[corp-focus] The First Amendment Gone Wild: Big Pharma's "Right" to Find Out What Doctors Are Prescribing

robert weissman rob@essential.org
Thu, 10 Jan 2008 15:51:03 -0500


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The First Amendment Gone Wild: Big Pharma's "Right" to Find Out What 
Doctors Are Prescribing
By Robert Weissman
January 10, 2008

The founders of the United States took the First Amendment to the U.S. 
Constitution and the concepts of free speech and freedom of conscience 
very seriously.

"Whoever would overthrow the liberty of a nation must begin by subduing 
the freeness of speech," said Benjamin Franklin.

"Information is the currency of democracy," intoned Thomas Jefferson -- 
one of countless Jefferson odes to the central importance of ideas and 
free transmission of information in fostering a working democracy.

But could they possibly have imagined the twisted purposes to which the 
First Amendment is put today?

Two crucial developments in U.S. constitutional jurisprudence -- the 
grant of Bill of Rights protections to corporations, and the extension 
of First Amendment protections to commercial speech -- have enabled 
corporations to invoke the First Amendment to defend their right to hawk 
goods, so long as they are legal, by almost any means short of outright 
lying or clear deception.

Now corporations are suggesting the First Amendment should effectively 
immunize them from government-imposed rules related to the simple 
commercial exchange of information.

This new expansion of the First Amendment to block broad public 
regulatory powers emerges from efforts in New England to control one of 
the most insidious pharmaceutical marketing practices.

Anyone who watches television in the United States, or reads magazines, 
is familiar with drug company advertisements to consumers. But these 
represent a relatively small fraction of industry marketing expenditures.

Drug companies devote much more money, and time, to influencing those 
with the power to prescribe medicines -- as much as $34 billion in the 
United States, more than eight times what is spent on direct-to-consumer 
marketing.

The most important element of the marketing onslaught directed at 
doctors is "detailing" -- the activities of the sales representatives 
who visit doctors constantly, and provide free lunches, free pens, free 
charts and other free goodies (including, very importantly, free 
samples). The average primary care physician sees drug detailers more 
than five times a day.

When a sales rep walks into a doctors office, he or she knows a lot 
about that doctor -- including exactly what medicines the doctor 
prescribes, and in what quantities. How can this be?

Pharmaceutical companies purchase the information from data-mining 
companies, the largest of which is IMS Health. Pharmacies track what 
drug is sold to each customer. IMS buys the data from the pharmacies, 
deletes all patient names, combines it with data that enables the 
identification of prescribers for each prescription, and aggregates the 
information.

Then, when the drug company representatives cheerfully bound in to a 
doctor's office, they know exactly what the doctor is prescribing. They 
know if the doctor prescribes a lot of medicine or a little (drug 
company reps rate the doctors on a scale of 1-10, or A-F), and whether 
they go for the rep's company's product or a competitor's or a generic. 
They know where to focus their efforts, and how to frame their sales 
pitches.

And, as the New York Times explained, quoting an e-mail message from a 
pharmaceutical executive to company salespeople, they use the data to 
"hold [doctors] accountable for all the time, samples, lunches, dinners, 
programs and past preceptorships that you have paid for and get the 
business!" The sales reps obviously do not have punitive power over the 
doctors, but they use the prescribing information to exploit and 
manipulate the social ties built on the giving relationship.

Neither doctors nor patients consent to this use of prescribing data, 
and only a tiny few even know about it.

New Hampshire decided to ban this use of the data in 2006. Vermont and 
Maine followed with similar laws.

IMS sued to block implementation of the laws, and won at the U.S. 
district court level. Judges agreed with IMS that the New Hampshire and 
Maine laws violate the company's claimed First Amendment rights.

The New Hampshire law permits IMS and other data miners to continue to 
collect prescription data, but they can't use individualized data -- 
information about specific doctors' prescribing practices -- for 
commercial purposes.

The law is a "speech restriction because it limits both the use and 
disclosure of prescriber-identifiable data for commercial purposes," 
District Judge Paul Barbadoro found in the New Hampshire case.

This was a misguided determination, challenged by the State of New 
Hampshire in an appeal argued before the First Circuit Court of Appeals 
yesterday. Leave aside the merits of providing First Amendment 
protections to corporations, or to commercial speech. Nothing about the 
New Hampshire law impinges on the expressive values that the First 
Amendment is intended to protect.

Contends Sean Flynn, the lead attorney for a coalition of public 
interest organizations supporting the New Hampshire law, "This case is 
not about speech, it is about industry surveillance of the 
doctor-patient relationship. New Hampshire acted through its data-mining 
law to safeguard that relationship, and the public health, by protecting 
it from industry surveillance and manipulation."

Flynn says that if the district court's ruling is upheld, and the 
principle of commercial speech protections is extended to cover any 
commercial exchange of text or data, then a host of existing laws are 
vulnerable to constitutional challenge. These include laws to protect 
consumer privacy and to mandate disclosure of financial information 
related to securities transactions.

It is very hard to defend government regulations determined to restrict 
commercial speech. Under Supreme Court rulings, judges must assess 
whether a commercial speech restriction advances a substantial 
governmental interest, directly advances the interest and is no more 
limiting of speech than necessary. In a case like New Hampshire's 
pharmaceutical data-mining restrictions, the test effectively requires 
the judge to closely scrutinize a government regulation and decide if it 
is both a good idea, and the best possible and least speech-restrictive 
way of achieving a desired ends. It gives the judge unwarranted 
authority -- comparable, as former Justice Rehnquist noted, to the 
discredited turn-of-the-20th-century Lochner authority to strike down 
economic regulations -- and makes it very hard to uphold a challenged 
regulation.

In applying the test, Judge Barbadoro knocked down the New Hampshire law 
on numerous grounds. There was no legitimate privacy interest involved, 
he found, especially since there is no evidence of drug sales reps 
harassing doctors. Pharmaceutical detailing may result in more 
brand-name and fewer generic drugs being prescribed, at greater expense, 
but there is no evidence that prescriber data "is being used to 
propagate false or misleading marketing messages." And, he found, there 
are other ways the State could aim to curb drug company gifts, counter 
detailers' messages and educate doctors, and aim to promote greater use 
of generic drugs.

Just to list the judge's findings is to show how much inappropriate 
power the commercial speech test confers on judges in a case like this.

Will the appeals court agree with Judge Barbadoro? We'll know in a few 
months.

Could Thomas Jefferson and his contemporaries have imagined the First 
Amendment being deployed for such purposes?

The world has obviously changed in the last 200-plus years, and 
Jefferson could not have envisioned even the existence of the modern 
pharmaceutical industry. But he did understand the threat that 
corporations posed to a working democracy.

"I hope that we shall crush in its birth the aristocracy of our monied 
corporations, which dare already to challenge our government to a trial 
of strength, and bid defiance to the laws of our country," he wrote.


Robert Weissman is editor of the Washington, D.C.-based Multinational 
Monitor, <http://www.multinationalmonitor.org> and director of Essential 
Action <http://www.essentialaction.org>.

(c) Robert Weissman

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