Posted by Flash (213.123.73.169) on October 17, 2000 at 13:41:39:
I phoned, emailed, and submitted information to the web sites of several major pharmacaeutical companies. I did this at the urging of my GP (who is quite interested in the shroom treatment).
Today I got an email back from YYYYYY, asking me to call Dr XXXXX, the Scientific Licensing Project Manager (CNS/GI/Pain) from their Global External Scientific Affairs Department.
I can't reveal the name of the company, or the Scientist I spoke to. Suffice to say that the company is to prescription drugs what BP is to oil. The scientist I called was happy to discuss this with me, and was also quite candid about the situation. The telephone call took place after I got this email:
Thank you very much for the interesting message you posted on the YYYYYY web site regarding a treatment for cluster headaches and possibly
migraine. As the Licensing Manager responsible for looking at products in
the CNS Area this was passed on to me.
We would definitely be interested in finding out more about your discovery
although it is worth noting at this stage that we usually consider the
following when looking at a prospective new medicine:
* Is the "therapeutic" a single chemically characterised entity, an
extract and/or a mixture? If not the first then our interest is low.
* Is the "therapeutic" obtained from a readily accessible and
sustainable source? If not then our interest is low.
* Can the "therapeutic" be synthesised in the laboratory? If not our
interest is low.
* Do you have objective biological data, e.g. from laboratory studies,
to support your claims for efficacy? If not our interest is low.
* Do you possess any safety data on the formulated material? If not
our interest is low.
* Do you have any clinical data from controlled studies? If not our
interest is low. Anecdotal data from tests on individuals are generally of
little value.
* What intellectual property rights exist for this product? If none
our interest is low.
From the information you have given it would appear that the substance you
describe fits some of these and I would be grateful therefore if you could
contact me in order that we could clarify some of the other points. In
particular we would need to know whether you, or anyone else, holds a patent
on the substance.
Best regards
XXXXXX
Dr XXXXXX
Scientific Licensing Project Manager (CNS/GI/Pain)
Global External Scientific Affairs
YYYYYY
Now I better point out that at that stage, she had no idea what the substance was - but suspected it might be LSD.
I filled her in on the details at the start of the phone call, told her who I was etc, and what the substance was. You must remember that pharmaceutical companies are run as businesses (DUH!) and therefore they rate drugs on criteria other than how well they work, or how safe they are.
she informed me that the biggest stumbling block relates to the patent. If the substance was already patented by YYYYYY then they'd be very interested. If the substance was patented by another organisation, then they might still be interested, since they could license it. It's important to note that the patent relates to the substance combined with it's use. In other words the patent would not relate to Psilocybin, but to using Psilocybin as a treatment for vascular headches.
If the substance is already patented for something else (therefore proven to be safe in trials), then they might still be interested because they could easily take out a patent relating to another use. If there is no patent, then they are not really interested because then they have to fund research into it. I realise this might no make sense to you at first, but if a drug is patented then the research has all been paid for aleady so there is no real obsticle to bringing the drug to market. Of course they do carry out their own R&D, but they will have this budget targeted where they see the most profits.
She indicated that if the MAPS study went ahead, then this might open things up a little. It's unlikely that companies the size of YYYYYY would be interested, but some smaller pharmaceutical companies might. It's the same in any industry. The fact that it's a controlled substance is an issue, but not necessarily insurmountable. There is no point in speculating on the attitudes of the various governments at this stage. Remember that Cocaine and Heroin are both licensed for treating CH, both in the UK and the US (and I imagine elsewhere).
At the end of the conversation she said she would talk to the people in R&D. Later she called back to ask some more questions, like whether we knew it was specifically Psilocybin, or could it be something else present in the mushrooms? I think you can guess where that was heading... But she did say, that the R&D people were more interested than she expected, and promised to keep me updated.
There is little point in pursuing other pharmaceutical giants, since they operate in what's more or less a closed market. It's unlikely that another would have a different opinion. The smaller companies might be worth approaching, but only after the MAPS study is complete. Likewise it's pointless to lobby the government until a study is published.
So that's where we stand.
Please contact me if anyone wishes to discuss this further.
Flash