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There is no excuse for government agencies to hide in secret meetings as a norm!
Nationwide Prostate Cancer Rally MAY 30th Over FDA Failure to Approve Safe, Effective Immunotherapy.
1 in 6 men get prostate cancer. 75 American men die from it every day. The FDA has not approved a treatment for stage IV prostate cancer in over 43 years.
Care To Live, a not for profit corporation, seeks transparency and accountability from the FDA, as to why they disregarded the advice of their hand selected Congressionally mandated Advisory Panel of experts, who voted Provenge overwhelmingly safe and effective. Without cause or explanation, in an unprecedented action, the FDA denied licensure. We are seeking immediate access to Provenge for all men with end stage prostate cancer.
On May 30, 2008, CareToLive will take to the streets to protest with the men desperately seeking Provenge. Over a year has passed, and 27,000 American men have died without hope, since the FDA denied the licensure of Provenge, an immunotherapy the FDA panel voted 17-0 safe and overwhelmingly voted effective. This is a noninvasive, non-toxic, immune building treatment, which works by employing your own body?s healthy cells to fight the cancer.
Men like Eduardo Garcia, who have had the 3 treatments, have gone from being incapacitated, to living healthy, productive lives, for as long as six years and counting. Dendreon, the company that perfected this treatment, also has similar treatments for breast, ovarian, colon, lung, kidney, and cervical cancers, in their sights.
The dysfunctional FDA's reason for delay has never been explained, as it was not science based, since survival and safety have clearly been demonstrated.
CareToLive filed a Citizens Petition for the FDA to reconsider the wrongful denial, (the only recourse the FDA allows), on July 26, 2007. The FDA has failed to follow Federal regulation and to this day they have not properly responded to our Petition, which seeks immediate access to Provenge for these desperate men. The FDA also refuses to respond to the CareToLive Freedom of Information Act request, which they know would prove that a few FDA insiders, who cared more about serving their own interests, rather than the best interest of the patients, purposely sabotaged Provenge.
?In memory of our members who have recently passed away, never having been given the chance Provenge recipient Eduardo Garcia had, we will continue to fight on, every day, in every way we can. Please come out and join us,? said CareToLive spokesperson, Mike Kearney.
Please join with me on May 30th, 2008, in Westlake Park, outside in downtown Seattle, Washington, from 1 PM to 3 PM, as a show of solidarity with our brothers who have been tossed aside by our incompetent, cold blooded health czars. Visit www.CareToLive.com for additional details.
Thank You, Jason Burdine Coordinator Seattle Jason.Burdine@gmail.com
David F. Plummer
Bellevue, WA
A fiduciary duty is the highest standard of care imposed by law. As an employee of the FDA, Dr. Scher has a fiduciary duty up hold to all Americans and is expected to be loyal to and act in the best interests of all Americans. As such, Dr. Scher must put aside his own personal interests and must not profit from his position. The foundation of Dr. Scher?s position is based upon good faith, loyalty, and trust. A fiduciary must not put themselves in a position where their interest and duty conflict.
As a Board Member to ProQuest Investments, a $1 billion venture capital fund, whose largest single investment was in Novacea, and whose lead product, Asentar, is in direct competition with Provenge, Dr Scher?s fiduciary duty at the FDA conflicted with his fiduciary duty to promote the interests of ProQuest and its investment in Novacea. This is like a lawyer representing both the plaintiff and the defendant in the same legal matter. The lawyer cannot make either the plaintiff or the defendant?s interes ts a top priority if both the plaintiff and the defendant?s interests are diametrically opposed. Dr. Scher should have recused himself from the Provenge Advisory Committee.
I am unaware of any action by the FDA to investigate and correct the obvious conflicts of interest that surround Dr. Scher's participation. Justice delayed is justice denied. This principle is the basis of the right to a speedy trial. The FDA has acted too slowly in investigating this issue. Even in responding to FOIA (Freedom of Information Act) requests, the FDA has stated that they can not reply timely because it is overburdened!
Dr. Scher should have recused himself from the Provenge advisory committee. He had a fiduciary duty to do so. Furthermore, it was inappropriate for Dr. Scher to lobby Dr. von Eschenbach personally to delay Provenge after the advisory committee meeting. And the leaking of letters from Dr. Scher, Dr. Maha Hussain and Dr. Thomas Fleming to the public was inappropriate, inimical to Provenge approval and dastardly. What is going on at the FDA to ignore these obvious attempts to sabotage a non-toxic treatment for terminal cancer?
Clinical Study of Abiraterone Acetate and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485303
Contacts
Contact: Howard Scher, MD 646-422-4323
http://clinicaltrials.gov/ct2/show/NCT00485303
This is the FDA's very Watergate of scandals, yet the press tells us, "No story here; everyone just move along."
David Litschel
Santa Barbara, CA
This seems like a very topical subject. How does one access all 15 comments?
Alistair Grisham PhD
Seattle FDA District Office
22201 23rd Dr. S.E.
Bothell, WA 98021
Coordinator - Monica Sagen - bikeriding2@yahoo.com
Co-coordinator - Jason Burdine - jnaburdine@comcast.net.
30,000 Men/ year
82 Men/ Day
Will Die from Prostate Cancer Yet, The FDA wants more data.
"A Right Delayed is a Right Denied"
Approve Provenge Now!
WHY did the FDA reject a product that was rated 17-0 for safety and 13-4 for SUBSTANTIAL efficacy by an EXPERT panel that was convened by the FDA itself??
Also...why are the key players in the rejection all stonewalling virtually every effort to uncover what REALLY happened in the days between the AC meeting and the FDA rejection on May 9th, 2007??
Why are NO journalists interested in seeking the truth in this gigantic scandal?
Tens of thousands of PCa victims might benefit from treatment with DNDN's Provenge. Why are forces so strongly arrayed against a new and innovative treatment for late stage and presently incurable PCa?
I'm disgusted with the deafening journalistic silence surrounding the Provenge rejection debacle.
What is our country coming to??
Bravo on shining more light on the Provenge saga?a saga that is fast becoming more suggestive of a literary epic in terms of size and scale.
Meanwhile, I have a question I hope you can answer regarding the FDA?s decision:
I do not think it can be overstated that the FDA has never overruled an overwhelming AC recommendation for approval of a drug for an end-stage disease...making the FDA's action "unprecedented.? Which begs the question: Why was it this time? It was a decision, as you noted, that ?made waves.? I find it ironic, however, that our media have failed to ask the FDA ?who made that decision??
Specifically:
If a public Advisory Committee (AC) hearing recommends the approval of a new drug and the FDA later issues a Complete Response Letter is there public access or a public record kept at the FDA regarding the ?non-public? closed door hearing (s) that resulted in the FDA overruling such a ?positive? AC panel?
The FDA has been unable or unwilling to answer the simple question of whether there is even a public record available (even if one is ?unavailable? to the public now). And if there is no public record, is the FDA telling Americans that it does not keep transcripts of all the arguments, notes and votes of those who attend the ?non-public? meetings? Are life and death decisions at the FDA made with ?winks & nods? without serious discussion and debate? And who would that benefit? It would also be nice to know who calls the meeting to order, and who decides who attends these ?non-public? meetings? Is there even a meeting?
Considering this is The United States of America, it appears that it is not meaningful if the public AC hearing is merely a sham and the ?real meeting? occurs behind closed doors.
I hope Eric Fetters-Walp that you will be able to get answers to these questions. Americans deserve better than an FDA operating in secrecy in the name of good science?
If the above poster's info isn't enough to whet your appetite to further investigate this story, perhaps, the below facts can spur you on.
In case you and your reader's are unfamiliar with the specifics on some of the allegations of wrong doings in the FDA process, consider these:
A. Dr. Howard Isadore Scher of Sloan-Kettering in NYC submitted to the FDA, as part of his qualifications to sit in judgment of Provenge on the March 29th '07 FDA Advisory Committee, that he had 3 Conflict of Interests (COI).
17 (SEVENTEEN) Conflicts of Interest for Scher can be found on the internet and are:
*** NOTE particularly items 1 & 17
1. NOVACEA: grants & research support; STUDY CHAIR of DN-101
?. and DIRECT COMPETITOR to Provenge
.. which Scher was involved in not only as the Primary Investigator, but also with his financial and advisory capacity through Proquest Investments as noted below.
... and BTW, this clinical trial has been halted due, as I recall, for having too many DEATHS.
2. GPB BIOTECH: financial conflict of interest per Scher in MedPage
3. PHARMION: financial conflict of interest per Scher in MedPage
4. SANOFI-AVENTIS: grants & research support
5. BRISTOL MYERSSQUIBB: consultant, grants & research
6. MILLENNIUM PHARMCEUTICALS: grant of research support
7. COUGAR BIOTECHNOLOGY: principal investigator; advisory board
8. INNOVIVE PHARMACEUTICALS: principal investigator
9. INFINITY PHARMACEUTICALS: principal investigator
10. BIOGEN-IDEC: jointly held stock with spouse
11. PFIZER: jointly held stock with spouse
12. GENTA: scientific advisory board (as of Mar 6, 07; since removed but cached)
13. CONFOMA THERAPEUTICS: scientific advisory board
14. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2
15. AMBRILIABIOPHARMA INC: Principal Investigator PCK3145, Phase I/II
16. MEDIVATION, INC: principal investigator MDV3100
17. PROQUEST INVESTMENTS, Board of Directors, Advisor. Novacea Investor
B. Even after having his say at the AC meeting, Scher went beyond the call of duty. He wrote the FDA in opposition of Provenge approval via a CONFIDENTIAL letter.
Somehow, mysteriously, this CONFIDENTIAL letter was leaked outside the FDA to a local DC area Mom and Pop publication (run by a Russian immigrant and his wife out of their basement) circulated in the cancer community. This publication's acquisition of a CONFIDENTIAL FDA correspondence has never been investigated, despite calls on the Department of Health and Human services and the FDA to do so.
C. Suspiciously, 2 other individuals, Maha Hussain of University of Michigan and a local Washington state resident likewise wrote CONFIDENTIAL letters in opposition to Provenge's approval which also, coincidentially, were leaked to and published in this same DC cancer publication as Scher's. Again... no investigation by HHS or the FDA as to how and by whom these internal government documents were leaked.
D. Despite the "claims" of threats by Scher and Hussain, neither has provided copies of these alleged threats nor have any police report which surely should have been made surfaced, despite questions about them being made. They remain just that.. their word such illegal activities were made against them with absolute no concrete proof.
E. A local Seattle area resident, Dr. Thomas Fleming--a professor at the University of Washington--was also 1 of 3 individuals who--after the AC meeting--wrote a CONFIDENTIAL letter to the FDA urging disapproval.
Fleming, who claimed in his leaked CONFIDENTIAL FDA letter, had sleepless nights worrying about Provenge being Approved. Flemming was not eligible to sit in judgment on the FDA Provenge AC hearings.
Why? Because he'd performed statistical work (and presumably had access to confidential company clinical trial data) and apparently received remuneration from Dendreon for the work performed for Dendreon.
For Fleming to write such a letter is, imo, beyond being UNETHICAL and one has to wonder what his dog is in the fight against Provenge and Dendreon.
And, if I were a company in need of statistical consulting work, Fleming would not be considered by me because he's shown CONFIDENTIAL information he acquires by working for a company "can" become public in the future.
Some ethics for a statistician and a professor, isn't it?
E. Despite requesting investigations to both the HHS and the FDA with claims of legal wrong-doing regarding the 3 CONFIDENTIAL letters written to the FDA which were subsequently leaked outside the agency AND regarding the above claims that Scher has more and disqualifying COI than he reported to the FDA, neither agency has responded to these requests for investigations for almost a year now.
However, when 2 individuals sent flowers to the FDA Commissioner on the 1st anniversary of the FDA AC meeting several weeks ago, a mere 1 business day later, 2 (TWO) investigators showed up at the floral shop requesting the identity and contact info on the flower senders.
F. Others have noted that even more suspicious activities involved in the Provenge saga such as the refusal of the FDA to abide by the Freedom of Information Act to provide requested documents timely; questions about the role of Dr. Richard Pazdur, the head of the FDA cancer division which did NOT get to judge Provenge because Provenge--while treating cancer--is a BIOLOGIC agent and was assigned to the biological division of the FDA; and the story goes on and on.
Sadly, since the May 9th '07 refusal to approve Provenge, men continue to die at the rate of 83 men each and every day, 24/7. Since the FDA's decision last year, some
29,299 deaths
has occurred. Many of these men could have benefited from Provenge by having their life extended and with a BETTER QUALITY OF LIFE with their family and friends.
I sincerely hope that you and your publication will see, with all the information provided by comments here, that there is a REAL story to had in the Provenge saga.
The Provenge case exemplifies how certain individuals within FDA have distorted that standard well beyond congressional intent and to the detriment of patients. Misguided adherence to unreasonable statistical rigor, for the sake of statistical purity (perhaps well-intentioned), played a major role in delaying Provenge approval.
All the immunology experts on the advisory panel, after carefully reviewing both the statistical data and other information, were among the 13 who voted that there was substantial evidence of efficacy. Who better than they (from the nation's leading cancer centers and academic institutions, M.D. Anderson, Moffitt, Harvard, Stanford, Duke, and the NIH, to name a few) to interpret all the information? But no, a few less-qualified bureaucrats at FDA, for the first time in history, rejected the real experts' overwhelming recommendation to approve a drug for an end-stage disease.
Statistics never tell the whole story in any scientific inquiry. Were they so reliable, there would be no need for an advisory panel. A computer could make the decision. Use of advisory panels is required for good reason.
True, whether the post AC process was corrupted should be investigated and any guilty parties punished. More importantly, however, the American public must demand that realistic standards for evaluating efficacy be employed, especially for unequivocally safe drugs that are used in terminal diseases. Sadly, Provenge is not the first life-extending drug approval of which the FDA will have unreasonably delayed. It will be the last only if enough members of the public and the media motivate Congress to require significant change at FDA. How many additional Americans have to die before that happens?
On Friday May 30th demonstrations protesting the FDA decision will be held in numerous cities including Seattle (outside FDA offices in Bothell).
Other sites include Chicago (ASCO), Dearborn (Dingell's Office), Atlanta (FDA offices), Cleveland (public Square), Philly (outside FDA offices), Madison Wisconsin (Capitol building), New York, NY (MSK), Maitland Florida (FDA offices)
CareToLive filed a Citizen Petition on July 27, 2007 asking the FDA to reconsider this failure to approve Provenge. The FDA was to properly respond by January 24, 2008. Instead Jesse Goodman the head of the CBER division of the FDA said they needed more time, while 83 men a day die without access. Two FDA employees then told CareToLive that a committee had been formed and they were actively considering the petition along with the comments submitted (over 200 comments in support). That was two months ago and now appears to have been but a legal maneuver done without concern for the patients who sit in wait and have no viable treatment options.
Proof that Provenge was purposely sabotaged by Richard Pazdur, an FDA employee, is in the documents that were requested in a Freedom of Information Act request made by CareToLive. The FDA refuses to turn them over to the public.
The FDA commissioner knows what happened was wrong, but he refuses to fix it.
There could be a pulitzer at stake.
Ask yourself, who would bet against a positive AC vote which has never been over turned and ignored in the entire history of the FDA.
The FDA, insiders and Howie made hundreds of millions at the expense of many men dying.
Do you think the SEC would look at that? No.
Would Congress? No. Will the FDA even answer the questions put to them under the Freedom of Information Act? No.
A full investigation of the facts of last year should be a priority with the SEC. The fact that there was insider trading is obvious and the trail they left is uncoverable, but the SEC is a dog who doesn't hunt.
Just correcting the quote...
David Miller (president of Seattle-based Biotech Stock Research) was correct when he said ?"There are a lot of guys who think [Dendreon] got screwed," he says. "And they did."?
Among other things, you certainly would have done better to look behind the FDA?s ?curtain? and examine the issues surrounding Drs. Howard Scher and Maha Hussain than to dismiss the matter of their objections to the approval of Provenge in three short paragraphs.
Specifically, regarding the two Provenge advisory committee (AC) members you mentioned, Drs. Scher and Hussain, both were serving in the capacity of ?special government employees.? Both voted YES on the first question regarding Provenge?s Safety; both voted NO on the question regarding whether or not the drug evidenced Substantial Efficacy, the federal standard. Both are chemotherapists, not immunotherapists, and so, were in a distinct minority on the AC.
The following facts should be known, however, regarding their participation in the AC meeting and their actions in the days that followed:
1. Both Drs. Scher and Hussain were participating in the Provenge AC meeting under waivers granted to them by the FDA; these waivers were granted at a time when the FDA was considering tightening its rules for conflicts of interest (COI) under pressure from Congress. In fact, the FDA already had issued proposed new rules for public comment. An independent evaluation of Drs. Scher?s and Hussain?s eligibility to participate in the Provenge AC by Steve Usdin, Washington Editor of BioCentury, The Bernstein Report on BioBusiness, using the proposed new rules, yielded the following result (March 26, 2007 edition):
Dr. Maha Hussain: ?The waiver notes that Hussain is the principal investigator on a research contract awarded by a competing company for a product that is not related to Provenge. Under the draft guidance this probably would not be considered a conflict. However, the fact that her husband owns stock in three competing companies, valued at $15,000-$300,000, would at minimum prevent her from voting. If the total value of the stock exceeds $50,000, Hussain wouldn?t even be at the table if the new policy were in effect.?
Dr. Howard Scher: ?Under the draft guidance, Scher either would be prevented from voting or excluded from the meeting.
?He owns stock in a firm that competes with DNDN valued at $5,000-$100,000. In addition, Memorial Sloan-Kettering has a grant from a competing company valued at $100,000-$300,000 to study a licensed, approved drug in prostate cancer trials.?
Given the new rules then under consideration and the sensitivity to COIs already registered by the Congress that spring, it would have been prudent for the FDA to have rejected the waiver requests for Drs. Scher and Hussain. Rejections now appear all the more warranted, given that since the Provenge AC meeting, additional compromising information regarding these two AC members, and especially Dr. Scher, have come to light.
2. Specifically, we now know that the time of the Provenge AC meeting, Dr. Scher was on Novacea's (NOVC) scientific advisory board as co-lead investigator of what at that time was NOVC?s Asentar Phase III clinical trial in the same stage of prostate cancer as Provenge. (Note: since that time, this trial has been stopped because of the high death rate in the Asentar arm.).
3. We also know that at the time of the Provenge AC meeting (and, perhaps, even now), Dr. Scher was on the Scientific Advisory Board of, and may have been an officer and a member of the board of directors of, ProQuest Investments (?ProQuest?). At the time of the Provenge AC meeting (March 29, 2007), ProQuest had significant holdings (in excess of 8%) in NOVC (here's the URL to a 13d on NOVC filed by ProQuest in May, 2006: http://www.secinfo.com/dSEyn.v8d.htm; it shows that as of May, 2006, Proquest held 1,779,767 shares of NOVC). A ProQuest officer was, at the time of the Provenge AC meeting, on the board of directors of Novacea, but he has since resigned from that board.
4. On May 30, 2007, just 3 weeks after the FDA refused to approve Provenge, NOVC signed a major agreement with Schering-Plough to co-develop Asentar. These deals do not happen overnight; they can take 6-9 months, or longer, to mature. Basically, Novacea had found a large pharmaceutical partner with deep pockets for its late-stage prostate cancer drug, Asentar, and it licensed product rights to Schering-Plough in exchange for $60 million up-front and the potential for $380 million in milestones down the road. News of the worldwide development and commercialization agreement sent Novacea's shares shooting up more than 100% at one point in morning trading, going as high as $17.25 before closing at $15, up by $6.94, or 86%. That's the highest Novacea's shares have traded since the company went public with the May 2006 offering at $6.50 per share.
According to the 10-K filed with the SEC on April 2, 2007 (http://yahoo.brand.edgar-online.com/fetchFilingFrameset.aspx?dcn=0001193125-07-071961&Type=HTML), major concerns to NOVC going forward regarding market acceptance of Asentar were the ?potential advantages or disadvantages over alternative treatments.? Further, the 10-K noted that ?[I]f our future product candidates fail to achieve market acceptance, we may not be able to generate significant revenue or achieve or sustain profitability.? (Novacea?s agreement with Schering-Plough for the development of Asentar has since been terminated.)
5. Importantly, following the Provenge AC meeting, Drs. Scher and Hussain went on to write letters to the FDA, disparaging Provenge and calling for non-approval of the immunotherapy?letters that were leaked immediately upon their receipt at the agency (if not before) to the non-peer-reviewed The Cancer Letter. This is a highly (!) unusual act for a special government employee to take. Who asked Dr. Scher to write his letter and what part was played by personnel at the FDA and NCI in helping Dr. Scher write his letter? (A draft of Dr. Scher?s letter (version 3) was found on the computer of a researcher at the National Cancer Institute (NCI; this draft was obtained under a FOIA request) and at least one other NCI researcher attended a meeting at the FDA to discuss the development of Dr. Scher?s letter (information obtained under a FOIA request).) These questions never have been answered by the FDA or NCI. Nor has the person or persons responsible for leaking the letters written by Drs. Scher and Hussain (as well as a third letter written to the FDA by Dr. Thomas Fleming) to The Cancer Letter ever been identified and prosecuted. It is not even known whether or not an active investigation is being conducted by the HHS Office of the Inspector General!
So, while the Washington CEO article certainly presented a good review of Dendreon?s history in attempting to bring Provenge through the FDA approval cycle, it grabbed ?the low-hanging fruit? and left what many believe to be the most interesting ? really, the most compelling ? part of the story for others to investigate.
Meanwhile, by my count, almost 30,000 men have died of prostate cancer since the FDA sent Provenge an ?approvable? letter. How many of those could have been helped by a drug that 17 panel members voted Safe and 13 out of 17 panel members voted as having Substantial Efficacy?
A few issues I thought needed addressing are...
"The letters from panel members Howard Scher and Maha Hussain were strong"......Scher's letter has been throughly debunked, torn to shreads, by a rebuttal letter(it, however, wasn't published on The Cancer Letter site).
The supposed death threats are just that.."alleged" is a common term being used. A cash reward has been offered for any proof that a death threat took place at all....I believe even a police report will win the producer of such the bounty.
I don't rember reading, sorry if it was in the article, about how, for some reason, the FDA hasn't complied with the Freedom of Information Act requests from CaretoLive. They had 20 days to comply...it's been more than a year?
kel
As CEO Gold is quoted in the article..."the first time, that we know of, when the FDA went against the AC's approval advice"....it is indeed the first time in history in the case of a life threatening illness that the FDA went against the approval recomendation of the AC...RED FLAG!!!!
With all the recent problems at the FDA seemingly only worsening, perhaps it's time for Andy Von Eschenbach to resign his post of FDA Commish.
Thanks for your article and keeping the Provenge story alive, too bad a couple of conflicted AC panelists helped rip hope away from many of the some 30,000 American men who are now quite DEAD. Some of these men would still be alive if they were given the opportunity to choose Provenge..if only we could read their comments.
kel
I am not a real estate agent, I am an individual who use to lived next to this home.
Please if you could send me information how I can get information on this property.
An unfortunate miss in this article is the nationally recognized MBA in Sustainable Business program at the Bainbridge Graduate Institute (www.BGIedu.org ). BGI launched this pioneering program only 6 years ago and now has over 150 students in 2 and 3 year MBA programs as well as Certificate programs.
Recognized by the Aspen institute in their ?Beyond Gray Pinstripes? report, ranked 1st nationally two years running by the Net Impact MBA student survey and named by BusinessWeek Magazine as one of the top 10 design programs in the world (October 2007).
Drawing thought leading faculty from institutions such as Stanford, Darden, MIT and many others, the executive style program attracts mid-career professionals from around the country who come to the Bainbridge Island campus ? Islandwood one long weekend per month.
Sustainability is emerging as a set of mission critical skills for future business leaders. It?s a real miss to have such a successful, well recognized program not make your roundup.
Upcoming Seattle Info sessions (according to their web site):
Wed., April 23 @ 6:30 p.m.
Wed., May 7 @ 6:30 p.m.
Wed., May 21 @ 6:30 p.m.
In Seattle information sessions are held at the Clear Channel Network headquarters, 351 Elliot Ave W,
Kevin Hagen MBA Class of ?05
Our main purpose here is to create experiences for people that serve to strengthen relationships, increase self-awareness, and improve communication skills. We go about doing this by crafting a sequence of activities that produce dialog and help people take ownership of their learning. We support this process by being artful facilitators, asking the right questions at the right time, and encouraging participants to talk, ask questions, and engage. If we do our job right, participants feel like the conversations they?re having and the lessons they?re taking away were their own ideas.
All our programs are designed to support the following:
1. Socialization ? provide people with a relaxed environment to casually build connections and relationships.
2. Skills Development ? provide people with opportunities to test their ability to work as a unit, to form ideas into plans of action, to adapt to change and maintain positive relationships.
3. Entertainment ? offer engaging and often hilarious activities that are presented in a story that compels people to get involved
4. Education ? give participants control of what they?re talking about as a result of their experience and help them take away key lessons that will make a difference for their team community as well as their individual lives.
I look forward to talking with you about working together.
I work at Pacific Northwest National Laboratory on the eastern side of the mountains.
I just read your piece about the Tri-Cities and wanted to offer another resource to you for future stories, particularly related to economic development.
Gary Spanner, manager of our economic development office, chairs the Tri-Cities Research District board. Among other things, he's implemented several programs that can help diversify communities.
Give me a call if you find yourself writing about economic development, even if it isn't just east of the Cascades.
Andrea Turner
509-375-3893
Nice overview article about the hotel situation in the area.
A good relationship benefits the worker and the employer in many ways. Millions of dollars are spent every year to silence workers and your magazine doesn't seem to have a problem with that. I am disappointed in your magazine for supporting this inequity. What are companies afraid of? A contract helps with worker retention and conflict resolution. A contract makes sure that all rules are applied equally and that everyone follows the same rules. Isn't that what we all want?
A very sad state of affairs.
Richard Freese
Briefly (and simplified), "power" is the chance a clinical trial will show a positive result assuming the drug being tested actually works. Most oncology trials are powered around 90%. If your drug works, this means your trial has a 90% chance of coming back positive with a 10% of a false negative.
Dendreon's timeline shifting holds the power of their interim and final analyses nearly constant. The shifting neither increases nor decreases the power for either peek at the data.
As a covering analyst on Dendreon for over seven years, I can personally attest this has not been an easy story. While the power hasn't changed, some worry that advancing the final analysis will dampen the ability of the trial to be successful since Provenge has shown its biggest effect is later in the survival curve.
With a potential market in the billions of dollars for Provenge, it's safe to say all eyes will be on the results -- both here locally and on Wall Street.
No matter where I travel from Bremerton, to Seattle, points North and South, I always breathe a sigh of relief upon entering Bremerton.
My new home, for some time to come.
Joanne Victoria
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I wanted to personally invite you and a companion/colleague to join us for this special event, brought to you by friend, colleague and co-creator of ?What the BLEEP Do We Know!?? Betsy Chasse. Please let me know, as seating is limited and is by invitation only. Do hope you can make it. This is truly an extraordinary film. If you are unable to make it and would like to go to the theatre ? we will make a ticket available to you.
You and a friend are invited to a
FREE Press Screening of WATER
7:30 p.m. on Monday, March 17th
Hosted at:
Regal Meridian 16
1501 7th Ave
Seattle, WA 98101
What the BLEEP Do We Know?! Co-Creator Betsy Chasse and BLEEP Marketing Specialist Melissa Henderson of Intention Media are excited to announce their new film,,?.. WATER! Please join us for this private press screening at the Regal Meridian 16 Theater on Monday, March 17th.
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The film features an in-depth look into the single most important material for all life, essential to the biological makeup of all living matter... ?Water?, by Russian Filmmaker, Saida Medvedeva. WATER is a groundbreaking, new documentary which reveals breathtaking discoveries by researchers worldwide, including Dr. Masaru Emoto of What the BLEEP?!, as it delves deep into phenomenon of the most abundant material on the face of the earth.
A revolution has taken place in the science, understanding of the structure of water and how easily it can be changed. This and so much more fascinating and detailed information portrayed in this film in a vast array of topics including biology, religion, science, parenting, conservation efforts, behavior and politics to name a few.
Water Planet, a short film by Leonardo DiCaprio will be shown prior to the feature in an effort to share even more information and inspire people to contemplate this valuable resource and their relationship with it.
Seating is limited so please RSVP
You are welcome to bring one guest. If you feel there is someone else who might find this information of valuable, please let me know.
Please RSVP your names by emailing rhonah@ywave.com so we can check you off our list at the door.
For more information, please visit www.waterthemovie.com. If you are in need of press information, please email rhonah at rhonah@ywave.com
Dick Adams
I agree with this caveat. I'm not against quasi private/governmental redevelopment projects when the true costs and risks are fully disclosed, understood and equitably shared. With RPS the risks were not disclosed and in fact material facts were concealed from the public and the institutional bond investors. The public had to make the initial bond investors whole who were defrauded and successfully sued. The public took on most of the risk and got left holding the empty bag while the principals walked away with the pot. Had the public paid up front, the true costs would have been much less and the same beneficial effects would have occurred.
Ron the Cop
Friends of Mark Fuhrman>/a>
I agree with this caveat. I'm not against quasi private/governmental redevelopment projects when the true costs and risks are fully disclosed, understood and equitably shared. With RPS the risks were not disclosed and in fact material facts were concealed from the public and the institutional bond investors. The public had to make the initial bond investors whole who were defrauded and successfully sued. The public took on most of the risk and got left holding the empty bag while the principals walked away with the pot. Had the public paid up front, the true costs would have been much less and the same beneficial effects would have occurred.
Ron the Cop
Friends of Mark Fuhrman
I have not lived in WA for some time now; I live in Livingston, MT and work as a fine artist out of our rented log house just below Sheep Mountain. I am a painter, just like a lot of my old friends knew I would be when I finally grew up!
When I would return home in recent years I was saddened to see the state of the downtown area. I remember Christmas shopping at Penney's; getting a coke and french fries at O'berg Drugs. You had to spend at least $2.50 to sit in a booth back in the '60's. So my sister and her friend would pool our babysitting funds for the treat out.
My Mom worked at the lunch counter at Woolworths, and also at the 'dime store' Kresses that used to be on Pacific. My Dad worked in the pumpwells in PSNS after he was discharged from the Marine Corp. He was like many people of his generation that never worked anywhere else once they went to work at the shipyard.
I am happy to see folks with a vision investing in Bremerton. It was a great place to grow up, and it will be again.
Taylor Drew Kelly
Blazingcolors@yahoo.com
(formerly Terri J.Ponder-Myers)
Still the downturn in prices and building of inventories is starting to attract second home buyers from Florida looking for cool temperatures in our mountains. Also the dramatic decline in the dollar combined with weakness in American real estate markets are beginning to interest some bargain hunting European investors.
Ron Holland, Broker/Realtor with Wolf's Crossing Realty. See www.ronaldholland.com Ron markets resale mountain and ski resort properties in NC in Wolf Laurel and The Preserve at Wolf Laurel.
Nice job helping clients make sense of the local internet advertising possibilities.
My son is an aspiring business major at the UW and will appreciate the Dean Paton article, Top Dawg.
Keep up the subscriber friendly services.
Kevin Johnson
Regards
Diana
Bob Moylan
In short, we need to market solar as an investment that will save money while you own it and return most or all of your investment when you sell the building it's sitting on.
Chances are, as natural gas and oil prices go up, there will be a corresponding jump in your monthly electricity bill. So, instead of promoting a solar power system based on today's savings in electricity, we need to have easily understandable projections on what the savings will be over the life of a system. These numbers need to reflect what's really happening to the cost of energy!
Here are some ideas I'd like to share. First, we need to find a way to make renewable energy economically competitive without the tax incentives. We do this by answering the question: "What is the opportunity cost of not using solar to decrease your energy bill?"
There's something interesting I've found. There's a direct correlation among electrical rates, the cost of air conditioning a building, the heat index and the amount of sunshine on any given day. In other words, on the hottest, sunniest days, we use more electricity that costs more per kilowatt. So, why do we continue to promote average hours of solar production, when in fact (at least down here in California), we produce far more solar power per day during the heat of the summer when energy costs are highest, than we do in our temperate winter months when energy costs are lowest. A sound marketing approach would be to evaluate solar energy in "dollars" of production per year instead of in kilowatts. I'm sure there are some smart people out there who can match kilowatts of solar production on any given day of the year to what the rates will be (based on the projected costs of electricity).
Secondly, we should stop trying to sell a solar package as a "cost." In real estate, there is a principle that says anything affixed to real estate becomes an integral part of the real estate. Once a solar package is installed, it immediately increases the value of a property. So how can you predict how much more a building will be worth in 5-10 years with a package as opposed to without one? In the real estate appraisal business, there are three approaches to appraising a property. The market approach (what are comparable properties selling for), the reproduction cost (the cost of creating an identical building at current construction and material prices) and the actual original cost adjusted for inflation. In all three methods, there's a strong case that a system installed today will make the building worth more today and in future years.
We need some realistic numbers to predict how much more a property will be worth in the years following installation. I believe that if you sell a building 5-10 years after installing solar, you should recoup all of your investment in the system plus an added bonus. If the rumors are true, a residential system (using the market approach) adds $20 of value to a home for every $1 it saves on the electric bill.
For commercial appraisals, you would divide the income (savings) by a cap rate (which was about 9% at last report). A system that saves $2000 a year then would be worth $40,000 on a home or $25,000 on a business. But if the cost of electricity goes up (if that is remotely possible), then wouldn't the value of the solar power system increase as well? In reality, we are not selling something that costs ? we are actually offering a financial investment that grows comparably with other forms of energy.
In short, we need to market solar as an investment that will save money while you own it and return most or all of your investment when you sell the building it's sitting on. In commercial real estate, they use a "Cash Flow Analysis" form as the tool to evaluate a building's value using the income approach. We need a similar tool for putting a value on solar. If solar makes sense with this approach, then just think of how much better the systems look when you add the tax advantages!
This approach also applies to the cost of Energy efficiency implementation.
Reducing operational costs increases the value of the business and or property.
Compiled by Jay Draiman, Energy analyst
12/1/2007
prewell
yes I am fully
persuaded
Lori
Please contact me,
Todd Bouchard
CEO Kingslin Capital
503.750.0112
I strongly believe that in order for an organization to present themselves as Christian-based, the employees that make up that organization should aggree with and live up to those standards. An organization is only as strong as its employees. Anyone can make a claim, but the standards World Vision has in place truly prove them to be a "walk the walk" rather than "talk the talk" organization. And an organization whos employees are willing to put others before themselves, is an organization worth investing in. When you invest in an organization like World Vision, you're investing in people's lives. There's nothing more rewarding than that.
I have just put down my latest copy of Washington CEO. As President of Keiretsu Forum Northwest, the nation?s largest angel investing network, I have to say I am proud of your coverage and the distinction your magazine gave between angel investors and venture capitalist. In the Northwest, I think it is crucial we continue to feed our entrepreneurs spirits. We have the potential to create many more Boeings, Starbucks, Amazon and Fluke Industries.
We are also pleased we are expanding into co-investing with many venture funds and VC?s. Keiretsu Forum feels this new model is a way to support the growth for entrepreneurs which is creating the economic growth.
From my experience Mr. Majer's reputation is rightfully sterling.
Since December 2003 the State has seen only a slight increase in new facility construction as a result of the decision to locate the 787 here. In fact only five suppliers were new to Washington state and they all moved into existing facilities (Messier Dowty, Messier Bugatti, New Breed Logistics, Draeger Aerospace, Liebherr Aerospace Toulouse). At the state level, we have either become complacent, asleep at the switch or fat cats (and they don't hunt)!
Sent: Friday, September 21, 2007 5:28 PM
To: Leslie Helm
Subject: Letter to the editor
Casey Corr's observations about the impact of the arts in new business recruitment (August/2007, Putting Priority on People) represent a common misunderstanding regarding the definition of economic development. While the "soft" features of a location such as its appearance or "quality of life" activities such as the arts may have an influence on a company?s site selection process, these features better represent what are called community development. Community development has an internal focus and attempts to make life more pleasant for those in a particular location. Economic development as it relates to new business recruitment focuses on essential operational needs of a business such as power, water, sewer, transportation, shipping docks, etc. These features are commonly referred to as infrastructure and have an external focus for the operational needs of business.
It is also important to make a distinction between primary industries and secondary industries. Primary industries add wealth to a region by creating a product or service and selling it to those on the outside of the region. Secondary industries are supported by the distribution of that wealth with the purchasing and selling of goods and services among those inside the region. Without the money created by primary businesses, no one has the resources for the purchase of goods or services in secondary businesses. Nor will they have any money for community development projects such as the arts. The best thing that can happen to a secondary business like a mom-and-pop pizza joint is for a primary business like Boeing to flourish and prosper??make that extra large please.?
The cost of infrastructure, however, is often very expensive, and as businesses consider various locations for their operation they will simply choose a site that has the least development and infrastructure costs. The role of government in economic development then becomes the public policy question of how to reap the job-creation benefits of primary industries?do we collectively pay for the essential items needed for businesses to locate and grow in our region or do we place the entire burden on the private sector? Thankfully, the federal government offered free land to the railroad industry to provide incentives for the expansion of the western United States and also created the Rural Electrification Act that permitted public utilities to be formed to provide for the low-cost electrical infrastructure needs of primary industries such as agriculture and aluminum. Obviously, there is a role for both public and private investment in economic development, and the best type of infrastructure projects are public/private partnerships such as the dock project for the Boeing Corporation. While on the surface public contribution in the infrastructure needs of private industry may seem like ?sloppy science? and corporate welfare, for government to view the operational needs of businesses from their perspective provides a better understanding of what really stimulates economic development.
Pat Haley, Director
Port of Douglas County
www.portofdouglas.org
My goal with the event had been to create a new reality for the media - that from that day on they would need to pay attention to Microsoft as a game and entertainment company - and also to help promote those companies who were betting their future on Microsoft's untried commitment to the game industry.
Now the Seattle area's proximity to Asia also presents another unique opportunity for growth as the game industry becomes truly global.
That is the next chapter I hope to help write for the future of Washington state's entertainment industry.
Japanese do not create..they INNOVATE. Hence, i am not surprised if one day the Japanese becomes No.1 in this industry..just like they do in other industries e.g. automotive, etc.
Wanna know Japanese better? Know their language and you click!
Visit me here www.translationgoes.blogspot.com. I will be posting my experience dealing with the Japanese
And where can the city expand?
As the neighborhoods to the south expand, the situation will only get worse.
What happens as a result?
Traffic congestion doubles.
For less money we could have much better results from investing in both transit and roads.
Proposition 1 is the wrong plan; it costs too much; it does too little.
Vote No.
Thanks again -- the crowd request the image of Dustin! :-)
On one hand he accuses the proponents of subterfuge on the numbers, then turns around and uses wildly innaccurate figures in an attempt to cast doubt. This dubious figure of $157B appears to include all of the phase one ST costs approved by voters in 1996, PLUS all the ST2-RTID costs thru 2027, plus continued full taxation for another 30 years beyond completion.
Including first-phase costs is flat disingenuous, and assuming full taxation beyond program completion is something Mr. Niles knows full well the ST Board has no authority to do.
Then he attacks light rail for not carrying enough people without acknowledging that it will carry the most trips - 40%-50% - in and out of Seattle during rush hour--the two times a day the roads are clogged and dysfunctional. Techies out there will recognize this as bandwidth, and our system needs more of it.
Next he attack ST's record, stating it's only done half of what was promised. This again is not correct. ST has delivered all its express bus serivce, nearly all its bus capital improvements, and commuter rail as promised between Tacoma and Everett. Mr Niles knows the initial, 14-mile light rail segment, while three years late, will open in less than two years. He knows the 1.7-mile airport connection will open six months later. He knows the feds have a) approved final design, b) rated highest in the nation, and c) proposed funding for a rail extension from downtown to UW -- scheduled to break ground next year. All told, this means ST is delivering 19 of 21 miles of light rail promised in addition to the bus and Sounder improvements. Not perfect, but not bad for a start-up, either.
The coup de faux is the fact that Mr. Niles has no alternative, no solution of his own to propose, nor do the other critics of the plan. They'd rather scare people on the numbers rather than risk putting their solution - more buses and lots more tolls - because they know people are sick of buses getting stuck in traffic and dubious of paying thousands of dollars a year to cross the lake in a car.
This plan certainly is not perfect. I'd like to see rail to Ballard and Issaquah, among other things. But this is a thoughtful compromise that reflects the wisdom of our state and civic leaders, and it will certainly "move the dial" on mobility. So the question is whether to go forward, or backward. I thank WA CEO for seeing the practicality of maintaining forward progress.
www.generationalprofiles.com
The 20-year cost of "Roads & Transit" Proposition One construction in actual dollars, as opposed to back-dated 2006 dollars, is $38 billion. That's $24 billion for Sound Transit, $14 for roads.
And since the executive director of "Transportation Choices Coalition" is quoted in the article stating that the November measure is a 50-year investment, you should add up the 50 years of taxes: $157 billion, the biggest local tax proposition in American history. This sum comes close to an average of $2000 per household per year in the long term, and about $884 average per household in 2010.
However, the government agencies' forecasts of the results from all this spending and taxation show regional traffic delay doubling from today. Is more traffic the best that is possible for all these billions and billions? I sure hope not.
The single biggest part of the investment, Sound Transit's light rail, is forecast to carry less than two percent of the 20 million daily trips expected in 2040. This is because light rail is so expensive that it cannot be built to serve all the places where people travel every day, even with the billions to be collected and spent if November's Prop 1 passes.
But even if light rail is considered important, why would anyone want to vote to double Sound Transit's taxes when the agency's work to date is only 50% completed after ten years of the first ten year plan? Let them finish the "starter line" they promised in 1996!
Take a look at www.yesonroadsandtransit.org for a total absence of information on taxes and spending.
Then click on www.NoToProp1.org, started with seed funding and research from business people who looked carefully at the numbers that advocates of Proposition 1 aren't talking about.
By YJ Draiman, Energy Development Specialist
As you know, many serious problems are associated with our insatiable thirst for energy. The reason is simple: To gain the energy we must burn the fuels. The combustion, by the way quite inefficient, causes huge gaseous emissions polluting the air and forming an invisible screen responsible for the famous ? green house effect ?, i.e., blocking the dissipation of heat and thus causing the feared warming up of our planet, with deadly consequences for nature and man.
There is only a finite amount of oil in the world. Everybody knows this.
Someday, we'll run out. It will be gone.
Meanwhile, our insatiable thirst for oil -- which we burn -- has put enormous sums of money into the hands of fanatics who hate us and everything we stand for, and who use that oil money to fund the terrorists who murder Jews and Americans wherever they can.
We can't burn oil forever.
And it's bad strategy to base our economy on cheap oil when we have to buy at least some of it from our enemies.
Optimists tell us that the free market will eventually deal with the problem. Their theory is that as oil gets harder to extract cheaply, the price will go up; then other forms of energy will become economically attractive and we'll switch over to them.
Here's why their optimism is nothing short of suicidal.
First, there's no guarantee that without intense government-funded research and financial incentives now, the new energy sources will be available in quantities large enough to replace oil when it does run out.
In other words, if we wait until it's an emergency, our economy could easily crash and burn for lack of energy sources sufficient to drive it.
It's easy to supply energy for an economy that's only a tenth the size of the world's economy today. The question is how many people will die in the resulting chaos and famine, before new free-market equilibrium is established?
Second, how stupid do we have to be to wait until we run out of oil before acting to prevent its waste as a fuel? Petroleum is a vital source of plastics. We could use it for that purpose for hundreds of generations -- if we didn't burn any more of it. But if we wait till we've burned all the cheap petroleum, it won't be just fuel that we have to replace.
Third, market forces don't do anything for our national defense, our national security. We had a clear warning back in the 1970s with the first oil embargo. What if terrorism in the Middle East specifically targets all oil exports, from many countries?
And even if they keep the oil flowing, why are we pumping money into the pockets of militant extremists who want to destroy us? Why are we subsidizing our enemies, when instead we could be subsidizing the research that might set us free from our addiction to oil?
You notice that I haven't said anything about polluting the environment. Because this is not an environmental issue.
In the long run, it's an issue of whether we wish to provide for our children the same kind of prosperity that we've luxuriated in as a nation since World War II.
It is foolish optimism bordering on criminal neglect that we continue to think that our future will be all right as long as we find new ways to extract oil from proven reserves.
Instead of extracting it, we ought to be preserving it.
Congress ought to be giving greater incentives and then creating mandates that require hybrid vehicles to predominate within the next five years.
Within t