Speech versus Off Label Use
I am a big proponent of freedom of speech BUT what if it harms someone else in the process? You can’t yell fire in a movie theater unless there actually is a fire. In this case, a representative of Orphan Medical was promoting a narcolepsy drug (Xyren) for insomnia. Keep in mind that the FDA authorized sales of the drug for narcolepsy and not insomnia. If I remember correctly, the pharmaceutical company was in the process of performing studies for treatment of insomnia but the studies were not completed.
The sales rep was given information about these studies and consulted with doctors about what was on the horizon for the drug. There doesn’t seem anything wrong with that. However, this information can influence a doctor to treat someone with this drug for insomnia (it happened). The danger is that no one fully understood what possible side effects people can encounter. The side effects were understood for those who had narcolepsy. The mechanism by which their bodies were treated was understood and how the drug interacts with the body was well studied. Now what happens to a drug when that “defective” mechanism is not in place? How does the body react to it?
No one knows for sure. There is a chance that no additional side effects occur. There is also the chance that new side effects occur which can negatively impact the patient. That is why studies are performed. The FDA is there to protect us. I know that sometimes they are not perfect or slow to act but their end game is to protect citizens from fraudulent drugs.
FDA vs Big Pharma
I suspect somewhere down the road that this case will be sent to the Supreme Court. I worry that the FDA loses this case on the grounds of free speech. Think about it. If the FDA loses this case, big pharmaceutical companies have no incentive to file drugs with the FDA. They can circumvent the system. Imagine a sales force that talks to doctors and tells them that Viagra can cure cancer because they heard one patient beat cancer after taking Viagra. We would be back in the old days where medicine men went around selling snake oils that cured anything. There was no control, no care for the patient just profits.
Does that sound familiar?