Hi everyone, 

A herbalist that I know has developed a cure for Diabetes and has been
prescribing it for the last three years. He claims that the medicine
restores the Pancreas in 30 days to perform its normal functions; the
patient will be completely healed as result, and will not require any
diabetic medication at any time in the future.

Now, he is trying to introduce this medication to pharmaceutical
companies to get them to produce it commercially. The goal now is to
prove to pharmaceutical companies that this medicine is effective, so
that they develop enough interest so that they can handle all related
processes from filing a patent and obtaining official
approvals/registration (e.g., FDA?s) worldwide.

One problem is that the there is very little/no documentation
available now on the results of this medicine. (He is saying: ?It
works. Let?em try it an they?ll see!). So, one suggested solution is ?
after signing necessary agreements ? to send the companies samples of
the medicine so that they can research its effects. In this case,
there is another problem: he is not interested in giving out the
formula to anyone before guaranteeing his fees. (In other words, he
will give out as many samples as required, but he will not give out
the formula nor the ingredients.)

Having all of that in mind, what is the best way to approach
pharmaceutical companies to introduce this medicine?

Hello Octopia,
Is this the same Octopia I remember? Great to see you again.
Regarding your question, I believe it is difficult to approach
pharmaceutical companies without any legitimate scientific approval or
accreditation. Your friend could approach a third-party test
laboratory and have his product tested and rated, or he can just try
to manufacture and sell the product on his own. Just my opinion here,
I am not familiar with this industry, perhaps another researcher with
more experience or knowledge in this industry could help you more.
Good luck.

I suspect that if someone gets hold of a sample then it might be
possible to determine the formulation.

I presume big pharmacutical companies get daily letters from people
who think they have good treatments and cures. Likely they check out a
small percentage of these claims which typically do not lead to profit
for the drug company. Eli Lilly sells perhaps a billion dollars worth
of insulin per year, so they may want to buy control (keep it off the
market) of an effective cure to avoid loosing their very profitable
sales. Sorry I find it hard to be optimistic.  Neil

Hi Techtor, 

Yes, it is the same Octopia. I missed the Google answers community
over the last period, but it is good to hear from you, and hope all is
well?
 
You are right. It is all about getting the right referrals that could
make pharmaceutical companies go for it. The issue is getting these
labs to test it and how far they can go with out supplying the
formula. The least they can do is test it and determining if it
suitable for human use, but I guess in order to convince pharma
companies, we need some medical tests on real cases.

Speaking of that I don?t know what is the procedures for legitimizing
tests on volunteers. If it is too difficult in the US then, anywhere
around the world. Someone told me it involves several stages of that
begin by testing on animals and after so many phases, you can finally
test on volunteers. Yet, something tells there must be a shortcut
around this procedure, otherwise, a lot of potential medicines are not
making it to the market.

Note: Thanks for giving it a shot Techtor. Why not have a look at my
other new question on
http://answers.google.com/answers/threadview?id=317167)

Hi probonopublico, 

That is the first thing I thought of. So I contacted
solids-solutions.com who specializes in reverse engineering. Here is
their reply:
?It is very difficult to determine the origin of all components in a
mixture. It is not impossible if someone knows the ingredients but
those are [usually] not [unambiguously] to determine??

Hi neilzero, 

Yes, it is difficult and Eli Lilly is not the only ones to worry
about. If this thing work, then the whole Diabetic related industries
will phase out. Still there will always be a need for Diabetes cures
as long as the disease is there, which means more profits for that
company which will adopt it.

The process for FDA approval does involve a number of steps or phases,
usually starting with animal studies, then moving to safety studies,
then efficacy studies. In other words, before you prove it will work, 
you need to prove it is safe (withing reason-no drug on the market is
100% safe).  No pharmaceutical company is going to test an unknown
compound - it would violate bioethical standards, since they would be
giving something to a patient that they got from an unknown source. 
(Let's face it, would you sign up for a study where the doctor told
you, "try this, I'm not sure what it is, but some guy told me it would
work"?).  In regards to analyzing a sample, if it is a fairly pure
extract of an active ingredient, then it would be fairly easy for a
pharm. company to determine what it is.  If it is a more complex
herbal extract or combination of herbs, then it would be more
difficult to determine, however, the company would want to determine
the active ingredient or ingredients before getting FDA approval or
marketing, since otherwise it would be next to impossible to verify
the dosing needed to ensure safety and efficacy.  One of the
difficulties with herbal medicines is that plants vary in the amount
of different chemicals they produce depending on growing conditions,
plant strain, and processing methods.
I suppose the conspiracy theorist can always come up with some plot
where the evil drug companies squash a potential cure because it would
interfere with their profits.  However there would certainly be profit
to be had from this as well if it works as stated.  Further there are
different forms of diabetes, of which Type I is caused by pancreas
malfunction and Type II is caused by peripheral insensitivity to
insulin, not pancreas malfunction, so it doesn't sound like it would
necessarily work for all forms of diabetes, although it may work
differently than what you stated.

Rather than start with the drug companies, he may want to start with
Universities or other research labs, which are starting to do more
(long needed) studies on herbal or other alternative treatments.  He
would have to be very careful though, since they will often have
clauses that stipulate anything developed through research in their
labs becomes property of the University.  This would have to be very
clearly established ahead of time, if he wants to maintain rights.
The alternative is to continue doing what he is doing, but he must be
very careful about how he markets this, since the Govt takes a dim
view of claims of curing illness for anything that doesn't have FDA
approval.

The usual protocol would be to have a double blind study.  That is to
have two groups of people that have type I Diabetes. (The type you
describe.)  One group would take the "magic" pill and the other group
would take a placebo. (something proven to be harmless, and have no
effect on people)  The people giving the medication would not know who
got the "magic" pill and who got the placebo.  The choices between who
got which treatement would be random and only known to a third party.
(eg everyone gets a different number, and at random the choice of
treatments is assigned.  The fact that people with the following
numbers #1,4,5,7,9, 13,56 got treatment A and everyone else got
treatment B would be known, but someone who doesn't know who is number
#1 etc. would know that treatment A was the placebo and treatement B
was the ""magic" pill.  Once the study is concluded then the results
are looked at and which treatment the placebo etc. is revealed.)

That way no one who is involved in the study knows what they are
getting.  Then you need to determine that the tratment worked better
than chance.  That is people who got the placebo should not have
gotten better and people who got the "magic pill" should have gotten
better.  If they got better or had no change in equal propotions then
it isn't clear that the "magic pill" worked.

There is a cost to setting up a double blind study, but it is much
more effective than anecdotal evidence and is much more convincing to
anyone that would manufacture it for you.  (Of course, there are
plenty of charlatens who will do it for you, contact all the penis
enlargement via pills people!)

I wouldn't worry about Eli Lilly trying to buy it from you and take it
off the market.  You are describing Type I diabetes and your cure
won't work on type II or Type III.  Type II diabetes is Adult onset
Diabetes and is usually caused by obesity and Insulin resistance. 
These people do produce plenty of insulin and so restoring the
pancreas is not going to help them because their pancrease is just
fine.  I believe this is a much larger market than type I.  Type III
is Gestational Diabetes and the Mother still produces insulin, but
because of the pregnency needs to suppliment and control her diet and
the amount of Insulin.  Again this won't be cured by your pill.

Best sugestion is to find a University who will do a good double blind
study and publish it in a reputable scientific paper.  But there are a
ton of people out there claiming that they have cures for cancers
etc., but don't have time to do the studies or they gen up some excuse
that the drug companies and all scientists are in cahouts and can't
possibly understand their revolutionary technique.  Just send $149.95
for their magic pill...

If it really works then it should work in a double blind study.
Good luck.

As an added note - if it really works, patent the formulation.

I agree with Synarchy ...

Patent it ... At least in the more important countries ...

I wonder ....

Is the incidence of diabetes the same country by country?

Hi ac67 and scubajim

Thanks for a very informative comment. Any of your comments can be
taken as an answer.  Here are some additional comments from my side:
o	Analysis of the ingredients: A very valid point for knowing the
ingredients before the tests. In one instance that I know of, that
herbalist has provided a sample to an MD in order to test it on one of
the patients. The MD took the medication first and analyzed it to see
if it is suitable for human consumption. Well, the test came out
positive, but the point here is that this is the type of tests that I
expect research centers would require and there is no doubt about that
being necessary. As I mentioned, he would give out an as many samples
as necessary these tests, but would not give out the formula. Now, the
issue is whether a test could be documented without giving the
formulas or ingredients.
o	Building Credibility with Direct Testing:  What is your advice on
continuing direct testing, but having a medical institution monitor
the results this time. In other words, the patients would run a test
before and after, and the institution would just certify the changes.
Would this work? Could this be enough to publish results at medical
reviews/papers?
o	Types of Diabetes: Point well taken. 
o	FDA Approval: Yes, I completely agree with you. Also, this could
take years before the approval is granted. It is even more complicated
when getting approvals worldwide. So, the issue now is to convince the
pharmaceutical companies more than it is to get approvals. Would the
method above work to do that (under ?Building Credibility??)
o	Ingredients: It is a complex herbal mixture, and maybe that this why
he is somewhat confident that it is difficult to know the ingredients.
Plus, according to him, it also involves certain ?secret methods? of
processing to develop it.
o	Double Blind Study: Very informative, thanks. Can that herbalist do
it directly though, and register results at a well-known medical
institution? All they would do is testify the condition of the cases
on day 1 and after 30 days.
o	Scams: Point well taken. 
o	Herbal Testing: I know that some medications in the market are not
regulated by FDA, because they are natural extracts. Your point on
that being a different case when claiming the medication is a cure
(rather than a supplement) to a disease is valid, and in that case,
regulation would definitely need to take place. Again, we are not
trying to reach that stage, due to the time and resource requirements.
It is about getting a company to be interested enough to sponsor the
research and registration of this medicine. Just a small thought here:
What if it is introduced as a supplement to the Diabetes conditions
and then letting research discover that it cures to some extent. (I am
referring here to the famous story of how Viagra has been discovered
as medication for a completely different purpose.)
o	Patenting: Yes, this would be a necessary step. At least we could a
patent-pending status that we can build on.

I've posted a loosely related Question ...

See #320077

Just curious.

All these concerns are a waste of time.  This person or anybody else
CANNOT get a patent on this material, even if it worked, because it
has been IN USE and ON SALE for 3 years.  The applicable patent law
is:

35 U.S.C. 102  A person shall be entitled to a patent unless -
(b) the invention was patented or described in a printed publication
in this or a foreign country or in public use or on sale in this
country, more than one year prior to the date of the application for
patent in the United States,

The person has missed his chance and drug companies (again if it
worked) can make it without his permission or paying royalities.  All
he has is an opportunity to sell "snake oil" is desperate people.

Sorry, Socal, I must disagree.

My understanding is that the formulation has not been described in a
publication nor has it been 'in use' within the meaning of the Patent
regulations.

So patenting remains an option because no one other than the inventor
knows what it is.

Yes, I agree probonopublico. 'In use' applies if this use makes the
formula known to the public, which is not the case here.

Thanks everyone for your input, 

scubajim or ac67, if you are interested, please post your comments
above as the answer to this question.

All the best?

Octopia

Sorry probonopublico-ga and octopia-ga, 

But you are wrong when it comes to Patent Law.  The "in use" [102b]
bar does not relate to the public disclosure of the "invention" when
the item is actually being used or sold commercially.  The first
sentence of the question states the fact: "A herbalist that I know has
developed a cure for Diabetes and has been prescribing it for the last
three years."

This is "in use" and "on sale", and the US Patent Office is will cite
102b everytime.  There is no way to argue away the simple fact.

In general, patent law is one of those subjects where people believe
they understand the process, but in reality do not have any first hand
knowledge of this very technical field.  There are so many "urban
legends" about patents.  This is made obvious by the fact that two
very knowledgeable people -- probonopublico-ga and octopia-ga -- both
made an error on a rule (102b)that is one of the most basic concepts
in the US Patent system.

A comment for everybody reading this thread.  If you have a question
concerning patents and your rights, contact a Registered US Patent
Attorney/Agent.  "Common Knowledge" or "Information from friends" can
be very dangerous and expensive.

Neither I nor scubajim are official google researchers, only fellow
users/commenters, therefore we can't list our comments as answers.  If
you are satisfied that you won't get anything better, you could close
the question and you will only be charged the posting fee.

I agree with socal-ga, who I suspect is a patent agent or attorney (I
am also a patent attorney): If your herbalist has been prescribing his
"cure" for the last three years (presumably as part of his business)
in the United States, then it's too late to obtain a U.S. patent.

I also agree with socal-ga about something else: When it comes to law,
as with many other important topics, a little knowledge can be a very
dangerous thing. Google is not currently accepting additional
applications for "Researchers," so unless a Google already has an
actual patent attorney Researcher, I strongly recommend you seek a
qualified patent attorney elsewhere for further advice on patent law,
if your question is more than idle curiosity.

Hi Octopia:
I don't have an answer to your question but I have a firsthand
interest in your report as my infant son was recently diagnosed with
Type 1 diabetes (on Thanksgiving Day of all things) and supposedly
there are homeopathic treatments (such as this) that can reverse the
disease if it is caught early enough.  We are scrambling to find a
herbal cure that we can try.  How could I get in touch with this
person? I do have strong contact in the pharmaceutical field that
perhaps could be leveraged as well.  Thanks!