This week, House Energy and Commerce Committee Chair John Dingell (D-Mich) and Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) sent a letter to the FDA asking about just how and why the agency chose non-profit EthicAd to partner on the creation of the “Be Smart About Prescription Drugs” website, launched last month to help consumers navigate drug ads.

In September, we had some questions of our own about EthicAd’s mysterious funding sources and close ties to Shaw Science Partners, a pharmaceutical marketing company with a long list of Big Pharma clients.  We broke news of Shaw Science Partners and EthicAd’s office- and phone-sharing arrangement here on Postscript, and look forward to hearing of the agency’s reply. 

And the latest joint probe of the Senate Finance Committee and the Special Committee on Aging, Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) are looking into industry payments received by Columbia University cardiologist and stent entrepreneur Martin Leon and other Columbia researchers at the Cardiovascular Research Foundation.  The probe seems to center around the CRF’s industry–sponsored device conference, Transcatheter Cardiovascular Therapeutics, and Leon’s ties to the sponsoring companies.

Here’s more at Bloomberg.

But it’s only the latest investigation, and if history’s any guide, won’t be the last. With the troubling discovery of piles of undisclosed industry payments an Emory University psychiatrist took from a company whose drug he was testing on the government’s dime, and new revelations about the wag-the-dog marketing tactics used to push Neurontin, editors of the New York Times and Atlanta Journal-Constitution write this week that all this coziness between drug companies and doctors “underscores the need for Congress to pass a bipartisan bill, sponsored by Senators Chuck Grassley and Herb Kohl, that would require drug companies and other medical manufacturers to publicly disclose payments to physicians that exceed $500 a year.” (10/11, New York Times).

The Journal-Constitution went further in its recommendation, saying passage of the disclosure bill – also known as the Physician Payments Sunshine Act – is a “bare minimum,” and that the “culture that has infected drug company sponsorship of academic medicine needs a thorough cleansing,” including a “temporary reduction in the amount of money going into research and continuing physician education.”(10/12, Atlanta Journal-Constitution)

And another editorial in the Arizona Republic this week takes a puzzling non-stand on the PPSA: First they were against, then they were for it? In the end, we’re not really sure. Just like the writers don’t seem very sure whether or not doctors are influenced by pharmaceutical marketing. The verdict?  “Probably not.” Sure, we’d heard the West is a place of fewer words, but this is taking it too far.

The first two editorials were no doubt spurred by the controversy around Dr. Nemeroff’s busy speaking schedule. News came this week that he’s about to get a little less busy – the National Institutes of Health have hit pause on the 5-year, $9.3 depression grant that Nemeroff was heading up at Emory. The AJC says despite his freed up schedule, Nemeroff is still turning down interviews.

And over at A Healthy Blog, RxP’s Kathy Melley looks ahead at what we’ve all been waiting for. Our 401Ks back? Ok, the other thing we’ve been waiting for – the decision from the U.S. Court of Appeals on prescription data-mining bellwether case, Ayotte v. IMS Health.

“The court ruling could have the effect of ratcheting up or down state legislative activity on data mining,” Melley writes, but that “regardless of where the court comes down, there’s a good chance the U.S. Supreme Court may be the final arbiter on this issue.”

Medical students and local physicians will rally at the Harvard Medical School campus today, urging their adminstrators to create better conflict-of-interest policies around pharmaceutical marketing.  According to a press release from the American Medical Student Association, which is capping its National PharmFree Week at the Longwood medical campus in Boston, “Students are asking for involvement in the policy drafting process, increased transparency, mandatory lecturer disclosure and a reasonable timeline for drafting and implementation.”

Check out the AMSA scorecard rating medical school COI policies here.

Ghostwriters…

The big story from the Pharm Country this week is ghostwriting, in the wake of reports that some of the papers published about Vioxx were penned by Merck but attributed to physician authors.  If you haven’t seen the story, you need not look very far — it’s everywhere.  The Baltimore Sun and CNN here, plus some more in an earlier blog post.

Sen. Chuck Grassley (R-IA), sponsor of the Physician Payments Sunshine Act, wasted no time writing Merck a letter.

As FDA deadline approaches, so do lobbyists

And as the deadline for public comment on the FDA’s proposal to loosen restrictions on off-label marketing materials, pharma lobbyists descend on Washington.  The story is in the Wall Street Journal.  The approaching guidance would allow pharmaceutical salespeople to distribute journal articles about off-label uses of their drugs to doctors – but this review of Neurontin off-label use (spoiler alert: it’s dismal) is a good case study in why some worry about the legalization of such off-label promotion.

Massachusetts Senate cost control bill moves to House

In Massachusetts, the state Senate has passed a comprehensive cost-control bill that includes a gifts ban and academic detailing provision.  Now it moves on to the House.

But not before veteran pharma champion and biotech director Thomas Stossel MD of Harvard Medical School and co-writer and Harvard doc Dennis Ausiello MD got their word on the gift ban in.

“We believe that the best approach to optimize cost effectiveness of product prescribing is to promote more, not less, interaction among all stakeholders involved in health-care delivery, including company marketing reps,” Stossel and Ausiello wrote in the Boston Herald.

Hmm.  A call for more interaction among all stakeholders + a state shortage of primary care docs = Perhaps the reps could see patients themselves, to help the docs out?

We thought we were just poking fun, till we saw this post on Pharmalot – it’s almost happening! In Australia, medical practices have started to ask pharmaceutical companies to help with payroll for their staff.   A total pigs-on-the-runway moment for PostScript.

Pharmalot and the HealthBlog are really good about pointing out relevant ties to industry that may color the opinion columns and letters of pharma’s more prolific defenders like Stossel, which is good, because it seems the original publisher of those pieces rarely get disclosure of his industry ties right on the first try….

The Vytorin Connections

Part of Schering-Plough’s clean-up team for the Vytorin mess is on the board of the New York chapter of the American Heart Association,  as is one of S-P’s compliance officials, reports Pharmalot.  While consumer groups like the AHA taking funding from pharmaceutical companies is nothing new, Pharmalot says there are an awful lot of dots to connect in this picture.

On the street where you live

All politics are local, and now so are drug ads, like this Zyrtec pull-away flyer.  Streetcorner DTC? From what we know about the size of pharma’s marketing budget, we’d say this is cutting more than a few street corners.

A double-issue of the RxP Weekly Reader this week, as PostScript heads down to D.C. for a conference. Happy Reading.  

“Not it” say NIH, universities on tracking researcher COI

A new report from the Office of the Inspector General of Department of Health and Human Services says that the National Institutes of Health are doing not a whole lot to monitor conflicts of interest among grant recipients at universities, despite the fact that such ‘extramural’ researchers receive 80 percent of the agency’s $29 billion budget. 

Conflict of interest reports from researchers will be required come March 1, but neither the NIH nor the AAMC is keen on taking a larger role in such COI oversight.

Read more at the New York Times, Inside Higher Ed, GoozNews, and the response from the AAMC at Medical News Today.

Spring cleaning in January

A private health system in northern Minnesota and Wisconsin did some spring cleaning a little early, chucking more than 18,000 pharma freebies from its 4 hospitals and 17 clinics.  The move by SMDC health systems represents one of the biggest clean sweeps of pharma influence among private health providers since Kaiser Permanente instituted tougher conflict-of-interest policies in 2005.   

“We’re part of a leading trend that’s trying to get away from the pharmaceutical companies essentially controlling what’s prescribed in this country,” Dr. Kenneth Irons, chief of community clinics for SMDC told the Minneapolis Star-Tribune. “This shows people we’re not in the pharmaceutical companies’ back pockets.”

RxP assistant director Marcia Hams talks to the AP about what this means in the big picture of clinics and medical centers that are starting to put some space between themselves and the drug reps.

and farther east…

The Lewiston Sun-Journal looks at one such hospital, Franklin Memorial, and the changes that have come with the new policy.  Here, the Sun-Journal compares Franklin with other Maine hospitals. 

Left coast Rx legislation considered

And The Olympian reports on a set of bills being supported by the Washington Coalition for Prescribing Integrity, a group of doctors, lawmakers and advocates. The six bills, which have been heard bicamerally in the health care committees, would create a statewide academic detailing program, require public disclosure of all gifts to health care practitioners from pharmaceutical vendors, and restrict prescriber data-mining.

and on the Eastern Seaboard…

A group of advocates for lower prescription drug costs announced the new Massachusetts Prescription Reform Coalition at the State House. The coalition, spearheaded by Health Care for All, will work to support policy change that will limit undue industry marketing by banning gifts to physicians, prohibiting prescription data-mining, and provide doctors with academic detailing resources. State Senators Jim Marzilli and Mark Montigny, key players in the state’s health reform efforts, spoke in favor of the coalition’s goals.

The group includes the Prescription Project, AARP of Massachusetts, Massachusetts Senior Action Group, National Physicians Alliance, Neighborhood Health Plan and others. 

 For more information, read coverage in the Boston Globe, Patriot-Ledger, and the MPRC news release here.

Here’s another article on data-mining – this time from the ‘PhillyBurbs.com.’ [Which, we admit, is faster to type than the Bucks County Courier Times.]

Rep repellent education, courtesy of Pfizer

Businessweek takes a look at Adriane Fugh-Berman’s PharmedOut and Elissa Ladd’s nurse practitioner education program, efforts both aimed to increase awareness of the temptations of pharma reps among future medical practitioners.

Fugh-Berman and Ladd were both recipients of Consumer and Prescriber Grants awarded in a 2004 settlement with Warner-Lambert of Pfizer over off-label marketing of Neurontin.  

FDA issues public health advisory – no cough and cold meds for under-2s 

The FDA issued a formal public health advisory last week: don’t give your infants or toddlers pediatric cough-and-cold medications, because they are risky and have the potential for dangerous overdoses.  The statement follows advisory committee meetings last October, when committee members voted that the drugs were not effective for children under age 6.  Baltimore Health Commissioner Dr. Joshua Sharfstein told the AP that the next step is to get the FDA to assess safety and efficacy of these drugs for children under 12. 

Medicate…Medigate? The pharma tapes  The Philadelphia Inquirer frames the new taping on physician-patient conversations for commercial use as an entrepreneurial lightbulb.  But the scheme dreamed up by two former pharma reps who now run Verilogue, makes prescriber data-mining look like old-fashioned phone-shoe espionage. Doctors are being asked – and permitting – their conversations with patients to be taped for sale.   “To attract physicians,” the Inquirer reports, “the company sent e-mails and faxes, targeting specialty doctors, such as oncologists and psychiatrists who are paid for their time. The company said the fee is similar to stipends paid to medical investigators in other clinical research.” 

The taped talks, then scrubbed of identifiable information by Verilogue, are sold to pharmaceutical companies so they can learn more about the patient-doctor conversation, a dialogue which seems to grow less confidential and more valuable by the day. 

No pain, no gain

The New York Times reports that there is still a lot of debate over the existence fibromyalgia as a diagnosable disease, but that didn’t hinder the sales pitch of Lyrica, the first FDA-approved drug for the nebulous pain condition.  Pfizer spent $46 million ads for the fibromyalgia drug in the first nine months of 2007.  

The cost of keeping a pharma rep

This Pharmalot post based on a Marketwire report says on the average cost of a primary care pharmaceutical sales rep has trended up in recent years, and is now at $175,000 per rep (which includes samples). Food for thought: the average salary for a primary care internist is around $150,000, and a little less for a family practice doc.   

And in closing, the Macy Foundation released this executive summary of a report to be released later this year. The report calls for a complete separation of corporate interests from CME. If you’ve stayed up late worrying about industry supported-symposia, or ever pondered the fate of CME at the hands of Medical Education and Communication Companies (MECCs) and pharmaceutical company ghostwriters recently, this is a must read.

Community Catalyst, a national advocacy organization that builds consumer and community participation in shaping of our health system, has just launched the Generics are Powerful Medicine (GPM) campaign, a grant program to help nonprofits jumpstart creative education programs about the safety, efficacy and affordability of generic drugs. 

For more information on the GPM program, or to read the Request for Proposals, visit the Generics are Powerful Medicine website at www.genericsarepowerful.org.

When it comes to the value and power of generics drugs, the Prescription Project is the choir GPM is preaching to. PostScript talked with staff attorney Rishi Garg about the new grants and GPM’s big plan to get the word about generics out there.

PS: GPM comes out of a court settlement in a case over whether generics were illegally kept off the market. Do you think this settlement and others (the Neurontin settlement Consumer and Prescriber Grant Program) actually move the ball down the field more than if the off-labeling or buying-off hadn’t happened at all?

RG: While the creation of programs like GPM is one positive result from cases like these, everyone would much rather that pharmaceutical companies play by the rules and not stand in the way of generic competition in the first place. 

Pfizer allegedly filed frivolous patent applications and baseless patent infringement claims to keep a generic version of Neurontin off the market and maintain its billion dollar annual sales for  that drug.  Glaxo is alleged to have done many of the same things for Relafen, in the lawsuit GPM grew out of.  Both Neurontin, an anti-epileptic and Relafen, an anti-inflammatory, could have helped millions of people had it been made available as a generic earlier. 

So while consumer education programs are important, it would be best for consumers if these cases did not have to be brought.  In other words, programs like GPM are intended to cure a problem that it would be better to prevent in the first place.   

PS: Who’s your audience? Patients? Prescribers? Swing voters?

RG: Our target audience is patients, and our intent is to focus our education campaign on the uninsured or underinsured.  Low-income and minority communities are oftentimes the ones most hurt by high drug prices, the least aware of the benefits of switching to generic alternatives and yet the most likely to benefit from switching.  We hope to reach those communities. 

PS: You are starting a generics campaign in a brand-name nation.  Does your campaign have evidence that more public education about generics = increased usage? K-Mart offers Kathy Ireland blue jeans and sneakers are available cheaply at K-Mart, but women still shell out $200 plus for arguably a molecularly equivalent pair of Seven jeans, and would never think of wearing Kathy Irelands.

Setting aside safety concerns on newer drugs, is it possible that brand preference leaves less elasticity in the prescription drug market for you to work with?

RG: Perhaps, but there is a big difference between life-saving drugs and blue jeans.  A large part of the GPM campaign is dispelling myths about the quality of generics. 

People do seem to think of generic drugs as less than “the real thing.”  The challenge is to dispel that myth, and it’s a very real and large barrier.  We hope that working with medical leaders to produce accurate, consumer-friendly literature on the effectiveness of generics will help shatter some of these misconceptions.  Once the public perception changes, people will be willing to switch to generics since it will save them money, and will save the healthcare industry billions of dollars. 

PS: Following on that, what sort of outcomes are expected or tied to the GPM campaign?

RG: Our hope is that GPM becomes its own on-going self-sustaining project.  Over the next five years, numerous patents on blockbuster brand-name drugs will expire and less-costly generic  versions of those drugs will become available to millions of consumers.  A lot of education will be required so that brand-name drug companies aren’t able to fool people into continuing to purchase expensive brand name drugs in the face of less costly and equally-effective generic alternatives. 

PS: Are there any effective consumer education generic campaigns out there now that groups interested in the GPM grants might look to as models?

RG: There are a couple of consumer education campaigns, not just on generic drugs but on prescription drugs generally, that we think offer some useful models and lessons:
 
1. Blue Cross Blue Shield of Michigan tried a similar campaign to GPM a few years ago and created a great tool called “The Unadvertised Brand” at www.theunadvertisedbrand.com

2. The FDA has a great website which provides answers to common questions about generic drugs at http://www.fda.gov/cder/consumerinfo/generics_q&a.htm

3. A program out of Oregon Health and Science University compares drug effectiveness within different classes of drugs.  It can be found at http://www.ohsu.edu/drugeffectiveness/

4. Finally, Consumer Reports created a tool on their website that allows consumers to compare similar drugs and pick the most affordable at http://www.crbestbuydrugs.org/

PS:  Will you be making a GPM YouTube video?

RG: The idea of a You-Tube video has been  discussed!   Stay tuned…

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.

The Center for Knowledge Management at the University of California San Francisco wants to expand its Drug Industry Document Archive, an online storehouse for pharmaceutical industry documents.  When the Prescription Project, which supports increased disclosure of pharma-related info, got wind of the possible archive expansion, we wanted to find out more.

PostScript talked with Kim Klausner, who manages the Legacy Tobacco Digital Library at UCSF and is looking to expand DIDA.  She said the idea for DIDA grew out of the Legacy Tobacco Digital Library, a rich repository of documents turned over by the tobacco industry during its settlement with state Attorneys General in the late 1990s.

The Legacy library, which contains more than 40 million pages of corporate and court documents from the tobacco settlements, has proved a valuable asset to investigators, reporters, attorneys and public advocates as they continue to expose tobacco industry misdeeds against public health and trust. 

Established with help from a charitable gift in 2005, DIDA currently includes some 1,000 searchable documents, primarily court materials from the 2004 Neurontin case, in which a division of Warner-Lambert (now Pfizer) settled with the U.S. government for $430 million on charges of illegal marketing for off-label use.  The archive also contains documents related to Merck and the Vioxx suits. 

In a post-Vioxx world, many like Klausner believe that internal documents from pharmaceutical companies and the court cases brought against them could be of commensurate value to those interested in increasing drug safety and opening Big Pharma’s playbook to the public. 

PS: Do you think there are historical moments when archives such as the ones at DIDA are more necessary than others? What characterizes such a moment? Is this one of them?

KK: Since the mid-19th century, when national corporations started to develop, muckraking journalists, Congressional committees, and advocacy groups have tried to obtain information about corporate misdeeds in a variety of ways. But it was the confluence of two factors that exponentially increased the public’s ability to discover how an industry contributes to the degradation of the public’s health.  In 1998 the tobacco industry, in order to settle lawsuits by 26 state Attorneys General, agreed to make available to the public millions of documents from their files.  By 2000, digital technology had developed to a point that the University of California, San Francisco Library was able to take these memos, reports, correspondence, videos and more and put them in a searchable database on the Internet for all to see.  And, in 2006 we were able to make the text of the documents themselves fully searchable. 

Advocates for pharmaceutical industry reform will have the opportunity to learn about a wide variety of companies, drugs and issues because plaintiff attorneys in lawsuits against pharma companies can ask the courts to make the documents that have been submitted to them available to the public.  When that happens we’ll add the documents to DIDA. 

So, long story short, it’s always been necessary for advocates to have information about what corporations are doing but now it’s possible to a greater extent than it was before.

PS: At this juncture in the Information Age, it seems DIDA and the Legacy library are each part of a larger trend of information aggregation. Still, concerns about the consequences of too much information—data mining, wiretapping, corporate and government monitoring—have spread; for instance, in 2002 librarians became privacy advocates when the government invoked the Patriot Act to search library records. 

Are they flip sides of the coin, two ways that information abundance is used, sometimes to counteract one another? And must we take one with the other? Or is there good and bad information collection, and how do we parse that out in a public way?

KK: For the most part, technology is ethically neutral. But there are moral implications for the way that people use technology.  So, I don’t think that the aggregation of information is in itself a bad thing.  However, it can be used in a myriad of ways along the good – evil spectrum.  Yes, the public needs to be ever vigilant that the government and corporations don’t use data in a way that is harmful to people.

PS: What lessons did you take from the LTDL, and were there any that came as a surprise to you?

KK: I’m not sure I’ve learned any lessons from LTDL, but I have learned a lot about how the tobacco industry operates — how the companies manipulate scientific research and public opinion, how they’ve spent a great deal of money creating materials to convince their own employees that it’s okay to work for them, how they’ve pursued their legal strategies, and how tenacious they are in marketing their “nicotine-delivery devices” internationally, among other issues.

Sadly, none of this was surprising to me.  But it has been really interesting to watch videos and read documents that the companies never thought would see the light of day.