Articles
Dendreon Presents Data Correlating the Cumulative Potency of PROVENGE® to Overall Survival –New Data Presented at American Society of Clinical Oncology’s Genitourinary Symposium–
SEATTLE and SAN FRANCISCO, February 14, 2008 - Researchers from Dendreon Corporation (Nasdaq: DNDN) today presented data demonstrating the correlation of a measure of the cumulative potency of PROVENGE (sipuleucel-T), an investigational active cellular immunotherapy for hormone-refractory prostate cancer, with overall survival. This is the first time that an association between higher potency of an active immune therapy and increased patient survival has been reported. The correlation appeared to be independent of other important baseline prognostic factors.
http://investor.dendreon.com/ReleaseDetail.cfm?ReleaseID=294212&Header=News
We believe this information directly addresses the Mechanism of Action of Provenge. This is a direct piece of evidence that when the immune system of a patient is properly stimulated by Provenge, he will benefit from the treatment and survive longer.
We believe the CD54 data was questioned with some skepticism during the AC. This news now addresses those questions.
Nature Biotechnology 26, 1 (2008)Editorial: The regulator disapproves Abstract (click this link)
Pressure is mounting on the US Food and Drug Administration (FDA) to explain its decision to ignore an advisory committee’s positive recommendation for the cancer vaccine Provenge.
THE ROAD TO PROVENGE APPROVAL (click here to read full article) 1/20/08
By: Thomas A. Farrington President and Founder PHEN Prostate Health Education Network “From various accounts it now appears that our interests and needs may not have been the priority with the FDA’s decision making process.”
Robbing Cancer Patients of Hope by Dr. Chuck Bennett 1/26/ 2007
Prostate cancer kills 30,000 Americans every year, many of whom valiantly served their country. Pathetically, in the last 45 years just one drug has been approved by the FDA for the treatment of these terminal patients and that is a chemotherapy that is so marginally effective and wrought with devastating side effects(sometimes lethal) that most men either don’t want it or refuse it altogether. Then along came Provenge, an immunotherapy to treat prostate cancer that has demonstrated safety and efficacy in all of six different studies and has virtually no side effects.
Cancer Industry Fights To Keep Obscene Profits - Part I — by Evelyn Pringle 1/22/08 (click this link for full article)
A 2001 study by the National Institute of Health found that about a third of Medicare beneficiaries received chemotherapy in the last six months of their lives, even through their cancer was unresponsive to chemotherapy, which “strongly suggests overuse of chemotherapy at the end of life,” the report said. … A most despicable example of how far the chemotherapy industry will go to protect profits, involves an elaborate plot to stop a new class of immunotherapies from entering the market. These new products stimulate the body’s own immune system to attack only cancer cells. … The conflicts of interest of these doctors could not be more obvious. The top recipients of public and private cancer research funding in the US include Dr Pazdur’s previous employer of 11 years, the MD Anderson Cancer Center at the University of Texas, Dr Scher’s current employer, the Memorial Sloan-Kettering Cancer Center, and Dr Hussain’s Cancer Center at the University of Michigan.
Prostate Cancer Patients Pick Treatments That May Worsen Quality of Life 12/28/07 (click this link)
Men with early-stage prostate cancer frequently choose treatments that worsen problems they already have, according to a new study published in Cancer.
Researchers from Boston University School of Public Health, Dana-Farber Cancer Institute, Harvard Medical School, Harvard Radiation Oncology Program, and Massachusetts General Hospital found that of 438 men who completed the study, 389 (89%) reported pre-existing urinary, bowel, or sexual problems, yet more than one-third opted for treatments that made them more vulnerable in those areas.
Bush’s FDA - Perpetual Leaker of Insider Information by Evelyn Pringle 1/8/08 (click this link)
Get on the Bus Gus - Care To Live Press Release (click here)
FDA’s Refusal to Approve New Cancer Vaccine - The Plot Thickens - Part I 11/27/07 by Evelyn Pringle (click this link)
Washington, DC: Dying prostate cancer patients waiting for the approval of Provenge, a new life-extending cancer vaccine, are being held hostage by an FDA infested with industry insiders with enormous financial interests in what has become a multibillion dollar cancer treatment racket for drug companies, cancer researchers, and treatment providers alike. Read more…
Pazdur’s Cancer Rules - Wall Street Journal 7/6/05
Many observers — including some on Congressional oversight committees — are still puzzled by the Food and Drug Administration’s recent decision to effectively pull a good lung cancer treatment called Iressa from the U.S. market. Let us suggest that the best way to look at it is as an all-too-predictable case of bureaucratic revenge. … Never since the creation of the accelerated approval process in 1992 have the regulatory barriers to cancer research looked so oppressive. Read more …
FDA Officials Criticized For Secrecy 6/30/2007
For years, the public calendars of two top federal drug safety officials were largely blank _ devoid of the required detail about their contacts with the industry they regulated. … Once notified by the congressional staff, the FDA began to retroactively fill in the calendar. It showed that the two had met during that period with drug company executives, lobbyists, patient groups and others. Federal regulations require the FDA to maintain a public calendar that details all “significant meetings” between its top brass and anyone outside the executive branch. There is no punishment for failing to disclose the information, but open government experts called it crucial to make public all the same. “It’s important to disclose this kind of stuff so the public knows who these high-ranking FDA officials are talking to and who has their ear. That’s part of the process of assessing what’s going on at FDA and are decisions being made in the best interest of the public,” said Mary Boyle, a spokeswoman for the nonpartisan watchdog group Common Cause. … Frequent FDA critic Dr. Sidney Wolfe called it “ridiculous” that the FDA had failed to post the calendar listings but suggested the requirement should be expanded to cover even lower-level employees at the agency. It’s those employees, Wolfe said, who spend the most time meeting face-to-face with drug companies. “Before decisions that seem to be going in the wrong direction from the public health perspective, it might be nice to know a company was in there,” said Wolfe, of the watchdog group Public Citizen. Read more…
Former FDA Commissioner Crawford Pleads Guilty To Conflicts Of Interest & Falsely Reporting Info About Stocks He Owned 10/17/2006 — (Current Commissioner Andrew Von Eschenbach received a waiver for his stock ownership)
Former FDA commissioner Lester Crawford pleaded guilty Tuesday to conflict of interest and falsely reporting information about stocks he owned in food, beverage and medical device companies that he was in charge of regulating. Crawford appeared before U.S. Magistrate Deborah Robinson and admitted falsely reporting that he had sold the stock when he continued holding shares in the firms governed by FDA rules. The charges — conflict of interest and false reporting — are misdemeanors and each carries a maximum penalty of one year in prison. As head of the Food and Drug Administration, Crawford oversaw regulation of products that account for an estimated 25 cents of every dollar spent each year by U.S. consumers. At the same time, Crawford, through his broker, oversaw an investment portfolio that included tens of thousands of dollars in shares in Pepsico Inc., Sysco Corp., Kimberly-Clark Corp. and other companies that posed a conflict between his personal finances and his responsibilities as head of the federal agency. Federal regulations prohibited Crawford from owning shares in companies that are considered to be “significantly regulated” by the FDA. Read more…
Dr. Mark Moyad on Provenge for USToo
I really believe they thought that within 5-10 years there was going to be newer and more effective treatments offered, andsome doctors really believed that in 10-15 years the disease itself would be wiped out. Keep in mind that this was over 30years ago and now we have 1 drug (yes, 1 drug) approved for the extension of life for hormone refractory prostate cancer (HRPC) patients, and patients are aware that it is an interesting and potentially effective medication (Taxotere®), but it is not an easy drug to take or stay on for a long period of time. The bottom line is that it seems many of us, including myself, misjudged how difficult an enemy this HRPC really is when you consider all the compounds that have been thrown at it over the past 3 decades. Think about it for a second, hundreds or perhaps thousands of clinical trials and only one drug approved. Hundreds and really thousands upon thousands of lives and only one drug approved. … Provenge was overwhelmingly recommended to be approved by the FDA advisory panel in March and simply put it was a democracy and the FDA almost always follows this democratic recommendation. Read more…
Harry Petersik US New 3/26/06
“I never felt sick, not once,” says Harry Petersik, who had prostate surgery 12 years ago because a high prostate-specific antigen test led to the discovery of a tumor. Petersik, a 64-year-old electrician who lives near Edmonton in Alberta, Canada, thought he was out of the woods. But over the years his PSA levels kept climbing, indicating the cancer was back. Other treatments failed. By the start of 2005, the cancer had spread through his lymph system. And he had tumors in his back and shoulders. The problem in this case–in all cancer cases–is that tumors were evading his immune system, because that system didn’t recognize them as foreign invaders. So Petersik turned to a Seattle-based company called Dendreon that teaches old cells new tricks with a therapeutic vaccine called Provenge. Doctors take cells designed to spot intruders out of the patient’s body, juice them with prostate cancer molecules, and put them back in the patient. These cells then point the immune system toward the real enemy. In January, as part of a clinical trial, Petersik lay still for three hours while the vaccine flowed into his body through an IV drip. “I got infused three times,” says Petersik. “There had been a large tumor in my lower back. It practically disappeared. And the pain it caused went away, too.” Read more…
The FDA’s Ugly Track Record by RONALD L. TROWBRIDGE and STEVEN WALKER
In sum, these 12 drugs — had they been available to people denied entry to clinical trials — might have helped more than one million mothers, fathers, sons and daughters live longer, better lives. We have actually underestimated the number of “life-years” lost at more than 520,000, because we have not included other safe and effective uses of these drugs that the FDA has yet to approve. Recently, it was decided that Provenge (another drug we have been trying to get for years) will be kept away from prostate cancer sufferers for up to three more years. The reason for the delay? A small but aggressive club of FDA advisers hand-picked by the director of the agency’s Office of Oncology Drug Products, Dr. Richard Pazdur, think the statistics are not yet perfect enough. Read more…
READ Senator Grassley’s SHOCKING Press Release On The FDA
The Finance Committee has received hundreds of pages that say, “57 pages removed,” or “43 pages removed.” Other documents have whole pages, paragraphs or sentences redacted with no explanation as to why. Sometimes documents are marked redacted; other times they are not marked, even when it is evident that information is missing. There is no explanation for what documents have been withheld or redacted. It is incomprehensible and looks like the work of the Keystone cops rather than an agency responsible for drugs and devices. One of the FDA’s most incompetent and absurd moments was when it sent one of my own request letters back to me with information redacted out of it. On top of such nonsense, the FDA has produced versions of the same document redacted different ways. Recently, I wrote Secretary Leavitt and Attorney General Gonzales to explain the basis for some redactions. Again, two copies of the same document were redacted differently. It called into question the good faith basis for the redaction altogether. I could go on and on with examples showing the stonewalling and withholding of information from legitimate Congressional requests. Read more…
Dendreon Having Success With Neuvenge for Breast Cancer 8/17/07
Dendreon Corp., the developer of a treatment to stimulate the immune system against prostate cancer, said a small study suggests the same technique may help women with breast cancer. A clinical trial of Neuvenge showed that four of 18 patients taking the treatment, or 22 percent, had their tumors shrink or stabilize, according to results published in the Aug. 20 issue of the Journal of Clinical Oncology. Read more…
Bruce Tower Another Provenge Success Story 8/2/07
So Bruce joined 250 other “guinea pigs” for an experiment called the Provenge Trial. During that trial, he received his harvested dendritic immune cells, which were manipulated in a lab with prostate protein molecules and then infused back into his body as a new prostate cancer immune cell. The drug paid off. Read more … clarification Provenge approval was delayed.
FDA VIOLATION OF THE RULE OF LAW By Jonathan W. Emord
Most notably from the codification of the Kefauver-Harris Amendments of 1962 to the present, FDA has repeatedly exceeded the limits of its statutory authority to bring about changes designed to protect drug companies from competition. Many times those changes have come at the cost of human life. Courts have occasionally held FDA’s actions unlawful. Rarely has FDA respected court decisions against its exercise of authority. The agency’s usual course is either to ignore court orders or to render them ineffectual through the adoption of new rules, policies, or approaches that achieve the ends FDA desires through different means. The FDA’s lack of respect for the rule of law, its destruction of the rule of law itself, was a consequence predicted by the Framers of the Constitution who warned against delegation of legislative powers.
Since 1962, people within the FDA itself and outside the agency have complained bitterly that FDA is unduly influenced by drug companies. The complaining parties are many, have excellent reputations for honesty, and have spoken against their own economic interests and at considerable personal risk of FDA retaliation. FDA has approved numerous drugs over the objections of its drug safety officers. Read more…
Cancer Pays - The New York Times - Dr. Richard Deyo
In general, oncologists make money by providing chemotherapy, even when it has little chance of success. Oncologists naturally dislike telling cancer patients that they have exhausted all available treatments. Ending chemotherapy, after all, means acknowledging that a patient’s disease has become terminal. “There’s pretty good evidence at this point,” said Dr. Richard Deyo, professor of medicine at the University of Washington and an expert on health care spending, “that there are plenty of patients for whom there’s little hope, who are terminally ill, whom chemotherapy is not going to help, who get chemotherapy.” Read more…
The Seattle Times 7/31/2007 | FDA sued over Provenge delay
The heated controversy over Dendreon’s prostate-cancer drug Provenge has boiled over into the courtroom. A patient-advocacy group sued U.S. Food and Drug Administration officials Monday for withholding approval of the Seattle company’s genetically engineered therapy in May. The plaintiffs say the spurned drug is safe and effective, and claim the denial was the capricious outcome of political infighting within the agency. The lawsuit, filed by Dublin, Ohio-based nonprofit Care to Live in federal court in Columbus, also accuses the agency of ignoring conflict-of-interest issues with some medical advisers chosen to review the therapy. The suit doesn’t skimp on harsh words for the FDA. “There has never been such an incredible, irrational and unjustifiable denial of the rights of dying patients by such a dysfunctional agency,” the lawsuit says. Read more…
Michael Shulman - Denial of Provenge May Kill Thousands of Men Needlessly Each Year 8/10/07
If Provenge works on ten percent of patients, then a few more fathers and sons and husbands and heroes — just like our boys and girls in Iraq – will not wake up at all this morning. Let us hope this circuit court decision, which is about a different drug entirely, is appealed to the Supreme Court and the great, fighting protectors of human life – who oppose abortion but are also ardent supporters of the death penalty – reverse this reversal in the name of the sanctity of any human life. And the power of the patient and the marketplace. Read more…
Dr. West’s Evolving Views on the Provenge Story 8/12/07
At this point, I’ve learned more about the data behind the Provenge trial, the mixed messages that were generally quite favorable leading up to the actual decisions, and the potentially significant conflicts of interest. And while I haven’t concluded that there were economic and/or petty ego motives behind the FDA decision, I’m much less convinced of my prior assumption that the system works well with the only real guiding forces being the strength of the data and the benefits for the population. Read more…
FDA Officials Criticized For Secrecy June 30, 2007
Frequent FDA critic Dr. Sidney Wolfe called it “ridiculous” that the FDA had failed to post the calendar listings but suggested the requirement should be expanded to cover even lower-level employees at the agency. It’s those employees, Wolfe said, who spend the most time meeting face-to-face with drug companies. “Before decisions that seem to be going in the wrong direction from the public health perspective, it might be nice to know a company was in there,” said Wolfe, of the watchdog group Public Citizen. Indeed, separate findings recently released by Stupak and fellow Democrat Rep. Maurice Hinchey of New York revealed how much time those lower-level FDA employees can spend in meetings with the drug industry. The FDA disclosed, in response to questions posed by Hinchey, that agency officials met 112 times, between October 2005 and December 2006, with representatives of the drug industry to negotiate the agency’s proposal for reauthorizing the prescription drug user fee act program. Under that program, drug companies pay the FDA fees to have their products reviewed, exacting in return target timelines that make the process more predictable and expeditious. No senior FDA leaders attended any of those meetings, except for a single meeting at which Woodcock appeared, according to Stupak and Hinchey. Read more…
FDA Officials Sued Over Conflicts of Interests Part I by Evelyn Pringle
According to the lawsuit, the FDA indicated that there were sufficient data submitted from the clinical trials of Provenge to immediately evaluate the product, so Dendreon filed a Biologics License Application in December 2006, which was granted fast track approval designation in January 2007, establishing May 15, 2007 as the date for an FDA decision. Congress established the fast track approval program to expedite the approval of drugs for terminally ill patients. In a blatant attempt to corrupt the Provenge advisory panel, Dr Scher was granted a waiver even though he is the chief of genitourinary oncology services of the Center for Prostate Cancer, at the Memorial Sloan-Kettering Cancer Center and the Center has a received a grant for a study from a competing company valued at $100,000-$300,000 and he owns stock valued at between $5,000 and $100,000 in a company that competes with Dendreon. He also serves as an advisory board member to the venture capital fund ProQuest Investments LP. A 1998 document, entitled “The Opportunity in Cancer: Goldberg’s Variation” says “Prostate cancer will be the focus of the ProQuest Investment LP, a new venture fund founded by Jeremy Goldberg”, and “ProQuest raised $40.5 million in its first closing.” Dr Scher also is listed on some documents as an officer and member of the board of directors of ProQuest. Read more…
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