Friday, June 10, 2011

The US Seems To Have Drifted A Bit of Course Here!

The following editorial appeared a few days ago in the New England Journal of Medicine.


Prescriptions, Privacy, and the First Amendment

NEJM | April 27, 2011 | Topics: Health Law

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D.

On April 26, the Supreme Court heard oral arguments in a case that, when it is decided this spring, will have important repercussions for the practice of medicine. At issue in William H. Sorrell, Attorney General of Vermont, et al., Petitioners v. IMS Health Inc., et al. 1 is whether detailed information about prescriptions written by doctors, with the doctor identified, can be bought and sold. Currently, this practice is legal in almost every state, and the outcome of Sorrell v. IMS Health will signal whether states may restrict it.2

This is the way it works: Retail pharmacies retain information about all drug prescriptions that they fill, including the patient’s name, the identification of the prescriber, the name, dosage, and quantity of the prescribed drug, and the date the prescription was filled. This information is collected, along with the patient’s age, sex, and drug history, and sold, with the individual prescribing doctors identified but the patient’s names encrypted, to data-mining companies (IMS Health is one such company). The data-mining companies then further process the information by collating each physician’s prescribing history for each patient, and they sell it to pharmaceutical companies. The prescribing information of individual doctors can be linked to the Physician Masterfile of the American Medical Association (AMA), thereby enriching the data on prescribing physicians (the Masterfile, which is sold by the AMA, includes information on every physician’s education, licensure, certification, hospital privileges, and practice details). The companies’ marketing departments use the information to develop strategies to sell drugs to individual doctors, and the schemes are applied by pharmaceutical sales representatives (“detailers”) to make pitches to the doctors in their offices. These solicitations are not intended to communicate evidence-based information to doctors; they are intended to sell expensive drugs.3

It is a very successful business. When drug detailers have the prescribing history of the physicians they are visiting, they sell more drugs. This is one of the principal reasons why the Pharmaceutical Research and Manufacturers of America (PhRMA), the trade organization of the pharmaceutical industry, joined the data miners as a party to the lawsuit. It is quite clear who profits from the sale of the prescribing information: retail pharmacies, data-mining companies, drug companies, and the AMA. In the end, the costs are passed along to patients, and physicians’ prescribing practices are manipulated by drug salespeople who know the details of their interactions with their patients.


In Sorrell v. IMS Health, we have sided with the state of Vermont, and we have filed a friend-of-the-court brief supporting the appropriateness of the statute to protect the privacy rights of physicians and patients.9 We do not believe that the organizations challenging the Prescription Confidentiality Law are engaging in speech that warrants First Amendment protection. Rather, they are selling highly sensitive medical information as a mere commodity without consent. We are concerned that such selling of prescribing data to pharmaceutical companies results in the manipulation of physicians’ drug-prescribing practices, unwarranted intrusion into the privacy of the doctor-patient relationship, and an increase in costs at a time when our health care system is under unprecedented financial strain. Furthermore, the technique used to de-identify patient information is flawed (and is often performed with the use of software provided by the data-mining companies themselves), and the risk of re-identification poses a serious threat to the confidentiality of patient information.3,10 A patient’s drug history provides clear insight into that patient’s medical history. Therefore, we believe a finding by the Supreme Court overturning the action of the Vermont legislature in this case would have serious negative consequences for the practice of medicine and for the public health. Such a finding could also open the door to legal challenges to other reasonable restrictions on the marketing practices of pharmaceutical companies, including the current prohibition of the promotion of off-label uses of prescription drugs.11

The full editorial and references are freely available here:

This is really an important issue and I have to say I hope the wishes of the Editorial Writers are taken very seriously indeed.

We have had sales of some prescription information in Australia over the years and just as in the US this has made many Australian clinicians quite unhappy.

In Australia we really need to make sure that, in my view, we don’t go down the path the US has followed so far and it really would be a really good idea if this sort of activity was wound way back over there - First Amendment or not!


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