Indications for Alina - off label promotion

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Fraud

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Indications*
ALINIA® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.

Alina is only indicted for treating the two parasites referenced above (copy and pasted from Alina website), and then only if patient has diarrhea. If it was sold only for this purpose, then the primary call point would be infectious disease doctors. Romark would then want to buy data from lab companies, like Quest and Labcorp, to find out what doctors ordered significant numbers of tests to diagnose patients with Giardia and Crypto. That way the reps could promote the drug for the labeled indication to doctors that treat patients with these parasites. Romark does not do this. The primary call point is a “functional medicine” doctor who treats bad stuff in a patient’s gut. No tests for these two parasites are run by these types of docs before prescribing Alina for their patients.

This company is a sham!
 






Sour Grapes

Fraud said:
Indications*
ALINIA® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.

Alina is only indicted for treating the two parasites referenced above (copy and pasted from Alina website), and then only if patient has diarrhea. If it was sold only for this purpose, then the primary call point would be infectious disease doctors. Romark would then want to buy data from lab companies, like Quest and Labcorp, to find out what doctors ordered significant numbers of tests to diagnose patients with Giardia and Crypto. That way the reps could promote the drug for the labeled indication to doctors that treat patients with these parasites. Romark does not do this. The primary call point is a “functional medicine” doctor who treats bad stuff in a patient’s gut. No tests for these two parasites are run by these types of docs before prescribing Alina for their patients.

This company is a sham!
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I took the job for 5 minutes about 4 years ago and quickly found they were selling off label for C Diff, I don’t feel like getting tossed in jail for this shit. Can’t believe this company still exists
 






If the FDA thought it didn’t work for the off -label uses, they’d have cracked down long ago. Sometimes, it’s just too much to ask these small companies to do hugely expensive trials.
 






The FDA has rules and regulations that apply to all pharma companies regardless of the size! The last post is a direct reflection of the immoral, incompetent thought processes rampant in this company.
 






anonymous said:
If the FDA thought it didn’t work for the off -label uses, they’d have cracked down long ago. Sometimes, it’s just too much to ask these small companies to do hugely expensive trials.
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All pharma company's are selling off label. It’s the new norm, no big deal at all and nothing new about it.
 




































No, but they should attempt to get it into a trial over there. Even if it’s only partly effective, that would be enough. Of course, has to be in a cocktail to prevent resistance.
 












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