Re: you really want to be active in the fight for lyme rights?

a_weisman_at_yahoo.com
Date: 12/27/04 

Date: 27 Dec 2004 07:18:39 -0800

GregGerber@hotmail.com wrote:
> a_weisman@yahoo.com wrote:
> >Probably best not to make it
> > Lyme specific, but tout it as a Foundation for the Cure of
Autoimmune
> > Disease and sweep as much under it as possible.
>
> I would make it Lyme-specific and I would not tout the effort as the
> search for an autoimmune treatment, particularly. I suspect we are
> going to find a therapeutic that is NOT geared to autoimmunity but to
> the immune system directly --a dysfunctional immunity revved by
> persistent low-level infection or antigens in a cyclical state of
> disequilibrium, this is my guess.

Well that's a good guess as to what "autoimmunity" REALLY is.

A problem, and this is a BIG problem, with making this Lyme specific is
the current attitude towards Lyme (widely considered not a big deal).
Touting this as a Lyme specific venture is limiting in a number of
ways.

If one touts the Lyme MODEL as useful in understanding a wider range of
diseases, the potential market looks bigger, much bigger.

Think about it: if one argues that Lyme provides a good model for
understanding infectious arthritis, and autoimmune diseases (autoimmune
in the way you have described), the market is HUGE. If one argues that
the Lyme model is a good way to begin understanding demylienating nerve
diseases, the market is even bigger (*and Lyme is the ONLY KNOWN
etiology for demylienating nerve disease). Same if we suggest that Lyme
MAY be a good model for understanding a range of neurodegenerative
diseases too.

To my way of thinking THIS provides fodder for a business plan with a
potential target market that is STAGGERING.

One way that venture capital is attracted is to the idea of potentially
vast markets. The bigger the potential opportunity, the more risk
venture capital is prepared to take.

> Yale has some patents but many
> patents and therapeutic concepts are elsewhere and Yale is not
needed.

Well I was using Yale for two reasons: one, they hold potentially more
relevant intellecutal property here than any other single source; and
two, I was giving Greatclod a xmas gift so he could begin his rants at
his favorite target.

If you'd prefer we could call it Academia, or even more generically,
embedded or existing IP.

> What is needed that they have produced could be licensed, perhaps
--but
> can be done without Yale. Other work is more important, and let us
not
> forget some of the key Yale researchers (I mean the basic researchers
> who understand the chronic problem) have moved elsewhere.

Contractually many of the discoveries made while at a particular
institution involve sharing of IP rights with that institution, so Yale
may be involved anyway.

And YES existing IP might need to be licensed, but that involves
potential costs that are hard to estimate. Contracts have to be agreed
upon OR one has to risk infringing and paying later along with legal
fees and potential penalties (infringement can involve treble damages).
A cost worth incurring is IP insurance (not cheap but worth it).

> > So we need a LOT of money GIVEN to us with NO STRINGS to start. And
> > then a board that will direct research as we see fit, and that's a
> > problem. To have a TRULY independent board of experts, we give up
> > control. As board members they are guided by their fiduciary duty.
>
> yes this would need to be resolved. As to start-up money, I am
thinking
> a million could do it, but perhaps that is naive. I really don't
know,
> and you would need a better expert by legions than me to tell you the
> figure.

I don't think a million even buys you a CEO. Think about what CEOs make
these days!

> > And money from succesful treatments and diagnostics and
therapeutics
> > including vaccines, can be poured back into the enterprise.
>
> yes. I am convinced there can be therapeutics for most chronic Lyme,
> based on things we know or are at the cusp of knowing or can know if
> the specific goal is a cure or at least treatment to efficacy. If not
> curable this is treatable, I have come to believe. I think we have
> learned a lot in recent years. Hey it would not be overnight, but a
> Manhattan project could take a decade. The research needs to be very
> directed --and that is why it has to be taken outside of NIH.

Well the target market has to be larger than "chronic Lyme" because,
one, not everyone agrees it exists (credibility issue for raising
venture capital--I DO belive it exists personally); even if one accepts
that it exists, we are talking about a difficult to quantify market,
and one that may be too limited (how many chronic Lymies are there? see
threads on where have all the chronic lymies gone?). And you never want
to limit your market more than necessary.

> NIH has taken things on a bizarre tangent IMO what with all the
> long-term (yeah right!!) antibiotic treatment studies and the HLA
> emphasis (only a small percent of the chronic patients fall under
that
> umbrella.) None of these things are going to do ANYTHING for the
> majority of the chronic Lyme patients, yet this is where NIH has put
> millions upon millions in funds. What a tragic waste.

IF the Lyme model helps us to understand how to manage mixed infection
and destructive immune response disease, well the target market is huge
or potentially huge if one considers that there may be an infectious
origin to a wide range of what are thought to be autoimmune diseases,
then this work has applications beyond Lyme, and that is probably a big
plus for any business plan.

> > we can spin off for profits
> > with all the perqs of any company, all under the control and
ultimate
> > ownership of the non profit.
>
> all these things are possible keeping in mind the issue of true
patient
> oversight.

If patients are stakeholders, and by that I mean they are putting up
$$$ (not just that they have an interest in the outcome) then they
retain control. Otherwise it is hard to do. Those with a big stake $$$
are given stakes and votes on the board.

> > The problem is that until we have something more than a very
general
> > business plan (a cure for whatever with treatments diagnostics and
> > other therapeutics along the way) it is really hard to attract
> venture
> > capital.
>
> Yes, this is why the plan needs to be stepwise: A committee to search
> for a CEO, hopefully someone with a vested personal interest here.
You
> need top people to make a business plan that will fly, let's face it.
> This requires enormous expertise.

And commensurate expense.

> > And, harkening back to Yale, there's already some competetion out
> there
> > so there is no certainty and there are some competitive risks.
>
> ROFLMAO --hell will freeze over before Yale even recognizes chronic
> Lyme disease. Again, I am talking about the MDs, not the scientists
> like Fikrig etc.

Well it doesn't matter if it is the MDs or the scientists. Don't you
think they have done some basic research applicable to these concepts?
Maybe they have shown more interest in the basic science than the
medical aspects (treatment is less profitable than developing
therapeutics and models for understanding and treating other diseases).

I do. Looking at a lot of what has been done, I think they may be a few
steps ahead on this type of thing. Perhaps.

See it is LESS profitable for them to be treating Lyme patients, since
the managed care model puts them at risk for delivering health care,
they make more money by not treating than by treating.

> > And remember, the less tied to Lyme it is, the more possible it is
to
> > become something we can't control and don't like.
>
> understanding chronic Lyme will be a key to treating many other
> diseases --but perhaps chronic persistent infections as opposed to
> autoimmune disease.

But query, what role do chronic persistent infections play in what has
been thought to be, and called, autoimmune diseases? And what about
demylienating nerve disease? And neurodegenerative diseases?

The business plan can and should speak broadly in identifying POTENTIAL
markets. The business plan is more of a selling document to investors
than anything else. A strategic plan is really the marching orders for
the company and that is not the same as the business plan which is
mostly used to help raise $$$

> I think that probably a very small percent of the
> chronic patients have autoimmune disease though MANY perhaps MOST
have
> severe immune dysfunction related to other aspects, ie the tolllike
> receptors and outsized inflammation caused by small amounts of
> infection.

Yes I agree that this is very likely.

> The treatment will not likely be an antibiotic but perhaps something
> that restores immune equilibrium even if a small amount of infection
> persists.

Or perhaps treats or manages infection while still tamping down the
inflamatory and destructive aspects of disease. Instead of
"autoimmmune" treatments simply suppressing the immune response, and
thus making infection worse, they can suppress selective aspects of the
immune response (inflamatory and destructive ones) and perhaps
simultaneously manage treat or cure infection too. I don't know if that
is possible but it is a worthy goal. But I agree with the basic
premise of this being a therapeutic goal.

> You also need to get to the bottom of the cyst issue. Is it a big
> factor or not? This CAN be answered with science, the science needs
to
> be done.

Yes cyst forms are worth researching and researching whether this is an
issue beyond Lyme. Similarly immune complexing is an issue worth
looking into. And so are many others with potential for broader
application and relevance beyond Lyme.

> The best way to keep control is IF some Lyme patients were RICH
> > $$$$$$$$ and were willing to provide seed $$$$$$ and be on the
board.
>
> yes.

So, the way to make a billion dollars is FIRST GET A BILLION DOLLARS
and then... LOL

But this makes all things easier.

> > It isn't necessarily easy. That doesn't mean it isn't an idea. But
is
> > it viable? How to make it work?
>
> it would be very difficult to get this to fly but on the other hand,
> otherwise we're stuck with NIH science and I would be shocked if that
> will get us anywhere in the next century. If I were a betting person,
I
> would bet against it.

I think there are other ways to approach the problem and not simply be
stuck with NIH science. MANY disease advocacy groups raise LOTS of $$$
and fund their own research without using this model. They spend very
little time or resources lobbying government since they often don't
like the directions of research or the lack of control or inpput.

There are also other ways to bend the NIH to our way of thinking. One
is the hearing idea, if we can embarass them, we can get some leverage,
the approach to doing this in the past has been amateurish but done
right, we could make headway and THEN we might have more control over
what NIH is doing. There certainly have been a host of lost
opportunities, mishandled opportunities.

Ironically even some of the worst things (GAO report, Klempner Study)
have been opportunities, if they were handled right. But they weren't.

> So, though this idea is a longshot and very difficult to execute imo
it
> is also the best shot. All else is a finger in the dike.

You don't mean that in a lesbian sense I imagine? LOL Except for
Frank's postings, this is a PG13 site. ;-)

> > I think the idea of ONE patient member for such a non profit is a
> > mistake. It is always a mistake to assume that anyONE can represent
> > such broad interests. Better to make it several. And better to give
> > them some real power, either make it difficult to outvote them
> > (requiring a voting block assuming they act together) and
definitely
> > giving them voting power NOT ex oficio memberships.
>
> ok

But the best way is if there are Lyme patient stakeholders! What gets
me is that there ARE, there have to be, rich people with Lyme too!
Venture capitalists, people who summer on the Hamptons and Fire Island,
Paris Hiltons.

> > AND please remember that it would be NECESSARY to team up with
those
> > who already own patents on some of the key items, some of those are
> > Yalies or part of "the other side" and we have to beat them to the
> > punch in order to get them to join us.
>
>
> many of those with the relevant patents understand the issues,
believe
> me. They certainly do. One can license patents. These patents are NOT
> going to otherwise be used to treat chronic Lyme in a concerted way.

Yes one can license IP. However that can cost. And it depends on how
essential the IP is to the invention how much it costs.

> > Again, why the temporary board? I may be missing something but what
> is
> > the benefit to that?
>
> There needs to be a pre-effort to the effort, it needs to be
> bootstrapped step-wise --so a search for the top experts can be
> conducted under the umbrella of a dedicated organization.
> GG

Well that doesn't have to be a corporate pre effort. But I'm not going
to quibble over this detail, we are still discussing very broad
outlines, we're not down to details yet.

I certainly do think this is an idea worthy of further discussion.
Thanks for the contribution!

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