A confidential letter sent by top Amarin executives to doctors clearly demonstrates that the primary motive for the lawsuit the company filed yesterday against the FDA has far more to do with marketing than free speech. Amarin said it is suing the FDA to gain the right to disseminate information about Vascepa that would support use of the drug beyond its current highly restricted FDA-approved indication (see reports in Forbes, the New York Times, and the Wall Street Journal.)
“It’s a First Amendment case,” said Floyd Abrams in the Forbes article. Abrams is the highly distinguished lawyer who is representing Amarin. His presence lends gravity to Amarin's case. “It’s a case which challenges the ability and the power of the FDA to limit speech and potentially punish it notwithstanding that the speech is both important in nature and has every aim of serving the public."
But free speech, in the corporate world in general and the pharmaceutical industry in particular, means something quite different from what our country's founding fathers might have imagined. In this world, "free" speech is paid for, often handsomely, and the companies and people who pay out the money maintain exquisite control over that "free" speech.
At the same time Amarin announced that it had filed its lawsuit it sent a confidential letter (reprinted at the bottom of this story) to physicians who serve on its speakers' bureau and who are paid to speak to other physicians on behalf of the company. Every company has a similar program for its drugs. (See ProPublica's Dollars For Docs series for much more about this phenomenon.)
The Amarin letter makes clear that physicians who speak on behalf of Amarin do not have free speech. They must adhere to the strict guidelines of the company. Many of these guidelines are in place to make sure that the talks fall within what the FDA permits the company to say, but many of the talking points represent the company's best efforts to spin the available data and literature. There is no attempt to present a balanced position representing the views of the company's critics, for instance.
Much of the letter won't come as a surprise to industry observers. We've known for a long time that this sort of thing goes on all the time. But look at this one key sentence toward the end of the letter. It is crystal clear that in this lawsuit free speech is being used solely as a pretext to allow the company to expand its marketing efforts:
If we receive a judgement in our favor, we will move rapidly to deliver to you additional Company-approved training and updated promotional speaker materials related to the court’s interpretation of free speech related to the ANCHOR results.
Amarin's notion of the first amendment protects and enhances the free speech of corporations but severely limits the speech of individual people.
If you're a big fan of the Supreme Court's Citizens United decision then you'll probably support Amarin's lawsuit. Similarly, if you think the marketplace for vitamins and supplements is a great example of how free speech about health products should work in a capitalist society then you will also probably agree with Amarin's suit.
But if you think there's a difference between marketing and free speech then you probably won't support Amarin's suit. Or you might have a problem with it if you think that the right of free speech doesn't necessarily mean that companies and wealthy individuals should be free to purchase megaphones so loud that they drown out all other voices.
Here's the complete text of the letter sent to physicians who are Amarin speakers:
Also on Forbes:
