Business of Endocrinology

Off-label promotion and use of drugs in ‘Wonderland’

It was another trip down the rabbit hole. It occurred at a law school when I was attending a conference about pharmaceutical marketing.

Half the conference was spent debating the meaning of “freedom of speech” in the First Amendment and how the concept applied to the promotion and use of pharmaceutical drugs. A law professor argued that freedom of speech doesn’t mean “freedom of speech,” especially when applied to pharmaceutical companies. His arguments were clear, concise and to the point. They only lacked in common sense.

Off-label conversations

In the realm of medicine, the current interpretation of laws involving freedom of speech, instead of promoting free speech, is actually stifling it. Over the last 25 years, scientific discourse has stopped in its tracks. I remember attending medical presentations in the past when listeners could ask speakers any question that interested them, and the speaker could give his honest feedback. Each would learn from the other. I remember more than once a speaker saying, “That is a good point you raise. When I return to the lab I will look into it further.” This is how science advances.

Richard O. Dolinar

But not today. Now one must differentiate between types of presentations and the questions that can be answered at them. At a “promotional” presentation, only “on-label” questions can be answered in front of the audience. Questions about off-label use of drugs are to be addressed after the presentation is over, if at all.

I once attended a presentation on lipids given by a nationally known lipidologist. When I asked what he recommended for patients who are statin intolerant and have high LDL levels, he replied that he would not be able to answer due to the non-branded format of the talk. The answer would have to wait until another time. I assume he knew the answer to my question — after all, he was the authority on lipids — but he was restrained by regulations governing continuing medical education. Drug companies might err on the side of policing their own behavior even beyond what regulations mandate to avoid legal scrutiny.

Scientific discourse suffered that day. In situations in which questions about off-label use of drugs cannot be answered, speakers have been instructed to take the questioner off to the side for a private conversation. Some speakers have even been told that if more than one listener has the same question, each listener is to be addressed individually, away from the others. But if answering the question is beneficial to one person, would it not be beneficial to others in the audience?

Off-label practices

Another example of problems involving off-label use was brought up at the conference. A neurologist explained how years ago a drug was developed and received FDA approval for the treatment of narcolepsy. Then over the years, the drug was modified and improved and is currently used to effectively treat narcolepsy. The new iterations of the drug had to go through the FDA approval process. Some, but not all, of the previous indications for the drug were applied for. The indication for narcolepsy was not included. Thus, the new drug is being used off-label when it is used to treat narcolepsy. The old drug is no longer being manufactured since it has been replaced by the newer one. But now when a neurologist treats narcolepsy with the new drug, insurance companies refuse to pay for it because its use in narcolepsy is off-label and, thus, not indicated.

Over the years, the FDA has taken an increasingly aggressive approach to the marketing of pharmaceutical drugs. Any statements made about off-label use by the company or its representatives, such as physicians in its speakers’ bureau, can result in draconian financial loses. This can occur even though it is well recognized in the medical community and is acknowledged by the FDA that off-label use of drugs can not only be beneficial, as for example, in pediatrics and oncology, but is the standard of care in some cases. Not to use the drugs off-label can be malpractice. Yet, some of the settlements involving off-label promotion of pharmaceutical drugs have involved billions of dollars. GlaxoSmithKline paid $3 billion in its settlement alleging off-label promotion of Wellbutrin and Paxil. Abbott Laboratories paid $1.5 billion for off-label promotion of Depakote. Other companies have paid lesser but still huge sums, as for example, Amgen at more than $700 million for Aranesp off-label promotion.

Legal paradox

What irony. It is legal for physicians to use drugs off-label, but it is not legal for pharmaceutical companies to promote or even discuss their safe, effective off-label use. Thus, the action is legal, but promoting it is not. But who knows more about the drug and is in a better position to talk about it than the company that actually discovered it?

In regard to this, the 7th U.S. Circuit Court of Appeals has opined, “If a given use is lawful, and thus can be written about freely in newspapers and blogs, and discussed among hospitals … doesn’t it make good sense to allow speech by the manufacturer, which after all will have the best information? Why privilege speech by the uninformed?”

Are we so far down the rabbit hole that freedom of speech is dead, and telling the truth can be breaking the law?

Reference:
For more information:
  • Richard O. Dolinar, MD, is an Endocrine Today Editorial Board member and a senior fellow in health care policy at the Heartland Institute. He can be reached at rdolinar@heartland.org. He reports various financial relationships with multiple pharmaceutical companies.

It was another trip down the rabbit hole. It occurred at a law school when I was attending a conference about pharmaceutical marketing.

Half the conference was spent debating the meaning of “freedom of speech” in the First Amendment and how the concept applied to the promotion and use of pharmaceutical drugs. A law professor argued that freedom of speech doesn’t mean “freedom of speech,” especially when applied to pharmaceutical companies. His arguments were clear, concise and to the point. They only lacked in common sense.

Off-label conversations

In the realm of medicine, the current interpretation of laws involving freedom of speech, instead of promoting free speech, is actually stifling it. Over the last 25 years, scientific discourse has stopped in its tracks. I remember attending medical presentations in the past when listeners could ask speakers any question that interested them, and the speaker could give his honest feedback. Each would learn from the other. I remember more than once a speaker saying, “That is a good point you raise. When I return to the lab I will look into it further.” This is how science advances.

Richard O. Dolinar

But not today. Now one must differentiate between types of presentations and the questions that can be answered at them. At a “promotional” presentation, only “on-label” questions can be answered in front of the audience. Questions about off-label use of drugs are to be addressed after the presentation is over, if at all.

I once attended a presentation on lipids given by a nationally known lipidologist. When I asked what he recommended for patients who are statin intolerant and have high LDL levels, he replied that he would not be able to answer due to the non-branded format of the talk. The answer would have to wait until another time. I assume he knew the answer to my question — after all, he was the authority on lipids — but he was restrained by regulations governing continuing medical education. Drug companies might err on the side of policing their own behavior even beyond what regulations mandate to avoid legal scrutiny.

Scientific discourse suffered that day. In situations in which questions about off-label use of drugs cannot be answered, speakers have been instructed to take the questioner off to the side for a private conversation. Some speakers have even been told that if more than one listener has the same question, each listener is to be addressed individually, away from the others. But if answering the question is beneficial to one person, would it not be beneficial to others in the audience?

Off-label practices

Another example of problems involving off-label use was brought up at the conference. A neurologist explained how years ago a drug was developed and received FDA approval for the treatment of narcolepsy. Then over the years, the drug was modified and improved and is currently used to effectively treat narcolepsy. The new iterations of the drug had to go through the FDA approval process. Some, but not all, of the previous indications for the drug were applied for. The indication for narcolepsy was not included. Thus, the new drug is being used off-label when it is used to treat narcolepsy. The old drug is no longer being manufactured since it has been replaced by the newer one. But now when a neurologist treats narcolepsy with the new drug, insurance companies refuse to pay for it because its use in narcolepsy is off-label and, thus, not indicated.

Over the years, the FDA has taken an increasingly aggressive approach to the marketing of pharmaceutical drugs. Any statements made about off-label use by the company or its representatives, such as physicians in its speakers’ bureau, can result in draconian financial loses. This can occur even though it is well recognized in the medical community and is acknowledged by the FDA that off-label use of drugs can not only be beneficial, as for example, in pediatrics and oncology, but is the standard of care in some cases. Not to use the drugs off-label can be malpractice. Yet, some of the settlements involving off-label promotion of pharmaceutical drugs have involved billions of dollars. GlaxoSmithKline paid $3 billion in its settlement alleging off-label promotion of Wellbutrin and Paxil. Abbott Laboratories paid $1.5 billion for off-label promotion of Depakote. Other companies have paid lesser but still huge sums, as for example, Amgen at more than $700 million for Aranesp off-label promotion.

Legal paradox

What irony. It is legal for physicians to use drugs off-label, but it is not legal for pharmaceutical companies to promote or even discuss their safe, effective off-label use. Thus, the action is legal, but promoting it is not. But who knows more about the drug and is in a better position to talk about it than the company that actually discovered it?

In regard to this, the 7th U.S. Circuit Court of Appeals has opined, “If a given use is lawful, and thus can be written about freely in newspapers and blogs, and discussed among hospitals … doesn’t it make good sense to allow speech by the manufacturer, which after all will have the best information? Why privilege speech by the uninformed?”

Are we so far down the rabbit hole that freedom of speech is dead, and telling the truth can be breaking the law?

Reference:
For more information:
  • Richard O. Dolinar, MD, is an Endocrine Today Editorial Board member and a senior fellow in health care policy at the Heartland Institute. He can be reached at rdolinar@heartland.org. He reports various financial relationships with multiple pharmaceutical companies.