This may sound a little wonky and technical. But it is incredibly important to patients of murky, hard-to-define illnesses like ours. Basically the US Supreme Court has ruled that any doctor can prescribe any drug he wants to off label. The drug companies are allowed to do off-label promotions. A doctor could prescribe Prozac for bad breath, or anti-retrovirals for the flu. That's not an exaggeration. (Although, I suppose he would still be bound by possible malpractice, and maybe ethical charges by medical associations.)
There is a new class of mostly MS drugs coming on the market now which may benefit ME/CFS sufferers. Science has not come to a stop. It just pulled off the road for a 20 year nap. I'm optimistic for a change. I've been more frustrated and desperate than any patient on this forum. My oft-mentioned BG-12, neuro-anti-inflammatory, is scheduled to be on the market early 2013. If you go ask Lapp, Klimas, or Kogelnik to prescribe it, there are no rules whatsoever stopping him. The highest court in the land has ruled on this.
This was the case that ended in the ruling. The drug rep and the doc were exonerated.
http://abcnews.go.com/Health/Drugs/...ing-free-speech-court-rules/story?id=17883930
There is a new class of mostly MS drugs coming on the market now which may benefit ME/CFS sufferers. Science has not come to a stop. It just pulled off the road for a 20 year nap. I'm optimistic for a change. I've been more frustrated and desperate than any patient on this forum. My oft-mentioned BG-12, neuro-anti-inflammatory, is scheduled to be on the market early 2013. If you go ask Lapp, Klimas, or Kogelnik to prescribe it, there are no rules whatsoever stopping him. The highest court in the land has ruled on this.
This was the case that ended in the ruling. The drug rep and the doc were exonerated.
The case involves Alfred Caronia, a sales representative with Orphan Medical who was criminally prosecuted for making off-label promotional statements about Xyrem, a drug approved in 2002 to treat narcolepsy patients with a condition known as cataplexy. Cataplexy involves weak or paralyzed muscles.
The FDA required a black box warning on the drug stating that its safety and effectiveness had not been established in people under the age of 16. The active ingredient in Xyrem is GHB, is a powerful medication that acts on the central nervous system and also is known as the "date rape" drug.
In 2005, the federal government began investigating Orphan Medical for its alleged off-label promotion of Xyrem.
In a taped conversation Caronia had with a doctor who was cooperating with the government, he said the drug could be used for other muscle conditions such as fibromyalgia, restless leg syndrome, and Parkinson's
Caronia had claimed that his off-label promotion was constitutionally protected free speech, saying the First Amendment does not permit the government to prohibit or criminalize a drug company's truthful, nonmisleading off-label promotion to doctors.
http://abcnews.go.com/Health/Drugs/...ing-free-speech-court-rules/story?id=17883930