Wednesday, July 10, 2013

Drug Rep$

Meet your doctor's generous friend


Pharmaceutical companies have paid billions of dollars in fines in the US for giving bribes and kickbacks to doctors. Are their drug sales representatives behaving any differently in Victoria?
"Dinner and Yankee game with family. Talked about Paxil studies in children.” That note, written by a drug sales representative about his evening with a doctor and his family, was one of many records that forced GlaxoSmithKline (GSK) to pay a $3 billion fine to the U.S. government in 2012.
According to Public Citizen, since 1991, there have been 239 legal settlements between U.S. regulators and pharmaceutical companies adding up to $30.2 billion in penalties—a third of those in the past two years. Over half related to the kinds of activities that drug sales reps were doing in the GSK case: Reps promoted drugs with misleading information or for unapproved uses (the antidepressant Paxil carries government warnings against use in children), and gave doctors “expensive meals, weekend boondoggles, and lavish entertainment,” “trips to Bermuda and Jamaica, spa treatments and hunting trips,” and “cash payments” disguised as administrative reimbursements or consulting fees, all “to induce physicians to prescribe GSK’s drugs.”
The sheer scale of these cases is overwhelming, collectively involving dozens of multinationals, thousands of drug reps, and seemingly tens of thousands of doctors (although doctors have rarely been charged). And it shows no signs of abating, when such fines seem to be just the cost of doing business in a sector where profits rank with those of the oil and financial industries. 
Notably, these same multinational pharmaceutical companies spend billions of dollars promoting the same drugs to Canadian doctors. And surveys show many Canadian doctors meet with reps monthly, weekly, or more often, regularly attend their educational events, and regard them as a primary source for information about newer drugs. Yet there’s never been any similar lawsuits in Canada. Do drug companies play nicer here, or are we just bigger dupes?
There are over 200 drug reps registered to visit Vancouver Island Health Authority facilities, and more visiting private doctors’ offices, but there’s no central tracking of what they’re doing. However, two former sales representatives who worked in Victoria and Vancouver for four different pharmaceutical companies agreed to interviews with Focus, and they make the case that most Canadians are dangerously in the dark. (Both men requested anonymity, which required removing identifying details of companies, drugs, and doctors.) 

The “ethical” company
Bill graduated in a health-related field, and worked in pharmaceutical sales and promotion between 2002 and 2009 for two multinationals in the lower mainland. 
Bill says he chose to work at the first company precisely because its drug sales reps had a good ethical reputation among physicians, compared to other companies’ reps described as “shills” and “hucksters.” His company followed the conduct code of Rx&D, the Canadian self-regulating industry association whose voluntary members include many brand-name pharmaceutical companies. 
“We had very tight restrictions on what we could do,” says Bill. For example, that meant Bill’s entertainment budget was $3000 annually—low for the industry. “Generally, the guys would take the male doctors golfing or to hockey games, and the women would take the female doctors to the spa,” he says. His performance was measured partly based on how many such outings he did. Drug discussions were brief, Bill says, “so we could both get on with enjoying the game.” 
Bill felt this low-key “style” was effective. “You were trying to get [doctors] to feel good about you, so that they would use your product. In most cases, they didn’t see a lot of difference between the products out there, so it did come down to personal relationships.”  
Most often Bill pitched drugs to doctors in their offices. Did he disclose negative side effects? “I did pretty consistently,” answers Bill, “but often they were given short-shrift, to be honest. Our job was to sell the product and to highlight the good points.” He says he always left doctors with the drug’s “product monograph” with more detailed information. “Did [doctors] ever use it? Probably not. But I’d done what I was expected to do and what I felt was ethically responsible to do.”
Did he promote drugs for unapproved uses? Bill admits he sometimes worked grey areas, like promoting a study which demonstrated a drug’s effectiveness, but which had been done on a specific patient group for which it wasn’t approved. “It wasn’t like we were saying, ‘Go off and pour this into the water supply and use it for gout’,” says Bill. “But it was one of those little fuzzy areas.”
Bill says he felt like a “pizza guy” with all the free drug samples he delivered. When doctors have free samples, explains Bill, they’ll give them to patients, and if patients like the drug, doctors start prescribing it. “Our job was to make sure that [doctors] had as many samples as possible.”
Though patients like free samples, critics point out that we end up paying for them, personally and collectively, as more patients become attached to these typically newer, more expensive, less proven drugs. In fact, one drug which Bill was marketing especially effectively through free samples was eventually revealed to be potentially fatal. After he learned his company had been hiding the truth, Bill quit. 
At the next company, things were worse. “They talked a good shtick about ethical behaviour,” says Bill. “But my experience was that, really, the only thing that mattered was sales.” 
Once, Bill met with a physician who was heading an institute. They discussed the drug company possibly funding research chairs in return for its drugs being prescribed by all the institute’s doctors. “It left me with a really nasty feeling,” says Bill about the conflicts of interest. To his relief, the proposal fell apart, and Bill soon left for a job in hospital administration. “I think I’ve saved my soul, for whatever that’s worth.” 
Knowing he operated more ethically than many, Bill worries for patients who know nothing about what’s going on between drug companies, reps, and doctors. “In all of this, the patient is the one who’s at the most disadvantage.”
Indeed, no one learned that better than Sam. For 17 years, Sam was a committed, successful drug rep for successively less ethically “strict” companies. But Sam saw his profession differently after he became a patient himself.

High blood pressure sales
Starting in his twenties in 1989, Sam worked for two different companies as a pharmaceutical sales rep based in Victoria until 2006. 
“It was wonderful,” says Sam. He was using his Bachelor of Science, and had a great salary and benefits, a company car, and an expense account. “I was a blank slate. I wasn’t jaded, I wasn’t shaking with tremors, I wasn’t chronically depressed… None of these things had happened yet.”
A big, charismatic man with an expressive voice and emotionally engaging manner, Sam describes those early years as “like being a kid in a pill-filled candy store.” Success, he says, was all about delivering “the numbers” in sales volume, and he delivered. 
“Luckily, I was working for a company that had a really strong product line,” says Sam. “I had cardiology, neurology, endocrinology, psychiatry. The big classes of drugs.”
Sam’s group targeted about 150 South Island doctors. “We divided them into ‘key’ and ‘super key’ physicians. The others we just didn’t even spend any time on at all. You just go for where the cash cows are. They’re opinion leaders, people respect them, they have huge practices…” 
Sam distributed gifts like pens and notepads, set up displays in hospitals, brought in meals or took doctors and clinic staff out for meals, and distributed samples of popular and expensive patented drugs. For getting doctors to listen to sales pitches, these freebies worked, says Sam. “[The doctors] knew that if they didn’t talk to me, there were certain samples that they couldn’t get. And some of the samples that I had access to were gold.” 
Sam also organized luxurious weekend “medical education” events featuring drug company-paid speakers in beautiful BC locales like Whistler. When key sales targets got met, the company sent the reps themselves on five-star “incentive trips” to places like Brazil, Malaysia, and the Bahamas. “With ice sculptures, dancers, the best hotels, the best cuisine,” describes Sam. But this extravagance came with a price—ever-mounting pressures to increase sales. And not all the company’s drugs were winners.
“You’re launching the tenth [drug in a common class] in a market that’s already flooded, and you have tremendous pressure to bring in the results, when the drugs are all virtually the same,” says Sam. “Your parasympathetic nervous system is constantly on high alert…You’re only as good as your last quarter…If there’s a trend that’s not upward, all of a sudden out come the magnifying glasses and there’s meetings and there’s questions…And when you’ve been extremely successful, the hamster wheel just keeps going faster…” 
Sam took a buy-out during a merger, but soon returned to work. After intense training with a new company which Sam describes as “like being indoctrinated into a cult,” he accessed a whole new world, without Rx&D guidelines.

Drug-fuelled rocket ride
“At the beginning it was unbelievably amazing,” says Sam. “We had no rules.” Along with coffee mugs and golf balls, Sam delivered gift baskets with expensive bath soaps and confections, and sent doctors bags of popcorn with movie tickets inside. Even TVs and golf clubs weren’t out of the question.
“As far as continuing medical education events, you did whatever you wanted,” says Sam. “You just had to make sure the right [doctors] showed up.” Sam says he took doctors on horseback riding, mountain biking, and salmon fishing trips, with flimsy “medical education” add-ons.
“It became a way of rewarding the people who had been my health care partners for all of these years,” says Sam. 
The company offered an “uncapped bonus,” meaning that the more drugs the reps sold, the more money they made. “We just had a riot,” says Sam. “As long as we could prove a return on investment, we could do whatever we wanted, we could be as creative as we wanted…It was just this nosebleed upward trajectory at 10 G’s; you’re just pressed against the seat; you can’t believe it’s happening.”
He didn’t lie in drug pitches but, like Bill, Sam says he downplayed negatives and occasionally slipped in oblique mentions of unapproved uses. And he’d always buttress his pitches with gifts and trips to help build personal bonds.
Not every doctor accepted. “A lot of people were turned off completely; a lot of people just didn’t want to have anything to do with it,” says Sam. “But enough people did, and were so tickled…Some people just thought it was great, and were just like, ‘You guys are so refreshing, a breath of fresh air.’”
Sam also recruited doctors into surveillance studies, another practice reported in US lawsuits. He’d pay doctors varying amounts to give patients a particular drug and report clinical observations. But these “scientific studies” were a ruse to slip doctors money, and to get new doctors and patients using the drug. How often was this happening? “We said ‘honorarium’ like we said ‘hello’,” offers Sam. 
He also gave many South Island doctors money “to help cover administrative costs,” he says, when they switched a patient from a competitor’s drug to one of his company’s similar drugs. And this was done en masse—for example, Sam would get all the physicians in a clinic to sign a letter instructing pharmacies to automatically change their patients’ drugs when their prescriptions needed renewing.  
“It seemed like I was breaking the rules,” says Sam of this scheming. “There was definitely an ‘ick’ factor.”
To his recollection, Sam says he usually gave these participating doctors about $20 per patient switched. The kickback seems small for highly paid doctors, but in a US case just last year a drug company was giving $100 per patient in a similar drug-switching system, where doctors simply generated lists of suitable patients and then signed them over.
I ask Bill if he’s surprised to hear doctors were taking kickbacks in Victoria around the time he was a rep. “Nothing surprises me,” Bill comments. “A cash kickback—it really isn’t that much different than a trip to Pebble Beach, except it’s a little more transferable.”
Despite these achievements, Sam describes the relentless “screw-tightening” pressure to coerce doctors, “cannibalize the competition,” and maximize profits as “humiliating” and “soul destroying.” 
“After a while it became very apparent that the people who had more sociopathic tendencies tended to do really well,” he says.
Sam’s company got mired in a financial scandal, and simultaneously Sam’s mental and physical health deteriorated to a point where he couldn’t go on. In retrospect, Sam says he struggled with “a deep sense of internal conflict” about the ethics of what he was doing for years, and leaving the job precipitated a descent into regret, depression, anxiety, and health problems that have plagued him since. And he’s learning “karmic” lessons, he says, taking drugs he previously promoted.
“One doesn’t know, especially with psychiatric drugs, how horrible they can be until you turn from [drug sales] rep to patient,” says Sam. “And getting the push from the psychiatrists [to take the drugs] as if they’d just been spoken to by a rep…that opened my eyes in a big way.” He’s suffered through benzodiazepine addiction, and side effects from other drugs like enormous weight gain, crushing headaches, and hypertensive spikes. He also cared for an ailing relative and became concerned about the over-use of antipsychotics as chemical restraints in long-term care—an issue that, again, has been linked in US lawsuits to illegal promoting of such uses by drug reps.
“Have a lot of people benefited from these chemicals? Surely,” says Sam. But then he talks about how we often hear about widespread over-medicating for hypertension or cholesterol. “Have we been forced to convince people to prescribe more than is perhaps necessary? Yeah. And did it bother me? Yes.” He lists hemorrhages, cancer, and other common adverse drug effects people can suffer. “Did I contribute to any of those?”

Increasing “nonrational” prescribing
Later, Sam pitches a drug to me. I quickly realize that the gifts and money were probably his least powerful tools. He’s knowledgeable, well-versed, earnest, a caring listener, and a compelling speaker. And he displays a remarkable, subtle knack for putting me under pressure until I feel like the only reasonable response is for me to commit to save these patients with this drug right now. Unless I independently investigated every fact he uttered or completely shut him out, I’d succumb. 
And that’s what studies consistently show. Most doctors believe that gifts from drug reps do not strongly influence them, while in fact gifts dramatically increase what the scientific literature calls “nonrational” prescribing. But even without gifts, drug reps are extremely effective. A 2013 study, led by Barbara Mintzes of the University of BC-based Therapeutics Initiative, interviewed doctors after they’d met with drug reps in four cities, including Montreal and Vancouver. In only 1.7 percent of cases did the information that drug reps presented meet even a baseline, physician-defined standard of “minimally adequate” safety information. Even for drugs that had the highest-level warnings about seriously adverse, often life-threatening effects like heart attacks, extreme cancer risk, or liver failure, such warnings were mentioned only seven percent of the time. Nevertheless, nearly two-thirds of the time, the study authors wrote, physicians judged the quality of scientific information the reps provided to be “good or excellent” and “expressed willingness to increase prescribing” the promoted drugs. 
BC Medical Association president Dr. William Cunningham calls Mintzes’ findings “very concerning and disappointing.” As an emergency physician at Cowichan District Hospital, Cunningham says he frequently sees the negative impacts of improper prescribing. “In emergency, we actually see these side effects, and these [drug] interactions which have not good outcomes. And a lot of them are really simple things.” 
Nevertheless, Cunningham says, the BCMA doesn’t have authority to control doctors’ interactions with drug reps. “We just hope that they’re following the guidelines of the Canadian Medical Association.”
Canadian Medical Association guidelines for physician relationships with drug reps aren’t substantially different from Rx&D and various BC health authority policies. None clearly define what constitutes accuracy in drug promotions, while gifts, free meals, remuneration for surveillance studies, and trips to educational events are explained to be generally acceptable, so long as they aren’t “extravagant” or of “significant” value.
Such policies are “just silly,” says Dr. Warren Bell, a family physician in Salmon Arm who frequently speaks out on medical ethics issues. “It’s like saying, as long as you rob the bank but you don’t steal a whole bunch of money, no problem. Just a little bit of money. Just one teller. One teller, one drawer, that’s all.”
Bell has “cleansed” his own practice of industry influences. “There are no logos, no freebies, no knick-knacks, no so-called free samples,” says Bell. “When a new [drug rep] arrives on the block, I just tell them very nicely that they can go away.”
But how many Canadian doctors are voluntarily doing that? And it’s an important question, because none of these policies are being vigorously monitored or enforced, anyway.

Policing in the dark
Mintzes’ study notes that Health Canada could exercise legislative authority over drug rep practices, “but rarely does so in practice.” 
Rx&D investigated just 14 complaints about drug rep ethical violations between 2008 and 2011, of which eight resulted in fines of $10,000 to $25,000.
In the drug industry, “a $25,000 fine is a night out with your staff,” comments Bill. “It’s inconsequential.”
In 2010, the Vancouver Island Health Authority found its policies were being ignored: Half of drug reps did not even send in required disclosure forms declaring gifts and money they’d given out that year. The review also stated that policy violations were probably “significantly under-reported.” Meanwhile, most VIHA doctors maintain private practices, where health authority policies wouldn’t apply, anyway.
The BC College of Physicians has broad regulatory authority over doctors. According to College Deputy Registrar Dr. Galt Wilson, though, their regulating is “complaints driven” and they’ve never received any complaint about any doctor’s relationship with drug reps. 
Wilson believes that drug reps like Sam with their gift giving, lavish meals, bogus studies, and conferences in exotic locales are of a bygone era. “I think successive generations of doctors are more discerning. All of this has been tightened up,” says Wilson. 
“I think those practices have decreased somewhat,” concurs BCMA President Cunningham. “I couldn’t tell you for a fact that it doesn’t happen at all. But certainly you don’t hear about it the way you do in the US.”
University of Victoria drug policy researcher Alan Cassels, author of Selling Sickness, isn’t buying it. “It’s not as bad as it used to be,” he parrots. “I’ve been studying pharma policy for twenty years, and I’ve heard that all the time for the last twenty years.” So does he believe many drug reps and doctors are still today as corrupt in Canada as in the U.S.? “Absolutely,” answers Cassels. 
Who’s right? Some speculate that improved physician education and more ubiquitous generic drugs have reduced Canada’s problems, while America’s free market creed and private insurers are worsening theirs. Others suggest U.S. whistleblower incentives bring more problems to light, while Canadians are fogged by our deference to medical authority and tendencies to politely characterize as “gifts” and “administrative assistance” what Americans bluntly call bribes and kickbacks. “We don’t know what’s going on,” says Bill. “I think that’s really the problem.” 

A Canadian antidote
What should we do? Many argue that industry self-monitoring and self-regulating are inadequate. “If you really want to know what’s going on, you need to have a group of people dedicated to doing those types of investigations,” says Bill. “Health Canada needs to take a bigger role in regulating the promotional activities of pharmaceutical firms.”
Cassels believes an additional solution is equally simple: support independent research. “People who make products should be allowed to market them,” he says. “But if you’re not also investing in independent evaluation of treatments, then all [doctors] are getting is marketing.” 
On that, everyone I interview agrees.
“We feel very strongly that physicians should not rely solely on [drug company] information, and they should be consulting independent sources,” says BCMA President Cunningham. He points to medical education courses run by the independent drug-analysis group, the Therapeutics Initiative. “Those were totally unbiased, evidence-based, and were probably the best courses in BC,” says Cunningham. 
The BC Liberals, however—who themselves have taken hundreds of thousands of dollars in pharmaceutical industry “donations”—recently controversially axed the Therapeutics Initiative’s $550,000 annual budget. Medical experts have been calling for our government to resuscitate the TI before it’s too late, pointing to how some of TI’s recommendations have led to huge health care savings and hundreds of saved lives in BC alone. But considering that a TI meta-analysis of a drug’s safety and effectiveness is often so widely respected that a drug company can lose tens of millions in annual revenues after a TI critique, one can surmise how many persuasive Bills and Sams have been sent into BC government offices throwing “gifts” around and arguing the TI should die. 
“I think they need to be saved,” says Cunningham. “I think [the Therapeutics Initiative] is one of the most important institutions to help prescribe correctly in this very complex field.”
“The solution is unbiased information,” says the BC College’s Wilson, also expressing support for the Therapeutics Initiative. “[The College is] not allowed to be political because we’re a creature of the government of the day. But it’s tragic to my mind that there are untold amounts of money spent on commercial promotion of drugs, [while] a very small amount of money to counter that with objective information is somehow controversial.”
Some also propose full disclosure from family physicians. Certainly, hearing our personal doctors list every drug rep they’ve lunched with, every gift they’ve accepted, and every drug company “educational” vacation they’ve taken could help us all make more informed health care decisions. Currently, we can only wonder why most aren’t providing such disclosures.
Rob Wipond won this year’s Western Magazine Award in Science, Technology and Medicine for his Focus article “The Case for Electoshocking Mia” (Nov 2012).

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