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 11:17 AM EST, Fri December 26, 2014
Today's politicians should follow Ronald Reagan's advice and invest in science, research and development, Fareed Zakaria says.
updated 8:19 AM EST, Fri December 26, 2014
Artificial intelligence does not need to be malevolent to be catastrophically dangerous to humanity, writes Greg Scoblete.
updated 10:05 AM EST, Fri December 26, 2014
Historian Douglas Brinkley says a showing of Sony's film in Austin helped keep the city weird -- and spotlighted the heroes who stood up for free expression
updated 8:03 AM EST, Fri December 26, 2014
Tanya Odom that by calling only on women at his press conference, the President made clear why women and people of color should be more visible in boardrooms and conferences
updated 8:12 AM EST, Fri December 26, 2014
When oil spills happen, researchers are faced with the difficult choice of whether to use chemical dispersants, authors say
updated 1:33 AM EST, Thu December 25, 2014
Danny Cevallos says the legislature didn't have to get involved in regulating how people greet each other
updated 6:12 PM EST, Tue December 23, 2014
Marc Harrold suggests a way to move forward after the deaths of NYPD officers Wenjian Liu and Rafael Ramos.
updated 8:36 AM EST, Wed December 24, 2014
Simon Moya-Smith says Mah-hi-vist Goodblanket, who was killed by law enforcement officers, deserves justice.
updated 2:14 PM EST, Wed December 24, 2014
Val Lauder says that for 1,700 years, people have been debating when, and how, to celebrate Christmas
updated 3:27 PM EST, Tue December 23, 2014
Raphael Sperry says architects should change their ethics code to ban involvement in designing torture chambers
updated 10:35 PM EST, Tue December 23, 2014
Paul Callan says Sony is right to call for blocking the tweeting of private emails stolen by hackers
updated 7:57 AM EST, Tue December 23, 2014
As Christmas arrives, eyes turn naturally toward Bethlehem. But have we got our history of Christmas right? Jay Parini explores.
updated 11:29 PM EST, Mon December 22, 2014
The late Joe Cocker somehow found himself among the rock 'n' roll aristocracy who showed up in Woodstock to help administer a collective blessing upon a generation.
updated 4:15 PM EST, Tue December 23, 2014
History may not judge Obama kindly on Syria or even Iraq. But for a lame duck president, he seems to have quacking left to do, says Aaron Miller.
updated 1:11 PM EST, Tue December 23, 2014
Terrorism and WMD -- it's easy to understand why these consistently make the headlines. But small arms can be devastating too, says Rachel Stohl.
updated 1:08 PM EST, Mon December 22, 2014
Ever since "Bridge-gate" threatened to derail Chris Christie's chances for 2016, Jeb Bush has been hinting he might run. Julian Zelizer looks at why he could win.
updated 1:53 PM EST, Sat December 20, 2014
New York's decision to ban hydraulic fracturing was more about politics than good environmental policy, argues Jeremy Carl.
updated 3:19 PM EST, Sat December 20, 2014
On perhaps this year's most compelling drama, the credits have yet to roll. But we still need to learn some cyber lessons to protect America, suggest John McCain.
updated 5:39 PM EST, Mon December 22, 2014
Conservatives know easing the trade embargo with Cuba is good for America. They should just admit it, says Fareed Zakaria.
updated 8:12 PM EST, Fri December 19, 2014
We're a world away from Pakistan in geography, but not in sentiment, writes Donna Brazile.
updated 12:09 PM EST, Fri December 19, 2014
How about a world where we have murderers but no murders? The police still chase down criminals who commit murder, we have trials and justice is handed out...but no one dies.
updated 6:45 PM EST, Thu December 18, 2014
The U.S. must respond to North Korea's alleged hacking of Sony, says Christian Whiton. Failing to do so will only embolden it.
updated 4:34 PM EST, Fri December 19, 2014
President Obama has been flexing his executive muscles lately despite Democrat's losses, writes Gloria Borger
ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT