California has become a battleground in a debate over how Big Pharma's access to prescription data affects patient care and the price of drugs
- Jake Whitney
Sunday, August 6, 2006
One afternoon in early 2002, Dr. Brad Drexler, an obstetrician in Healdsburg, got a visit from a pharmaceutical sales representative. The drug rep was from a company called Berlex, and the drug she was selling was Yasmin, a birth control pill that had been on the market for about a year.
Unlike some physicians, Drexler enjoyed visiting with drug reps, and saw them routinely; only in rare instances did he refuse to speak with them. The visit with the Berlex rep that day was typically pleasant. The rep was so friendly, in fact, that she thanked Drexler for all the prescriptions he had been writing for Berlex's pharmaceuticals.
Drexler found the statement odd. He wasn't in the habit of divulging to salespeople how often he prescribed their company's drugs, so he wondered just how the rep knew. Drexler called local pharmacies and asked the pharmacists if they had any knowledge of drug reps gaining access to prescription records. But they were as befuddled as he was.
Then one day, a rep with whom Drexler was particularly friendly spilled the beans. He told Drexler that he and his fellow reps were provided with detailed prescription information, which was stored in their laptops, on every physician in their sales territory.
"It bothered me in two ways," Drexler said. "One, that this practice was so hidden that neither I nor any of the pharmacists I spoke with knew it occurred. And two, because this potentially changed the equation between doctor and drug rep." He added, "I felt like I lost a lot of privacy that day."
The discovery prompted Drexler to take his concerns to the California Medical Association, where he had been a member of its House of Delegates. He introduced a resolution there calling for the CMA to oppose drug company access to prescription records.
Today, three years after Drexler's resolution, California has become a key battleground in a growing debate over how drug companies' access to prescription data affects both patient care and the price of pharmaceuticals. A pilot program, to be launched imminently with 100 doctors, may determine just how easy, or difficult, it will be in the future for pharmaceutical companies to access this information.
Drug companies have been buying prescription records since the 1990s, yet the practice is still not widely known. Even many doctors don't know it occurs.
According to a Kaiser Family Foundation survey taken in 2001, 34 percent of doctors did not know that drug companies had access to their prescription writing history. In 2004, a survey sponsored by the American Medical Association found that number to have shrunk to about 25 percent. And, like Drexler, the more doctors learn of the practice, the more they try to stop it.
The imminent pilot program had its genesis in 2003, when, spurred by physician complaints and encouragement from the CMA, Assemblywoman Wilma Chan, D-Oakland, presented Assembly Bill 262 to the California Legislature. AB 262 would have banned statewide the use of prescription data for marketing purposes.
Despite strong support from the CMA, opposition to Chan's bill was intense. Between its introduction in February 2003 and its demise in August 2004, AB 262 was amended 13 times to mollify various interest groups. Concessions were made allowing prescription data to be collected for research purposes -- the bill's opponents' chief argument as to the benefits of the practice -- but, according to Chan, lobbying from the pharmaceutical industry and data mining companies, especially IMS Health, crushed it.
Data mining companies such as IMS Health play the role of middleman in tracking prescription records. These firms buy records from pharmacy chains and other sources before repackaging them and selling them to drug companies. When pharmacy chains sell the records, however, they do not include patient names and, in some cases, the doctors who wrote the prescriptions. So drug companies turn to a surprising source to complete the prescription profiles: the AMA.
The AMA leases its "physicians' Masterfile" to data mining companies and, through them, subleases it to pharmaceutical companies. This Masterfile contains personal and professional information, including the Drug Enforcement Agency number on all doctors practicing in the United States. And since every prescription written in the United States must include the prescribing physician's DEA number, drug companies use these physician-unique numbers on the Masterfile to match prescription records to doctors.
How important are the profiles to drug reps? "An enormous help," said Kathleen Slattery-Moschkau, whose 2005 film "Side Effects" is loosely based on her 10 years peddling pills for pharmaceutical giants Johnson & Johnson and Bristol-Myers Squibb. "They allow reps to enter doctors' offices armed and dangerous."
Slattery-Moschkau said that when she was a rep she was given reports on every doctor within her sales territory by drug class, as well as "numerous other reports, such as the 'Heavy Hitter List,'" which would include the top physicians her company was trying to "convert."
She said the profiles helped her decide which doctors "were worthy of spending my monthly budgets on for lunches, dinners, days at the spa, etc." Overall, she said, the reports "were a great tool for determining which marketing tactics worked best."
Jamie Reidy, a former Pfizer rep who chronicled his days selling Viagra in his 2005 memoir "Hard Sell," put it bluntly: "Prescription data was our greatest tool in planning our approach to manipulating doctors." But the pharmaceutical industry maintains that prescription profiles are collected primarily for research and for other reasons beneficial to patients.
The Pharmaceutical Research and Manufacturers Association, in an e-mailed statement prepared by Senior Vice President Ken Johnson, said that banning the practice (West Virginia, Arizona, Hawaii and New Hampshire are also considering or have considered legislation to ban or restrict it) "could chill important research that protects and improves public health."
The statement added that the data "can be analyzed by researchers to identify poor prescribing habits," and then cited a study by the Centers for Disease Control and Prevention that used the data to examine antibiotic use to help prevent antibiotic resistance and "reduce unnecessary prescribing." The statement concluded that, "Analyzing prescribing data is another way to make sure patients all over the country receive the best possible care."
The AMA shares this position. Its policy is that the data is collected for research, for locating doctors to participate in clinical trials, to assist in distributing drug samples and in case of a drug recall.
Robert Musacchio, the AMA's vice president of publishing and business services, said that as a general rule his organization has no problem with the data being used for marketing purposes, as long as it is not used to "overtly influence the physician/patient relationship."
But critics point to insider revelations like those of Reidy and Slattery-Moschkau as proof that drug companies use the data precisely in this way: to influence doctors' prescription writing. Drexler said it was just this potentiality that engendered his 2003 resolution. He said his concerns were that visits by drug reps, "could be used to inappropriately reward doctors who were prescribing the company's products."
And that with prescription data in their hands, "the potential existed for reps to influence doctors." When asked whether Drexler's fears were merited, Reidy said yes, that reps "totally reward doctors," but not so it's obvious. He illustrated: "Say Dr. X is prescribing a lot of Zithromax (a Pfizer antibiotic) when he used to prescribe Amoxicillin for similar conditions. If the rep rewards him by giving him gift certificates to Morton's Steakhouse and saying things like, 'Thanks for all the business,' then suddenly Dr. X may feel sleazy and stop writing for Zithromax. On the other hand, he may realize what's going on and start asking the rep for gift certificates to Peter Luger Steakhouse."
Physicians' staffs are also targets, Reidy said, especially nurses. He said that in his case he would take nurses out to happy hour where he would thank them for their help in encouraging Dr. X to prescribe Zithromax. Reidy said this would make the nurses feel as if they were a part of his "team," and they'd "know that if the doctor keeps writing Zithromax they'll be having regular happy hours."
Dr. Sharon Levine, an executive director with Kaiser Permanente, the nation's largest HMO, said that it is because of tactics like these that Kaiser's doctors are prohibited from accepting personal gifts from reps (they are allowed to accept gifts that could benefit their practice -- i.e. they can accept a pen, but not a gift certificate to Morton's), and have never made their prescription records available to drug companies.
Studies support these concerns. A 2000 study published in the European Journal of Clinical Pharmacology, for example, found that increased interaction with drug reps led physicians to prescribe against their patients' best interests. A 2003 study in the American Journal of Bioethics found that when a person accepts a gift, no matter how small, "the obligation to directly reciprocate, whether or not the recipient is conscious of it, tends to influence behavior."
And then there's the cost. Drug companies lay out hefty sums for the profiles. IMS Health, just one of a handful of data mining companies, generated $1.7 billion in revenues last year, $847 million from its "Sales Force Effectiveness Offerings." Critics say pharmaceutical companies should be spending that money seeking new medications. (The major pharmaceutical companies generally spend more than twice as much on marketing as they do on research and development. In 2005, for example, Pfizer spent $17 billion globally on "selling, information and administration" and $7.4 billion on research and development.)
Levine said that the high cost of the profiles manifests itself on drug prices in two ways. Not only is the high cost reflected directly in higher drug prices, but the data is used to persuade doctors to prescribe expensive, brand-name drugs -- often when much cheaper generics would do -- which jacks up co-pays and insurance premiums. Physician privacy is another concern. Dr. Zoe Berna, a family practitioner in Vacaville, is against drug companies gaining access to her records because she thinks she should be free to write prescriptions without salespeople looking over her shoulder. "I definitely feel (drug company access to prescription records) is an invasion of my privacy," she said. Berna added that she would support an outright ban of the release of the data.
In California, at least, that possibility may have died along with AB 262.
But, according to Dr. Jack Lewin, the CMA's chief executive officer, though Chan's bill failed to become law, it initiated almost two years of negotiations among the AMA, IMS Health and the CMA, at the end of which a happy compromise was reached.
Lewin went as far as to assert that the results of the compromise would benefit physicians more so than Chan's bill would have. "We could have gotten (AB 262) passed in any event, except we think we have the better option now," Lewin said in an e-mail.
"The better option" is a new program, unique to the state, built around three main facets.
The primary feature is an "opt out" mechanism that will allow doctors to choose whether or not drug companies may access their physician-specific data.
Second, for those physicians who do not use the "opt out" mechanism, IMS will be required to send them the same data package containing their personal prescription profile it sends to drug companies. In addition, IMS will provide reports comparing the "opting in" physician's prescription patterns with those of area doctors who share the same specialty.
Third, physicians who "opt in" will be e-mailed, on a quarterly basis, an unbiased educational newsletter about the latest medications and developments in their field.
Lewin said that a pilot of the new program is imminent. The statewide rollout is scheduled for January 2007.
The AMA launched its own "opt out" program on July 1. According to Musacchio, the AMA's Physician Data Restriction Program (PDRP) allows physicians to request their individual prescribing data be hidden from pharmaceutical sales representatives -- similar to the California program, but minus the requirements of IMS Health. (In both programs drug companies would continue to have access to aggregated prescription data, including the data of the physicians who have "opted out.")
A spokesperson for IMS Health said in an e-mail that the company supports the AMA's PDRP program, and that the California compromise "will give physicians better insights into their own practices and those of their peers, helping to drive improvements in patient care."
Critics, however, assert that both programs suffer from an inherent flaw: with so many doctors still oblivious to the practice in the first place, the reliance on an "opt out" mechanism is ludicrous -- you can't "opt out" of something you don't know exists.
One of the harshest critics, especially of the AMA's program, is New Hampshire state Rep. Cindy Rosenwald, D-Nashua, who in May pushed a bill through the New Hampshire legislature that would ban statewide the release of prescription data for all commercial purposes. Gov. John Lynch signed the bill June 30, making it the first such legislation in the nation.
Rosenwald said the PDRP program doesn't go nearly as far, and suggested it was simply an effort by the AMA to prevent more bills like hers, and more compromises such as California's. Pointing out that the AMA generates millions of dollars per year with the lease of its Masterfile (the AMA would not comment on how much it made), Rosenwald said, "The AMA has absolutely no incentive to stop the practice."
(Mussachio said that the AMA recognizes that there has been inappropriate use of the data, but there was no need for an outright ban because the PDRP program gives physicians a choice. He added that a lot of younger physicians like being presented with the data because it helps them measure their "performance.")
So what did Drexler think of these "opt out" programs, particularly the California compromise he may have helped engender after an innocent encounter with a birth control rep more than three years ago?
"I still believe drug company access to physician data should be banned," he said, adding that it may be time to "rethink (his) attitude" toward drug reps. He concluded, "but the compromise is a good thing, because it's the best we could get."
New York freelancer Jake Whitney's work has appeared in New York magazine, the Long Island Press and Guernicamag.com.
Sunday, August 06, 2006
California has become a battleground in a debate over how Big Pharma's access to prescription data affects patient care and the price of drugs
Posted by david at 11:38 AM Permalink