Skip to main content

Drug industry's free speech helps doctors

By David Frum, CNN Contributor
updated 2:00 PM EST, Mon December 10, 2012
Herbal and dietary supplements are subject to much less stringent regulations than pharmaceuticals, David Frum writes.
Herbal and dietary supplements are subject to much less stringent regulations than pharmaceuticals, David Frum writes.
STORY HIGHLIGHTS
  • David Frum: Court ruling may dramatically open drug companies' free speech rights
  • Drug salesman convicted of promoting uses not approved by FDA for a legal drug
  • Frum: But doctors often use drugs "off-label"; court said it's free speech to discuss
  • By trying to protect public, he says, FDA risks depriving doctors of good information

Editor's note: David Frum, a CNN contributor, is a contributing editor at Newsweek and The Daily Beast. He is the author of eight books, including a new novel "Patriots" and his post-election e-book, "Why Romney Lost." Frum was a special assistant to President George W. Bush from 2001 to 2002.

(CNN) -- Red wine in moderation has been shown to reduce the risks of heart disease. Enjoy a glass with dinner tonight.

Those words accord with the best available medical knowledge. When I write them here, I am protected by the First Amendment. If, however, a winemaker were to include those words on a wine label, that winemaker would find itself in serious legal trouble.

Fortunately, most of us have a pretty good idea of the health risks and benefits of wine. But when it comes to other important health-affecting products, we depend on doctors, and they, in turn, depend on medical researchers. The free flow of information among medical researchers is regulated very nearly as tightly as advertising by winemakers but by a different government agency: the Food and Drug Administration.

The FDA tells pharmaceutical companies what they may say about their products. Any use of the drugs must be approved by the FDA before companies can recommend that use. They are forbidden to mention anything beyond that. Up until last week anyway.

David Frum
David Frum

Last week, the U.S. Second Circuit Court of Appeals decided a case (PDF) that could that could dramatically expand the free-speech rights of pharmaceutical companies, allowing them to share unapproved information about the drugs they make.

The case involved a salesman who talked too much.

Become a fan of CNNOpinion
Stay up to date on the latest opinion, analysis and conversations through social media. Join us at Facebook/CNNOpinion and follow us @CNNOpinion on Twitter. We welcome your ideas and comments.



Alfred Caronia worked as a sales representative for Orphan Medical Inc., now called Jazz Pharmaceuticals, the company that makes Xyrem, a drug approved to treat a severe version of the sleep disorder narcolepsy. This is a rare condition, and the market for Xyrem was small, about $20 million a year in 2005.

Caronia's job was to promote the use of Xyrem to physicians. He seems not to have been very successful at it. In 2005, the federal government began an investigation into Caronia for illegally promoting the drug for uses unapproved by the Federal Drug Administration.

He was recorded saying that Xyrem could be used on patients under age 16, unapproved by the FDA. Caronia also suggested that Xyrem could be used to treat fibromyalgia, ditto unapproved. He finally suggested that the drug could be used to treat excessive daytime sleepiness, a use unapproved at the time but approved later.

Caronia and an associate were sentenced to a year's probation.

All Caronia did was to speak. One of his claims was corroborated later by the FDA itself. The FDA made no contention that any of his other claims were false or misleading. He was punished not for speaking fraudulently but for speaking without permission.

Other people are allowed to speak about off-label use of drugs. If you take aspirin for your heart, but have not had a previous heart attack, you are engaged in an off-label use of drugs right now: FDA-approved labels only mention aspirin as a remedy against recurrent heart trouble. Yet many doctors recommend aspirin as a prophylactic for everyone at risk of heart disease.

Doctors freely debate this issue. So do many laypeople. The only people forbidden to join the discussion are the companies who actually make aspirin.

Caronia's words became a crime only because he happened to be an employee of the company that made Xyrem. How, Caronia and his employer asked, can that be constitutional?

On December 3, a 2-to-1 majority of the Second Circuit agreed with Caronia and Jazz: It's not.

The court said, "the government cannot prosecute pharmaceutical manufacturers and their representatives ... for speech promoting the lawful, off-label use of an FDA-approved drug."

This is big, big news for the drug industry.

The ban on discussion of "off-label" uses of medicine is based on a binary vision of how medicines operate. In this vision, any potential use of a drug is either "safe and effective" or not "safe and effective." Until the FDA says yes, the answer must be no.

The trouble is, that vision does not describe the real world very well. Rather than fit into clearly defined categories of "effective" or "not effective," the value of drugs often blurs across a spectrum.

A friend who thinks profoundly about these issues calls pharmaceuticals "useful poisons." They always come with harms attached. The harms and benefits are always uncertain. For example, FDA-approved advertising will recommend aspirin only for those who have had one heart attack already, but many doctors recommend aspirin prophylactically for people at risk for a first attack.

The FDA applies bright line rules, backed by criminal penalties, to an area of science where the lines are not bright at all.

There's no mystery to the evil FDA seeks to prevent. It's well-described by the dissent in the Caronia case.

"Hardware stores are generally free to sell bottles of turpentine, but may not label those bottles, 'Hamlin's Wizard Oil: There is no Sore it will Not Heal; No Pain it will not Subdue,' " the judge wrote. Hamlin's Wizard Oil was one of the very first products shut down by the Food and Drug Act in the early 20th century.

But in trying to protect the public from flim-flam, the FDA also risks depriving doctors of early notice of information that could treat and cure their patients.

The irony is that the law allows "all-natural food supplements" to make all kinds of wild promises: They're subject to a different and much more permissive regulatory scheme. You'll hear radio ads for "supplements" that tout these products as "so effective, clinical trials have already begun." Yet for pharmaceutical products, even the news that a clinical trial has been completed was, until this week, forbidden speech unless the FDA gave the word.

That rule has abruptly changed. You're going to hear more talk about what scientists think medicines might be able to do. Where the side effects of a medicine are high, and where good alternatives are available, doctors and patients will want to exercise caution until the final experiments conclude. But where alternatives do not exist, where something is better than nothing, the Caronia ruling offers hope for a more transparent drug-approval regime.

Nothing is certain until the Supreme Court weighs in. But it's looking likelier that freer speech is coming to American medicine.

Follow us on Twitter @CNNOpinion.

Join us on Facebook/CNNOpinion.

The opinions in this commentary are solely those of David Frum.

ADVERTISEMENT
Part of complete coverage on
updated 6:10 PM EST, Mon November 24, 2014
If Obama thinks pushing out Hagel will be seen as the housecleaning many have eyed for his national security process, he'll be disappointed, says David Rothkopf.
updated 8:11 AM EST, Tue November 25, 2014
The decision by the St. Louis County prosecuting attorney to announce the Ferguson grand jury decision at night was dangerous, says Jeff Toobin.
updated 3:57 AM EST, Tue November 25, 2014
China's influence in Latin America is nothing new. Beijing has a voracious appetite for natural resources and deep pockets, says Frida Ghitis.
updated 4:51 PM EST, Mon November 24, 2014
Iranian President Hassan Rouhani speaks during a press conference in the capital Tehran on June 14, 2014.
The decision to extend the deadline for talks over Iran's nuclear program doesn't change Tehran's dubious history on the issue, writes Michael Rubin.
updated 2:25 PM EST, Fri November 21, 2014
Maria Cardona says Republicans should appreciate President Obama's executive action on immigration.
updated 7:44 AM EST, Fri November 21, 2014
Van Jones says the Hunger Games is a more sweeping critique of wealth inequality than Elizabeth Warren's speech.
updated 6:29 PM EST, Thu November 20, 2014
obama immigration
David Gergen: It's deeply troubling to grant legal safe haven to unauthorized immigrants by executive order.
updated 8:34 PM EST, Thu November 20, 2014
Charles Kaiser recalls a four-hour lunch that offered insight into the famed director's genius.
updated 3:12 PM EST, Thu November 20, 2014
The plan by President Obama to provide legal status to millions of undocumented adults living in the U.S. leaves Republicans in a political quandary.
updated 10:13 PM EST, Thu November 20, 2014
Despite criticism from those on the right, Obama's expected immigration plans won't make much difference to deportation numbers, says Ruben Navarette.
updated 8:21 PM EST, Thu November 20, 2014
As new information and accusers against Bill Cosby are brought to light, we are reminded of an unshakable feature of American life: rape culture.
updated 5:56 PM EST, Thu November 20, 2014
When black people protest against police violence in Ferguson, Missouri, they're thought of as a "mob."
updated 3:11 PM EST, Wed November 19, 2014
Lost in much of the coverage of ISIS brutality is how successful the group has been at attracting other groups, says Peter Bergen.
updated 8:45 AM EST, Wed November 19, 2014
Do recent developments mean that full legalization of pot is inevitable? Not necessarily, but one would hope so, says Jeffrey Miron.
updated 8:19 AM EST, Wed November 19, 2014
We don't know what Bill Cosby did or did not do, but these allegations should not be easily dismissed, says Leslie Morgan Steiner.
updated 10:19 AM EST, Wed November 19, 2014
Does Palestinian leader Mahmoud Abbas have the influence to bring stability to Jerusalem?
updated 12:59 PM EST, Wed November 19, 2014
Even though there are far fewer people being stopped, does continued use of "broken windows" strategy mean minorities are still the target of undue police enforcement?
updated 9:58 PM EST, Mon November 17, 2014
The truth is, we ran away from the best progressive persuasion voice in our times because the ghost of our country's original sin still haunts us, writes Cornell Belcher.
updated 4:41 PM EST, Tue November 18, 2014
Children living in the Syrian city of Aleppo watch the sky. Not for signs of winter's approach, although the cold winds are already blowing, but for barrel bombs.
updated 8:21 AM EST, Mon November 17, 2014
We're stuck in a kind of Middle East Bermuda Triangle where messy outcomes are more likely than neat solutions, says Aaron David Miller.
updated 7:16 AM EST, Mon November 17, 2014
In the midst of the fight against Islamist rebels seeking to turn the clock back, a Kurdish region in Syria has approved a law ordering equality for women. Take that, ISIS!
updated 11:07 PM EST, Sun November 16, 2014
Ruben Navarrette says President Obama would be justified in acting on his own to limit deportations
ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT