The RX files

When Dr. David Mitchell was a third-year medical student in 1998, he attended a lunch thrown by a group of Aventis pharmaceutical representatives. Mitchell was short on money and went along solely for the free food. But the purpose of the lunch, he soon discovered, was to discuss Aventis’ high-blood-pressure medication, Cardizem CD.

During lunch, one of the representatives turned to a family-practitioner friend of Mitchell’s who had accompanied him and asked her why she wasn’t prescribing much of their drug. The doctor told her hosts they had nothing to worry about and that she was prescribing Cardizem.

The inquiring Aventis representative then pulled out a palmtop computer and confronted the physician with exactly how little Cardizem CD she had prescribed the previous month compared with competing high-blood-pressure medications.

The data on the computer screen, Mitchell noted, included the names and quantities of every drug Mitchell’s physician friend had prescribed in the previous three months.

“It was,” Mitchell said, “my first exposure to the tracking.”

Drug companies have been buying prescription records without much public notice since the early 1990s, but recently California has become a major battleground in a growing debate over how this practice affects patient care. In fact, a pilot program to be launched next month, with 100 doctors, may well decide just how easy it will be for drug companies to access these records in the future.

Drug companies purchase the records from health-information organizations (HIOs), which get the data from various sources, primarily pharmacy chains.

When pharmacies sell these prescription records, they do not include patient names and, in some cases, the names of the doctors who wrote them. So, drug companies turn to another source to complete the profiles: the American Medical Association (AMA).

The AMA leases its “physicians’ master file” to research firms and pharmaceutical companies. This file contains personal and professional information, including the Drug Enforcement Administration (DEA) number, on all doctors practicing in the United States. Because every prescription written in the United States must include the prescribing physician’s DEA number, drug companies use the master file to match doctors to prescription records.

Once the information taken from the various sources has been consolidated into detailed profiles, drug companies use them for marketing purposes—to “target” doctors whom the companies want to prescribe more of their drugs, as in the case of Mitchell’s friend.

In 2003, the California Legislature considered a bill that would have greatly restricted drug companies’ access to these records. The bill was supported by the California Medical Association (CMA), many of whose 35,000 doctor-members were concerned about third parties viewing their data.

Critics said that access to prescription records allowed pharmaceutical representatives to exert an undue influence on the prescribing patterns of physicians.

Dr. Sharon Levine, an executive director with Kaiser Permanente, said that it is for this reason that the prescription records of Kaiser’s doctors have never been made available to drug companies. Levine called drug companies’ use of this data, “marketing in sheep’s clothing.”

“It’s not about research; it’s about marketing high-cost drugs independent of health benefits,” she said. “The data is used to target physicians and promote drug companies’ high-margin drugs.”

This has had detrimental effects on our health system, she said, driving up prescription costs and possibly even health hazards—as in the cases of drugs like Vioxx and Bextra, which were recalled from pharmacy shelves after links to heart risks were detected. In these cases, Levine said, drug reps “appear to have substantially underrepresented the risks and overrepresented the benefits” of the medications.

The Sacramento-area physicians interviewed for this story had varying opinions on drug companies accessing their records. “It doesn’t surprise me; they’ll use every trick in the book,” said Dr. Doug DeSalles, a family practitioner with offices in Roseville and Stockton.

Dr. David Kosh, a Sacramento-based physician, was well aware that this practice occurred, and though he views reps much like “lobbyists,” he said he didn’t mind that they had access to his prescribing information.

“Everything is getting more high-tech,” he said. “Pretty soon, reps will come into my office knowing what I prescribed the day before.”

Dr. Jack Lewin, the CMA’s chief executive officer, said the California bill was set to pass into law when lobbying by IMS Health, one of the nation’s largest HIOs, halted it.

IMS stood to lose market share if the bill became law, and, with the support of the AMA (which also had a pecuniary interest in the practice, with the leasing of its master file), IMS convinced the CMA that there was, or at least could be, value in drug companies accessing these records.

After two years of negotiations among the CMA, the AMA and IMS, a compromise was reached. In return for killing the bill, the CMA agreed to a new statewide program with three features.

The first is an “opt out” mechanism that will allow doctors to choose whether third parties may access their data, with physicians reminded of the opt-out function annually.

Second, for those physicians who do not opt out, IMS will be required to provide them the same data being sent to drug companies.

In addition, IMS will provide reports comparing the “opting in” physicians’ prescription profiles with those of area doctors within the same specialty.

Patient compliance is also a part, and doctors will be sent data on how often their patients refill prescriptions (patient names will continue to be omitted).

Third, physicians who opt in will be e-mailed quarterly an unbiased educational newsletter with information about the latest developments in their field.

Lewin said the pilot is set for May, with a statewide rollout planned for January 2007. Although he foresees a significant number of physicians opting out, Lewin said the above features would give doctors something valuable by opting in.

“We see [the new program] as empowering physicians, and we think most will see the value in it,” he said.

Asked to clarify the AMA’s position, Robert Musacchio, the AMA’s senior vice president of publishing and business services, said that as a rule, his organization has no problem with drug companies using prescription data for marketing. “Essentially, we are against the inappropriate use [of the data],” he said, adding that the AMA’s interpretation of inappropriate use “is for anyone to overtly influence the physician/patient relationship.”

As to why drug companies would want the information at all, if not to “overtly influence” physicians’ prescribing habits, AMA policy is that the data helps drug companies locate doctors for participation in clinical trials, assist in distributing drug samples and assist in alerting doctors to a drug recall.

Musacchio also said that the AMA would be implementing its own opt-out program as part of its master-file lease agreement. Beginning this July, Musacchio said, physicians across the United States will have the right to request that their individual prescribing data be kept secret from pharmaceutical companies—much the same as the California program but minus the requirements of IMS.

IMS Health did not comment on the California compromise, but in response to repeated requests for comment, a spokesman said in an e-mail, “IMS Health supports the spirit and intent of the [AMA opt-out program]. We applaud the AMA for addressing physicians’ concerns and are committed to successfully implementing [the program].”

Musacchio admitted that there are still logistics to be worked out. For example, he is still not sure what type of punishment the AMA would levy on a company that ignored a physician’s request to keep his individual data private. He said that the AMA would investigate how the rep got the data and demand an apology.

“What we’re still working on is what we do then. Do we suspend their contract [to the AMA master file]? Do we give them another chance? It depends. We’re working those things out.”