[boann]

if so, i have a question for them...

[The Godfather]

Yes........

[Stitcher]

In additional to The Godfather...

You may find a few names at Paula's website http://www.grassrootsconnection.com

[boann]

ok this is on the long side - my apologies

i imagine there will be lots of things i haven't thought of in your response, but please bear with me.

Novartis/Sandoz/Roche/Orion, Teva/Ivax, Mylan/Somerset/Watson and BMS/Dupont/Merck/Endo all have a pretty compelling vested interest in Parkinson's therapy remaining levodopa-centric – just as an example, the Novartis empire makes three levodopa products and eight adjuncts.

setting aside for the moment the cost of coming up with a completely new drug, if one did appear that actually worked, 1) it would topple the levodopa/adjunct empire, 2) it would eliminate all potential for future growth, because it would actually work, and 3) it would not be generic for some years, i.e., only one company would profit from it for X years, and all the others would lose the income they have relied on for years and years.

even a company with a vested interest were the one to come up with the new drug, and even if revenues were equivalent to what they are under the current arrangement, eventually it would go generic and without the potential growth in adjuncts, it becomes a losing venture in the long term.

and then you ladle on the cost of coming up with something brand new, which is much higher than reworking something old, et voila! the perfect recipe for the continued supremacy of the status quo!

ok so all of that goes to my point that there is little to no incentive for industry to shake it up. some are interested in neuroprotection, but what is the anticipated timeline on that, and what are we all going to do while we wait? we need a symptomatic therapy that works ASAP. There could be something in the pipeline right now, but if there is not…

so now to my question - if industry is out of the picture, who is left? academic researchers? would the prospect of a prize – a big one – what would an academic researcher consider to be a big prize - for the finding of a therapy that works (or a cure - i would take a cure, too) have a beneficial affect on the timeline?

[The Godfather]

Originally Posted by boann

setting aside for the moment the cost of coming up with a completely new drug, if one did appear that actually worked, 1) it would topple the levodopa/adjunct empire, 2) it would eliminate all potential for future growth, because it would actually work, and 3) it would not be generic for some years, i.e., only one company would profit from it for X years, and all the others would lose the income they have relied on for years and years.

All completely true.

The medical process has a fundamental flaw.

1. In order to market a medical product a company needs a marketing licence from the medical authorities (such as the FDA).

2. In order to get a medical licence you must provide evidence from clinical trials.

3. Clinical trials can be very expensive (asyou've sen from your other thread).

4. Large pharmaceutical companies are largely the only ones that can afford such clinical trials.

5. In order to protect their product they will insist on patent protection.

6. Unless a medicine is synthetic it is very very difficult to get patent protection.

7. Synthetic substances can be effective at first but will (largely via feedback inhibition) be counterproductive in the long term. They eventually cause the problems they initially relieved.

Therefore, the medical process largely limits new medicines to patented synthetic substances produced by large finance driven pharmaceutical companies that eventually end up making people worse.

Do they care ?

Not as long as they keep on making their huge profits.

They have the medical establishment in their pockets - with eminent professors and doctors on their pay roles. Their large sales teams convince medical practitioners that their products are actually good.

What can be done ?

Make the medical licence process far far cheaper with less stringent requirements for non synthetic substances and methods.

This would open up the process to a greater diversity of people and products.

The pharmaceutical companies will do and have done everything to prevent this from occurring.

Who are the losers in this ?

The people with illnesses, the people who they make their profits from.

[boann]

it is nice, in a depressing sort of way, to hear that my perception is accurate.

but i think my ultimate question got lost - if one is trying to think of ways to create incentive for players in the research field to go at it hammer and tongs, and there is are few ways to create incentive for industry, who else coulld be influenced, and how?

One idea i have heard is a big ol' pot of money - a prize. could never be large enough to be a carrot for industry, but perhaps for an academic researcher? do you think offering a prize could have a beneficial effect on the timeline to either a therapy that works or a cure (I would take either ;-))

[RLSmi]

on this subject, although not entirely unfounded, is not very helpful. One certainly does not have to look far to find abundant evidence of systematic avarice on the part of big pharma, along with what might be interpreted as collusion by government agencies who are supposed to be protecting the interests of their citizens.
I attended a panel session at the Parkinsons Congress sponsored by the Parkinson Pipeline in which I discovered that the major drug makers pay the FDA to expedite the process of study and approval of drugs they have submitted. When I asked how long this has been going on, some individuals whom I later identified as big pharma employees, said "Oh, five or ten years." When I raised the question of the apparent conflict of interest created by that situation, it was explained to me that those "fees" were used to pay for additional clerical and administrative personnel the FDA needed in order to prevent major backogs in the process created by the multiple submissions from those large companies. Sounds reasonable... (???)

Back to the matter of cynicism; I know enough really hard-working, dedicated, honest researchers in the fields of neuroscience and neuropharmacology to keep me from being a complete cynic. There are some really exciting discoveries emerging from some academic laboratories studying the basic science of neurodegenerative diseases. In particular, I think that effective neuroprotection will be available within the decade as the funtions of some of the recently discovered PD-predisposing genes such as LRRK2 are worked out. As a scientist with familial PD, and also a father and grandfather, I recognize that pessimism and skepticism are simply too destructive for me to allow those attitudes to smother the hope necessary to stay in the fight.

[The Godfather]

I dealt extensively first hand with Novartis, Sandoz, Roche, Merck, DuPont, and many more. It left me with real contempt for the pharmaceutical industry. The entire medical development process that they have to deal with is fundamentally flawed.

There are already plenty of prizes and awards for researchers. The main problem is then going from that research through the clinical trials to a licensed medical product. Most researchers wouldn't have a clue how to do it, even if they could afford it.

Even the smaller marketing and research companies don't know to do it and can't afford it anyway.

However, if the requirements for getting a medicine licensed were far less, and if the smaller companies were given funding for doing it, then you would see a vast number of new and varied medical products become available.

[boann]

Hi RLSmi,

I'm betting that this was all new news to you at one time, as well, and my guess is that you, too, gave it some thought. I think it is ok if I do the same.

And I agree that cynicism on its own is not very productive. The ultimate goal of the post was to bounce an idea for a solution off someone.

And yes, I am sure there are researchers with integrity out there - in fact, they are the ones who would most likely get my imaginary prize!

boann

[reverett123]

As Dr. Lieberman has pointed out, although more diplomatically, there hasn't been a whole hell of a lot of progress in the treatment of PD in the last 40 years. They found ldopa and everything froze in place until agonists came along as the patents on ldopa expired. In both cases we are a cash cow.

Treatments make money. Cures don't. Money/power is a fascinating subject. One of its truisms, going much farther back than Machiaveli's "The Prince", is that one may control power by channeling its flow to create bottlenecks. Once these points of concentration exist, simply controlling them controls the whole. That's why we have two political parties, three networks, one press feed, etc That's also why They are determined to control the Net.

In our case, it has been concentrate healing under the control of allopathic medicine, institute pharmacology as its base, install a system of hurdles that only Big Pharma can negotiate, and eliminate, by force if necessary, anyone who threatens that system.

The result is a rigid system where conformity is the norm, info spreads slowly against the barrier of tradition, treatments are common and cures rare, etc.