Cover Story
The Drug Rep Debate
Some miss them. Some have moved on. Docs weigh in on the value of pharmaceutical reps.
By Howard Bell
When Jon Hallberg, M.D., was medical director of the University of Minnesota’s Primary Care Center in the early 2000s, managing the sample closet was a full-time job for a nurse. In 2004, the clinic went sample-free and drug rep-free, and Hallberg hasn’t looked back. “Once you get rid of the samples and drug reps,” he says, “you practice evidence-based prescribing. You don’t get excited about new drugs that haven’t been fully scrutinized and often aren’t more effective than older drugs that cost much less. I don’t miss the free lunches or the cakes shaped like Prozac. And I don’t miss the information they provided, which is always one-sided.” Instead, Hallberg uses UpToDate and the Prescriber’s Letter, which he says is “fantastic,” plus the New England Journal of Medicine and the Journal of the American Medical Association (JAMA) to learn how new drugs stack up against old ones.
Now medical director at Mill City Clinic in Minneapolis, where reps aren’t allowed past the front desk, Hallberg says, “We’ve entered the golden age of generics, where we can prescribe so many great meds so cheaply. Cost is now part of the conversation between physicians and patients. I rarely put a patient on a new medication and only if there’s a clear benefit to the patient.”
Clinics and hospitals big and small throughout Minnesota have restricted drug company reps’ access to physicians or completely banned them from their premises. It’s a trend that gained momentum five years ago, after influential physicians writing in the January 25, 2006, issue of JAMA called on academic medical centers to set an example by no longer allowing their physicians to accept gifts, trinkets, vacations, tickets to shows and sporting events, or payment for speaking about a drug or device company’s products. The concern was that such gifts influence prescribing.
As a result of hospitals and clinics tightening their rules about allowing drug reps through the door, physicians have had to find new ways to learn about the pharmaceuticals they prescribe. Some are happy with this change, others aren’t. Here’s how a few feel about the issue.
Moving ON
Relying on Pharmacists
At Essentia Health in Duluth, “drug reps are pretty much totally out of the picture,” says Kenneth Irons, M.D., a family physician who spearheaded Essentia’s effort to purge its clinics of drug-related gifts and trinkets back in 2006. “I know a lot of reps in northeast Minnesota have lost their jobs in the last three years,” he says.
There are a couple of exceptions to Essentia’s no-rep, no-sample policy. Physicians can make a special request to get a sample of a particular drug. For example, some cardiologists request samples of Plavix, a medication used to prevent blood clots, which they will give to patients going home on weekends after a heart catheterization procedure to ensure that they have the medications they need until they can fill their prescription. Essentia doctors are allowed to attend dinners sponsored by drug companies on their own time, but Irons believes attendance at such events has drastically declined.
Essentia’s electronic medical record (EMR) is linked to the Medical Letter, the Pharmacist’s Letter, and UpToDate, along with a few peer-reviewed journals. “None of these accept grant money, donations, or advertising,” Irons says.
In addition, Essentia’s pharmacists research the safety, effectiveness, and cost of all drugs before they’re added to the formulary. They also brief physicians on medical management issues, for example, for patients on warfarin. “Our staff pharmacists provide us good reviews on new drugs,” Irons says.
Looking to Peers
At Olmsted Medical Center in Rochester, drug company reps used to be the ones to show nurses and physicians how to use technique-critical devices such as inhalers. So when Olmsted went rep-free five years ago, there was no one to take over that teaching role, according to Barbara Yawn, M.D., a family physician and director of research. That has since changed. Today, the allergy nurses, the allergist, and Yawn offer regular training sessions for the nurses, who then teach patients.
Reps are still allowed to give lunch talks at Olmsted, but Yawn says they’re poorly attended because physicians are busy and many presenters “have no clinical experience and are unlikely to provide a balanced view.” Instead, Yawn says, most of her colleagues rely on in-house CME sessions, along with “the usual journals of choice” and informal chats with other physicians to learn about new drugs. As for samples, most Olmsted docs don’t long for the old days, although some psychiatrists wish they could still get samples.
Nearby at Mayo Clinic, hospitalist Christopher McCoy, M.D., says Mayo physicians get “excellent information” from clinical pharmacists, who answer questions about dosing, interactions, and appropriate uses. For information about newer meds, they sometimes rely on other Mayo physicians, who are experts on that particular drug. For example, McCoy’s internal medicine hospitalist group recently invited a cardiologist to talk about dabigatran, a new anticoagulant. “I’ve never heard a Mayo physician lament no longer having the opportunity to meet with a drug rep,” he says.
Nothing but Net
David Ross, M.D., a family physician at Affiliated Community Medical Centers in Willmar still relies on drug companies for information—but not the reps. “I Google a drug company website, where I read the factual drug information rather than the brochure propaganda,” he says. He also likes the Prescriber’s Letter, which he says tends to cover drugs germane to primary care and offers him the opportunity to earn CME credit. “It also provides alerts to the lines of reasoning drug reps may use for new drugs and comments on their validity,” he adds.
The Internet has made Ross’s withdrawal from drug reps easier. “In the age of computers, mobile devices, and applications, technology has placed a new spin on rural medicine,” he says. “I’m a few keystrokes away from a wealth of information. Personally, I don’t miss rep visits one bit. I got tired of the interruptions, the patronizing, the graphic distortion, and the donuts. And I agree with the studies that show that even minor gifts can influence prescribing habits.”
Ross helped Affiliated change its policies and go sample-free and partially rep-free in 2007. No one-on-one visits are allowed in patient-care areas, but reps can still set up displays in nonpatient-care areas, where physicians can seek them out instead of the other way around. He says physicians sometimes meet with drug reps by appointment. “We just don’t want them popping up in the middle of the day to fill sample closets and interrupt patient care.”
He says a few specialists still accept branded samples of drugs that have no generic alternative or where special patient instruction is needed. For example, Affiliated’s neurologist requests injectable (branded) imitrex, which works more quickly than the oral generic version of the drug. He uses samples to show patients how easy it is to administer the injection in order to get them over their fear of doing them.
Turning to EMRs
Electronic medical record systems have made it possible to provide physicians with real-time, evidence-based drug information, according to Brian Rank, M.D., an oncologist and medical director of HealthPartners Medical Group. “A couple of clicks in the EMR gets us access to a number of resources including the Medical Letter, Micromedex, the Cochrane Library, UpToDate, and the Institute for Clinical Systems Improvement guidelines,” he says. But physicians don’t have to do all the searching themselves. HealthPartners’ Pharmacy and Therapeutics Committee analyzes the clinical and cost-effectiveness of all drugs before they’re added to the formulary. “We link our docs to the safest, most effective drugs, and that’s typically a generic,” Rank says. “Eighty-two percent of drugs we prescribe are generic.”
Only a couple of the 150 clinical departments at HealthPartners still give samples to patients, according to Rank. Usually they do so to make sure the drug is effective and tolerated before it’s prescribed, or if the drug requires prior authorization and the clinician believes the medication is needed immediately. He says drug and device reps can visit physicians only if a physician leader requests it, which rarely happens. “Physicians are way too busy, and there are far less biased sources of information readily available.”
HealthPartners, Park Nicollet Health Services, Hennepin County Medical Center, Fairview Health Services, and Allina Hospitals and Clinics have all been learning from each other about best practices for interacting with drug and device companies, according to Rank. “We all have our own policies,” he says. “But we’re all headed in the same direction.”
Do We Need Firewalls?
In 1993, Minnesota became the first state in the nation to ban gifts and payments from drug companies to physicians and other prescribers. Since then, a handful of states have followed suit with some sort of restriction on gifts.
Minnesota’s gift ban does not apply to drug samples, items with a total combined retail value of less than $50 in a given year, consulting fees, paying reasonable amounts for expenses to physicians who present at conferences and meetings, and educational materials including textbooks.
In recent years, several attempts have been made to tighten up the law. In 2009, Sen. John Marty (DFL-Roseville) and Rep. Tina Liebling (DFL-Rochester) introduced legislation that would clarify what is considered a gift, who is a prescriber, how records are made public, and penalties for not reporting. It would not have prohibited practitioners from receiving free drug samples. The bill received hearings that year and was reintroduced in 2010. It has not gone beyond committee hearings.
Although it is not as extensive as Minnesota’s gift ban, a provision in the 2010 Patient Protection and Affordable Care Act requires pharmaceutical companies and medical device manufacturers to report all direct payments or gifts made to physicians and teaching hospitals valued at more than $10 to the Department of Health and Human Services starting in January 2012. (Drug and device samples are exempt from this “sunshine provision.”) The information will be made available on a searchable website starting September 30, 2013.
Not all support such attempts to erect firewalls between doctors and pharmaceutical and biomedical device industry reps. One of Minnesota’s most vocal opponents is Eagan endocrinologist J. Michael Gonzalez-Campoy, M.D., Ph.D., FACE. Gonzalez-Campoy says physicians couldn’t practice medicine without the drugs and technology provided by industry, “so casting them as the enemy is just plain wrong. We need to consider the working relationships between physicians and industry for what they are: incredibly beneficial to science.”
Gonzalez-Campoy is so passionate about that belief that he’s helped launch two groups to promote the benefits of industry-medicine partnerships: the national Association of Clinical Researchers and Educators (ACRE), which was established in 2009 in Boston, and the Minnesota Clinical Research Alliance, which was formed last June in Minneapolis. Both groups have the goal of influencing the public’s and policy makers’ thinking, which they say is decidedly anti-industry these days.
Gonzalez-Campoy believes attempts to limit physicians’ access to industry reps is bad for medicine. “Physician education is advanced by marketing,” he says. “Physicians need to have access to medical information of all kinds—including marketing materials.” And he believes Minnesota’s actions to separate medicine and industry have had a negative impact on the state’s biomedical business climate. “The Minnesota economy has taken a tremendous hit because of all this. There has been a loss of sales jobs. Many biotech companies have gone under or chosen to move their business away from Minnesota. It’s a big contributor to the economic downturn.”
Gonzalez-Campoy does not believe he’s alone in his thinking. “I think a large number of physicians feel the way we do,” he says. “But most don’t want to rock the boat.”
Missing Them
Liaisons not Cheerleaders
Frank Rhame, M.D., an infectious disease specialist at Abbott Northwestern Hospital, reads journals and looks up drug information and consensus prescribing guidelines on UpToDate and Epocrates. But he doesn’t like the way Epocrates sells his online search history to pharmaceutical companies. “I decided to subvert their little side business by repeatedly looking up birth control pills, just to confuse them.”
Rhame, who’s practiced infectious disease medicine since 1975, says he learned good information from drug reps if they were there to talk about drugs for infectious diseases. “I know that topic cold,” he says, “so they can’t shade things with me. But if they want to talk about drugs for hypertension or depression, then I needed protection from them.”
As an HIV clinician, Rhame has always felt it’s important for him to stay in touch with “medical science liaisons” from drug companies. Liaisons are usually M.D.s or pharmacy Ph.D.s who have a deeper knowledge than sales reps do. “Liaisons aren’t former cheerleaders who’ve memorized five sentences from the label, which you can read yourself,” he says. “Liaisons can talk about off-label uses and have high-level discussions about comparative research.”
The FDA allows liaisons to meet with researchers in order to facilitate innovation. “The research information that liaisons give me,” he says, “has already been presented somewhere else, like at resistance workshops, a metabolic side effect meeting, or a pharmacology meeting that I might not have attended and, therefore, might not see unless they talk with me.
“Some, shall we say, politically correct physicians might recoil from liaison meetings and dispute their benefit; but the fact is, infectious disease specialists benefit from talking with drug company folks with a high knowledge level. And if I benefit, then my patients benefit.”
Limiting Face Time
Dermatologist Charles Crutchfield III, M.D., of Crutchfield Dermatology in Eagan, relies on conferences, specialty society sources, journals, and colleagues for drug information. “But,” he says, “I still think pharmacy reps provide a valuable role in educating us about new meds, even given their bias.” He says his clinic allows two to four visits per month and that he gives reps five minutes of face time. “It’s very manageable.”
Dermatologists have traditionally given out a lot of samples, especially to patients who need only a small amount of medicine or who have trouble paying for it. “They seem to keep me well-stocked,” he says, “and the amount of time it takes to manage the cabinet is minimal.”
Crutchfield says he doesn’t miss the days when some reps had the audacity to ask if they could count on him to write the next five prescriptions for their medication. “Those really were the bad old days,” he says.
Sorry to See Samples Go
Cardiologist Les Forgosh, M.D., misses the easy access he used to have to drug reps and the samples they provided. HealthEast acquired his clinic last January, so he and his colleagues at St. Paul Cardiology now must follow HealthEast’s guidelines. “Yes, I know I can get the latest information from Medline, journals, and CME—and I use these,” Forgosh says. “But that all takes time, and when it comes to getting the latest information about the newest drugs, reps are walking encyclopedias.”
HealthEast allows each department to decide whether to meet with reps. As a group, the cardiologists decided not to, according to Forgosh. A physician can request a one-on-one meeting with a rep, but that rarely happens. Forgosh recently met with one for the first time in eight months.
“I’m a definite proponent of providing samples to patients, but I can’t do that now,” he says. “Samples are a good way to see if the patient tolerates a drug before they go out and buy it themselves, and samples provide a short-term supply until patients fill prescriptions.”
Cardiologists often prescribe expensive medications, and samples help defray the costs for patients. Plus reps provide coupons. “With Plavix, you’re talking about $180 per month. There are no generics, and it’s one of only two drugs in its class, both of which are very pricey,” he says. “Drugs for pulmonary hypertension can cost $1,000 per month. I know the coupons are online, but I have to search for them and that takes time. The reps just hand them to you.”
Preferring Presentations
Harvey Frank, M.D., a family physician in Allina’s clinic in Forest Lake, searches for drug information in UpToDate and Micromedex, which are embedded in Allina’s employee intranet. But having practiced medicine for 34 years, during which drug company lunches and dinners were part of the routine, he admits that he misses those outings. “Often, the speaker at these was a local specialist talking about general topics, not a drug rep,” Frank says. “But these went away along with the drug rep meetings. Historically, I’ve gotten my information from reps, articles, and conferences. Now I have to struggle to find what I need. Often, I don’t learn about a new drug until well after it’s released.”
Frank also misses the quarterly presentations by Allina’s Ph.D. pharmacists about new drugs and new uses for old drugs. Budget tightening put an end to those, he says. “I feel like primary care physicians are unfairly portrayed as being too quick to use branded meds because of drug rep presentations or samples. There’s ample pressure from patients to stay away from high copays. Generally, we’re all careful to prescribe generics whenever we can.”
Devices are Different
Anesthesiologist Mark Eggen M.D., who practices at Allina’s Unity and Mercy hospitals and admits to planning his route through the hospitals to avoid drug reps, says he still relies on reps from medical device companies for how-to information. “For new devices I use, such as ultrasounds for placing nerve blocks, the reps offer useful advice. Every hip and knee replacement I’m at, there’s an orthopedic implant rep present in the OR and available if any questions arise.”
Minnesota’s gift ban law doesn’t apply to device reps, according to Eggen, so it’s common to see them outside the ORs where cardiac and orthopedic procedures are done.
That’s changing, however. A sign recently posted outside the door to the physicians’ lounge in Unity’s surgery area says “Physicians only—vendors are prohibited from this area.” In addition, Allina is changing its policy so that vendors will only be allowed in the surgical services area of its hospitals by appointment.
Maintaining avenues of communication can benefit both physicians and reps, according to Mayo’s Christopher McCoy, M.D. “Especially for devices,” he says, “it can be helpful for physicians and reps to meet face-to-face, so the reps can demonstrate how to use new devices and physicians can offer feedback on ways to improve them.”
“You need a certain degree of engagement between clinicians and industry,” HealthPartner’s Brian Rank, M.D., says. “We do sometimes allow reps in the OR to assist with a new device, particularly when learning to use or researching a new device, which we recently did for percutaneous aortic valves at Regions Hospital.” Rank says HealthPartners also has “entrepreneurial/inventor docs” who work with device industry researchers to invent or improve products, but not sales reps.
Who Should Teach Docs about Drugs?
In an article published in the New England Journal of Medicine in March, Jerry Avorn, M.D., of Harvard, pointed out that the United States has been debating the issue of who should teach doctors about drugs for 50 years, ever since Sen. Estes Kefauver (D-Tennessee) introduced legislation that sought, among other things, to place the burden of educating physicians on the federal government.
Opposed by the pharmaceutical industry and the American Medical Association, Kefauver’s bill might have been defeated altogether had it not been for the thalidomide crisis in the early 1960s, which raised public consciousness about the potential dangers of pharmaceuticals as well as the public’s general comfort with the idea of the government protecting their health. The resulting law wasn’t quite what Kefauver envisioned, but it gave the Food and Drug Administration the authority to require pharmaceutical companies to provide evidence of efficacy and safety before a drug could be marketed. Since then, drug companies have been doing most of the educating about prescription drugs.
Academic Detailing
Some states, however, have tried an approach “invented” by Avorn himself. Hospitals and clinics have replaced visits from drug company reps with visits from physicians, nurses, and pharmacists who have been trained to provide doctors with independent drug reviews rather than sales pitches. Called “academic detailers,” they provide information, much of which comes from Harvard’s Independent Drug Information Service and Oregon Health & Science University’s Drug Effectiveness Review Project.
The idea for academic detailing emerged 30 years ago when Avorn proposed using the pharmaceutical industry’s marketing tactic of one-on-one visits with physicians to promote evidence-based prescribing. “Academic detailers even bring pizza for lunch,” says Peter Wyckoff, director of the Minnesota Prescription Coalition, a group of consumers, providers, payers, and labor and professional organizations that has worked, so far unsuccessfully, with the Pew Charitable Trust Prescription Project to create an academic detailing program in Minnesota. “What changes is who’s bringing lunch and how objective their information is.” Academic detailers discuss the pros and cons of competing drugs and share a scope of knowledge that might be broader than the typical drug rep’s.
Pennsylvania’s academic detailing program is the nation’s largest and oldest. It receives state funding because it is intended to reduce the amount the state spends on its Medicaid patients. A 2008 study by Harvard Medical School and the Pew Prescription Project showed that Pennsylvania doctors who participated in academic detailing visits for acid reflux medications saved $120 per doctor per month. Results of a multi-state randomized trial published in the New England Journal of Medicine in 1983 showed that academic detailing programs save $2 on drugs for every $1 it costs to run the program.
“Academic detailing saves money,” Wyckoff says, “but it’s not just about saving money by using generic drugs. We’re talking about what’s safest, cheapest, and most effective based on the best research available.” For many chronic conditions, there’s wide variation in prescribing patterns, according to Wyckoff. The research, he says, “shows there are best-in-class ways to treat most conditions. Academic detailing narrows the gap between evidence-based prescribing and actual prescribing that is often blamed on vigorous marketing of newer, more expensive drugs.”
Supporters say academic detailing improves patient outcomes. But good data for that are lacking, according to Marjorie Powell, senior assistant general counsel for the Pharmaceutical Research and Manufacturers of America. “Some of these drug comparison studies don’t even factor in the benefits some newer drugs offer,” she says. For example, a newer drug might have fewer or less-severe side effects than its cheaper generic counterpart. Patients might not have to take a newer drug as often. And a newer drug might reduce or eliminate the need for frequent lab tests. “Everyone has their biases,” Powell says. “Some academic detailers do little more than tell doctors, ‘You don’t need to use the newer drug.’ The more money they can save a state in drug expenditures, the better they look, even if costs increase in other areas such as lab tests or more doctor visits.”
As the cost of medications for chronic conditions has escalated, the number of state-sponsored academic detailing programs has grown, although slowly. Today, 17 such programs exist. Minnesota’s Prescription Coalition submitted two bills to the Minnesota House and Senate in 2010 that would have established a detailing program in the state. They generated interest on both sides of the aisle in both chambers, according to Wyckoff, but not enough. “The mistake we made the first time around was in trying to do too much all at once,” he explains. “We accidentally designed the nation’s largest detailing program.” Next time, he says, they’ll start with a pilot program for one class of drugs in a limited geographic area. Minnesota’s Department of Human Services would receive the money to administer the program and train detailers. Wyckoff estimates that a reasonably sized pilot would cost about $1 million per year.
Still Debating
Whether state-funded academic detailing programs will become a reality in Minnesota and elsewhere in the country and whether this approach is indeed the best way to help physicians make better decisions about prescription drugs remains to be seen. Indeed, for many, the answer to the question of who ought to be teaching physicians about new pharmaceuticals is still being sought.
Avorn wrote in his article that given current competing concerns about government intervention and industry involvement in medicine, the most likely answer today is some sort of public-nonprofit entity—one that is funded by government but run by a nongovernmental organization that has no ties to industry and that would generate the scientific content.
Avorn concluded, “Enlightened by our tumultuous experience with medications and drug communications over the past half-century, we are still working on a sustainable answer to this question that lies at the heart of medical practice.” MM
Howard Bell is a freelance writer in Onalaska, Wisconsin. Carmen Peota and Kim Kiser contributed to this article.