Minneapolisnick has mentioned before that it should be malpractice for an M.D. to refuse to prescribe naltrexone for use under TSM protocol. Unfortunately, DuPont provided doctors a defense when it held the patent on nal. DuPont authored the package insert, which is the prescribing info for doctors. DuPont's patent has since expired, but of course that insert is the same for all brand-name and generic naltrexone.

The insert is set out in the chapter For Medical Professionals in Eskapa, pp. 209-231, and includes comments/explanation/rebuttal by Eskapa. Without Dr. Eskapa's comments, the insert is murky and confusing as to how naltrexone supposedly works for alcoholism, except to say that some clinical trials reported a reduction in consumption and relapse after twelve weeks, which is the recommended course of treatment. So the clear implication is that, for alcolism treatment, nal is an anti-craving med to aid as part of a comprehensive program in achieving abstinence.

We know this is crazy, but if that is what the M.D.'s are told, they are actually taking a leap of faith (and professional risk) if they prescribe it any other way. It must seem wildly risky to prescribe nal for a patient who announces she plans to take it and continue to drink as she normally does.

There's a fascinating back story here, set out in Eskapa's book (at 61-62 and App. C). Sinclair got a patent on his research in behalf of his employer, mainly to try to work w/ DuPont to have input into the prescribing information. Dupont ended up end-running him and his patent by using prescribing info based on research other than Sinclair's -- in other words, the anti-craving instructions we see now. That left Sinclair to wonder whether his patent strategy -- calculated to spread the word about TSM -- backfired.

My point is that we really do have an uphill battle re-teaching M.D.'s about the proper use of nal. We will be no longer fighting the pharmas much; nal is now a generic and there is no money in it. We WILL be fighting the formidable rehab industry on two fronts: the cultish AA, who hang on to the their-way-or-the-gutter-alongside-the-highway mentality like grim death; and the behemoth that is the billion-dollar rehab industry. The latter is especially tricky because, although it is profitable, rehab is so tied to twelve-step "recovery" that you get the double whammy of money and the cultish irrational attitude about alternatives.

We are giant killers. We are David against Goliath.

Remember, David won.

Dr. Sinclair may be back to the drawing board with the patent strategy to spread the word about TSM. Just as the last patent, it is not about money. There is no big buck to be made by anyone from TSM, which is essentially DIY. Dr. Sinclair's passion is to spread the word.

His daughter Stephanie works with her Dad. Stephanie has a thread here on the board. If you have a sec, drop by.

http://www.thesinclairmethod.com/commun ... =lightlake

This makes me so mad I want to scream.

Dupont, because it owned the patent and manufactured naltrexone, creates the inserts with instructions to MDs, right? Doesn't Dupont have some sort of obligation to include in its instructions the correct protocol for using the drugs as outlined in the studies? I mean, if the studies show that using naltrexone while abstaining is worthless -- which is what they do show --- well then HOW IN THE HELL CAN DUPONT LEGALLY/ETHICALLY/MORALLY include instructions to the doctors that naltrexone should be used with abstinence?? What am I missing here? If Dupont includes the following instructions in the insert, "kick patient in head immediately after prescribing naltrexone", then what is the protocol for correcting such a patently absurd instruction?? There must be something that can be done to get around these blatantly false instructions!

Next question: who made the package inserts the final authority on anything? What if you still have the package inserts but 50 studies that show naltrexone only works while drinking?? What is the mechanism or procedure that must be followed in order to require that doctors follow the protocol dictated by the studies? How do we get the doctors to rightfully disregard the inserts?

It just seems so absurd to me that the patent holder can write whatever the hell they want in the instructions when the instructions completely contradict the correct protocol established in the studies.

I admit that I know absolutely nothing about the patenting, manufacturing and the sale of pharmaceutical products as I'm sure this post demonstrates. I'm just trying to figure out the proper response when an MD says, "the instructions say use this with abstinence." Ideally, one could say, "Oh yeah, well STUDY X conclusive says naltrexone is most effective while continuing consumption and if you prescribe naltrexone with abstinence you are (a) helping no one and (b) committing malpractice."

Nick - On a June 25th post, I read that you are a lawyer. Now I know that law is a vast area of knowledge and no doubt you are specialized in a specific area. Still, it would seem you would be more qualified than most here to investigate some of the questions we are posing.

What would be ideal would be a collaboration between an attorney and a physician, but I know of no physicians here... yet.

Bob

PS Excellent posts lena and Nick!

Yeah, I'm an attorney Bob, but I practice family law -- divorce, mostly. (Only licensed in Minnesota and can't give out advice to people outside of MN -- sorry.) I know nothing about this area of the law. I didn't even take patents in law school. My physician, who has required a follow-up after one month on nal and who I'll be meeting with soon, may have some answers about these inserts. I'm going to ask her after I give her my glowing one-month review of naltrexone. She didn't want to give it to me at first until I gave her the New York Times article. I'll be curious to see her response to my initial success.

Hi Everyone,

I was inspired by Nick's advice to me to stand up to my GP (who refused to prescribe) and bring facts/evidence to support that fact that GPs can prescribe naltrexone. BUT when the reality of that uphill battle versus my need hit me, I decided to "opt out" and go to an addiction psychiatrist who treated me in the past.

I am hoping she, with her knowledge of naltrexone and my drinking history, will prescribe for me. This will not be cheaper than going off-shore, but it will give me some peace of mind (and maybe help educate a professional in the field).

I hope none of you -- Nick especially -- will be offended by my weakness. I need help and want to get going as soon as possible, and I'm hoping this is the "path of least resistance".

Peace to all of you,
Sante

Hell no I'm not offended! In fact, I admire your intelligence -- the path of least resistance is always wisest. Just do what you have to do to get the nal and worry about taking care of yourself. Then take the nal one hour before drinking and watch your life change for the better!

Best wishes,

Nick

hehe

i just read this thread again, and something struck me that hadn't before.

If your doctor recommends using it according to the instructions - ask them why bother going to him/her? And then tell him/her about the studies

The package insert is authored by and can only be changed by the FDA. The change can only occur after approved research studies. TSM studies are very impressive, but would never qualify as an FDA approved study. Since no one is ever going to pay for a huge study on a generic drug, TSM will never be on the Nal product insert. That may not be the case with the injectible form, Vivitrol--which is still not generic and may indeed be studied.