Skip to main content

Drug industry's free speech helps doctors

By David Frum, CNN Contributor
December 10, 2012 -- Updated 1900 GMT (0300 HKT)
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
September 1, 2014 -- Updated 1221 GMT (2021 HKT)
Carlos Moreno says atheists, a sizable fraction of Americans, deserve representation in Congress.
August 31, 2014 -- Updated 1625 GMT (0025 HKT)
Julian Zelizer says Democrats and unions have a long history of mutual support that's on the decline. But in a time of income inequality they need each other more than ever
August 31, 2014 -- Updated 0423 GMT (1223 HKT)
William McRaven
Peter Bergen says Admiral William McRaven leaves the military with a legacy of strategic thinking about special operations
August 29, 2014 -- Updated 1611 GMT (0011 HKT)
Leon Aron says the U.S. and Europe can help get Russia out of Ukraine by helping Ukraine win its just war, sharing defense technologies and intelligence
August 29, 2014 -- Updated 1724 GMT (0124 HKT)
Timothy Stanley the report on widespread child abuse in a British town reveals an institutional betrayal by police, social services and politicians. Negligent officials must face justice
August 30, 2014 -- Updated 0106 GMT (0906 HKT)
Peter Bergen and David Sterman say a new video of an American suicide bomber shows how Turkey's militant networks are key to jihadists' movement into Syria and Iraq. Turkey must stem the flow
September 1, 2014 -- Updated 1554 GMT (2354 HKT)
Whitney Barkley says many for-profit colleges deceive students, charge exorbitant tuitions and make false promises
August 29, 2014 -- Updated 1434 GMT (2234 HKT)
Mark O'Mara says the time has come to decide whether we really want police empowered to shoot those they believe are 'fleeing felons'
August 28, 2014 -- Updated 1432 GMT (2232 HKT)
Bill Frelick says a tool of rights workers is 'naming and shaming,' ensuring accountability for human rights crimes in conflicts. But what if wrongdoers know no shame?
August 29, 2014 -- Updated 0243 GMT (1043 HKT)
Jay Parini says, no, a little girl shouldn't fire an Uzi, but none of should have easy access to guns: The Second Amendment was not written to give us such a 'right,' no matter what the NRA says
August 30, 2014 -- Updated 1722 GMT (0122 HKT)
Terra Ziporyn Snider says many adolescents suffer chronic sleep deprivation, which can indeed lead to safety problems. Would starting school an hour later be so wrong?
August 29, 2014 -- Updated 1330 GMT (2130 HKT)
Peggy Drexler says after all the celebrity divorces, it's tempting to ask the question. But there are still considerable benefits to getting hitched
August 29, 2014 -- Updated 1849 GMT (0249 HKT)
The death of Douglas McAuthur McCain, the first American killed fighting for ISIS, highlights the pull of Syria's war for Western jihadists, writes Peter Bergen.
August 26, 2014 -- Updated 2242 GMT (0642 HKT)
Former ambassador to Syria Robert Ford says the West should be helping moderates in the Syrian armed opposition end the al-Assad regime and form a government to focus on driving ISIS out
August 27, 2014 -- Updated 1321 GMT (2121 HKT)
Ruben Navarrette says a great country does not deport thousands of vulnerable, unaccompanied minors who fled in fear for their lives
August 27, 2014 -- Updated 1319 GMT (2119 HKT)
Robert McIntyre says Congress is the culprit for letting Burger King pay lower taxes after merging with Tim Hortons.
August 26, 2014 -- Updated 2335 GMT (0735 HKT)
Wesley Clark says the U.S. can offer support to its Islamic friends in the region most threatened by ISIS, but it can't fight their war
August 26, 2014 -- Updated 2053 GMT (0453 HKT)
America's painful struggle with racism has often brought great satisfaction to the country's rivals, critics, and foes. The killing of Michael Brown and its tumultuous aftermath has been a bonanza.
August 26, 2014 -- Updated 1919 GMT (0319 HKT)
Rick Martin says the death of Robin Williams brought back memories of his own battle facing down depression as a young man
August 26, 2014 -- Updated 1558 GMT (2358 HKT)
David Perry asks: What's the best way for police officers to handle people with psychiatric disabilities?
August 25, 2014 -- Updated 1950 GMT (0350 HKT)
Julian Zelizer says it's not crazy to think Mitt Romney would be able to end up at the top of the GOP ticket in 2016
August 25, 2014 -- Updated 2052 GMT (0452 HKT)
Roxanne Jones and her girlfriends would cheer from the sidelines for the boys playing Little League. But they really wanted to play. Now Mo'ne Davis shows the world that girls really can throw.
August 25, 2014 -- Updated 2104 GMT (0504 HKT)
Kimberly Norwood is a black mom who lives in an affluent neighborhood not far from Ferguson, but she has the same fears for her children as people in that troubled town do
August 22, 2014 -- Updated 2145 GMT (0545 HKT)
It apparently has worked for France, say Peter Bergen and Emily Schneider, but carries uncomfortable risks. When it comes to kidnappings, nations face grim options.
ADVERTISEMENT