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I AIN'T LEAVIN' TILL THEY THROW ME OUT!
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by RoryKearney | August 28, 2008 at 11:16 am
713 views | 2 Recommendations | 2 comments
Part #11
Scroll down for updates.
http://www.youtube.com/watch?v=TfZ5m-oGmtQ
Here's My Mike's take: for mature audiences only
Let all the jackasses bray!
I am really steamed up over this Alison Martin bullshit. I bet she worked on this Milken project while our tax dollars paid her to work at NCI. She probably worked on the gov't computers putting this thing together. Watch they'll be shaking cans at Safeway for her.
Alison is now the President and CEO of Milken's Melanoma Research Alliance. The e-mail goes to his organization fastercures.org, (cough...cough) another leg of Milken's octopus in the Health Care Arena. He founded the Prostate Cancer Foundation, yet never says a word about the delay of the immunotherapy Provenge which showed increased survival, for men with prostate cancer who are out of options. 1 in 6 men get prostate cancer. Only one new treatment for end stage prostate cancer has been approved in over 43 years. It is so toxic, most men refuse to take it.
To me, it sure looks like Milken is definitely entrenched in NCI which leads to FDA and a sad bunch of medical bastards! There are bad oncologists here. They give the other oncologists a bad name. Let me be clear, most oncologists are not bad, just those named here: Pazdur, Scher, Hussain, & Martin.
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Don't Miss The Can Can starring Maha, Howie, Rick, Alison, & what's a Can Can without FDA Commissioner Andy Von Eschenbach.
THE CAN CAN
http://www.jibjab.com/starring_you/receipt/2111682
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Alison! Leaving the National Cancer Institute (NCI) after all these years, and going over to work for Milken. Is that a payback for helping write letters at the NCI telling the FDA to delay Provenge? What are you hiding Alison. Why are they delaying this non toxic, non invasive, safe and effective immunotherapy for prostate cancer? Why didn't you hand over all your Freedom of Information documents. Why did you say the letter between you and Howard Scher was Private. It was written on taxpayer's time. Another sad day for the healthcare industry and America. We all just got a little less hope of better medicine for people and not for profits.
Alison Martin, M.D., named MRA President and Chief Executive Officer
http://www.melanomaresearchalliance.org/
Media Inquiries:
Cecilia Arradaza
Communications Director
p: 202-336-8912
e: carradaza@fastercures.org
Alison Martin, M.D., to lead the Melanoma Research Alliance
Washington, DC, August 19, 2008 – Alison Martin, M.D., one of oncology’s respected research leaders, has been named President and Chief Executive Officer of the Melanoma Research Alliance (MRA), a new organization created to stimulate research that will lead to new preventive, diagnostic, and therapeutic options for melanoma.
The MRA is a public charity formed in November 2007 under the auspices of the Milken Institute, with the initial generous support of Debra and Leon Black. Results of the first competitive grant cycle will be announced shortly.
Dr. Martin, a medical oncologist with over 20 years experience in clinical research, joins the MRA from the National Cancer Institute where she was most recently Head of Genitourinary Cancers and Melanoma Therapeutics in the Clinical Investigations Branch of the Cancer Therapy Evaluation Program (CTEP). She was scientific co-chair along with Dr. Meenhard Herlyn of the 2007 NCI-Community-Oriented Strategic Action Plan for Melanoma Research. She has served as liaison to three of NCI’s cooperative groups and been a senior investigator in the Investigational Drug Branch of CTEP.
In addition to experience at NCI, Dr. Martin was a team leader in the Office of Oncology Drug Products at the U.S. Food and Drug Administration and has experience working with the biotechnology and pharmaceutical industries.
Dr. Martin is known for innovative efforts, such as enabling the launch of E2805, an ongoing trial of adjuvant therapy for renal cancer that uses a single trial to provide a control arm and data for registration of products from two separate companies; working to develop the definition of noninferiority for oncology trials used at the FDA which supported approval of capecitabine in colorectal cancer; and, most recently, ushering in the GU Steering Committee, the new strategic NCI trans-program body incorporating funded investigators, that will set the clinical research agendas for NCI in prostate, renal and bladder cancers
“Dr. Martin’s broad background in drug development, strategic planning, cross-sector collaboration and leadership, as well as her understanding of the melanoma community uniquely positions her to lead our efforts at the Melanoma Research Alliance,” said Debra Black, co-founder and Chair of the Board of Directors.
“It is a pleasure to join the team that has, in less than a year, convened a conference of international experts, written a scientific agenda and funded eight million dollars in peer-reviewed grants,” said Dr. Martin. “Our operating principles are to continue to support innovative, high risk research; create a stable financial environment to draw the best minds into the field and to allow existing highly motivated investigators to conduct their research; find opportunities to synergize with other funders to avoid duplication and maximize impact; and foster a collaborative, multidisciplinary process with early sharing of results that will allow identification of new opportunities. With research funding from the government decreasing, we must all work together to create the engine that will move us toward eliminating suffering and death due to melanoma.”
Dr. Martin was a member of the Scientific Advisory Board of the Southwest Oncology Group; Biomarker Consortium of the Interagency Oncology Task Force; as well as the American Society of Clinical Oncology’s Scientific Program, Nominating and Cancer Communication Committees.
Dr. Martin received her bachelor’s degree from New York University and a medical degree from the George Washington University Medical School. She completed residency and chief residency at the University Health Center Hospitals of Pittsburgh and fellowship training at the Clinical Oncology Program of the National Cancer Institute.
About the Melanoma Research Alliance: The Melanoma Research Alliance is an international, cross-disciplinary group of biomedical researchers possessing clinical and scientific expertise to explore, identify, and pursue innovative solutions to critical research issues leading to better treatments and a cure for melanoma. MRA is a public charity formed under the auspices of the Milken Institute, with the initial generous founding support of Debra and Leon Black. For more information, please visit: www.melanomaresearchalliance.org.
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http://www.investorvillage.com/smbd.asp?mb=971&mn=212708&pt=msg&mid=5493498
Decisions, Decisions
With the sad news about CELE's GVAX, for the forseeable future, Prostate Cancer sufferers will be limited to only 2 options. Taxotere and Provenge, if it is approved.
When the FDA deep-sixed Provenge in May 2007 there were 3-4 competing drugs which either showed promise or were backed by the conflicted doctors.
Now there is only one.
Public pressure and focus on the FDA decision will never be higher. Can the FDA afford to delay this beneficial treatment for another year? Especially if the interim narrowly misses it's endpoints?
What are the cost-benefits? Waiting for the final look as 30,000 more men are denied or granting conditional approval and letting patients receive immediate access. What is the downside? The treatement has already been voted as SAFE, 17-0. There are NO other HUMANE options. Can't the results of treated patients be the TRUE LITMUS TEST especially if the treatment is considered SAFE .
The real test will be to see if there is any common sense at the FDA.
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REPOST OF JIM CRAMER WRITING BULL ON A SUBPOENA AND THROWING IT ON THE FLOOR ON NATIONAL TV. OF COURSE HIS OLD HAARVAD ROOMMATE, ELIOT SPITZER, WAS ATTORNEY GENERAL OF NY AT THE TIME, PRIOR TO BECOMING THE NY GOVERNOR THAT RESIGNED AFTER CAUGHT CHARGING AT LEAST PARTS OF TRYSTS WITH $4000 A NIGHT HOOKERS, TO THE TAXPAYER.
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http://www.fool.com/investing/general/2008/08/27/jim-cramers-regrettable-investment-advice.aspx
Jim Cramer's Regrettable Investment Advice
August 27, 2008
Let's get one thing straight: There's a difference between an honest mistake founded on solid reasoning that simply didn't work out, and a mistake whose rationale is so imaginative, Peter Pan would giggle at it. I'd like to share with you two examples of the latter.
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BAD NEWS! WE LOST THE APPEAL!
The court is still saying we don't have the right to have this case heard since the FDA only delayed the treatment (over a year) and did not deny it. Tell that to our dead members.
FEAR NOT!
MOTION TO THE SUPREME COURT TO REVIEW Coming Soon!
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CareToLive Continues Fight for Prostate Cancer Patients Rights! August 28th, 2008 | Posted by Rory Kearney Share This
The court ruled,
“Appeal Denied”.
Kerry is very sorry we could not win this for the patients suffering with AIPC. “We will take the fight to the Supreme Court but we understand that this is not timely enough for many thousands of suffering men.”
We are unripe. We are in FDA limbo. We haven’t been denied a license, yet you can’t get Provenge, but it is not denied, just delayed a few years. To our fathers, husbands, sons and brothers who have passed away, it is as final as anything can get. The FDA needs to be disbanded and the patients rights given back to the patients and not the corporations, and “venture capitalists.”
Unconscionable!
We fight on!
Next Stop
Kerry Donahue, our lawyer extraordinaire, has incredible fortitude to pursue this fight on behalf of men with late stage prostate cancer. The Courts are passing this hot potato up the hill. Kerry has filed a lawsuit on behalf of CareToLive to try to get men with late stage prostate cancer access to Provenge, a safe, non toxic, non invasive immunotherapy. Somebody needs to get the ear of the right fat cats on the hill, exchange a few suitcases of cash, no, wait a minute, that would be illegal. We have men we love who need Provenge NOW! Approve it because it is the right thing for a civilized society to do. Visions of Soylent Green come to mind.
FEAR NOT!
MOTION TO THE SUPREME COURT TO REVIEW Coming Soon!
Kerry, We LOVE You. You are doing an incredible job. You stand among America’s finest. Your amazing work on behalf of men with late stage prostate cancer is unrivaled!
http://caretolive.com/lawsuit-news/
The courts are part of the system, pushing us aside, shutting off another route to redress. We will stay in their face. What choice do we have.
Ted needs Provenge NOW!
http://www.youtube.com/watch?v=6Q0uQAL_YDA
http://www.youtube.com/watch?v=UqAx7uZAS90
THE CAN CAN
http://www.jibjab.com/starring_you/receipt/2111682
Tags: andy von eschenbach, Dendreon, frank lautenberg, Howard Scher, Janet Woodcock, Jesse Goodman, Kerry Donahue, maha hussain, michael milken remains silent, prostate cancer foundation still silent, provenge, Richard Pazdur
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No rights at all.
They did not even think it worthy of a full decision.
Its unripe until the FDA denies it.
ctldecision.pdf
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Unripe. Is that like the unwashed masses. They can't hear the case because it is still in FDA purgatory.
You have the right to die without access to modern treatments.
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CareToLive Continues Fight for Prostate Cancer Patients Rights!
The court ruled,
“Appeal Denied”.
Kerry is very sorry we could not win this for the patients suffering with AIPC. “We will take the fight to the Supreme Court but we understand that this is not timely enough for many thousands of suffering men.”
We are unripe. We are in FDA limbo. We haven’t been denied a license, yet you can’t get Provenge, but it is not denied, just delayed a few years. To our fathers, husbands, sons and brothers who have passed away, it is as final as anything can get. The FDA needs to be disbanded and the patients rights given back to the patients and not the corporations, and “venture capitalists.”
Unconscionable!
We fight on!
Next Stop
Kerry Donahue, our lawyer extraordinaire, has incredible fortitude to pursue this fight on behalf of men with late stage prostate cancer. The Courts are passing this hot potato up the hill. Kerry has filed a lawsuit on behalf of CareToLive to try to get men with late stage prostate cancer access to Provenge, a safe, non toxic, non invasive immunotherapy. Somebody needs to get the ear of the right fat cats on the hill, exchange a few suitcases of cash, no, wait a minute, that would be illegal. We have men we love who need Provenge NOW! Approve it because it is the right thing for a civilized society to do. Visions of Soylent Green come to mind.
The courts are part of the system, pushing us aside, shutting off another route to redress. We will stay in their face. What choice do we have.
Ted needs Provenge NOW!
http://www.youtube.com/watch?v=6Q0uQAL_YDA
http://www.youtube.com/watch?v=UqAx7uZAS90
ABC Reporter Arrested in Denver Taking Pictures of Senators, Big Donors
Asa Eslocker Was Investigating the Role of Lobbyists and Top Donors at the Convention
DENVER -- Police in Denver arrested an ABC News producer today as he and a camera crew were attempting to take pictures on a public sidewalk of Democratic senators and VIP donors leaving a private meeting at the Brown Palace Hotel.
(ABC News)
More Photos
Police on the scene refused to tell ABC lawyers the charges against the producer, Asa Eslocker, who works with the ABC News investigative unit.
(Click here to watch video of the arrest.)
http://abcnews.go.com/Blotter/Conventions/story?id=5668622&page=1
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http://www.cleveland.com/business/plaindealer/index.ssf?/base/business-7/1219912212176210.xml&coll=2
Excerpts
A few can sway oil market trading
Swiss firm more of a speculator, industry group finds
Thursday, August 28, 2008David Cho
Washington Post
Washington- Regulators had long classified a private Swiss energy conglomerate called Vitol as a trader that primarily helped industrial firms that needed oil to run their businesses.
But when the Commodity Futures Trading Commission examined Vitol's books last month, it found that the firm was, in fact, more of a speculator, holding oil contracts as a profit-making investment rather than a means of lining up the actual delivery of fuel. Even more surprising to the commodities markets was the massive size of Vitol's portfolio - at one point in July, the firm held 11 percent of all the oil contracts on the regulated New York Mercantile Exchange.
The discovery revealed how an individual financial player had gained enormous sway over the oil market without the knowledge of regulators. Other CFTC data showed that a significant amount of trading activity was concentrated in the hands of just a few speculators.
The CFTC, which learned about the nature of Vitol's activities only after making an unusual request for data from the firm, now reports that financial firms speculating for their clients or for themselves account for 81 percent of the oil contracts on NYMEX, a far bigger share than had previously been stated by the agency. That figure may rise in coming weeks as the CFTC checks the status of other big traders.
Some lawmakers have blamed these firms for the volatility of oil prices, including the tremendous run-up that peaked earlier in the summer.
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More from Mike
Stunned!
This Court of Appeals ruling is most disgusting. I can't believe they filed it the day after the bad GVAX news.
Since when did the concept of ripeness supersede the right to live? And why side with ripeness when that ripeness was a product of people disregarding and trampling upon Federal regulations? Life supersedes everything! Without life, ripeness is as good as dirt. What a sham, shame and evil agenda. And worse, on the heels of Scher's sleepless nights turning into a nightmare for some unfortunate patients and their loved ones!
As I said yesterday, Scher would not pull the lever for Provenge at the AC hearing because he was worried about other treatments under development. He reiterated that in the concocted leaked letter he signed which NCI's Alison Martin helped him write. Then Thomas Fleming ran with the same idea in his leaked letter. If I was a patient, I would run away as fast as I could from these three would-be doctors!
Novacea had to stop a Phase III trial of its oncology treatment Asentar (DN-101) in advanced prostate cancer due to a high number of deaths in the Asentar arm.
Cell Genesys ended the second trial of two Phase III clinical trials of Gvaxas recommended by its independent data monitoring committee (IDMC) which observed an imbalance in deaths between the two treatment arms of the study. The IDMC based its recommendation on 114 deaths of which 67 occurred in the Gvax plus Taxotere combination treatment arm and 47 deaths occurred in the Taxotere control arm.
This is absolutely unbelievable! All the way to the Supreme Court, baby!!
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Judd Bagley AntiSocialMedia.net
Exposing user-generated discontent.
How not to respond to a subpoena by the SEC
Take a trip with me, back to early 2006.
On January 7, Jordan Goldstein, general counsel of TheStreet.com, pronounced that company co-founder Jim Cramer had never sold a single share of TSCM stock.
Exactly one month later, Jim Cramer announces, via the adoption of a rule 10b5-1 plan, his intention to exercise 150,000 stock options over the course of one year.
In the announcement, the plan’s purpose is expressed as being:
“…designed to avoid any real or perceived conflict of interest in connection with the trading of company securities. The program is established at a time when the executive does not have material inside information.
“…It is Mr. Cramer’s intention to provide an orderly liquidation of these options through this plan, which provides for the sale of approximately 12,500 shares on a monthly basis.”
Such an orderly liquidation, as outlined in the plan, would have looked like the chart to the right (click to enlarge).
In reality, the record reflects a very different selling pattern by Mr. Cramer; one which looks like the chart to the left (click to enlarge).
You’ll note that 112,500 (exactly 75%) of the options expected to be exercised in an orderly manner over the course of 12 months were actually exercised within two weeks.
What could account for such a deviation from Cramer’s 10b5-1 plan?
A little historical context might add some clarity.
What was not mentioned in the 10b5-1 plan was the fact that just days beforehand, Jim Cramer had received a subpoena by the SEC…something that might be considered by some to be material inside information.
That subpoena would not be disclosed by Cramer until February 27, by which time 100,000 options had already been exercised. Adding this information to Cramer’s TSCM selling chart would tend to raise serious questions relating to insider trading on Cramer’s part, and the low regard Cramer would appear to have for his company’s investors.
NOTE: Thanks to Evren Karpak and another un-named supporter of market reform for their time in handling key portions of the research on this topic.
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We started filming our movie about prostate cancer last week and this corruptly denied treatment. I will update as soon as I get the okay. Ming, get the popcorn.
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Another Opinion Post from Mike (mrserious) on the dndn IV board
http://www.investorvillage.com/smbd.asp?mb=971&mn=212600&pt=msg&mid=5489495
As The Days Go By
Remember at the Provenge Advisory Committee hearing when Mr. Howard Scher said the following (page 322 AC transcript):
"So I say well, what if we think that this really should be available, start thinking about the number of agents that are currently under development."
Well, I took it to mean:
"So I say well, what if we think that this (Provenge) really should be available, start thinking about the number of agents (Asentar and GVAX) that are currently under development."
That was because Scher was leading the Asentar trial for Novacea and did Phase I work for GVAX. Then he told Marilyn Chase he did free work for Bristol-Myers Squibb (BMY) which I am sure made BMY investors very happy as well as Richard Pazdur who has a close friend who is a lobbyist for BMY. It turns out BMY was working with Medarex on a compound called ipilimumab which was being used to develop GVAX
(see http://www.cellgenesys.com/clinical-prostate-cancer.shtml).
Then remember what Thomas Fleming wrote in a letter to the FDA that eventually got leaked to the Cancer Letter about 4 days before the CR Letter came out:
"In a letter to FDA in the April 13, 2007 Cancer Letter, Howard Scher of Memorial Sloan-Kettering Cancer Center presented valid and compelling arguments that FDA await the completion of an ongoing 500 patient (9902B) Phase 3 trial before deciding whether to approve Sipuluecel-T in prostate cancer patients. Reportedly, Scher felt motivated to write the letter after being kept awake the night following the March 29, 2007, FDA Cellular, Tissue and Gene Therapies Advisory Committee by the thought that if Sipuluecel-T were approved, patients may well forego more effective treatment alternatives."
Well, I took it to mean:
"Scher felt motivated to write the letter after being kept awake the night following the March 29, 2007, FDA Cellular, Tissue and Gene Therapies Advisory Committee by the thought that if Sipuluecel-T were approved, patients may well forego more effective treatment alternatives like Asentar and GVAX."
So now here we are today. Asentar was stopped on November 5, 2007 and GVAX was halted today, August 27, 2008. Mr. Scher stopped Provenge for two agents under development which are now swept under the carpet. And this guy and Fleming are the ones FDA chose to listen to? Now I really want to see Scher's personal opinion which he sent to Alison Martin that the folks at NCI omitted in the FOIA documents. These people have a lot of nerve.
How silly is it that FDA listened to a quack who said this:
"Personally I have no experience with this agent (Provenge), so I'd just like to ask clinicians who have used it." -Mr. Scher (page 87 AC transcript)
Why didn't he and FDA listen to Dr. David Penson who administered the Provenge treatment? He spoke at the AC hearing.
"This is not like classic chemo; there is no loss of hair, no sickness associated with it. We are disappointed because I think that many of the people who are involved in the study, many of the site investigators who are experienced with the drug, feel that it's a safe drug and that it works...that it extends life in a very desperate group of patients." -Dr. David Penson
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The silence of the silent majority advocacy groups is so quiet you could hear a man drop. I have learned more in the past few years, then I can ever forget.
CareToLive does have a great support system with groups like Abigail Alliance, and Scott Riccio and Melody Davis (cben) of A Right to Live , and Charles Reinwald of Cancer Cure Coalition, and stop by my friend Cliff's Provenge Blogspot, all Die Hard Provenge Supporters and Patient's Rights Advocates, along with thousands of us in the Provenge Alliance following this story daily.
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Take me back Country Roads, West Virginia Mountain Momma http://www.youtube.com/watch?v=DC8nDdPM_Qk
I spent Friday and Saturday last weekend in Virginia where we filmed a scene in the movie with Frank Burroughs of Abigail Alliance.
Thanks Frank for staying in the fight! Frank has to be one of the most loved men on the planet, fighting for the dyings right to live. Every drug that Abigail-Alliance supported over the past 16 years, eventually got approved. Of course, not in time for so many. HECK! WE ARE GROWN MEN (& WOMEN) AND WE WANT ACCESS TO PROVENGE IMMUNOTHERAPY NOW! IT'S OUR OWN WHITE BLOOD CELLS FIGHTING OUR OWN CANCER. PROVENGE DEMONSTRATED SURVIVAL!
FDA has the health of 90,000 American men in their care, and instead of helping them, they sent them over to the grim reaper.
SHAME ON THE FDA!
What's Andy's Take. http://www.fda.gov/oc/vonEschenbach/andys_take/default.html
Well, let's see. His first sentence is just more "bridge building" sound bites. We are the invisible Andy. Why no way to leave a comment Andy? You can come over here an leave one for me. Better yet, call. My phone number is on file with the petition we filed for the FDA to reconsider the decision to delay Provenge, which over a year later, your agency, has refused to answer the CareToLive Citizen's Petition. You have a blog now, like you are accessible, but you are not even remotely accessible to anybody but your cronies. Isn't it time you had the FDA answer the CTL petition. Isn't it time to license Provenge. Talk to Mikey. Hurry Up!
"Science is at the core of every decision we make about the FDA-regulated products you and your family use on a daily basis. Yet the science behind those regulatory decisions is often invisible."
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You can still comment on our Petition. I am on the dusty trail trying to find where you can comment on it, unless it is closed now. Nobody at FDA could even tell me that. Paul Richards did tell me that it will not slow down their not replying to it, so comment away when I find it. I will post it when I do.
Looking for the place they moved our comment option to. NO TRANSPARENCY AT THE FDA. I can't even find the CareToLive Citzen's petition anymore. Another hour wasted looking.
Here is our copy.
FDA’s Reply to CareToLive’s Petition for the FDA To Reconsider the Provenge delay 1/17/08 (click this link) We are officially in FDA Petition Limbo
Summary: In your citizen petition you request the Commissioner of Food and Drugs to reconsider FDA’s failure to grant a biologics license application for Provenge…We are still considering your request and supporting information stated in your citizen petition….we will respond to your petition as soon as we have reached a decision on your request.
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Here are a few of our comments (sorry , the link doens't work, I will locate a new one) although hundreds have been omitted from the site when they migrated the Citizen's Petitions for the FDA over here. I am still waiting for them to post them. Paul Richards (consumer advocate (cough...cough) at FDA for CBER) is supposed to be handling that for me. Yo Paul, great advocacy job being an FDA puppet. You took every ill conceived idea to make Provenge appear faulty, like lies that it doesn't show survival Paul, even Maha admits it shows survival, and you choose to ignore the truth, and refuse to answer whether Provenge is safe, and refuse to act like a consumer advocate and make sure they investigate the Conflicts of Interest and the bastardized question and maha's and howie's "leaked letter" and the Freedom of Information scandal now going on at the FDA! Shameful! You can call me anytime Paul and clear this up.
______
http://www.thoreau-fda.com/letter.php
Customize this letter and tell FDA Commissioner “Andy” (as he likes to be called) Von Eschenbach what you really think about the delay for over a year of the immunotherapy Provenge for the 30,000 American men who die of prostate cancer every year without any options (not to mention the rest of the men in the world)
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There is a better treatment for prostate cancer.
It is over a year since the delay of Provenge and the Daily Death Count: Today = 39,591 .
Let Ted Girgus have PROVENGE NOW!
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| ource: Endotec Inc. |
| |
FDA Gets Knocked Out in Endotec, Inc. Ruling
Monday August 18, 9:30 am ET
Historic First Loss on Custom Medical Devices
| |
SOUTH ORANGE, N.J., Aug. 18 /PRNewswire/ -- The following is being issued by Endotec, Inc. -- Vincent J. Capricci, 56, is a former public school superintendent for the Rockwood, PA school district, and an avid hunter, golfer and fisherman. After minor surgery a few years ago, he experienced a life threatening infection which destroyed his ankle joint. He was out of work for nine weeks and wheelchair bound. "I was walking bone-on-bone," Capricci said. "I had no cartilage and my ankle was the size of a grapefruit."
After several surgical consultations, Capricci faced two options; fusing the ankle which would severely limit his activity; or, surgically implanting a fixed-bearing ankle device which would last only about three years. Neither option seemed to fit Capricci's active lifestyle.
Soon however, Capricci discovered a third option; a custom mobile bearing ankle replacement system offered by Endotec, Inc. of South Orange, New Jersey, and used by Dr. Frederick Buechel of South Mountain Orthopedic Associates, South Orange, New Jersey. Capricci had 17 previous surgeries for ankle issues and the ankle replacement would be number 18.
But, if the Food and Drug Administration (FDA) had its way, Capricci would have never received the surgery that allows him to hunt, fish and bike. In 2006, the FDA sued Endotec claiming the company had distributed unapproved joint replacement devices. For 25 years the FDA has pursued a policy which has prevented custom mobile bearings ankle joints from reaching the US market. Mobile bearing ankle devices are used exclusively outside the US, which means that US citizens must travel abroad for this treatment.
When the trial kicked off in April 2008, the FDA came out brimming with confidence but quickly was knocked flat in a Florida federal courtroom. To the dismay of the FDA, Senior Judge G. Kendall Sharp ruled the ankle devices were custom-made medical devices exempt from FDA regulation.
Eight years after his ankle replacement surgery, Vincent has no restrictions. He exercises regularly three-days a week, rides a stationary bike, lifts weights, hikes over mountain roads, traverses trout streams, and rides his 15-speed bike five to 10 miles several days each week.
"I have my life back," said Vincent. "I was a college athlete and high-school basketball coach, and I was extremely active. Following this surgery, I no longer have sharp or stabbing pains. I am continuing to improve and can get around better than I have in years."
"This is a huge victory because it allows me to do what I've been doing for 30 years which is replacing ankles in patients who need it," said Dr. Buechel. "The FDA is out of touch with reality. When they take common sense and distort it and try to limit it, they overstep their bounds and become bureaucrats -- ignoring the science underlying their regulatory authority."
Judge Sharp criticized the FDA in his decision, saying that the agency's "stringent regulations and strict interpretation of procedural requirements are resulting in technological innovation being stymied, rather than advanced." He noted that the FDA never alleged that Endotec's devices harmed any patients or were dangerous. Judge Sharp twice took the FDA to task for "stymieing progress and technological advancement." Moreover, he rebuked the FDA's expert witness on custom devices, associate director of regulatory guidance, Casper Uldriks, for defining a custom device in a way that was "so narrow as to make the definition useless."
"For the first time in history, the FDA has brought a suit on custom medical devices and lost," said Michael Pappas, Ph.D, CEO, Endotec, Inc. "This sends a powerful message to the industry not to fear the FDA, or to be intimidated by their tactics. Power not only breeds corruption, it also breeds arrogance, and arrogance breeds stupidity."
According to the July 21, 2008 e-newsletter, Health Imaging News, the FDA has lost enormous expertise in medical device regulation. " ... almost all of the leadership at the office of regulatory is leaving, including Associate Commissioner of Regulatory Affairs Margaret Glavin, who is retiring, and Assistant Commissioner for Compliance Policy David Horowitz, who was recently promoted to assistant commissioner for policy for the FDA. Deputy Director Deborah Ralston has left the agency as well."
The Endotec case revolved around the specifics of the FDA's approval procedures for medical devices. Most "class III" devices, which support human life or present a risk of injury, require FDA approval before they can be sold. The only exception is for "custom devices," which are not generally available and are intended for a specific patient, or made to the specifications of a specific surgeon for use in his or her practice.
http://biz.yahoo.com/prnews/080818/nym020.html
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To enter our $75,000 "Crack the Wall Street Cover-up!" contest read to the bottom of this (very long) story.
The Columbia School of Journalism is our nation’s finest. They grant the Pulitzer Prize, and their journal, The Columbia Journalism Review, is the profession’s gold standard. CJR reporters are high priests of a decaying temple, tending a flame in a land going dark.
In 2006 a CJR editor (a seasoned journalist formerly with Time magazine in Asia, The Wall Street Journal Europe, and The Far Eastern Economic Review) called me to discuss suspicions he was forming about the US financial media. I gave him leads but warned, “Chasing this will take you down a rabbit hole with no bottom.” For months he pursued his story against pressure and threats he once described as, “something out of a Hollywood B movie, but unlike the movies, the evil corporations fighting the journalist are not thugs burying toxic waste, they are Wall Street and the financial media itself.”
His exposé reveals a circle of corruption enclosing venerable Wall Street banks, shady offshore financiers, and suspiciously compliant reporters at The Wall Street Journal, Fortune, CNBC, and The New York Times. If you ever wonder how reporters react when a journalist investigates them (answer: like white-collar crooks they dodge interviews, lie, and hide behind lawyers), or if financial corruption interests you, then this is for you. It makes Grisham read like a book of bedtime stories, and exposes a scandal that may make Enron look like an afternoon tea.
By Patrick M. Byrne, Deep Capture Reporter
NEW! Download the Story of Deep Capture in .pdf format.
By Mark Mitchell, with reporting by the Deep Capture Team
Introduction - by Mark Mitchell
I began working on a version of this story in January 2006, while serving as an editor for the Columbia Journalism Review, a publication tasked with upholding the standards of the American media. In November 2006, a hedge fund that was at the center of the scandal I was investigating offered the Columbia Journalism Review a great deal of money. Shortly before CJR accepted the money, I left my job, so I do not know if my editors, whom I believe to be honest people, would have allowed me to persevere. But I have no doubt that the hedge fund’s “beneficence” was aimed at preventing the publication of stories like this one.
And it might well have succeeded if Patrick Byrne had not approached me with an idea. Why not combine forces and spearhead a whole new approach to investigative journalism? Most media content is produced by rumpled journalists (i.e., people like me), working alone under tight constraints. Deep Capture could be something different - a power team circumventing the traditional media and pushing limits to uncover the truth.
When I entered the picture, this team had already established that a small number of law-breaking hedge funds had put the American financial system at risk of collapse. Indeed, the hedge funds are employing the same tactics that contributed to the stock market crash of 1929 and the Great Depression that followed. If you want to understand the current turmoil in our financial markets, you could do no better than to read the material in Deep Capture: The Analysis.
The lengthy (40,000 word) story that follows should help you to understand how - and why — Patrick came to embark on this project. I am the author of the story, and attest to its accuracy, but it benefits substantially from the work of the Deep Capture team: freelance researchers, bloggers, gonzo computer hackers, economists, and even a one-time foreign intelligence agent.
Some mainstream journalists will not like this story. They will perhaps disapprove of our methods or decry the advent of vigilante journalism. But most of all, they will not like this story because it is largely about them - a tale of reporters who seek to be players, but instead become pawns - a tale of prominent journalists who help cover up a massive financial crime while toadying to some of Wall Street’s slimiest operators.
* * * * * * * *
And it all starts when Patrick Byrne gets a phone call from the Easter Bunny. Really, that’s what the guy calls himself - the Easter Bunny - and he talks like the Bee Gees on fast forward, a nasally frantic falsetto, on and on about some kind of conspiracy involving big time Wall Street operators, the Mafia, and a bunch of famous journalists. Somebody’s got to stop these people, the Bunny says, or the American financial system is going to come crashing to its knees. Also, the bad guys might put a bullet between the Easter Bunny’s ears.
* * * * *
Part 1 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up
by RoryKearney | July 11, 2008 at 07:13 am | 6607 views | 33 comments
http://www.nowpublic.com/world/naked-shorts-75-000-cracking-wall-street-cover
Part 2 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up
by RoryKearney | July 18, 2008 at 08:43 am | 531 views | 1 comment
http://www.nowpublic.com/world/part-2-naked-shorts-75-000-cracking-wall-street-cover-redux
Part 3 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
by by RoryKearney | July 19, 2008 at 06:32 am |1162 views | 3 comments
http://www.nowpublic.com/world/part-3-naked-shorts-75-000-cracking-wall-street-cover-redux
Part 4 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
by RoryKearney | July 23, 2008 at 10:05 am | 550 views | add comment
http://www.nowpublic.com/world/part-4-naked-shorts-75-000-cracking-wall-street-cover-redux
Part 5 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
by RoryKearney | July 23, 2008 at 10:05 am |1760 views | add comment
http://www.nowpublic.com/world/part-5-naked-shorts-75-000-cracking-wall-street-cover-redux
Part 6— Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
by RoryKearney | July 26, 2008 at 08:03 am | 626 views | 2 comments
http://www.nowpublic.com/world/part-6-naked-shorts-75-000-cracking-wall-street-cover-redux
Part 7— Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
by RoryKearney | July 29, 2008 at 08:13 pm | 1783 views | add comment
http://www.nowpublic.com/world/part-7-naked-shorts-75-000-cracking-wall-street-cover-redux
Part 8 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
by RoryKearney | July 31, 2008 at 05:05 pm | 374 views | add comment
http://www.nowpublic.com/world/part-8-naked-shorts-75-000-cracking-wall-street-cover-redux
Part 9 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
by RoryKearney | August 6, 2008 at 07:56 am | 350 views | add comment
http://www.nowpublic.com/world/part-9-naked-shorts-75-000-cracking-wall-street-cover-redux
Part 10 - Overstock CEO Patrick Byrne Carpet Bombs Wall Street & The Media on the Don Harrold Show (Video)
by RoryKearney | August 26, 2008 at 12:27 pm | 386 views | 2 comment
http://www.nowpublic.com/world/overstock-ceo-patrick-byrne-carpet-bombs-wall-street-media-don-harrold-show-video
Part 11- I AIN'T LEAVIN' TILL THEY THROW ME OUT!
by RoryKearney | August 28, 2008 at 03:16 pm | 409 views | 2 comments
http://www.nowpublic.com/world/i-aint-leavin-till-they-throw-me-out
Just Say Yes. The FDA Ties That Bind. A Saturday Morning Rant.
by
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Most RecentMost Recommended Comments (2)
at 11:36 on August 28th, 2008
RoryKearney, I like this story. It's good stuff.
The cancer business is probably almost as big as the weapons business - do you think they really want to actually cure it ?
I know you know better - but a lot people out there actually believe they're seriously trying to find a way to put themselves out of business ...
Nice one !!
at 12:09 on August 28th, 2008
It may take every uncaptured man, woman and child to get us access to immunotherapy, but we are determined to fight for our right to better treatments, regardless of the way cancer was treated previously. Tumor shrinkage is a poor marker. The FDA can't keep up with the science, and in my opinion, they don't really want to. Imagine, Alison Martin helps blow up the Provenge approval, withholds Freedom of Information documents, and gets promoted out of the lucrative federal union to serve as Milken's lapdog, a much greener pasture. Milken pays his foundation employees about a quarter of what is raked in. Chemo is a nice cash cow for investors, for patients, not so nice. The FDA wants to keep things status quo. The patients want access.