[quote]Doesn't the FDA only oversee the package insert layout format for U.S. Prescribing package inserts, and may time to time review. Someone one else in the pharmeceitcal,company is writing that, and use simlar to the MSDS's package inserts for chemicals.[/quote]

sorry Paul, missed this question

the answer is YES, the pharmaceutical company writes the prescribing information under very strict guidelines. And NO the FDA is not responsible for the layout and format of the document. The FDA is responsible to ensure that every word is scrutinised for accuracy before being approved (hopefully). This includes any changes the company wants to make, any new data to be added and any reviews. If the information is not approved, the product cannot be sold.

there are normally two types of information - one is the information for physicians which contains the approved indication and the other is for patients which contains a shortened version with less mumbo jumbo and more practical advice. Both are submitted and approved by the FDA

There are shortened versions that appear on advertising and internet sites and these may not be approved by the FDA but must be true to the already FDA approved versions. These versions should also direct you to the full version for further information.

Here is the "informationn for healthcare Professionals on FDA's New Prescribing Information for Drugs."

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084189.htm

This is a clearing house by the FDA and National Library of meds, DailyMed, for up to date drug information, lined to the above.

http://dailymed.nlm.nih.gov/dailymed/about.cfm

It does say Erbitix for first line treatment, amomgst the other reasons. I guess they snuck that in somewhere I didnt see. Anyway the it's not up to me, and just reporting what I read. Anyway, chemo can be used "off market" if I have the name correct, but don;t know the finer details. The good thing that cameoput of this is I have a new dailymed link I'm going to bed, my eyes hurt, and making too many typos.Nice chatting, and got losts of info pout there lol, although the link was highjacked.

Paul & Karen,

Please continue this discussion, if you wish, by starting it's own thread. We need to return this back to Nancy. I'm sure she has enough info on the 2 chemo approaches to go forward.

Nancy,

I was treated in 2006 by Moffitt and they recommended radiating both sides of my neck even though only 2 nodes on my left side were indicated if this helps.

Hi Nancy and welcome. My husband's BOT tumor was right to midline but he had both sides radiated. Good luck!

I am not going to get involved really in the whole Erbitux vs Cisplatin convo.

However I am going to say to the original poster. I fully believe in new trial drugs, it is the way we get new treatments, and sometimes the work for some people. However, you have a tried and true treatment that works well against the type of cancer your hubby has. As a first line of combat against cancer I would choose the known. It may be more toxic, it may make you sick, you may even have a bad reaction to it (some do - but then they generally switch you to carbo) but overall it is effective and I personally am not willing to risk my life or the life of someone I care for on a drug that is still in trials. I might if the tried and true has failed but not as a first line.

best of luck - I know the whole back and forth has probably muddied the waters.

I can say based on reading what you have written likely the reason they are suggesting Erbitux is because he has no nodal involvement that is apparent on a scan. But Erbitux is not without it's issues either. A friend who's ex had it had a horrible reaction to only a few doses and has had issues ever since.

A drug is a drug, and since we are all individuals we respond differently.

take care.

I will question, once again, all doctors involved. Still have second opinion tomorrow and am curious which treatment they suggest. We just want to start the journey and come back here and say "we beat the beast"!

Thanks, Cheryl

Nancy