The FDA was seriously wrong when it delayed the safe and effective immunotherapy called Provenge, which is for late stage prostate cancer. Here are just a few pictures from each location as friends and members of CareToLive delivered another strong message to the FDA while educating people around the country. By way of review, here is the story. Every year, 218,890 men get prostate cancer in America. 96,000 of them will advance to late stage. Only one treatment has been approved by the FDA in the last 43 years and it is so toxic, most of the men do not want to take it. Go to www.taxotere.com and read the black warning box!

30,000 of these men die every year in America. The FDA was presented with a treatment option called Provenge. The FDA granted it Fast Track Status because it knew it was a lethal disease and there were no other options. Then the FDA used our tax dollars and made this a public issue by calling for an Advisory Committee. Plus, the FDA granted Priority Review because, once again, it was for a lethal disease and there were no other options.

So the FDA brought us into this story. It made us well aware of the unmet need for a terminal disease. We watched as the Advisory Committee panel did indeed advise the FDA.

This panel, selected by the FDA itself, said Provenge is safe by a vote of 17-0. It passed the dreaded Vioxx test. The panel said Provenge shows substantial evidence of efficacy by a vote of 13-4. It passed the Congressional threshhold for approval. And yet, the FDA turned its back on the 30,000 men in dire need and delayed getting the treatment to them. It has been well over a year now. And sadly, three CareToLive members have died while waiting on the FDA.

The FDA brought the public into this story and then shut it out so it could make a decision behind closed doors. The only thing the public got to see were three leaked letters crafted by several at the FDA and NCI to spin this story the way they wanted it. Then we found out the decision was squarely made because of the investments and business relationships of Drs. Scher, Hussain and Pazdur.

CareToLive responded by protesting. And it sent thousands upon thousands of letters to the media and elected officials. Then it filed a Citizens Petition, which the FDA still has not properly responded to as of today.

Next, CareToLive filed a lawsuit. We were denied a fair chance to present our case in court as all the windows, shutters and doors were slammed in our face. On July 29th, the US Court of Appeals will look at how that case was handled. We are hoping for that chance to present our case.

In the meantime, we took advantage of our right to access information under the Freedom of Information Act. We received some revealing stuff but not all of it. What is the FDA hiding. This is not the way a government agency is supposed to behave. It is supposed to serve the people, answer to the people, and adhere to the law. We want answers. We demand answers.

Meanwhile, one out of every six men in the United States will get prostate cancer. The shenanigans of some people at the FDA has slowed the scientific progress to help these men. The citizens of America should be outraged and demand more from our government. It is our tax dollars at work here and we are getting a terrible return on that investment.

Tell your elected officials we want this case investigated, we want the guilty parties brought to justice and we want the suffering men in America to get Provenge now!