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Dr. Doug Lieuallen visits with Reba Powell, of Madras, before starting her exam Wednesday afternoon at Madras Medical Group. After the clinic

went pharma-free, I don't really recall any really negative kickback," Lieuallen said. Ryan Brennecke / The Bulletin

Drug reps and doctors

Madras clinic ousts salesmen and their samples
By Markian Hawryluk / The Bulletin
Last modied: July 16. 2013 1:20PM PST

Drug reps and samples

Surveys of physician practices by market-research rm SK&A in 2010 and 2011 found that about a quarter of physicians do not see drug reps. About three-quarters of practices still accept free drug samples. Doctors who accept drug samples All practices 77% Practices with 3 to 5 doctors 76% Practices with 10 to 19 doctors 54% Doctors who refuse to see drug reps All practices 23% Practices with 1 to 2 doctors 13% Practices with 10+ doctors 42% Specialists who have a high rate of prescribing medications as compared with specialists such as radiologists refuse the least: Allergists/immunologists 4% Orthopedists 5% Diabetes specialists 8% Neuroradiologists 91% Radiologists 92% Pathologists 92% Source: SK&A Pharmaceutical promotion Industry spending to promote brand name drugs has dropped since 2004, a reection both of the downturn in the economy as well as a number of top-selling drugs that lost patent protection.

Spent on physicians ... and free samples 2001 $5,897,000 $12,884,000 2004 $7,621,000 $18,056,000 2007 $6,147,000 $15,615,000 2010 $5,306,000 $13,850,000 Source: PLOS One Doctors at the Madras Medical Group had grown wary of the pharmaceutical sales pitch. They were thinking of banning drug reps from their practice, but worried their low-income patients would lose access to the free samples the drug reps left behind. That changed when a rep arrived with a gourmet meal over which he planned to educate the doctors about the benets of his company's latest brand-name drug. We had this really lavish meal, butter with all the fancy curlicues it was really something," Dr. Doug Lieuallen recalls. As they eyed the creamy yellow rosettes and the elaborate spread on the table for the six providers and two dozen staff members, it became clear the drug company had spent a tidy sum to butter them up. That," he said, sort of pushed us over the edge." Drug reps weren't always a problem for the rural clinic. A town of only 6,000 people, Madras wasn't even on the radar for most of the big pharmaceutical companies in the 1990s. When Dr. David Evans joined the primary care practice, he'd see no more than a single rep each month. But by the early 2000s, Bend had grown from sleepy lumber town to recreational mecca with a thriving medical community, attracting reps from miles around. Seemingly overnight, Madras became a regular stop for Portland-based drug reps on their way to Bend. When it started being several per day, it made us start to think a little bit more," Evans said. What is this all about? It just doesn't feel right." Drug company sales representatives are, in essence, sales people with no access to their customers. It's the patients who buy the drugs, but it's the doctors who control the sale. The way to sell more drugs is to get the doctors to write more prescriptions. And to do that, the reps need to get face to face with the men and women with the prescribing pad. As the Madras doctors emerged from their exam room in between patients, the nurses would pull them aside and let them know a drug rep was waiting. It was never anybody by name," Evans said. It was always the Lipitor guy or the Effexor guy." The drug reps said they needed a doctor's signature for the samples, and used that to ensure a face-to-face meeting. The reps wanted to talk to as many doctors as they could, handing them their glossy handouts, touting the benets of their drugs over those of their competitors.

Reps are trained to assess personalities, analyze prescribing patterns and determine what needs to be done to get the physician prescribing more of the company's products. The drug rms buy prescribing information from health informatics companies who purchase de-identied records from pharmacies, then match each record with the doctor's prescriber number sold to them by the American Medical Association. In 2006, the AMA allowed doctors to opt out of the reporting and withhold most prescribing information from drug reps and their supervisors. But few do. Doctors are categorized by drug reps into percentile groups based on their prescribing volume and given colorful monikers such as high-prescriber, spreader, mercenary or sample-grabber. Reps have a specic strategy for each category, said Dr. Shahram Ahari, a drug rep turned physician, who described a rep's strategy in a 2007 article in the online journal PLOS Medicine. For some it's dinner in the nest restaurants, for others it's enough convincing data to let them prescribe condently, and for others, it's my attention and friendship," Ahari said. But at the most basic level, everything is for sale and everything is an exchange." Biased information The Madras Medical doctors grew more and more uncomfortable with the process. The reps showed them only the data that put their drugs in the most favorable light, highlighting company-funded studies published in less-than-prestigious journals. It didn't have any meaning to it," Lieuallen said. The doctors would attend drug company-sponsored educational meetings that became gloried pitches for pharmaceutical drugs. Whatever the patient's illness, the sponsor's product was sure to be the cure. If it's sponsored by whoever makes Nexium, it's amazing, the only thing that is going to make them any better is Nexium," he said. It just got very, very old and all of us felt that we were whores." Lieuallen said that of the ve practitioners at the clinic, two he and Evans wanted to kick the reps out. Two others, however, were opposed, concerned about the loss of drug samples. A fth was on the fence. The two doctors who opposed kicking the reps out were managing a number of patients out of the sample closet. Patients who have no insurance or who can't afford the copays would get free samples, often for months at a time, as the doctors tried to keep them on their medicines. For a while, it was a stalemate as the practitioners debated what to do. In 2004, however, they hired another physician, Dr. Gary Plant, shifting the balance of the internal politics. Plant was accustomed to choosing generics over brand-name drugs and was bothered by the notion that patients were being prescribed drugs that were not better, just more expensive. They offered reps a compromise. They would listen to the sales pitch if the reps would give them the money they would normally spend on lunches and promotional materials so they could help low-income patients buy generic drugs.

Don't buy us lunch; give us $100 and we'll buy 25 people a month's worth of their blood-pressure pills," Plant said. They thought the clinic could become a dispensing practice, diverting the funds the reps were spending to woo their prescribing to sample" patients with low-cost generic drugs. Of course, that went over like a lead balloon," Lieuallen said. Only one of the drug reps agreed to the new arrangement but was summarily overruled by his supervisor. Then the Vioxx scandal hit. Off the fence Vioxx was Merck's blockbuster anti-inammatory pain drug. Approved in 1999, it was touted as a safer alternative to naproxen sodium or ibuprofen, causing less gastrointestinal bleeding. By 2004, however, the company could no longer hide the increased risk of heart attacks caused by the drugs. It pulled the product, but not until 25 million Americans had taken the drug, suffering an estimated 38,000 heart attacks as a result, according to a Food and Drug Administration report. I remember asking the rep to tell me about the heart attacks, and they would very artfully steer the conversation in a different direction," Evans said. Congress launched investigations. Company documents were leaked, pharmaceutical tactics revealed, and the holdout docs at Madras Medical were converted. It moved everybody over a little bit," Evans said. Those of us who were happy with the drug reps became a little bit more skeptical; those who were on the fence got off the fence in our direction." In six months before Madras Medical cut the cord, reps visited the clinic 199 times, an average of 33 times per month. From February to November 2005, the reps brought 23 lunches, a rate of two to three each month. A analysis of the sample closet revealed very few rst-line drugs, the type of medications that doctors would normally try rst because they work best for most patients. The samples were for drugs that cost patients an average of $90 a month. There were less expensive generics available for 38 of the 46 sample drugs, cutting the patients' average cost to $22 a month. Research suggests there's a hidden cost to samples. In 2008, researchers from the University of Chicago calculated that patients who received samples paid between $212 and $244 a month in average prescription costs, compared with $168 a month for those who never got a sample.

Samples are primarily given to promote the use of the more expensive, brand-name drugs, which in the end may be no more effective than lower-cost generics. But studies show that once a patient is started on a medication with a free sample, he is rarely switched to a lower-cost alternative. It's not really charity, or that we're giving out drugs because we're nice people," Ahari said. Once you're on it and you establish a therapeutic effect, most doctors will be reluctant to switch you to an equally effective but cheaper generic." Studies have also shown that most samples don't end up in the hands of the most needy patients anyway. They're more likely to end up in the hands of higher-income, insured patients, or taken home by staff for their own family. There are some physicians who manage to get samples for their poor patients, but they're the exception, not the rule," Ahari said. And if the drug rep generally speaking isn't getting something out of it, you'll see your supply dry up." Samples tend to be the most expensive drugs, new drugs that companies are trying to establish, or drugs that are vying for market share after another drug has left the market. In 2002, for example, the most widely distributed sample was Vioxx. Truthfully, the pharmacy reps don't leave anything that's useful to our patients," said Judy Carroll, a nurse at Madras Medical. It's the expensive stuff that no one in this area can afford." About 30 percent of the clinic's patients are on Medicare, another 25 percent on Medicaid, while 15 percent are self-pay. Many of the clinic's patients cannot afford the copays on a brand-name drug, much less pay the entire cost out of pocket. The rst question Lieuallen would always ask the drug reps about a new drug was whether it was covered by the Oregon Health Plan, the state's Medicaid program. I think that helped us make the decision," Plant said. We got tired of hearing people say, 'No, but it's covered by Blue Cross.'" Going pharma-free The nurses told the doctors how disruptive the rep visits had become, and how banning drug reps would make it easier to deal with patients who called regularly seeking free samples of their medications. The staff liked the pens and mugs they got for free from the reps. There were toys they could give their children or the odd collectibles their families would covet. The Viagra pens were particularly popular. But what the staff would really miss were the lunches. Each month when drug reps brought in food, the staff had a chance to sit down in the middle of a hectic day and catch up on their lives and families. Really, it was the social interaction the staff was concerned about," Evans said. It was easy for us as a practice to spend $50 to $80 a month to

have a little luncheon that served the social purpose and didn't want us to take a shower afterward." Now each month, the doctors order pizza, Chinese food or lasagna for the ofce, rotating through the local restaurants. It's a far cry from the catered gourmet lunches they once got. But we don't have to listen to the sales pitch," said Margo Alley, a nurse at the clinic. The clinic notied the sales reps that starting Jan. 1, 2006, they would no longer be welcome in the clinic. As the date neared, the staff worked to clear the detritus after years of intense marketing. The whole ofce was sort of permeated with all this pharmaceutical paraphernalia," Lieuallen said. It was actually challenging when we started to get rid of it. We were going to have to buy clocks. We had to start buying scratch paper. We had to start buying pens." The doctors lled a garbage can full of pens and mugs and other trinkets, and tossed it all into a dumpster. The ofce manager purchased $200 worth of ofce supplies to restock the clinic. Meanwhile, the decision did not go over well with the drug reps. Most of them tried to convince us that was the wrong thing to do," Evans said. 'How on Earth, doctor, will you stay up to date if we're not here to keep you up to date? What will your indigent patients do if you don't have samples of this, that or the other thing?'" Some brought in their supervisors to try to convince the doctors otherwise. They denitely tried," he said. But we had made our decision." The reps continued to try to nd ways around the ban, talking to staff instead of doctors, asking them to pass the marketing brochures and promotional trinkets to their bosses. Others enlisted the U.S. Postal Service, sending the usual glossy brochures in plain brown envelopes. Evans received one with a sticky note attached. Only Avandia has 5-year data on glycemic control!" it said. Please try to get more patients on our therapy." Like Vioxx, Avandia was subsequently linked to an increased risk of heart attacks. The FDA opted not to pull the drug from the market, but it placed signicant restrictions on its use. Patient reaction For the most part, patients applauded the move. Many commended the doctors on the new policy. Others bemoaned the lack of free samples but understood. The patients who were most upset about the loss of the sample cabinet were the ones who most had the means to pay for their medicines," Evans

said. Those who had been stomped on by the man in other aspects of their life could certainly understand how Big Brother could be inuencing my prescribing patterns." The doctors worked to help their low-income, uninsured patient nd ways of affording their drugs without the freebies. That year, Wal-Mart announced a new $4 generic program, which was then matched by some of the local pharmacies in Madras. It turns out a lot of those patients probably could afford a $4-a-month medicine," Plant said. The clinic tried to quantify the savings, comparing their level of generic use with that of doctors in a neighboring county. But with a number of blockbuster brand-name drugs going generic around the same time, it was hard to quantify the impact. I don't really recall any really negative kickback," Lieuallen said. I bet a few people were frustrated because I couldn't get them their Cialis, but that's a $25-a-pop pill." As long as the doctors had a sample closet, they could convince themselves they were helping patients by giving them free medications. Removal of the sample closet, they said, forced them to prescribe more based on cost and efcacy, eliminating their irrational prescribing patterns. For example, patients might come in with a garden-variety infection needing antibiotic therapy. If they couldn't afford it, doctors wouldn't have any rst-line antibiotics to give them. The samples invariably were for newer broad-spectrum antibiotics best reserved for treating difcult, drug-resistant cases. When you're getting it out of the sample closet," Lieuallen said, what you've got is the latest gorillacillin." Within months, the doctors knew they had made the right decision. They didn't miss the drug reps and thought their patients were better off in a pharma-free clinic. I know that I lost one patient as a result," Evans said. He just could not gure out how I could keep current and know about the best drugs without having the industry rep come talk to me about it." Medical education The majority of physicians still rely on drug reps to bring them that information. But increasingly doctors are becoming skeptical of the bias. The Madras Medical doctors always felt they were getting half of the story, with data presented in the most favorable way. They realized they needed a better way of learning about the hundreds of drugs they could prescribe to their patients. They had long subscribed to two independent publications, The Medical Letter and the Prescriber's Letter, which gave unbiased reviews of medications. Every rst Wednesday of the month, the doctors invite other physicians from the community and review the literature and discuss the pros and cons of various therapies.

It's made us better doctors," Lieuallen said. Their decision also had broader impacts for the community. Madras Medical treated more than half of the town and the surrounding community. Other doctors told them the number of reps has dropped off since they made their decision. In Bend, other primary clinics are following suit. St. Charles Family Care, which was launched in 2011, does not see drug reps, and Bend Memorial Clinic, the region's largest multispecialty clinic, plans to cut ties within its primary care ofces this year. Recent surveys of more than 237,000 physician ofces by Irvine, Calif.-based research rm SK&A found that only 23 percent of doctors refuse to see sales reps and an equal number refuse drug samples. In one survey, 84 percent of physicians agreed that drug reps inuenced prescribing habits, but 61 percent maintained they themselves were not affected. Drug companies aren't stupid. If they didn't think they could inuence you with that pen or that notepad or that clock, they wouldn't do it," Lieuallen said. All of the Madras Medical doctors, even those who were most skeptical about the drug reps, believe the interactions affected their prescribing patterns. When a class of high-blood-pressure medications called angiotension-receptor blockers rst came out, there were six to eight equally effective, similarly priced brand-name drugs on the market with no generic alternative. So the one that you're going to use is the rst one that you think of," Plant said. So they know that if their pen or their notepad is in front of you, that's the name you think of, that's the drug you're going to prescribe." Higher education Larger academic medical centers and medical schools have been more likely than smaller community-based practices to close their doors to drug reps. The American Medical Students Association began advocating for medical schools to become pharma-free in 2002, and in 2007 released its rst scorecard grading schools on their rules regarding industry contact with students. Out of 158 U.S. medical schools graded in 2013, 114 received an A or B score, compared with only 21 in 2008. The University of Washington, where Evans now teaches in the Department of Family Medicine, received an A. As a teaching exercise, the faculty decided to invite sales reps to talk to their medical students. Despite hearing that the professors planned to critique their presentation for usefulness and accuracy, the reps jumped at the chance. They know if they get 10 minutes of your time, even if you're going to spend a half an hour afterward kicking their message apart, you have just lled everybody's head with your drug," Evans said. I'm sure that these (reps) went back to their bosses and said, 'Hey, I got in the University of Washington!' and counted it as a real score." While the scorecard shows a signicant change in reps' access to students over the past ve years, most of the physicians in practice today were

trained in a different atmosphere. Plant said when he was in medical school, attendance at noon lectures generally depended on whether drug reps were bringing a free lunch. I remember we were having discussions about (banning drug reps) back in the early 2000s, and we were saying, 'Who's going to provide the lunch if the drug reps aren't there?'" Plant said. Studies conducted around the same time found that residents received an average of six gifts a year from pharmaceutical companies. Many doctors bristle at the notion they can be bought" with a pen or a free meal, but research suggests it's not the size of the gift that really matters. Social science research shows that smaller-value gifts can be as effective or more effective than big gifts, because the giver believes that because it's small it doesn't have an inuence," said Dr. Eric Campbell, a sociologist with the Institute for Health Policy in Boston, who specializes in physician conict-of-interest issues. If you think about it, it's brilliant. If you give somebody something of great, great value, they assume you want something from them." Several studies have shown the more gifts doctors get, the more likely they are to believe the gifts didn't inuence them. I've often argued if you really want to see the drug reps, see them. But don't take their food, don't take their money, don't take their gifts, don't go to dinner with them," Campbell said. What's interesting is when you put those restrictions on it, doctors aren't that interested in drug reps." Industry response The Bulletin's calls to pharmaceutical manufacturers and drug reps in the region were referred to the Pharmaceutical Research and Manufacturers of America. Ofcials for the industry trade group maintain that drug reps serve a valuable purpose, passing on information to overworked doctors about the safety and efcacy of prescription drugs that might not be available yet in the published literature. The demands on their time is increasing, and their ability to wade through all of the information and stay on top of it is kind of limited," said Kendra Martello, assistant general counsel for the group. Drug reps, she said, can also provide a vehicle for doctors to provide feedback to the drugmaker on the way the drug behaves in real-world situations. Ultimately I think that benets patient care," she said. If you take that away and cut off that open line of communications, then the worry is that patients ultimately could suffer." Martello also defended the use of drug samples as a way for patients to try out a new medication, to see whether it works and is tolerable, without having to pay for a full prescription.

We think they're benecial in also helping patients start their medication earlier," she said. We would hate to see them banned, but we do understand that some practices have made that decision." An industry-funded study published last year tried to quantify the potential harm of doctors not seeing drug reps. The researchers looked at prescriptions for diabetes drugs among high-prescribing doctors and how those correlated with the number of drug rep visits. Physicians who saw the fewest drug reps took longer to begin prescribing Januvia, the rst in a new class of diabetes medication when it came on the market in 2006. They were slower to cut back on Avandia prescriptions after the FDA added a black box warning about heart attacks in 2007. Both doctors' groups and the pharmaceutical industry have taken steps over the years to rein in the worst of the gift-giving behavior. The American Medical Association adopted voluntary guidelines that allow doctors to accept patient-care-related items valued under $100. And in 2009, the pharmaceutical industry updated a voluntary code that eliminated the brand-name laden pens or mugs, and the lavish meals. It would still allow a modest lunch aimed at educating providers or promotional items that doctors can use in patient care. More than 50 pharmaceutical manufacturers have signed on to the code. In August, pharmaceutical companies will have to start reporting their payments and gifts to physicians under the Sunshine Act, a provision passed as part of the Affordable Care Act in 2010. It requires companies to disclose any payment or gift over $10 in value and any combination of gifts that exceed $100 for the year. Campbell said that while the Sunshine law may help, unless the eld of medicine polices itself, the relationship isn't going to change. Physicians have to come to the realization that it is unethical for them to pass the cost of their lunches and their trinkets on to the American people in the form of higher drug prices," he said. (That's) just what they're doing, and it is not professional behavior and it needs to stop." In the 12 months ending March 2012, the number of drug reps in the U.S. dropped to 72,000, down from 105,000 in 2007, according to marketresearch rm Cegedim Strategic Data. Spending on drug samples fell from $8.4 billion in 2007 to $6.3 billion in 2011. And the number of drug rep visits that included samples dropped 35 percent from 116 million in 2007 to 76 million in 2011. Some of that may be due to the economic downturn, and some to the large number of brand-name drugs whose patent protection has expired in recent years. But while the number of physicians who don't see drug reps has been inching up, many doctors still vehemently defend the right of drug reps to inuence them. I think most doctors have a subconscious desire to be OK with this," said Ahari, the former drug rep. That's the name of the game when you're a drug rep, too. You're supposed to generate this subconscious OK with the doctor that it's not as bad as it seems, that the doctor is really independent, autonomous and can't be swayed. You cultivate that illusion." Campbell said the relationship between drug reps and doctors represented a sort of underground economy" that only in recent years has come to light. The average physician, he said, receives about $5,000 a year in gifts from drug reps.

A quarter of that will get you a brand-new, high-def TV. It probably gets you a couple of seats to the Super Bowl," he said. When you put it in that perspective, it's hard to argue that these things aren't inuential." Reporter: 541-617-7814 mhawryluk@bendbulletin.com View The Bulletin's commenting policy
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