Prescription drug problems have hit the presidential radar screen. With an announcement of a plan to rein in the pharmaceutical industry this weekend at a campaign stop in Laconia, NH, John Edwards became the first major 2008 presidential candidate to take on the drug companies.  Here’s coverage in the Associated Press and Concord Monitor. Check out the full Edwards platform here on the campaign website.  Though much of it’s pulled from measures stripped from the FDA reauthorization bill passed earlier this year, Edwards’ proposal, which includes provision for a comparative effectiveness drug-testing center, full disclosure of safety and comparative effectiveness information on drug labeling and ads, empowering the FDA to go after drug companies that run misleading ads, and a two year moratorium on consumer ads for new drugs, is smart, and represents a leap forward in the candidates’ health care conversation.

On one hand, the fact that pharmaceutical marketing and industry reform is showing up in the presidential platforms only now is curious.  After all, talk of health care reform is as ubiquitous on the presidential campaign trail as American flag lapel pins, and the cost of prescription drugs is an issue that has emotional resonance with a pharmacy nation like ours.  Conventional (or perhaps campaign) wisdom has led candidates to focus on coverage, access and Medicare—how to cover more people without charging anyone else—these are the big ticket items. Catch is, conflicts of interest and undue marketing influence on prescribers have the power to affect the cost of those items, and recent reports indicate that they have.

On the other hand, it’s no surprise: health care groups, pharma included, have been some of the most aggressive lobbyists and generous contributors to presidential contenders, according to the Wall Street Journal Health blog, which has done a good job of keeping track.  And today the New York Times reported that health care groups have given $6.5 million to Democratic candidates and $4.8 million to Republicans so far. 

Pfizer has been the pharmaceutical company with the deepest pockets, giving the most to Hillary Clinton ($12,150), followed by Rudy Guiliani ($8,600).  Predictably, Edwards has received the least health care sector contributions to date (the Health blog points to his career as a plaintiff’s lawyer as explanation.)

So far, the headlines have focused on Edward’s DTCA moratorium, and the Monitor piece makes clear why: On the stump, it’s easier to lampoon the endless Flomax ads during the World Series or summon, as Edwards did, goofy images of allergen-free skipping fields. That’s fine—a two-year hold on ads for new drugs certainly won’t hurt matters, and may even decelerate the dubious consumer-marketing machine pharma’s driving.

But voters and the media should remember that DTCA is just a portion of a bigger problem—companies spend nearly twice as much in direct-to-physician marketing each year.  A candidate committed to these issues should address the rough reality that drug ads are just the tip of a really big iceberg: the potential for conflict of interest spills into academic medical centers, university research, continuing medical education, and physician marketing.  We must address those areas, too, if we are to truly tackle our nation’s prescription problem.

Renee Rulin, Medical Director at Commonwealth Care Alliance and a clinical professor of family medicine at Brown University, talked to PostScript about the way pharmaceutical companies affected her days in private practice, and the work CCA is doing now.  She says that just showing up is often the biggest weapon in a drug reps arsenal.

PS: As medical director of Commonwealth Care Alliance, how does pharmaceutical marketing influence the work you do?

RR: Well, as vendors for Medicare and Medicaid, we have a pretty standard formulary, and we negotiate with the drug companies through our Pharmacy Benefit Manager.  So the pharmaceutical companies interact with our PBM, who then selects drugs for the CCA formulary based on our requests.  But a lot of times the way drugs are “bundled” by pharmaceutical companies creates a formulary based more on cost than clinical relevance. 

Despite this, our formulary is broad and follows our philosophy of giving all the authority and decision making back to the doctor, who does the best job of patient care.  We want to get the doctors free to do what they do best.  We really try to get out of the way.

PS: So do doctors make their own decisions about drug reps, or does CCA have a policy?

RR: CCA does not have such a policy.  Our docs make their own decisions.

PS: As a physician and a professor now at Brown, have you seen any shift in how the pharmaceutical companies operate throughout your training and teaching?

RR: Over time, AMCs have really tried to keep Pharma out.  Faculty have begun to see the magnitude of influence they exert in teaching hospitals and in the wards, and are making efforts to replace drug rep visits and CME with real teaching, evidence-based teaching.

But when I was in private practice, every pen was from a drug company, every post-it note.  And that’s true in every private practice, you always end up in a negotiated relationship with the drug reps.

PS: In every practice?  What do you mean by a negotiated relationship?

RR: They would just show up constantly–constantly.  They just sail in, sweet talk the receptionist.  “Can I see the doctor?”  You try to restrict them as much as possible, but they bring lunch for your staff, chocolate chip cookies, and the samples, of course.  I mean, it’s like a gift to have some one show up and  tell you something you want to and need to  know, on your schedule. 

They are generally attractive, well-dressed, and articulate and mostly they are there, willing to talk to you whenever you have a minute.  And all of that is very attractive.  So you sort of delude yourself, saying you’ll pull out those nuggets of information you can use and ignore the marketing.  And it is, it’s a delusion.

Frankly, the docs tend to like that conversation; they like to hear from drug reps.  I think that if academics could counter-detail in the very same way–to really meet docs where they are–they’d do very well.

PS: So when it comes to Academic Medical Centers, you mentioned you see somewhat of a turning tide.

RR: Yes.  They are much more conscientious about keeping out the drug representatives—all the time. 

For instance, the Family Care Center at Memorial Hospital (Brown Family Medicine Residency training program) does not allow pharmaceutical reps into the clinic.

PS: Did you have any particular interactions with drug reps that stand out?

RR: I was no longer a resident, I was a clinical precept, but the reps brought in a lasagna for the whole teaching hospital and gave half of all family medicine residents salmonella.  Half the staff couldn’t work for two months.

Then there are docs that say, “I read the Medical Letter, and I let the drug reps in.”  And I think there are probably people who do that—who get their information independently, take their food and free samples, maybe argue with them.  But I think they are the exception, not the rule. 

PS: So beyond the Medical Letter, are there other good alternatives to detailing out there?

RR: Yes, I think that information is out there: online, in organized courses, in publications such as the Medical Letter.  The thing about drug reps is they just show up, and they have goodies.  And it’s tough to push back against that, it just is.

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.

Hundreds of infant multi-symptom cough and cold medicines are being voluntarily pulled from drug store shelves in the wake of pressure from pediatricians and a call by FDA officials to ban the sale of cough and cold meds marketed for children under six. 

Right now, the only items being pulled are those explicitly geared toward infants, but all that could change next week when the FDA meets with outside experts on the issue. Check out the New York Times, Wall Street Journal, and Associated Press coverage here.

The drugs in question are a common household item for many with kids, who tend to get more colds each year than adults.  According to an earlier Times report, a study in the Journal of the American Medical Association in 1994 found that in one 30-day period, one-third of all American kids had taken one of these drugs.

Despite their ubiquity in the American medicine cabinet, there is no safety or efficacy data for these drugs in kids, and no dosing guidelines for children under two.  According to the trade association, the Consumer Healthcare Product Association, more than 60 deaths related to these drugs have been voluntarily reported since 1969. Check out the CHPA press release here.

And yet, the makers of these drugs—including big hitters like Johnson and Johnson, Wyeth and Novartis—spent over $50 million to advertise these over-the counter remedies last year alone. And it seemed to pay off: more than 41 million units of the drugs were sold during that time, with some stores stocking over 30 different types.

PostScript found about that many when we went shopping to confirm what the Gray Lady hinted: that two weeks after the CHPA’s own recommendation to remove infant cough meds from shelves, many still hadn’t been pulled.

In addition to oral droppers indicating infant use, we found a couple expectorant tongue strips, called mini melts, which PostScript used to think was the name of an ice cream topping. 

Whether the under-2 ban holds or is extended to other pediatric therapies, the cold remedy aisle at the local CVS is bound to become a little less friendly.  Less kids on bikes. Less kids waiting for the school bus. Less Mucinex Mini Mes.  Less kite flying and fruit punch and grape. And less of Postscript’s favorite—the kid on antihistamines sharing a pillow with the family dog. 

But less of that means less kids at risk, and that is a relief—in the true sense of the word.

Elissa Ladd’s career as a nurse practitioner has run parallel to the nursing field’s entry into the prescribing world.  Ladd, who holds nursing degrees from the University of Pennsylvania and Rush University and a doctorate in health policy and nursing from the University of Massachusetts, is now an assistant clinical professor of nursing at the Massachusetts General Hospital Institute of Health Professions.  She recently received a $400,000 grant from the Attorney General Consumer and Prescriber Grant Program to create an education program to teach advanced practice nurses about pharmaceutical companies’ influence on prescribing.  

Ladd talked with PostScript about her time in the classroom and the exam room, and how she’s seen pharma pay increasing attention to nurse prescribers in both. 

PS: How does the pharmaceutical industry interact with the nursing profession? Does it differ from industry interaction with physicians?

EL: Throughout my career, I’ve watched the evolution of prescribing influence on nursing grow.  When I first started practicing as a nurse practitioners, most NPs across the country didn’t have the statutory authority to prescribe yet—we would be practicing, and we’d get scripts from physicians.  About 20 years ago, NPs began to gain prescriptive authority on a state by state basis.

PS: So how wide does nurse prescribing power extend?

EL: Nurse practitioners can now prescribe in all 50 states, as can a group of advanced practice nurses (APNs), which includes psychiatric nurse specialists/clinicians, nurse anesthetists and nurse-midwives.  And that whole group of APNs who prescribe – 150,000—is comparable to the number of family practice physicians practicing in the U.S. today. So we are a sizable force, and Pharma has begun to recognize that.

For the last decade, it’s been interesting to watch the drug company influence grow.  Drug detailers are heavily, heavily targeting NPs now.  It’s the same thing as physicians — annual meetings, continuing education.  And even though there’s been a lot written in the press, I think it’s going to be a developmental process for our profession, because we haven’t had prescribing authority as long as doctors have. Advance practice nurses are now getting  a lot of attention from pharma, and they are enjoying the recognition in a sense, but it’s, you know, perverse. 

PS: In the course of your training and career, when did you become aware of the relationship between the drug industry and the medical profession?  Was industry present in nursing school? 

EL: Well, there wasn’t any pharmaceutical influence during my training at nursing school.  We took pharmacology, but that’s about it.  We didn’t have prescriptive authority, and though it was understood to be just a matter of time and regulation, industry influence was never an issue.  The same is true today: they really haven’t injected themselves into NP training and nursing school, and Im not sure the reason for this – it could be now that pharma influence in medical schools is being scrutinized more closely.

PS: In your view, what is the most worrisome part of the pharmaceutical industry’s relationship with prescribers?

EL: Continuing Education. Absolutely.

PS: Why?

EL: CE is required in order to maintain your nursing license and nurse practitioner certification, just as CME is for physicians, and many times the ones that are free are offered by pharma—and that means pharma provides the speakers.  There’s clearly a conflict of interest operating in this system, and people are really naïve about that.  They can get CE credits and go to these sponsored luncheons.  The problem is that most people think it’s educational, but the programs are really biased.  It’s a veiled process of marketing that people don’t acknowledge or understand, but it’s clearly marketing, nonetheless.  I just think a lot of people aren’t even at the point of acknowledging it.  But both nurses and physicians are very influenced by industry-funded continuing education programs.

PS: Are there alternatives?

EL: Yes, you can find industry-free CE programs, but you have to go looking.  The thing that concerns me is that a lot of the industry-free content  is for CME, not CE, which is what nurses need to get recertified.  I know there are some NIH ones.  But I’d say overall it’s probably less available for nurses than physicians. 

PS: You’ve written that there is a dearth of literature about pharmaceutical influence on your profession—have we missed an opportunity by not paying enough attention to industry relations with nurses?

EL: As I said, nurses are still a bit naïve about this whole thing, since prescribing is a relatively new aspect of the profession.  Physicians are naïve, too, but also in denial.  Oh, it doesn’t influence me, you hear them say.  But of course, pharmaceutical companies aren’t stupid, and they wouldn’t be spending billions unless it influenced practices.  So they know, but they don’t want to know. 

PS: From your vantage as a professor and clinician, do you see this relationship between industry and medicine changing?

EL: I do think there is a tremendous momentum around this.  I think that there’s not only an individual awareness, but policy-wide awareness is growing, too.  Academic Medical Centers are leaders in terms of practice issues, and I think changes there will really trickle down into smaller practices and hospitals, and filter into the NP community as well.  Whether people like it or not, I think the culture is changing. 

PS: A recent survey by the Center for Congressional and Presidential Studies at American University reported that 82 percent of Americans trust the FDA to oversee medication approval, 67 percent trust drugmakers, and 53 percent trust Congress.

In your opinion, how much unrealized public outrage is out there to be harnessed?  And is public outrage—grassroots anger—necessary to move this issue?  Whom must we convince?

EL: There have been some interesting studies that have asked patients: “Do you know your doc takes gifts from pharmaceutical reps?”  It’s funny because most of the patients didn’t know that, and they are angry once they find out.  I see a shift happening at the physician and medical center level.  But once consumers become more aware, I think there will be even a larger shift.

The Attorney General Consumer and Prescriber Grant Program [of which Ladd is a recipient] will be awarding a grant to a consumer education project on these issues in the coming months, which I think will help patients  become more involved in this issue, too, the way they did with antibiotics.

PS: A shift in antibiotics?

EL: Once the public learned that about bacterial resistance – from their doctors and the CDC guidelines issued in 2001 about antibiotic overuse – we saw a lot of awareness, a big decrease in prescribing, especially among pediatricians.  It was a significant shift.  That’s an example where the docs, especially pediatricians, have done a very good job of changing their own culture. 

PS: What has been your most memorable experience with pharmaceutical reps or marketing? How did it change the way you practice or prescribe?

EL: It was a couple of years ago and I was working at a family practice, with two docs.  I had never seen so much drug paraphernalia—it was plastered all over the place, down to the paper on the exam table.  It was like the Nexium ad or something.  He couldn’t even buy his own exam paper?  I mean, that’s pretty in-your-face.  I’ve actually seen it on toilet paper, too.

And this practice was getting free lunches every day.  Every day!  And you listen to a talk while you eat.  You don’t really think about it initially.  But one day, I did start thinking: Wait a second, they’re doing this every day, and I just didn’t feel right about it. So I decided I wasn’t going to go to the next lunch.  One of the docs passed me on his way there. 

“Don’t you want to get some lunch?”  I said no, I was just going to stay and work on my charts.  Then there was this silence, probably ten seconds.  “It doesn’t affect what I prescribe,” he said.  “I just go in there and eat their food.”

But ultimately, it’s the patients that pay for those meals, in the form of higher cost drugs.  It was a cascading clarity that I got about this issue.  It’s all unconscious, that name recognition.  It works for drugs, for cars, for washing machines.  It works for refrigerators.  It just works.

The amazing thing to me is that we know this happens.  We know.  They wouldn’t be spending what they spend if they weren’t getting some return.

The Prescription Project has been invited to testify before the joint committee on health care financing tomorrow at the Massachusetts State House. The hearing is on a set of 17 health care reform measures called “An Act Controlling Health Care Costs and Improving Health Care Quality.” Health Care For All, a Massachusetts-based consumer advocacy organization that worked closely with legislators on the bill, has all you ever wanted to know about this bill and more on its website.

The RxP team is especially jazzed about five provisions in the bill to improve cost and quality in prescription drugs. They include:

• creating drug formularies based on evidence-based drug effectiveness review information
• providing for a statewide academic detailing program to educate physicians on cost-effective drug options like generics and to counter unscientific drug marketing
• banning the sale of prescriber information to drug marketers
• prohibiting gifts to prescribers from drug companies, and requiring disclosure of industry marketing payments
• eliminating copays and coinsurance for chronic and preventive care

The last one—or sweet 16 in the bill—at first doesn’t seem to fit with the cluster of prescription-related actions. Eliminating copays and coinsurance for preventive and chronic care? What does that have to do with pushy salespeople?

But what we take and whether we take the recommended dosage or get our prescription refilled on time often depends heavily on how much we have to pay. This is especially true for chronic diseases that require long-term therapeutic regimens to maintain. Annual exams. Family Planning. Diabetes and cholesterol medication. Precisely the things this bill proposes to eliminate patient costs on. Think of sixteen as a smart public health move with an Rx twist.

And that’s why this bill is so on track. Its whole cloth reform agenda extends the length of the health care field in Massachusetts, not just to certain sectors. It acknowledges the thick and sometimes tangled web of stakeholders and interests in play, and how cost and quality pressures fundamentally affect how a person seeks and receives medical care.

And though its objectives are bold, the proposed act is not mere pie-in-the-skyness. This bill has to be wide-angle and comprehensive to address the super-wide-angle health reform that passed last year. That law—which requires every Massachusetts resident to obtain health insurance —allows for and demands that all players be at the table because when coverage is mandated, health care is everyone’s concern. This providence, which has made Massachusetts a leader on the national health care scene, demands a corresponding stewardship to ensure that the practice and delivery of that universal health care is safe, effective, and fiscally sound.

This bill—and tomorrow’s hearing—is that stewardship articulated: from making sure there are enough properly trained primary care physicians in the state, to requiring public accountability for all insurance rate increases, to ensuring the drugs a patient picks up at the pharmacy are the best ones he or she can get at the best cost. And as it stands on Beacon Hill, such stewardship comes in seventeen parts.