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…

Right now, Dr. Daniel Carlat’s article, “Dr. Drug Rep,” is sitting atop the vaunted Most E-mailed list on nytimes.com.  Featured in Sunday’s New York Times Magazine, Dr. Carlat’s narrative recounts his year as a paid speaker for Wyeth Pharmaceuticals and its depression drug, Effexor.  Carlat, a psychiatrist with a practice in Newburyport, MA and author of a great blog, spins an intriguing tale complete with dialogue, disillusionment, and Broadway glitz in four parts.  If you haven’t already read it, chances are someone has sent it to your inbox.

No doubt: We are a list-crazed culture. From the fatalistic travel book series 1000 Places to See Before You Die to the Seven Habits of Highly Effective People to Casey Kasem’s American Top 40, we are a people in love with the list.  And “Most E-mailed” at nytimes is no exception, showing a real-time ranking of the stories being sent (and to extrapolate, being read) most frequently from the New York Times website.  “Most E-mailed” has been elbowed as an echo-chamber metric, perhaps most charmingly by The Onion, which reported in April that the coveted top-ten was tearing the New York Times newsroom apart.

But despite this and other “real news” criticisms, nytimes.com “Most E-mailed” has become the sidebar to watch for what people are talking about around the web-based water-cooler.

And what they are talking about today is Carlat’s “Dr. Drug Rep.”  Over every other Times news story.  We read this as a really good sign that pharmaceutical influence on doctors—the economics of it, the tactics, the pervasiveness (Carlat cites a report that estimates about 25 percent of U.S. physicians receive money for speaking about or helping to market drugs)—is at the top of readers’ minds.  And though we’re biased, we think that’s where it should be.

The blogosphere is also a-flutter with Carlat’s confessional (the story is currently at #8 on the Times Most-Blogged tab), and is yielding some interesting side stories, including a comment on Pharmalot from an ex drug rep who says that some pharmaceutical reps just go through the motions of setting up speaking engagements and ‘ghost-dinners’ under pressure to spend their speaking budgets. More blogs here, here, and here.

All of this buzz comes along as more and more legislation is being introduced at the city, state, and federal level to alter the way drug companies court and co-opt doctors.  Recent headliners include the Physician Payments Sunshine Act, similar legislation slated to be introduced in the House, Maine’s data-mining restriction bill, and the Safe Rx Act being considered by the D.C City Council.  It’s a natural feedback loop, and the volume is growing. 

Does all this add up to our nation taking stock, just as Carlat did, about the ethics and consequences of our relationship with medicine and the pharmaceutical industry, and the relationship we permit between the two?  Perhaps.  Or perhaps it’s too a big leap to see the patchwork of moves by individual, corporate, academic, and public healthcare stakeholders as the actions of a united, albeit clumsy, moral agent.  Either way, it seems we can read the growing policy and media attention—measured in bills and newspaper inches and airtime—like a loudening macro version of the silent internal dialogue Carlat describes having with his conscience after each Wyeth talk he gave. 

It will be interesting to follow this story and see whether this interplay among policymakers, press and the public concludes, as Carlat’s tale did, in a collective, incremental “No Thanks.”

Then Shakespeare might have enjoyed these 5-minute videos from PharmedOut.  Dubbed “Pharma Insider Parts I and II,” former insider Doug Melnick, MD MPH talks with Pharmed Out’s Adriane Fugh-Berman, MD about off-label prescribing and competitive intelligence. 

And the bard meets YouTube.

Exeunt.

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Howard Brody is a professor of family medicine and director of the Institute for the Medical Humanities at University of Texas Medical Branch in Galveston, Texas.  Prior to joining the faculty at UTMB, Dr. Brody was a professor of medicine at Michigan State University and director of the Center for Ethics and Humanities in the Life Sciences.  He holds an M.D. and Ph.D. in Philosophy from Michigan State University and has written five books, including most recently Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry.  Brody, a member of the National Physicians Alliance, also keeps the Hooked blog, a terrific companion to the book which tracks medical conflicts of interest in the news.  

PS: You do a good deal of touring and giving talks about the ethical conflicts between medicine and pharmaceutical dollars. Do you get the sense that the medical students you encounter are the right amount of worried about pharma influence?

HB: Well, among general audiences, there’s always the question of preaching to the choir.  But it seems from the talks I give that those who didn’t see this as an issue before are more concerned and engaged now. I sense an amount of general commitment increasing, and actions being taken to do something. 

For instance, when I did Grand Rounds at the dept. of medicine at UC Irvine a few weeks ago, they told me they had already ended all drug lunches a couple of years ago. I talked to some med students who were having trouble convincing the administration, but on the other hand they were already engaged in doing something.

PS: You mentioned general audiences: is public outrage and involvement key to this movement?

HB: Well, a superficial look might indicate it’s not the public’s business. From that standpoint, this is an issue of medical professionalism, an internal matter for physicians to decide. But at the next level we say: okay, this absolutely has to do with public trust. Physicians should be making decisions based on science and their patients’ well-being, not which rep just took them to dinner last. The public ought to be able to trust that your physician can trust what he reads in the med journals, and that the content there hasn’t been influenced by who buys the ads.

So there needs to be a dialogue with the public eventually. We have to turn to them and say, “If we do these things, will you trust us?” 

Reform has to be a two-pronged thing. First, a professional level of reform: individual physicians growing a certain underdeveloped piece of anatomy….we need our professional spines to be strengthened. And the second piece is regulatory reform: We need to take back medical research from the pharmaceutical industry. There’s got to be some accounting for the bennies that these contract research organizations and investigators get from the drug companies. 

The public simply cannot demand further tax cuts unless they confront the fact that they are selling medical integrity to the hands of private industry.  I think that means we are going to have to pay so that science remains a public good, and not property of the commercial outfits.

PS: Do you consider yourself a doctor or ethicist first? Did you have a wakeup call that linked the issues for you, or is your interest in bioethics just the transfer of a worldview into academic pursuit?

HB: Fast backward: I’m in med school, it’s the early 1970s and students are uppity, they’ve been throwing their weight around.  When stuff comes in from the drug companies, there was a vocal group that said we don’t want this stuff, maybe it came from a general distrust of traditional authority. In a drawer at home I still have my Eli Lilly stethoscope that I was given my first day of medical school—so I’m not saying I was totally pure about that stuff back then. But somehow, as a med student I got the idea it was not a good use of my time to see drug reps. 

During my residency in family medicine at Virginia, each resident rotated for two months as head resident at the clinic, which meant you saw every drug rep that came in.  At that time, we gave out a lot of stuff from the sample cupboard. I told my chief I wasn’t really into seeing the reps.  And he said tough, it’s your job.  So okay, I said, for two months I’ll have to see all the drug reps, and this is my chance to see what I’ve been missing.  I had already finished my Ph.D. in bioethics but it wasn’t about this–these issues just weren’t on my ethic radar screen yet. There was one rep out of all of them that might have taught me something, but that’s it. One. It seemed it’d be a much better use of my time to spend that same time reading The Medical Letter.

Over the years, I served on a residency committee on industry relations and became known as anti-drug rep for trying to push policy in that direction. At no time was I thinking this is an ethical issue; this is just me in my medical existence.

But then in 1997, I read Drummond Rennie’s editorial, “Thyroid Storm,” which described the saga over publication of an article on generic vs. brand-name levothyroxine that showed that the generic was equivalent to the brand name. The article was blocked for four years by the brand name manufacturer, Boots-Knoll. At one point JAMA tried to resolve the impasse by seeking independent reviewers to referee the paper, and in this editorial, Rennie noted that it was extremely hard to find any thyroid experts in the U.S. who were not paid consultants of Boots-Knoll.

I had no idea that the waterhole of science was so polluted by industry funding. I thought: “Where is this in the bioethics literature?  I’ve got to get involved here.” And that lead to [writing] Hooked. 

But it took me awhile for the ethics piece to come on board with the doctor piece of my thinking.

PS: Has this issue begun to get attention in bioethics?

HB; Yes, I think so. There was a panel on these topics last year at the American Society for Bioethics in the Humanities. So that barometer would suggest that some people are working on this.
 
PS: Why only now?

HB: For too long, it appeared all we were talking about small scale stuff: pens, lunches, that sort of thing.  But then the article, “All Gifts Large and Small” (Katz, Mertz, Caplan. “All Gifts Large and Small,” American Journal of Bioethics 3(3):39-46)  came out, and that paper was a pivotal moment because it demonstrated that we are not just talking about pens and coffee mugs, we are also talking about principles. 

In writing Hooked, one of the things I thought was important to do is get at: how did this all happen? And I found the degree by which the pharma rep and the investigator rose up as dual presences in American medicine was very gradual—a case of the proverbial fish not noticing the water. Physicians and ethicists both were lulled because it was such a gradual intrusion.