Hi Maggie..I met you and your husband Steve at the WPC..My experience there was one I will never forget..ie..meeting BT forum members for the first time..some of whom who had posted about GDNF prior to the WPC..etc..Meeting your husband Steve was the picture that spoke a thousand words..I became involved in pd advocacy immedietely upon returning home and became the PAN Coordinator in Rhode Island because of what I learned and what I witnessed at the WPC..Thank You for sharing your miraculous story with me/us

Steve

maggie, i am so happy for you and your husband that you have experienced this reprieve, and are still experiencing it. my questions may already be answered on grassrootsconnection but i will ask anyway because i am here - actually, lindah might already have answered this one - all the phase II participants now know whether they got the real thing or placebo, right? is anyone regressing?

Linda, thank you for the information – I agree that the motivation, if not as stated, would most likely be money, but in what capacity? That they would not make a big enough profit on this? That would make more sense if they were already invested in the current levodopa-centric set up, and could even make sense if they weren’t, but according to what Perlmutter says in the video (which I haven’t watched), they were well aware that this would not be a huge boon to their bottom line and were going to push on anyway – so, what changed six months later?

I am going to try and find out – SEC filings are a treasure trove of information – for example, did anyone know that Perlmutter is on the board of StemCells Inc.? I don’t see his name on their website but maybe I am missing something – he was re-elected to a three year term this year. Genentech, which is owned by Roche, which is in turn owned by Novartis (33%), owned a chunk of StemCells Inc’s previous incarnation, CytoTherapeutics in the mid to late 90s but Perlmutter was not a director of StemCells Inc until 2000. More currently there is a connection between Abgenix, Genentech and Amgen but I have to learn more about that. Must check out Kevin Sharer, too. (CytoTherapeutics happens to be the company the gentleman who coined the term “the gold standard”’ for levodopa in 1996 said he worked for – leaving out the fact that he also worked for Bristol Myers Squibb, makers or marketers of Sinemet.)

Paula - thank you for all of the background. i am glad there are those who are those who of a different mind than those that may think that they are not worth it for no profit, that the machine is too big to fight and that companies doing what they have to do, even when that includes making sick people irrelevant.

as far as i am concerned, not pursuing a therapy that could help or cure millions of people for monetary reasons is criminal – the head of Amgen’s salary - and this is just his salary - was $1.4 million for 2005. His bonus was $4.5 million, and “other compensation,” which seems inconsequential in comparison to that until you remember that it is more than 14 times your annual salary, totaled $740K. He also owned, as of 12/31/05 (and these are no doubt 100% compensation rather than purchased at his expense) at least 225,000 shares of Amgen stock - which, at today's share price, is equal to over $15 million dollars. That totals more than $21 million. Oh, and then there is the $200,000 worth of personal use of the company plane and the minimum of $25,000 worth of personal use of the company car – AND driver.

The head of Novartis’ salary was $3 million in 2005 and at the end of that year he owned at least $60 million worth of Novartis stock calculated using today’s share price.

The head of BMS cash compensation for 2005 was about $4.7 million. I can’t even go into his stock.

I should look up what those companies’ profits were.

i can barely make ends meet – I have received one tiny raise since I started working where I do now, which was four years ago, and I didn’t make much to begin with - and i am going to accept less than the best possible outcome for myself with this disease just so that all the pharmaceutical mukky muks can take home few more hundred million? not likely.

As Joni Mitchell said, the greed is the unraveling, it’s the unraveling, and it undoes all the joy that could be.

the success OF GDNF in human trials appears to have thrown up more questions than we have answers for. Ceo's salaries i'm convinced will have no relivance in holding back any scientific developments. Progress in any area of science cannot be stopped such is the competitive nature of business and the unbridled passion we as humans have for success. We are a curious species who will simply not rest until we have all the answers. "While much is unknown nothing is unknowable" Whoever said that is a genius.

Consider the expense of the operation involved in bringing GDNF to the commercial market and how close other human trials are, such as the gene therapy trials currently in progress with Neurologix www.neurologix.net. If Neurologix trials make it through to the commercial market, possibly by 2008, it will make GDNF treatment seem unwarranted, expensive and outdated. Maybe, just maybe there are better cures just around the corner, and any CEO worth their weight in gold (huge salaries, perks, and share portfolios ) will be aware of this.

Wherever the answer lies in why GDNF was pulled from commercial reality I am convinced we are closer than we think to the cure. Science is moving at such an exponential pace it is outrunning those who need to consider all social concerns.......and expenses.

Consider also, wherever the answer lies there is always going to be someone somewhere asking the difficult questions. Such is progress. We are living in exciting times.

GO HARD SCIENCE

Howard I understand your thinking but here's the reality. It will be years, years before we have something else. How many people do you sacrifice looking for the most streamlined delivery? This treatment works now. To do any less than at least grant compassionate use to the trial participants and gain more answers at the same time is cruel.

We do not know if gene therapy works. We do not know what stem cell therapy will develop. What we do know, is that DBS is the only option, and that nothing will save an advanced pd patient for many years.

You have to be suffering to understand it fully. Literally a generation will be lost. For what? Money and convenience.

If GDNF cured prostate cancer or similar ailments it would be in the FDA approval process already.

sorry lol

Edited to add - the author of the article that leads off this thread is suggesting we go back to more basic research before putting stuff in people that "doesn't work".

Hi Howard,

I wish I shared your optimism and confidence in the competitive nature of business and the desire for success.

To Paula's point regarding there being no guarantees that the exciting things going on in the research world will pan out, I remember how sure folks were that we were on the verge of great things with cell transplantation – and look where that went – back to the drawing board.

Regarding a desire for success, I don’t question its existence – but success can have infinite meanings. Publicly held companies’ bottom line, their definition of success, if they had to pick just one, is making money for their shareholders – pharmaceutical companies included. I could be wrong, but I don’t think there is any arguing with that statement. My idea of success for a pharmaceutical company is the development of a cure or an effective treatment. The only way my idea of success will be realized is if it intersects at the right price point with a pharmaceutical company's idea of success. To a pharmaceutical company, relevance of patient well-being is directly proportional to the amount of money it can bring in.

If the suspicions about Amgen are true and the safety concerns were not legitimate cause for stopping the trial, then it is a perfect example of what I describe – you say it yourself, in fact – consider the expense, particularly in view of how close other therapies seem to realization – but as Paula points out, what if one needs an effective therapy now? Deciding not to pursue a very promising therapy for – as you suggest – monetary reasons is not my idea of success, and that is why the CEO salaries/compensation are relevant – because our well-being is not their primary measure of success – their salaries and the companies’ bottom lines are.

As far as the promise the competitive nature of business holds, what has it done for us in the 36 years since levodopa hit the market? Not a whole heck of a lot – it took 27 years to come up with a dopamine agonist (mirapex, approved 1997) that is giving levodopa a run for its money – actually, dopamine agonists as a whole globally accounted for 50% of the Parkinson’s therapies market share in 2002 (the most recent numbers I could find) as compared with levodopa’s 30%* - which was a surprise to me, given the constant references to levodopa as the most commonly prescribed PD med – but both can be true, given the price differential between generics and branded products - so, while dopamine agonists (which really means Mirapex, i suspect) are clobbering levodopa in terms of dollars, levodopa still has a firm grip on the market in terms of penetration - which will be handy once Mirapex goes generic.

And finally, there is the hard evidence from the FTC that pharmaceutical companies break the law and yes, even engage in collusion to stifle competition (that would be a real life conspiracy) in order protect and maximize their profits, i.e., in order to achieve their idea of success – at the expense of people like us:

• Sandoz Pharmaceuticals Corporation, 115 F.T.C. 625 (1992) (consent order). The complaint charged that Sandoz unlawfully required those who purchased its schizophrenia drug, clozapine (the first new drug for the treatment of schizophrenia in more than 20 years), to also purchase distribution and patient-monitoring services from Sandoz. …The order prohibits Sandoz from requiring any purchaser of clozapine, or a patient taking clozapine, to buy other goods or services from Sandoz. http://www.ftc.gov/bc/rxupdate021108...20to%20Compete

• FTC v. Mylan Laboratories et al., 62 F. Supp. 2d 25 (D.D.C. 1999) (FTC Commission Actions: November 29, 2000 (www.ftc.gov)). In a complaint seeking injunctive and other relief … the Commission charged Mylan Laboratories and three other companies… with restraint of trade and conspiracy to monopolize the markets for two generic anti-anxiety drugs... The complaint also charged Mylan with monopolization and attempted monopolization of those markets.... On November 29, 2000, the Commission approved a proposed settlement, subject to approval by the federal district court…The defendants also agreed to an injunction barring them from entering into similar unlawful conduct in the future. http://www.ftc.gov/bc/rxupdate021108...20to%20Compete

• Bristol-Myers Squibb: On March 7, 2003, the Commission settled charges with Bristol-Myers Squibb Company (Bristol)… that it engaged in a series of anticompetitive acts over the past decade to obstruct the entry of low-price generic competition for three of Bristol's widely-used pharmaceutical products…. According to the FTC's complaint, Bristol's illegal conduct protected nearly $2 billion in annual sales at a high cost to cancer patients and other consumers who were denied access to lower-cost alternatives, and were forced to overpay by hundreds of millions of dollars for important and often life-saving medications.

Sandoz is Novartis’ generic arm – together they make generic sinemet, stalevo, bromocriptine, comtan, amantadine, clozapine, amitriptyline, selegiline, and nortriptyline.

Mylan and its subsidiaries/partners make, sinemet, generic sinemet, bromocriptine, selegiline, clozapine, amitriptyline, nortriptyline, apomorphine, artane and amantadine.

Bristol Myers Sqibb makes or markets (I think it is markets) Sinemet.

All three companies derive income from levodopa carbidopa, and two out of three also derive income from a variety of drugs that attempt to fix the problems levodopa causes. In other words, each of these companies has a substantial interest in maintaining the status quo in terms of PD therapies, which could put a dent in the potential held by “the competitive nature of business,” in my opinion. That each of these companies has either been found guilty of or come under fire for engaging in illegal activities directed at protecting/maximizing profits is indicative of just how far some companies will go in pursuit of their definition of success - i.e., not just breaking the law to achieve "success,", but doing it at our expense.

boann


* Orion in the Parkinson’s Disease Market, a presentation by Timo Lappalainen, Senior VP, Orion Pharma, 11/17/04 – I found it online and would be happy to email it to anyone who is interested

Hi Steve:
Thank you for responding. We are very happy to hear that we helped to inspire you to be more involved. The main reason why we went to the WPC
is to show everyone the wonderful affects of GDNF and make everyone informed of the mistake Amgen is making by not pursuing this drug and how poorly Amgen has treated the patients.

We have done everything we can think of to convince Amgen to change their minds from the media to legal avenues and nothing has worked. I truly believe that when a new delivery system is introduced, we'll see GDNF once again. I just pray that it's not too late for the original GDNF patients. There are some who are doing well and some who have regressed significantly.

I can go on for hours about my theories! If you have any ideas of what to do going forward or have any questions, please feel free to contact me or my husband Steve.

God Bless!
Maggie