Data Mining: Fatal First Amendment Flaw in Prescription Restraint Statutes

With the recent attention of health care focusing on the use of prescription data, civil liberties attorney and Harvard Law scholar Laurence H. Tribe wrote an article titled The Fatal First Amendment Flaw In Prescription Restraint Statutes, to help explain the ramifications this issue could have for patients and the health care system.

Mr. Tribe notes how states such as New Hampshire, Maine, and Vermont have each “recently enacted laws generally making it a crime to transfer entirely truthful information about prescriptions with the purpose of promoting prescription drugs.” As he points out, these laws are neither to “prevent misleading drug advertising or labeling nor to protect patient privacy” because other rules already do so.

Instead, he notes that these new laws “are intended to prevent conversations between doctors and drug companies about the merits of different treatments — and are designed to do so by bottling up prescription-related information at its source in the pharmacies that fill the prescriptions.” Basically, these laws prohibit “the transfer of information in order to make it harder for drug companies to locate the doctors who would be most interested in how (not by whom) the companies' products have been used.”

Prescription Data

One of the obvious reasons academic clinicians and pharmaceutical manufacturers began using the complex data from prescriptions was for drug safety. These providers wanted to “identify unforeseen problems like drug complications and rising antibiotic resistance.” In doing so, these companies, “when presented with new and relevant information, would contact doctors who are known to prescribe certain medications in order to alert them to what has been learned.” 

Mr. Tribe also noted that pharmaceutical companies use prescriber-specific data “to help them market new and alternative therapies directly to doctors,” through a process known as detailing. Not only does the prescription history data let a company target those doctors who would most want to know about the company's products, it does so without including any private information about the patient. Doctors are not forced into meeting with detailers but, usually choose to do so “because they receive useful information about current developments.” 

What makes this data particularly useful is that “pharmaceutical companies do not themselves generate the data that detailers use to locate interested physicians.” This data comes from companies who collect the prescription drug records maintained by pharmacies throughout the country. Mr. Tribe compared this data publishing practice to the way The Wall Street Journal reports on hedge fund performance — in which the names of all investors remain anonymous, but the fund managers and the investments they make are the subject of independent evaluation. 

Ban on Data

Although the laws in New Hampshire, Maine and Vermont did not directly ban detailing, they “generally forbid data research and publishing companies from acquiring, analyzing, and providing pharmaceutical companies with such data, even when indisputably accurate, when one of the purposes of such data acquisition and dissemination may be commercial.” The laws also served to prevent “pharmaceutical companies themselves from relying on the publishers' reports as a means to tailor their marketing strategies.” 

Consequently, Mr. Tribe noted that these restrictions make “it more difficult for doctors to receive truthful information from drug companies that the states think will lead doctors to make bad prescribing decisions.” The problems with such restrictions are not offset by the rationale states use for the laws, such as cost-reduction, improved patient safety, and protecting patient privacy, because doctors are being prohibited from truthful information.

Interestingly, the problems these laws have created have been tested in court. “In New Hampshire, a trial court struck down that state's statute, but the court of appeals reversed.  In Maine, the statute has been struck down in part, a ruling that is now on appeal.  Vermont's restriction remains pending before the U.S. Court Appeals for the Second Circuit.” Mr. Tribe asserts that “these lawsuits should be easily decided in favor of holding the statutes unconstitutional.”

He reasons that the statues abridge freedom of communication and regulate speech by directly banning data researchers to publish reports of pharmaceutical relevance. As a result, Mr. Tribe uses two Supreme Court cases which affirmed the view that “obstructing access to the informational building blocks of speech is every bit as pernicious an abuse of governmental power over the free flow of information and ideas as is restricting the resulting speech itself.” 

Accordingly, he notes that the new statutes “cannot survive application of these core principles and the precedents embodying them because the transmission of the truthful pharmaceutical information itself is fully protected by the First Amendment.” Moreover, because the companies that distribute prescription history information are not proposing any commercial relationship, “their speech too warrants heightened protection because it includes extensive scientific information on matters of profound public importance.” 

The laws are also a problem and deserve strict judicial scrutiny according to Mr. Tribe because while they “try to make it harder for drug companies to contact doctors, the statutes also encourage the use of the identical information by the state itself and by health insurers to try to dissuade doctors from prescribing brand-name drugs.” Such a practice he notes has been struck down by the Supreme Court numerous times. 

Conclusion

Mr. Tribe uses the word of Supreme Court Justice Oliver Wendell Holmes to sum up his ideas precisely. Justice Holmes observed that, "the ultimate good desired is better reached by free trade in ideas," for "the best test of truth is the power of the thought to get itself accepted in the competition of the market," and "truth is the only ground upon which [peoples'] wishes can safely be carried out." 

As a result, if States have problems with detailing, they should devote their considerable “resources to loudly voicing that opposition and debating ways to regulate its supposed abuses — but not to silencing the free flow of truthful information that these new and dangerous laws target.”

Since these statutes violate the core principle that the government may not restrict even commercial communication merely to block the dissemination of truth, Mr. Tribe asserts that they should be overturned and changed. Ultimately, to think that States are better “able to make prescription drug choices than are the highly trained doctors who actually know their patients and prescribe medications for them” is a serious problem. Hopefully Mr. Tribe’s insight will show patients why.