Pharmaceutical rep licensing bill survives first D.C. Council vote
Washington Business Journal - by Vandana Sinha Staff Reporter
Tuesday, December 11, 2007 - 7:21 PM EST
A bill that would make the District the country's first jurisdiction to license drug sales representatives scraped by with a 7-6 vote Tuesday as it passed its initial test in the D.C. Council.
That vote advances the bill, dubbed SafeRx, to the council's next meeting, Jan. 8.
In addition to requiring pharmaceutical sales representatives to be licensed by the D.C. Board of Pharmacy going forward, the bill mandates that they have a bachelor's degree, adhere to a code of ethics, refrain from giving doctors gifts and no longer use area prescribing data as a marketing tool to target specific physicians unless those physicians choose to share that data.
The bill also requires physicians to tell their patients when they're prescribing medication for a treatment not specifically authorized by the Food and Drug Administration. Finally, it sets the framework for a new city-funded system of educating area physicians about new drugs on the market.
In what was often a testy debate, council supporters championed the legislation as a way to regulate locally what they described as an otherwise uncontrolled influence by drug companies over the health care industry. But opponents said the bill repeated existing federal mandates and created a bureaucracy that would dissuade pharmaceutical companies from doing business in the nation's capital.
Councilman David Catania, I-at large, the bill's lead sponsor and chairman of the council's health committee, said the country's 100,000 drug reps need more than the current 30 FDA employees as overseers. If the FDA does find that drug reps have misled physicians with their sales mantras, Catania said, the federal agency's only authorized response is a stern letter.
"There are no consequences of false and misleading advertising," Catania said. "We can say, 'While the federal government will do nothing, we will take away your license.'"
But Councilwoman Muriel Bowser, D-Ward 4, said she worried that the SafeRx bill would set D.C. down the same path as the FDA: too few employees and too small of a budget to combat a far bigger problem.
"It promises exactly what the FDA can't accomplish," said Bowser, who voted against the measure, but said she would have supported pieces if they were carved out separately. "It's also incumbent upon us to go down that road and to make sure we're putting in place legislation that is sufficient to a problem."
Supporters said the bill wasn't perfect but did more to address a pharmaceutical rep's behavior than any alternative.
"We could have a law that's silent on the issue, which I think many of my colleagues want. And I don't think that's reasonable," said Councilman Phil Mendelsohn, D-at large, who voted for the bill. "I think those concerns [from opponents] have been met in a large way, and what's left is reasonable legislation."
Originally, the bill had demanded that pharmaceutical reps hold advanced degrees in biological or chemical fields and that they enter all clinical trial information into a city-managed database for health care providers and patients. The initial bill had also required doctors to get a patient's written consent before prescribing any off-label uses of drugs, a common practice in the industry. Those requirements were thrown out in more recent rewrites.
But the licensure requirement remains a concern for some. They consider that requirement an extra expense for reps who may choose to locate elsewhere in the region and for pharmaceutical companies that may pass those costs along in patient prescriptions. The result, they said, would be a new regulatory process that would be hard for D.C. officials to police.
"Any lawyer can tell you that this is going to be very difficult to enforce," said Councilman Marion Barry, D-Ward 8, who voted against the bill. "It's a waste of time to try to do this. ... It does nothing to protect patients or enhance their quality of life."
Following the Script: How Drug Reps Make Friends and Influence Doctors
Adriane Fugh-Berman*, Shahram Ahari
Funding: This work was supported by a grant from the Attorney General Prescriber and Consumer Education Grant Program, created as part of a 2004 settlement between Warner-Lambert, a division of Pfizer, and the Attorneys General of 50 States and the District of Columbia, to settle allegations that Warner-Lambert conducted an unlawful marketing campaign for the drug Neurontin (gabapentin) that violated state consumer protection laws.
Competing Interests: Shahram Ahari is a former pharmaceutical sales representative for Eli Lilly, and the primary findings of this paper summarize points he made in testimony as a paid expert witness on the defendant's side in litigation against a New Hampshire law prohibiting the sale of prescription data. Adriane Fugh-Berman has accepted payment as an expert witness on the plaintiff's side in litigation regarding menopausal hormone therapy.
Citation: Fugh-Berman A, Ahari S (2007) Following the Script: How Drug Reps Make Friends and Influence Doctors. PLoS Med 4(4): e150 doi:10.1371/journal.pmed.0040150
Published: April 24, 2007
Abbreviations: AMA, American Medical Association
Adriane Fugh-Berman is an Associate Professor in the Department of Physiology and Biophysics, Georgetown University Medical Center, Washington, District of Columbia, United States of America. Shahram Ahari is with the School of Pharmacy, University of California San Francisco, San Francisco, California, United States of America.
* To whom correspondence should be addressed. E-mail:email@example.com
It's my job to figure out what a physician's price is. For some it's dinner at the finest restaurants, for others it's enough convincing data to let them prescribe confidently and for others it's my attention and friendship...but at the most basic level, everything is for sale and everything is an exchange.
You are absolutely buying love.
-James Reidy 
In 2000, pharmaceutical companies spent more than 15.7 billion dollars on promoting prescription drugs in the United States . More than 4.8 billion dollars was spent on detailing, the one-on-one promotion of drugs to doctors by pharmaceutical sales representatives, commonly called drug reps. The average sales force expenditure for pharmaceutical companies is $875 million annually .
Unlike the door-to-door vendors of cosmetics and vacuum cleaners, drug reps do not sell their product directly to buyers. Consumers pay for prescription drugs, but physicians control access. Drug reps increase drug sales by influencing physicians, and they do so with finely titrated doses of friendship. This article, which grew out of conversations between a former drug rep (SA) and a physician who researches pharmaceutical marketing (AFB), reveals the strategies used by reps to manipulate physician prescribing.
Better Than You Know Yourself
During training, I was told, when you're out to dinner with a doctor, "The physician is eating with a friend. You are eating with a client."
Reps may be genuinely friendly, but they are not genuine friends. Drug reps are selected for their presentability and outgoing natures, and are trained to be observant, personable, and helpful. They are also trained to assess physicians' personalities, practice styles, and preferences, and to relay this information back to the company. Personal information may be more important than prescribing preferences. Reps ask for and remember details about a physician's family life, professional interests, and recreational pursuits. A photo on a desk presents an opportunity to inquire about family members and memorize whatever tidbits are offered (including names, birthdays, and interests); these are usually typed into a database after the encounter. Reps scour a doctor's office for objects-a tennis racquet, Russian novels, seventies rock music, fashion magazines, travel mementos, or cultural or religious symbols-that can be used to establish a personal connection with the doctor.
Good details are dynamic; the best reps tailor their messages constantly according to their client's reaction. A friendly physician makes the rep's job easy, because the rep can use the "friendship" to request favors, in the form of prescriptions. Physicians who view the relationship as a straightforward goods-for-prescriptions exchange are dealt with in a businesslike manner. Skeptical doctors who favor evidence over charm are approached respectfully, supplied with reprints from the medical literature, and wooed as teachers. Physicians who refuse to see reps are detailed by proxy; their staff is dined and flattered in hopes that they will act as emissaries for a rep's messages. (See Table 1 for specific tactics used to manipulate physicians.)
Gifts create both expectation and obligation. "The importance of developing loyalty through gifting cannot be overstated," writes Michael Oldani, an anthropologist and former drug rep . Pharmaceutical gifting, however, involves carefully calibrated generosity. Many prescribers receive pens, notepads, and coffee mugs, all items kept close at hand, ensuring that a targeted drug's name stays uppermost in a physician's subconscious mind. High prescribers receive higher-end presents, for example, silk ties or golf bags. As Oldani states, "The essence of pharmaceutical gifting..is ebribes that aren't considered bribesf" .
Reps also recruit and audition "thought leaders" (physicians respected by their peers) to groom for the speaking circuit. Physicians invited and paid by a rep to speak to their peers may express their gratitude in increased prescriptions (see Table 1). Anything that improves the relationship between the rep and the client usually leads to improved market share.
An official job description for a pharmaceutical sales rep would read: Provide health-care professionals with product information, answer their questions on the use of products, and deliver product samples. An unofficial, and more accurate, description would have been: Change the prescribing habits of physicians.
-James Reidy 
Pharmaceutical companies monitor the return on investment of detailing-and all promotional efforts-by prescription tracking. Information distribution companies, also called health information organizations (including IMS Health, Dendrite, Verispan, and Wolters Kluwer), purchase prescription records from pharmacies. The majority of pharmacies sell these records; IMS Health, the largest information distribution company, procures records on about 70% of prescriptions filled in community pharmacies. Patient names are not included, and physicians may be identified only by state license number, Drug Enforcement Administration number, or a pharmacy-specific identifier . Data that identify physicians only by numbers are linked to physician names through licensing agreements with the American Medical Association (AMA), which maintains the Physician Masterfile, a database containing demographic information on all US. physicians (living or dead, member or non-member, licensed or non-licensed). In 2005, database product sales, including an unknown amount from licensing Masterfile information, provided more than $44 million to the AMA .
Pharmaceutical companies are the primary customers for prescribing data, which are used both to identify "high-prescribers" and to track the effects of promotion. Physicians are ranked on a scale from one to ten based on how many prescriptions they write. Reps lavish high-prescribers with attention, gifts, and unrestricted "educational" grants (Table 1). Cardiologists and other specialists write relatively few prescriptions, but are targeted because specialist prescriptions are perpetuated for years by primary care physicians, thus affecting market share.
Reps use prescribing data to see how many of a physician's patients receive specific drugs, how many prescriptions the physician writes for targeted and competing drugs, and how a physician's prescribing habits change over time. One training guide states that an "individual market share report for each physician..pinpoints a prescriber's current habits" and is "used to identify which products are currently in favor with the physician in order to develop a strategy to change those prescriptions into Merck prescriptions" .
A Pharmaceutical Executive article states, "A physician's prescribing value is a function of the opportunity to prescribe, plus his or her attitude toward prescribing, along with outside influences. By building these multiple dimensions into physicians' profiles, it is possible to understand the ewhyf behind the ewhatf and ehowf of their behavior."  To this end, some companies combine data sources. For example, Medical Marketing Service "enhances the AMA Masterfile with non-AMA data from a variety of sources to not only include demographic selections, but also behavioral and psychographic selections that help you to better target your perfect prospects" .
The goal of this demographic slicing and dicing is to identify physicians who are most susceptible to marketing efforts. One industry article suggests categorizing physicians as "hidden gems": "Initially considered elow valuef because they are low prescribers, these physicians can change their prescribing habits after targeted, effective marketing." "Growers" are "Physicians who are early adopters of a brand. Pharmaceutical companies employ retention strategies to continue to reinforce their growth behavior." Physicians are considered "low value" "due to low category share and prescribing level" .
In an interview with Pharmaceutical Representative, Fred Marshall, president of Quantum Learning, explained, ".. One type might be called ethe spreaderf who uses a little bit of everybody's product. The second type might be a eloyalistf, who's very loyal to one particular product and uses it for most patient types. Another physician might be a enichef physician, who reserves our product only for a very narrowly defined patient type. And the idea in physician segmentation would be to have a different messaging strategy for each of those physician segments " .
In Pharmaceutical Executive, Ron Brand of IMS Consulting writes "..integrated segmentation analyzes individual prescribing behaviors, demographics, and psychographics (attitudes, beliefs, and values) to fine-tune sales targets. For a particular product, for example, one segment might consist of price-sensitive physicians, another might include doctors loyal to a given manufacturers brand, and a third may include those unfriendly towards reps" .
In recent years, physicians have become aware of-and dismayed by-script tracking. In July 2006, the AMA launched the Prescribing Data Restriction Program (see http://www.ama-assn.org/ama/pub/category/12054.html), which allows physicians the opportunity to withhold most prescribing information from reps and their supervisors (anyone above that level, however, has full access to all data). According to an article in Pharmaceutical Executive, "Reps and direct managers can view the physician's prescribing volume quantiled at the therapeutic class level" and can still view aggregated or segmented data including "categories into which the prescriber falls, such as an early-adopter of drugs, for example..." . The pharmaceutical industry supports the Prescribing Data Restriction Program, which is seen as a less onerous alternative to, for example, state legislation passed in New Hampshire forbidding the sale of prescription data to commercial entities .
The Value of Samples
The purpose of supplying drug samples is to gain entry into doctors' offices, and to habituate physicians to prescribing targeted drugs. Physicians appreciate samples, which can be used to start therapy immediately, test tolerance to a new drug, or reduce the total cost of a prescription. Even physicians who refuse to see drug reps usually want samples (these docs are denigrated as "sample-grabbers"). Patients like samples too; it's nice to get a little present from the doctor. Samples also double as unacknowledged gifts to physicians and their staff. The convenience of an in-house pharmacy increases loyalty to both the reps and the drugs they represent.
Some physicians use samples to provide drugs to indigent patients [14,15]. Using samples for an entire course of treatment is anathema to pharmaceutical companies because this "cannibalizes" sales. Among the aims of one industry sample-tracking program are to "reallocate samples to high-opportunity prescribers most receptive to sampling as a promotional vehicle" and "identify prescribers who were oversampled and take corrective action immediately" .
Studies consistently show that samples influence prescribing choices [14,15,17]. Reps provide samples only of the most promoted, usually most expensive, drugs, and patients given a sample for part of a course of treatment almost always receive a prescription for the same drug.
While it's the doctors' job to treat patients and not to justify their actions, it's my job to constantly sway the doctors. It's a job I'm paid and trained to do. Doctors are neither trained nor paid to negotiate. Most of the time they don't even realize that's what they're doing..
Drug costs now account for 10.7% of health-care expenditures in the US . In 2004, spending for prescription drugs was $188.5 billion, almost five times as much as what was spent in 1990 . Between 1995 and 2005, the number of drug reps in the US increased from 38,000 to 100,000 , about one for every six physicians. The actual ratio is close to one drug rep per 2.5 targeted doctors , because not all physicians practice, and not all practicing physicians are detailed. Low-prescribers are ignored by drug reps.
Physicians view drug information provided by reps as a convenient, if not entirely reliable, educational service. An industry survey found that more than half of "high-prescribing" doctors cited drug reps as their main source of information about new drugs . In another study, three quarters of 2,608 practicing physicians found information provided by reps "very useful" (15%) or "somewhat useful" (59%) . However, only 9% agreed that the information was "very accurate"; 72% thought the information was "somewhat accurate"; and 14% said that it was "not very" or "not at all" accurate.
Whether or not physicians believe in the accuracy of information provided, detailing is extremely effective at changing prescribing behavior, which is why it is worth its substantial expense. The average annual income for a drug rep is $81,700, which includes $62,400 in base salary plus $19,300 in bonuses. The average cost of recruiting, hiring, and training a new rep is estimated to be $89,000 . When expenses are added to income and training, pharmaceutical companies spend $150,000 annually per primary care sales representative and $330,000 per specialty sales representative . An industry article states, "The pharmaceutical industry averages $31.9 million in annual sales spending per primary-care drug..Sales spending for specialty drugs that treat a narrowed population segment average $25.3 million per product across the industry." 
As one of us (SA) explained in testimony in the litigation over New Hampshire's new ban on the commercial sale of prescription data, the concept that reps provide necessary services to physicians and patients is a fiction. Pharmaceutical companies spend billions of dollars annually to ensure that physicians most susceptible to marketing prescribe the most expensive, most promoted drugs to the most people possible. The foundation of this influence is a sales force of 100,000 drug reps that provides rationed doses of samples, gifts, services, and flattery to a subset of physicians. If detailing were an educational service, it would be provided to all physicians, not just those who affect market share.
Physicians are susceptible to corporate influence because they are overworked, overwhelmed with information and paperwork, and feel underappreciated. Cheerful and charming, bearing food and gifts, drug reps provide respite and sympathy; they appreciate how hard doctor's lives are, and seem only to want to ease their burdens. But, as SA's New Hampshire testimony reflects, every word, every courtesy, every gift, and every piece of information provided is carefully crafted, not to assist doctors or patients, but to increase market share for targeted drugs (see Table 1). In the interests of patients, physicians must reject the false friendship provided by reps. Physicians must rely on information on drugs from unconflicted sources, and seek friends among those who are not paid to be friends.
Reference 26 is cited out of order in the article because it was added while the article was in proof.
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