Pharmaceutical Data-Mining, Health Care Privacy and “Free” Speech: Sorrell vs. IMS Health
Today the US Supreme Court is due to hear arguments in Sorrell vs. IMS Health, a pharmaceutical data-mining case that has potentially far reaching implications for health care privacy, as well as how pharmaceutical companies detail (or market to) doctors.
A previous blog post outlines the crux of the practice at the center of the lawsuit, sometimes called âprescriber identifiable prescription tracking.â And hereâs an abstract from a presentation at the American Public Health Association meeting about the potential impacts of the practice.
The legal case hinges on a Vermont law (âSorrellâ in the Supremeâs case refers to Bill Sorrell, the Vermont State Attorney General) that sought to ban the practice. More details on the case itself can be read and heard here, and a very informative interview with AG Sorrell that includes some of the wider implications of the suit can be heard here. Interested in amicus briefs and more legal details? Try the NLARx website.
Predicting how the Supreme Court might rule is of course a bit like reading tea-leaves, which is why most wise folks refrain from making such predictions. But this writer lacks such wisdom, so here goes.
Supreme Court Likely to Side With Industry
The industryâs case is based on free speech. It is notable that they do not make any claims that what they are doing has positive health or social value, only that it is protected by their first amendment rights. The current Supreme Courtâs attitude that corporations should have similar constitutional protections as individuals might hint towards their support for IMS Health and the coterie of pharmaceutical industry heavy weights that support them. But their support is likely to be much more fundamental than even that.
Hereâs how the majority might read the case: The privacy at stake here is not patient privacy, which we all hold to be sacrosanct and worthy of protection, but the privacy of your doctor's prescribing records. These records are currently not private in that regulators such as the DEA and state Medicaid officials and private insurance have access to them for compliance and quality reasons. Plus, doctors are highly trained professionals, so they are capable of hearing a sales pitch and ignoring it if the information they are presented with is not in the best interests of their patients.
Hereâre Three Reasons why They are Wrong
1. Drug marketing is about selling more higher-priced drugs. It is not about improving health. Thatâs why the drugs that are most commonly advertised are the most expensive, and the newest, not the most effective. In fact, by being so new, we know the least about their safety so they often end up being some of the most dangerous in real world settings. Direct-to-consumer drug advertising is currently allowed in large part because of the âlearned intermediaryâ principle: I canât simply see an ad for a potent atypical antipsychotic, then go out and buy it. I have to go to a doctor first, a learned intermediary who will determine whether it is appropriate for me based on her clinical knowledge, experience and training.
Unfortunately the type of targeted physician profiling that occurs with the data in question allows pharmaceutical marketers to corrupt the learned intermediary who is supposed to bring rational, evidenced-based analysis to my desire to buy that potent drug. And all evidence suggests that marketing to doctors, which is closely tied to marketing to consumers so that both parties are âeducatedâ about the same drug, increases prescription of marketed drugs, increases prescription costs, but doesnât improve health.
2. Because of the above effect, prescriber-identifiable prescription tracking does infringe on patient health and patient privacy. Anything that adversely affects my doctorâs judgment when she reaches for a prescription pad influences my health. Its as if a drug rep were allowed to sit in the exam room, minding his own business (even wiggling his fingers in his ear when my name is mentioned) until he hears that I have high cholesterol, at which point he hands glossy informational brochures and a few minor gifts to my doctor to help make the prescribing decision. This s not a free speech issue, it is a patient health issue.
3. Despite the industryâs claims of free speech there is the persistent irony that once theyâve compiled the data on specific identified prescribers, that information is no longer free. To begin with, it is priced so prohibitively high that it is generally well-beyond the reach of even the most well-funded academic, objective researchers. Secondly, in at least one instance a company such as IMS Health would not allow researchers from a very prestigious institution to purchase their data for a research project that essentially was aimed at exposing some of the negative public health risks associated with the industry practice. Finally, the fact that everyone in the chain of information stands to potentially benefit EXCEPT the patient is reprehensible: Pharmacies get paid to provide raw data, health information organizations like IMS Health get paid by pharma for their reports, pharma gets more money from increased drug sales, and doctors get sometimes significant gifts. The patient get prescribed a higher priced drug whose safety and effectiveness amy not be as well known as a competitor drug.
So what to do? First, lets hope this prediction is dead wrong. Second, lets hope that the Global 1000 pharmaceutical industry heavy weights such as Pfizer, Merck, and Glaxosmithkline extend CSR to their marketing practice and reform their behavior. Without their financial support, this practice would wither and die. Finally, thereâs a clear need for regulators and advocates for evidence-based medicine, patient care, and health care privacy to be as innovative as industry is wealthy to fight back against the overwhelmingly negative patient health effects of prescriber-identifiable prescription tracking. This is an information struggle, and perhaps social media and information technology can give health-concerned Davids some ammunition to battle drug slinging Goliaths?
Photo credit: The Author