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.