[jeanb]

Paula

you went to the ASENT meeting, didn't you?

how was it?

[paula_w]

Hi Jean,

Yes it ended today and as always,we learned things. This was a medical/pharma community so I think we may have been the only 3 patients there. Met lots of people and attended a very good meeting on neuroethics. It was very interesting - one of the presenters was a judge, some from the FDA, researchers - See patent post. Thanks for asking.

paula

[jeanb]

Anything you want to share on neuroethics? I'm curious!

[paula_w]

Well the judge gave us a lesson in the history of ethics, which was very interesting for us non-ethics scholars.

From Socrates - Dalawisdalaw;
Kant - The Golden Rule;
Culture - America is "We reason to be right."
Utilitarian - example was when Churchill let Germany bomb his own people to save the greater number of lives by not giving away that they had cracked the German code. Good-Bad= (I can't read my writing...lol).
Social contract - in society, we agree to agree. In the case of a governed society vs. nature - for example,the ship is sinking - who gets the lifeboat, guests or crew. Otherwise we would have to fight to survive.

More modern things like sham surgery aren't going to be easy to convince them to reconsider. but when DBS was mentioned there was a "I don't know about that." They pointed out that placebo is not just needed to prove efficacy, but also needed to prove safety. They likened some trial participants to gamblers thinking - 50% chance for treatment.

They don't deny that it's about money. This was discussed in different contexts.

Met a drug rep who is a child advocate - refreshing.

If i think of more i'll post again.

paula
Sleep disorders covered in depth - one of pD first symptoms?

[Perryc]

Paula,

Good summary. I especially like the Judge who really appreciated the patient perspective. Intellectual Property is a big issue in government and academic research labs, as entreprenurial researchers, take advantage of laws allowing private companies to utilize publically funded science to further the public health mission of the NIH and others. Private companies are encouraged to take big risks of developing products which takes an average of 15 years and $800 mil. if all the failures are factored in. This tap on the explosion of new science relies on Patent protection for innovators to reward the successful companies quite handsomely. Some of the new developments in patent law were worrysome, however. For example, a new therapy can be tied up in courts for years if a litigation oriented company wants to use legal muscle to freeze out another (usually smaller and less financially secure start up) company by challenging their patents. Apparently new court cases from the Supreme Court (Justice Scalia) allow greater flexibility for this kind of threat. The companies in these legal battles often seem to forget their public responsibility based on the underlying science basis for their product. I didnt get the exact case name. Do you remember Paula?

In addition to ethics, which focused on conflicts of interests for researchers, a big part of the meeting addressed clincal trial design, and as Paula said, a whole session was devoted to sleep research. Sleep disorders are common in PD and like exercize, good sleep seems to be beneficial for a range of functioning. I for one went 10 years without good sleep, but since stopping mirapex, 1.5 years ago I am sleeping more normally and thinking clearer too. Exercize also can help sleep. The bottom line is Most PWP should have their sleep evaluated to find ways to improve sleep.

In clinical research, this meeting was somewhat overlapping with a similar meeting two weeks prior in DC of ISCTM (International Society for CNS Clinical Trials Methodology) sponsored by the Michael J Fox Foundation on clinical research design for neuro-protection research. It was suggested at both meetings that these 2 groups should get together.

The most interesting element of the clinical trials sessions was the discussion of adaptive clinical trial designs, particularly for the discovery phases of new therapy development (Phase II) where learning from early experience is incorporated into the design of subsequent steps. Identification of 'responders' and dose finding studies for use in future efficacy studies are important outcomes of this phase.

I have been attending ASENT for 5 or 6 years and have been on the Advocacy Group Forum planning committee for most of that time. I am glad to say that the advocacy organizations are looked at as an essential ingredient in the development of new therapies, and even Patients ourselves are increasingly recognized as providing a unique perspective and one that should be heard. For example the professional journal of ASENT, "Neurotherapeutics" is publishing a special issue on ethics this July, and I was invited to prepare an article from the Patient perspective. This a view rarely heard in neurology according to the Editor. Some of my colleagues including Paula, have been contributing to this effort.

Also, it has been slow going but now after nearly 3 years in the proposal stage and another 2 years in recruitment, training and launching the program, Parkinson's patient advocates are now active consultants to FDA reviewers at the pre-approval stages of drug development when industry sponsors and researchers present their study protocols and their analyses of the phase data. This gives PD a seat at the table (the first in all of CNS - neurology and psychiatry) where the decisions can be made to impact outcomes and regain lagging momentum in realizing new therapies promised by science.

Although the content is decidedly technical and scientific, many patients are qualified to understand enough to make important contributions from the patient perspective. I was happy that I was joined by Paula W. and Linda H. from the Parkinson Pipeline Project at this meeting, to represent patients views. The more we participate in the process as patients, the more comfortable the scientists will come to appreciate our views and our urgent needs for more effective therapies.

Perry C.

[lou_lou]

hello!

if this is as interesting to you as it is to me...
I thank you - dear paula and perry.

please -look up these words:

Neuroscientists,

bioethicists,

cognitive psychologists,

and

philosophers of law and mind

[jeanb]

Perry,

It's terrific to hear about patients attending these events.

Last week I attended a trade association meeting of medical device companies. I think I was the only patient there - but I was warmly received. An exec. vp told me he enjoyed meeting & working with pwp because we are informed and dedicated. And I was very happy to hear the keynote speaker speak about "putting patients first" and supporting "code of ethics" and especially" the patient voice is growing... but it is not as strong as it needs to be"