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Dendreon CEO Mitchell Gold acknowledges the company's fortunes largely rest on the outcome of trials of its cancer drug, Provenge. (Photo courtesy of Lincoln Potter)
Ted Girgus, a former college administrator who lives in Bellingham, has been keeping an eye on Seattle biotech company Dendreon Corp. Girgus has been fighting prostate cancer for more than a decade and sees the company's principal product, Provenge, as a potential lifeline. Early results from clinical trials indicate that the drug may bear out that hope.
"Provenge has been the light at the end of the tunnel," he says.
But Girgus' other hopes aren't going so well. He's also an investor in Dendreon, and the company's ordeal in getting Provenge approved by the Food and Drug Administration has been harrowing, wiping out hundreds of millions of dollars in value.
Getting a drug approved by the FDA is a long, exacting process that takes money, research and patience. It's not usually the catalyst for dramatic stories and conspiracy theories.
But the saga of Dendreon and the not-yetapproved Provenge has captured the attention of many patients, investors, regulatory critics and even Congress during the past year.
Throw in the stakes of big money, personal threats to FDA advisers and real questions of risks versus benefits when trying to treat a deadly disease, and it's easy to see why the story of Dendreon and Provenge has become one of the most compelling in the biotechnology world.
It's also a stark reminder of why biotech remains one of the biggest gambles for investors. Dendreon's stock has taken a roller-coaster ride from a peak of more than $25 to below $4 at times -- that's just in the past year.
"The magnitude of how this got picked up from the public-interest perspective is more than we could have imagined," says Mitchell Gold, Dendreon's CEO for the past five years. "It's a story that people remain interested in."
And unlike software start-up companies, the extended drug development cycle means that the average biotechnology start-up is in research mode for a decade or more and often has to go public in order to keep the capital flowing in. By the time a drug makes it into the final clinical trials, it has often become the company's flagship product. Other drugs may be in the works, but the fortunes of the company as a whole often rest on the first product through the pipeline.
If a company's principal drug candidate fails, the stock price plunges, staff are often let go, and the company likely becomes a takeover target for a larger conglomerate looking to scoop up some potential drug candidates on the cheap. That is, if the start-up doesn't just go under completely. Among biotech start-ups, it's boom or bust, and there aren't many do-overs.
Dendreon has been struggling with the latter scenario, starting a year ago.
On May 8, 2007, the FDA issued an "approvable" letter for Provenge, which actually means the agency is not approving the drug, but leaving the door open to future approval. The agency asked Dendreon for more clinical data about the drug's reported efficacy.
Even though some analysts had predicted such an outcome, the decision made waves. Less than two months earlier, an FDA advisory panel recommended Provenge's approval, voting 17-0 that the drug was safe and, in a 13-4 vote, that it prolonged the lives of prostate cancer patients.
"Never in the history of the FDA, as far as we know, has the FDA not gone with the recommendation on a life-saving drug," Gold says.
David Miller, president of Seattle-based Biotech Stock Research, puts it more bluntly. "There are a lot of guys who think they got screwed," he says. "And they did."
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
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."