Officials Swallow Industry Claims
Antidepressants are back in the news, with Americans, as usual, being tormented by contradictory messages about the drugs, now prescribed to more than 10 million children and adolescents annually, largely without FDA approval.
Early this month, the National Institute of Mental Health issued a study showing that one member of the family of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, was effective for treating adolescent depression.
That was comforting.
The next day, the attorney general of New York sued GlaxoSmithKline, the maker of another SSRI, Paxil, for fraud, saying the firm had covered up unappealing safety problems in kids who took the medication, including some who had experienced suicidal thoughts or committed suicidal acts.
That wasn’t so comforting.
The reasons behind these conflicting messages can and do fill millions of pages of legal briefs and clinical trial reports, with varying levels of clarity and veracity in both domains. But on the wider question -- how did it become so easy for a drug firm to promote its wares for unapproved uses? -- the answer is stunningly clear: Drug companies now enjoy the same license to promote their products that the food, beverage and, until recently, tobacco industries have enjoyed for decades. And for that we have two institutions to thank: the Supreme Court and the Food and Drug Administration.
Liberals and consumer activists might be surprised to learn that a series of court cases initiated by Ralph Nader in the 1970s gave rise to today’s reigning legal notions about commercial speech, which supply the legal framework for such things as off-label promotion of drugs (the marketing to doctors of medications for uses other than those approved by the FDA) and direct-to-consumer advertising of prescription drugs.
In a 1976 case known as Virginia State Board of Pharmacy, Nader’s attorneys argued that consumers were entitled to information about drug prices -- to be able to shop for the best price -- and that state laws that barred pharmacy advertising violated “the consumer’s right to know.”
Except for Justice William H. Rehnquist, the court agreed, establishing the consumer’s right to know, or, more broadly, the listener’s “right to hear” all information, commercial or political.
The doctrine slowly worked its way through business and regulatory agencies, but the FDA was still able to retain its control over claims made for a drug’s safety and efficacy. And, under that umbrella, the agency fiercely protected its ability to regulate off-label promotion. The practice was -- and still is -- illegal, but what is and isn’t legal has gotten murkier.
Should a drug company be able to distribute, via highly trained and restrained medical affairs people, studies showing that a drug approved for one purpose also “seems” to help kids with, say, end-stage brain cancer, an unapproved use? The average consumer would probably say yes. But the waters quickly get muddier. Should a drug company be allowed, as has been the case with antidepressants, to dispatch tens of thousands of young, barely trained sales reps, most just out of college, to give general practitioners -- many with no experience in psychiatric medications -- studies that “suggest” that adult antidepressants “might” help kids with depression? The FDA’s traditional response was to come down hard on the latter but not on the former, and most of us would be likely to agree with that inclination.
But beginning in the early 1990s, a new generation of legal activists, many working for the broadcast and advertising industries, instituted a wave of commercial speech cases, which, though not specifically aimed at curtailing the FDA’s power to regulate off-label promotion, had that effect.
One such case took aim at a Rhode Island law that prohibited advertising the price of liquor except at the point of purchase. Arguing a strict constructionist theory in front of an increasingly conservative, strict constructionist court, conservative activist attorney Daniel E. Troy, who once clerked for Judge Robert Bork, focused on the intentions of the founding fathers when it came to the 1st Amendment and advertising. Citing a range of colonial newspapers, their publishers and leading Revolutionary War-era thinkers, including Benjamin Franklin, Troy told the court that “colonial Americans plainly viewed the freedom of speech as protecting far more than just political speech.”
This lack of distinction between commercial and political speech was important because most colonial newspapers were primarily vehicles for advertising, hardly the impartial beacons that modern papers are expected to be, but Troy did not dwell on that technicality. Instead, he told the court that “there is no evidence on the other side -- nothing at all -- to suggest that, as an original matter, commercial messages should be treated differently from other types of messages.”
The court was unanimous in striking down the Rhode Island law, with Justice Antonin Scalia writing about his “aversion toward paternalistic governmental policies that prevent men and women from hearing facts that might not be good for them.”
In 1999, the same doctrine was invoked in another action, this one in a district court case specifically involving off-label promotion of prescription drugs. The case had been brought by the conservative Washington Legal Foundation, which was partly funded by advertising trade groups. In this case, Troy, working beside attorneys for the foundation, argued the same line, but the key to the win was the anti-paternalism argument.
The government “cannot justify a restriction of truthful, non-misleading speech on the paternalistic assumption that such restriction is necessary to protect the listener from ignorantly or inadvertently misusing the information,” the court wrote. With that ruling, the “consumer’s right to know” -- Nader’s great triumph of the 1970s -- became the corporation’s right to “subtly encourage.”
The FDA’s response was to embrace the decision. Soon, advocating the regulation of anything but the most over-the-top and misleading drug promotion activity was viewed, internally, as a career-killing move. The Division of Drug Marketing, Advertising and Communications, the tiny department charged with such regulation, was routinely underfunded and rife with institutional second-guessing. This year, a congressional report found that in 2003 the division issued drug makers 75% fewer warning letters, its chief enforcement device, than during the last two years of the Clinton administration. Even the pharmaceuticals trade press was stunned by the change, noting in one headline that “most medical promotion is out of sight of regulators.”
The FDA’s tolerance of drug company product promotion reached new heights under Bush appointee Mark McClellan, until March the agency’s chief. McClellan made clear to the pharmaceutical industry immediately after his appointment that he intended to change the FDA’s image. Under him, that image morphed from one of a tough, independent-minded regulatory body to a partner in nurturing pharmaceutical innovation. On the January 2004 cover of Medical Marketing & Media, for example, then-Commissioner McClellan could be found with Peter Pitts, his new public affairs director, alongside the headline, “We won’t bite.”
In an interview inside the magazine, Pitts bragged about how he had welcomed visiting drug representatives, even offering to edit advertising and communication proposals before the agency. Pitts and McClellan have since been ubiquitous on the (unpaid) pharmaceuticals industry speakers’ circuits, appearing at marketing confabs that promise to teach attendees things like “how to push the promotional envelope.” (McClellan is probably less desired nowadays because he has ended his once-virulent anti-imports stance since being named head of the Medicare agency.)
But even if a new commissioner decides to again get tough on off-label promotions, the agency would seem to have little leeway left to regulate commercial speech unless it’s demonstrably false. And the agency’s chief legal counsel is unlikely to push the envelope because the FDA’s top lawyer is now ... Dan Troy.
Will the responsibility of public life reshape Troy’s thinking? Apparently not. One of his first acts in office was to file a “friend of the court” brief in two legal cases involving antidepressants. In both, he entered on the side of the industry.
