS’ defined list of teaching hospitals fails to include facilities that that state’s government pays for to provide services, more specifically the prescribing of medical products, it may prompt further requirements to be introduced. As Helman puts it, there’s an ambiguous ‘wait and see’ period as to how states will respond on this issue.

The bottom line is that compliance remains a dynamic area, especially with the possibility of stepped up international requirements being introduced to the mix in the future.  For now, the Act urges that companies continue to comply with state and local authorities in their reporting requirements until August 1st, when the federal requirements take effect.

Andrew Schafer, president, ISR

Despite fewer restrictions placed on MSLS, in terms of access to oncologists, 77% of the US-based oncologists and hematologist/oncologists surveyed said they’d seen a sales rep in the last month, while only 37% said they’d seen an MSL, said Andrew Schafer, president at ISR. This suggests a “visit gap” and a missed opportunity, said Schafer. “Fifty-three percent of academic medical centers don’t have policies restricting MSL access,” said Schafer. “Only twenty-five percent don’t have sales rep restrictions.”

Despite thousands of job cuts over the last few years, sales reps are still more plentiful among big pharma than MSLs, which may account for part of the visit gap identified by Schafer. However, there are signs that MSLs are performing key functions that, traditionally, have been part of rep detail. Oncologists reported that new efficacy data read-outs from clinical trials, and competing product information, ranked highest in terms of the most valuable information MSLs provide to docs, the study found.

The relationship between an oncologist and an MSL “more closely resembles a peer-to-peer” kind of exchange; less promotional and more on the level, said Schafer, noting that oncologists like for MSLs to connect them with KOLs and other leaders in their field. Oncologists don’t, however, like to be presented with preexisting data or information regarding other KOL opinions or behaviors, said Schafer.

It varies, but most oncologists do still prefer in-person engagement as opposed to non-personal engagement or e-details. From sales reps, oncologists say they want, first and foremost, patient education materials, according to the study.

Asked how much influence private and government payers had on prescribing decisions three years ago, versus how much influence they’re likely to have three years from now, oncologists said they expect payers to exert twice as much influence on their decisions in three years time, said Schafer.

Finally, which pharmaceutical company has the best MSLs? Based on ISR’s sample size of 102 respondents spread across academic medical centers (35%), community settings (31%), private and family practices (14%), mulch-specialty clinics (11%), hospitals (7%) and military/VA hospitals (2%), Genentech was number one, Schafer said.

By challenging physicians to be The SmartestDoc, MDLinx and the Cleveland Clinic are using competition to promote education.

Stephen Smith

On Tuesday, M3 USA’s MDLinx, a pharma advertising supported informational website for physicians, launched a new quiz – The SmartestDoc – for internal medicine and family physicians. In collaboration with MDLinx, the Cleveland Clinic is providing educational materials from its Center for Continuing Education to be used in the quiz, which tests a physician’s knowledge of recent medical literature, practice-related issues, and other med ed topics. While the quiz itself isn’t new, the Cleveland Clinic’s participation and provision of materials will bring new physicians into the competition.

The five-question quiz, which hopes to reach roughly 200,000 US docs in the first 90 days, allows registered physicians to quiz themselves once a day, and then see how their scores shape up against other physicians regionally and nationally. Anyone can take the daily quiz, and revisit past quizzes for review, but only verified physicians are included in the leaderboard. Each month, the doc with the most points will receive a certificate deeming him or her the “Smartest Family Physician.” Physicians can also form teams of five and compete against other teams. Quizzes are ranked by difficulty, and physicians can evaluate their strengths according to different practice areas. “There are performance pages – private to the physician – that measure expertise levels, and how they stack up against the community,” says Stephen Smith, chief marketing officer at M3, owner of MDLinx.

Smith says that content contributions from the Cleveland Clinic augment the quiz by giving it “a better blend…in addition to the new medical literature, there’s now enduring educational materials. It’s the mix of material that provides a robust learning environment.” Staff editors at MDLinx convert the materials received from the Cleveland Clinic into quiz questions.

As of now, the quizzes don’t offer CME credits, but Smith says he hopes to add this capability in the future. MDLinx has had preliminary discussions about integrating the quiz into live meetings as well as a certification review course, according to Smith.

Medical Economics is a venerable play, with a publication record that dates back to 1923. Like many titles with a long track record, the magazine hit some bumps several years ago, but new leadership and a commitment to making one with the customer—175,000 reading primary care physicians—has put the grease back on the wheels. Ad revenues rose nearly 40 percent from 2010 to 2011, while the readership average per issue posted a 3.9 percent increase over roughly the same period, much higher than the average 1 percent score in this market segment. It’s a performance that lends credence to the principle that money follows quality.

How did this happen? The turnaround built heavily on a deep-dive effort to engage with the readership and understand what the magazine could do for it. Says Advanstar’s executive vice president Georgiann Decenzo, “We refocused on specific ways to deliver value to our audience of primary care physicians, a community challenged left and right by external forces that threaten its very existence. Information, analytics, and advice on coping with these challenges was defined as our editorial mission—every feature is bench-marked around a precise mission: to help these physicians stay in practice.”

With the magazine performing nicely in terms of ad revenue, the next step is a redesign and overhaul of Medical Economics’ online offerings, including a new website due for unveiling later in the spring.

The code, which is open for public comment until June 30^th, states that “no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe” a drug. Additionally, “gifts for the personal benefit of healthcare professionals (such as tickets to entertainment events) also are not [to] be offered or provided,” the code states.

However, some concessions are made for continuing medical education (CME). For example, pharma companies may provide monetary assistance covering “actual travel expenses, meals, refreshments, accommodation and registration fees” for physicians, but the events and expenses “have to be organized in India only…and incurred only for the events held in India.” Assistance funds are not to be extended to “spouses or other accompanying persons” hoping to travel to CME events, and companies are barred from organizing meetings that “coincide with sporting, entertainment or other leisure events or activities.”

On his MedCom Strategies blog, Dr. Neelesh Bhandari, a New Delhi-based medical communications consultant, took issue with the rule about meetings coinciding with other events. “This is a totally uncalled for limitation. Why shouldn’t healthcare professionals attend meetings because of the IPL [Indian Premier League] being held at the same time?” wrote Bhandari. The IPL is a professional cricket league.

Other proposed rules in the code limit drug sampling “to prescribed dosages for three patients,” and sample packs “shall not be larger than the smallest pack presented in the market.” Providing samples of “anti-depressant, hypnotic, sedative or tranquillizer” drugs in any amount or packaging unit is disallowed, under the proposed code.

Regarding textual and audio-visual promotional material, marketers are prohibited from using the “names or photographs of healthcare professionals.” Marketers are also asked to avoid “extremes of format, size or cost of promotional material.” On his blog, Bhandari wondered if that rule would “limit the size and costs in pharma marketing projects.” Audio-visual material “must be accompanied by all appropriate printed material” as well, prompting Bhandari to suggest that “this could kill digital pharma marketing in India.”

The full document and code is available here. The regulations are voluntary for now, but “its implementation will be reviewed after a period of six months form the date of its coming into force, and if it is found that it has not been implemented effectively…the government would consider making it a statutory code,” the document says. The Department of Pharmaceuticals is a division of India’s Ministry of Chemicals and Fertilizers.

To put health IT in the hands of patients, to foster more open communication between patients and physicians, to promote better health and wellness (and lower costs) for the public overall — these are the (somewhat daunting) objectives of the National eHealth Collaborative (NeHC) Consortium.

Headed by CEO Kate Berry and led by a steering committee that includes experts from the Office of the National Coordinator for Health IT (ONC), the Consumers Union, the National Patient Advocate Foundation, the American Association of People with Disabilities, and others, the Consortium last week tasked itself with inventorying current available resources, devising outreach strategies, and reducing disparities.

The first goal is to pool resources and share expertise and best practices, explains Berry. “Given that these many different identities may already be doing something around [health information] education and engagement … we’re hoping to serve as a forum for sharing … to come up with a comprehensive inventory of what everyone is doing and identify where the gaps are.”

Second, the consortium is offering a chance for all stakeholders to ask and answer questions: What are the most important messages patients need to know? Why should I care about health IT? What can this mean to me? The idea is to reach an agreement among stakeholders on what the key messages concerning health IT are, who the most trusted messengers are, and the best strategies for disseminating that information.

For the purposes of the Consumer Consortium, “Health IT” and “eHealth” are defined very broadly: any information that the general public can access regarding health, wellness, disease conditions, treatment options, and other information via websites, mobile applications, online databases and resources, and other tech tools.

By “enabling coordination and organization” NeHC “can have a greater impact than any one member or organization could on their own,” Berry says. “It serves as a neutral convener of all the interested stakeholders on this topic, so we’ve got pretty much everyone at the table.” Attendees included patient advocacy organizations, pharmaceutical companies, and even individuals not associated with any particular organization, but who are passionate about the widespread use of health IT.

Berry adds: “We’re really trying to take advantage of the energy and momentum around this work and have some concrete deliverables… The ONC recently released a strategic plan for the coming five years, and consumer engagement is one of the top five strategic priorities in ONC’s plan.” She expects the second meeting (this July), to serve as a reconvening of the consortium’s smaller work groups to present one another and additional attendees with their recommendations for specific plans of action around these issues. In the meantime, she says, all workforces and steering committee members will be in close contact with one another.

Looking into the future, Berry has several ideas of how health IT can educate and empower the public, and what that could eventually mean for the healthcare industry as a whole. She suggests online resources that allow patients to make doctor appointments or order prescription refills from pharmacies online, databases that allow patients to keep track of their own health records, and apps that track blood sugar or other vital statistics in the same way a pedometer tracks your daily steps. “There are all sorts of ways that technology can be leveraged to help a patient better manage [their health] to avoid hospitalization or emergency visits,” she says. “So we may spend a little bit more on medications but we’ll spend a lot less on other downstream costs.”

Overall, Berry feels that the first meeting was a strong debut to what she says could become a multi-year project. “We had a number of participants who spoke with great passion from the perspective of patients, drawing on their own experiences of having been very ill and navigating that process,” she says. “That voice was strongly present. We got the dialogue going. We had enthusiasm and excitement about the consortium across the board and a resounding yes—that these issues are important, that they are timely, and that this is a worthwhile endeavor.”

There’s no question, of course, that pharma is still being hesitant when it comes to actually engaging with social media, regardless of the desire to do so. Faceoff participant Bruce Grant, SVP, Strategic Services, Digitas Health, advises that it’s helpful “for us as marketers to think of social media not as a channel but as a conversation.” But, he adds “a conversation is not a natural instinct for a marketer, it’s learned behavior.” Currently, it seems pharma marketers main hesitancy stems from uncertainty of operating in a world where “marketers are no longer in sole control of the conversation.”

So will the FDA smooth the way with more guidance on social media? Jennifer A. Colapietro, Partner, Pharmaceutical and Life Sciences Advisory, Pricewaterhouse Coopers, doesn’t think so.  FDA hearings are only likely to result in guidelines and perameters and provisions, she says, “but the rubber really hits the road in your individual interpretations, and operationalizing those within your organization.”

So what can pharma do? One thing is to gain a proper understanding of what social media is. “There’s a common misconception that social media is just the triumvirate of Facebook, Twitter and YouTube. That’s not what social media is,” says Colapietro. “There needs to be some awareness and education about what it is, what the risks are and how you can use it.” Tune in here to find out more!

The first of this new Pharma Faceoff series is already generating some positive responses from industry. Steve Woodruff, President of Impactiviti, says on his blog: “Kudos to Pharm Exec for taking it on… let’s face it – video is where it’s at for on-line communications, and this is a great way to hash out some issues and gain needed exposure.”

Watch this space for more Faceoffs to come.

Last week, Big Pharma’s practice of paying doctors to do medical education, promote its products, or both was the focus of a multimedia blitz launched by ProPublica in collaboration with National Public Radio, the PBS Nightly Business Report, the Chicago Tribune, the Boston Globe, and Consumer Reports. In what must be seen as a wake-up call for the industry on its handling of compliance issues, each of these major media outlets ran its own major story raising questions about the ethics of paying physicians to help increase sales of medicines. Whether the avalanche of data and juicy anecdotes of physician behavior found in ProPublica’s “Dollars for Docs” report actually answered any of those questions l depends on your point of view.

That pharma sales strategies can encompass elements of fraud, kickbacks, and other funny-money exchanges isn’t exactly news. Billion-dollar settlements with the Department of Justice have become so ho-hum over the past decade that the chorus of threats of criminal prosecutions of drug-company executives by officials at Justice, HHS, and FDA is reaching almost credible levels. What is news—and ProPublica’s new contribution to the debate—is the searchable database for consumers containing the names of some 17,700 US doctors and other practitioners who raked in a total of $257.8 million in pharma payments since mid-2009, a considerable technological feat (aided by Google Refiner) given the mix and sloppiness of the data. The list remains far from complete—it records the fees for speaking, consulting, researching, or related activities paid to doctors by only seven of the top pharma firms: Pfizer, Glaxo, Merck, J&J, AstraZeneca, Lilly, and Cephalon. Of the seven, only Merck and Glaxo volunteered the info; ProPublica got the rest from disclosures the other five companies were forced to make as a condition of false-claims and other settlements.

The sharing of its database with other news organizations (and ultimately the public) is central to ProPublica’s alternative business model. The nonprofit Internet news organization’s mission is public-interest investigative journalism—a resource-consuming enterprise increasingly viewed as nonessential by an industry in financial free-fall. Since its launch in mid-2008, the group has earned its credibility, winning many of the nation’s top journalism awards, including a Pulitzer last year for investigative reporting. It counts among its funders the Gates, MacArthur, and Ford foundations; its newsroom is led and staffed by veteran editors and reporters from the New York Times and the Wall Street Journal. By lending its pharma-physician database to other national and local news outlets—and orchestrating a simultaneous delivery—ProPublica ensured that it got maximum bang for its investigative buck. And the investigations into the pharma industry’s financial ties continue this week with a report based on research into its payments to lobbyists and to political campaigns.

In the week since the stories broke, many lines of debate have developed among readers, including physicians, sales reps, patients, and pharma analysts. There is the usual shouting match between the pro- and anti-pharma lobbies, but the conclusions that emerge from ProPublica’s analysis are based on data that has been independently sourced from credible third parties.  ProPublica’s analysis contradicts a  few of the pharma industry’s most frequent justifications for the practice of putting the very professionals who write prescriptions for its products on its own payroll.

Contrary to drug makers’ claim that they only hire thought leaders and other top specialists to move their message, the sheer volume of names in the database indicates this contingency is broadly framed. Among the 384 doctors who earned $100,000 or more during this period, more than one in nine had no board certification in any specialty at all. A search of physician licensing records in 18 states found that more than 250 doctors who accepted speaker fees, including some very high earners, had been sanctioned for misconduct, not surprisingly including inappropriately prescribing drugs. More than 40 got slapped by the FDA for research wrongs, lost hospital privileges, or had criminal convictions, while at least 20 others had two or more malpractice judgments or settlements.

These numbers inevitably give rise to some unsettling questions. For example, why is pharma paying anything at all to doctors who have been sanctioned for professional misbehavior?

When asked if background checks are done on doctors, only Cephalon and J&J said that they review state websites. Nevertheless, ProPublica data base shows that one physician accused of sexual misconduct with female patients was Cephalon’s  third-highest-paid speaker in 2009.

Critics of the ProPublica presentation, including healthcare journalists, point out that the accounting was incomplete, even unfair, because it failed to put the final tally in perspective. Most notably, only 1.5 percent of doctors on company pay  had been sanctioned, while the average payment to a physician came to $15,000, not exactly small potatoes but not necessarily an amount worth risking your reputation over. But at the same time, in a survey by Consumer Reports that accompanied its own reporting, about half of all Americans said that they would be concerned about the quality of care from a doctor who took even as little as $500 from pharma.

According to Medscape, pharma paid more psychiatrists than any other specialists—they also had the highest number in the $100,000-plus club, 116 out of 384. This frequency may be explained by the fact antipsychotics topped the 2009 list of best-selling drugs, while antidepressants came in at no. 4. In addition, the off-label use of these drugs is among the highest for any category.

Neither ProPublica nor any of the other news organizations reports in significant detail about the content of the speaking or consulting or researching for which pharma is paying these many thousands of doctors. While PhRMA reps and many physicians have been quick to point out that all materials must strictly conform to the product label and are regulated by FDA and other agencies, it’s an open secret that many of the scripts and slides that doctors rely on are produced by agencies paid by drugmakers and never vetted by any official. Companies invest in such information in order to reach as many prescribers as possible with a message about a brand-name drug that is as positive as possible. Whether you call this medical education or product promotion is beside the point. ]

Starting in 2013, the new US healthcare reform law requires all drugmakers to publicly disclose the amount and date of every physician payment, the name and address of the physician, and the drug or device that the doctor helped promote. This is should help build confidence in the integrity and accuracy of the data, which some experts have questioned as leading to extreme conclusions when accessed by investigative journalists.   Until then, the ProPublica-based media blitz will continue to spark controversy and conversation over the ethics of industry practices.

To their credit, both Lilly and GSK responded to the ProPublica revelations that the companies had sanctioned doctors on their payroll by launching their own investigations. In a statement, GSK said “we do have criteria in place to evaluate potential speakers.  However, ProPublic has raised issues to our attention that we are investigating further. We will also use this information as we continue to improve the processes by which our speakers are evaluated.”  Likewise, Lilly noted that “reporting by ProPublica and other media outlets has raised valid and important questions about some of our processes, which we take seriously.” And over the past week, all seven of the drugmakers featured in the stories have commented on the reporting. The PBS Nightly Business Report has posted these responses on its website.  Hence the debate continues—and soomer rather than later, expect the investigations to spread to practices in other countries led by renewed regulator interest in provisions of the 1977 Foreign Corrupt Practices Act.

The AHRQ program fits proposals from leading Congressional Democrats, including House Energy & Commerce Committee chairman Henry Waxman (D-Calif), Senate Aging Committee chairman Herb Kohn (D-Wis) and Senate majority whip Dick Durbin (D-Ill). They and others sponsored legislation last year to fund “independent drug education and outreach” similar to the AHRQ initiative. Kohl held a hearing in March 2008 on academic detailing that reflected his long-term interest in efforts to counter messages from pharmaceutical sales reps.

The idea doesn’t seem to go down very well with the docs, however, according to a poll by Pri-Med, a continuing medical education provider. Out of 268 physicians, they found that 92 percent disagree with the AMA committee’s call to end commercial support of CME. The overwhelming majority said, that among other things, it would make it harder for them to stay up-to-date, which in turn would affect patient care.

Is it possible, too, that the doctors were able to imagine what pharma-free CME would look like, and it didn’t seem all that much fun? After all, where would the speakers come from? How would they be paid? What about the food? And where would the programs be held?

A glimpse is provided by Pharmedout.Org, (www.pharmedout.org) at Georgetown’s Universary Medical Center, Department of Physiology and Biophysics along with the American Medical Student Association’s (www.pharmfree.org) in their pamphlet “How to Hold Pharma-Free Meetings.”

When it comes to finding speakers, they suggest using local talent. “Invite a physician from another department—for example, a surgery department could invite an infectious disease fellow to discuss antibiotics. As for payment? “Encourage speakers to forego an honorarium as a gesture of support for pharma-free education.” Or invite Federal employees. “Many wonderful scientists and physicians are employed by Federal agencies or state or county health departments. But what about the food? The organization suggests brown bagging it, or having potlucks in people’s homes. They also offer a guide on how make sandwiches. And finally how to handle all those freebies? Confiscate them, of course. Replace all branded pens, sticky pads, and tote bags and cover the pharmaceutical logos on the items with Pharm-Free logos.

The AMA’s report’s recommendations will be taken up by the AMA House of Delegates at its annual meeting, June 14-18 in Chicago.