Ethical Virus

Ethical drugs

It May be Legal, but is it Ethical to Advertise Prescription Drugs for Off-label Use?
I couldn't believe my eyes when I saw the headline that read: "FDA considers loosening rule on (prescription drug) ads." Loosening the rule? How about tightening the rule? Or better yet, how about a total or at least temporary ban on direct to consumer prescription drug advertising. A ban on DTCA is what the AMA would like to see. And, the rest of the world disallows DTCA; there are only two exceptions — the United States and New Zealand (population 4 million) that allow direct to consumer prescription drug advertising.
In the early 1980s DTCA wasn't even allowed in the U.S., but then it slowly began to appear but in a very convoluted manner. An advertiser could mention the name of a drug, but not mention what the drug was used for, or the advertisement could describe what the drug was to be used for, but couldn't name the drug. When the allergy medication Claritin was the only prescription drug of its kind (it's no longer a prescription drug), the ads talked generally about suffering from allergies, and the commercial suggested that consumers visit their doctor, but it never mentioned Claritin by name. As Claritin was the only option, doctors would automatically know what the patient was talking about when they asked about allergy medication.
In 1997 the rules were changed so that the advertiser could mention both the name of the drug and the condition it was suppose to treat, but the ad also had to include the contraindications. The FDA referred to this as fair balance. In the case of a TV ad where the list of contraindications would be too long to fit in a 30 second commercial, the advertiser had to include a 1–800 number and website address where consumers could obtain additional information. Opening up the regulations led to a corresponding run-up of advertising expenditures that peaked around 2007 — the start of the economic downturn — at $4.9 billion.
Off label refers to the use of a drug to treat an ailment or condition for which it has not received FDA approval.
Now the FDA is apparently about to extend the reach of pharmaceutical marketers by allowing them to advertise prescription drugs for "off label" uses. Off label refers to the use of a drug to treat an ailment or condition for which it has not received FDA approval. You read that correctly: advertising prescription medications for uses that have not been approved. To be fair, doctors are already prescribing drugs for off label use, but to allow such uses to be promoted? Come now. The rationale for the change in policy is that 20% of prescriptions written by physicians are already off-label. But it seems to me that it's a pretty long leap from what doctors and patients discuss during an office visit over a pretty wide chasm to promoting drugs through television and magazines for uses for which the drugs have not been approved. This is, in this writer's opinion, nothing more than a power struggle between the authority of the prescribing physician and drug manufacturers promoting their products.
off-label marketing is protected free speech as long as the information in the ads is truthful and not misleading
The impetus for this change in regulation comes not from the FDA; the pharmaceutical industry is pushing for this change, as two court cases make this a first amendment issue. The plaintiffs in those cases argued that off-label marketing is protected free speech as long as the information in the ads is truthful and not misleading. In other words, the courts determined that the pharmaceutical industry has the same right to free speech as any other individual or corporation. Advertising is partially protected under the first amendment based on the FTC regulation regarding false and deceptive advertising.
Although not an example of off label advertising, campaigns like the one for Xarelto are indicative of the controversy surrounding direct to consumer prescription drug advertising. Perhaps you've seen the advertisements for Xarelto featuring several celebrities including basketball player Chris Bosh, comedian Kevin Nealon and the recently deceased golfer Arnold Palmer. It's worth noting that in 2015 $106 million was spent on advertising for this drug that is made by Bayer and marketed in the U.S. by Janssen Pharmaceuticals, a division of Johnson & Johnson. The advertisement included references to the use of Xarelto for nonvalvular atrial fibrillation. And, it included additional references to the drug's ability to treat deep vein thrombosis and treatment of pulmonary embolisms. This is a drug that generates over a billion dollars in revenue, so there is a lot at stake. Although the drug continues to be widely advertised, there have been several thousand lawsuits levied against the manufacturer. The commercial more recently, however, has been modified — the message now delivered by basketball great Jerry West focuses solely on treating atrial fibrillation.
If the FDA's regulations are changed to allow for advertising of off- label use of prescriptions drugs, we can anticipate that the floodgates will open.
The pharmaceutical industry spent $5 billion on advertising this past year, and more than that on sales and marketing of prescription drugs. If the FDA's regulations are changed to allow for advertising of off- label use of prescriptions drugs, we can anticipate that the floodgates will open. In other words, advertising, sales and promotion expenditures will increase significantly.
Of what possible benefit could such advertising provide? Would we expect a cancer patient, for example, who sees an advertisement for an off label use of a cancer drug to call her or his doctor to discuss the medication or simply request or perhaps demand the medication? Are such advertisements for information purposes only? Advertising doesn't work that way. Advertising is not neutral; it is inherently persuasive, and that persuasion is exacerbated by the use of celebrities hawking drugs.
There are three major stakeholders in this struggle: the government agency that regulates drugs, the pharmaceutical industry and consumers. What is at stake for the government is the central role that the FDA plays in keeping patients who need medications safe. For the pharmaceutical industry a significant amount of money is at stake. But just because it may become legal to advertise prescription drugs for off label purposes, does it make it ethical? As for consumers: they are only a pawn in their plans