More Prostate Cancer Smoke & Mirrors From the Broken FDA

MUCH ADO ABOUT NOTHING! The FDA recently issued a press release touting their approval of Degarelix®, "the first new drug to treat prostate cancer in several years". They would have you believe that they actually have compassion for the 30,000 American men who die every year of prostate cancer. I am sure many were fooled by their ploy. Those of us who are fighting for the men with late stage prostate cancer, know what a sham this approval is.

It is not any kind of breakthrough, as there are several similar treatments currently available. It is just more horn blowing and smoke and mirrors from the broken FDA.

Provenge®, a non toxic, non invasive immunotherapy, which demonstrated 20% survival for men with late stage PC, still sits on the shelf gathering dust since the FDA delayed its approval almost 2 years ago. Now the dysfunctional FDA does a year end approval of a drug which has little new to offer.

Think this is not important for you? 1 in 6 men will get prostate cancer in their lifetime. Almost 50,000 Americans have died from PC since the FDA delayed Provenge approval. We all need to raise our voices and shout, MEN MATTER!

Ted Girgus Desperately Seeking Provenge with three of his five Sons
Listen to Ted on Andrew Schorr’s Patient Power “Prostate Cancer: Fighting the FDA for your Life” (or read transcript)

Why is the FDA stonewalling us and not turning over all the Freedom of Information documents we requested. Why is the Department of Justice defending the FDA against our lawsuit! The FDA is supposed to protect the public health.

I know a doctor who wants to give his patients Provenge. The FDA won't allow it. They want more proof. These men are out of options. They have already had either a prostatectomy or some type of radiation therapy, and failed it, and they have been on hormone therapy, and failed that. The only choice left is chemotherapy, which is so toxic, that most men with end stage pc refuse to take it.

Here is an radiation oncologist's opinion about the FDA's recent approval of Degarelix®:

MUCH ADO ABOUT NOTHING!

"The FDA approved this drug because it demonstrated the same castrate levels of testosterone as did lupron. Survival was not an endpoint. It is assumed that because the same low levels of testosterone were achieved, that the drugs were equivalent.

The hoopla about the lack of a testosterone surge for this drug is clinically meaningless. Testosterone surge is rare and not a big deal with lupron.

The drug caused more skin reactions at the injection site than did lupron 40 vs 1 %. A big disadvantage is that after the initial injection, the patient goe s back for a monthly injection. Lupron comes in 1, 3, and 4 month depot form and there is another drug out there that lasts a year.

Reading that piece made me wonder exactly who the principals are behind this injectable drug, and if they happen to have influence with the FDA.

Yes you do have to wonder. Iressa has been shown to be equivalent to taxotere for second line treatment of non small cell lung ca with less side effects but that drug will never be approved.

CEGE's drug gvax had to be superior to taxotere to get approved in the vital trial. Equivalence didnt matter.

Now we take a drug Degarelix for which there are already three equivalent drugs out there on the market. It shows equivalent testosterone supression as did lupron at 12 months and it is approved. Forget survival as an endpoint.

* * * * *

So what gives? A selective double standard? Do certain drug companies have the FDA in their pockets? Is it because of petty jealousy over cber not odac having approval jurisdiction over biologics? While we wait for approval the clock ticks on for our members at CareToLive.com who are out of options and dying for approval.

* * * * *

Some Background

What is a Life Worth? 
 http://my.nowpublic.com/health/what-life-worth

Illegal Rumor Mongering at its Lousiest
http://my.nowpublic.com/world/catch-rat-illegal-rumor-mongering-its-lousiest

Michael Milken and the Prostate Cancer Foundation’s Foul Balls
http://caretolive.com/2007-11-18/michael-milken-and-the-prostate-cancer-foundations-foul-balls/ 

Hedge Funds to Cancer Patients: “Die.”
http://my.nowpublic.com/health/hedge-funds-cancer-patients-die

I Ain't Leaving Till They Throw Me Out 
http://my.nowpublic.com/world/i-aint-leavin-till-they-throw-me-out 
 

* * * * * 

  http://www.CareToLive.com 

* * * * * 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01935.html 

FDA News

FOR IMMEDIATE RELEASE
Dec. 29, 2008

Media Inquiries:
FDA Press Office, 301-796-4540
Consumer Inquiries:
888-INFO-FDA

FDA Approves Drug for Patients with Advanced Prostate Cancer

The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer.

Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer.

Hormonal treatments for prostate cancer may cause an initial surge in testosterone production before lowering testosterone levels. This initial stimulation of the hormone receptors may temporarily prompt tumor growth rather than inhibiting it. Degarelix doesn't do this.

“Prostate cancer is the second leading cause of cancer death among men in the United States and there is an ongoing need for additional treatment options for these patients,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA.

Prostate cancer is one of the most commonly diagnosed cancers in the United States. In 2004, the most recent year for which statistics are currently available, nearly 190,000 men were diagnosed with prostate cancer and 29,000 men died from the cancer.

Several treatment options exist for different stages of prostate cancer including observation, prostatectomy (surgical removal of the prostate gland), radiation therapy, chemotherapy, and hormone therapy with agents that affect GnRH receptors.

The efficacy of degarelix was established in a clinical trial in which patients with prostate cancer received either degarelix or leuprolide, a drug currently used for hormone therapy in treating advanced prostate cancer. Degarelix treatment did not cause the temporary increase in testosterone that is seen with some other drugs that affect GnRH receptors.

In fact, nearly all of the patients on either drug had suppression of testosterone to levels seen with surgical removal of the testes.

The most frequently reported adverse reactions in the clinical study included injection site reactions (pain, redness, and swelling), hot flashes, increased weight, fatigue, and increases in some liver enzymes.

Degarelix is manufactured for Ferring Pharmaceuticals Inc., Parsippany, N.J., by Rentschler Biotechnologie Gmbh, Laupheim, Germany.

 * * * * * 

http://youtube.com/watch?v=6Q0uQAL_YDA

Video of Care To Live member Ted Girgus taken at our nationwide protest in Seattle. Ted has stage IV prostate cancer, that has metastacized to his bones. Ted and his doctor, want him on Provenge NOW!

* * * * *

Here is a Video of the 2007 Rally

http://www.youtube.com/watch?v=UqAx7uZAS90

MAY 30, 2008 NATIONWIDE PROSTATE CANCER PROTEST

* * * * *