The Food and Drug Administration (FDA) is one of the major governmental entities that has a significant, direct and immediate affect on any of us who has any illness. All men with prostate cancer have had their life and their deaths impacted by the FDA. This impact has not been on just a few of us, but on each and everyone of us on each and every day.

The current commissioner of the FDA has announced that he plans on leaving the FDA once President elect Obama takes office. As of this time the president elect’s office has not announced who will be taking over the reigns at the FDA.

There has been a lot of speculation on who might get appointed including in the very ranks of big Pharma (Pharma Marketing News revealed the results of its fourteen pages “Who should be the next FDA Commissioner” survey.

The Wall Street Journal has reported that Bart Stupak (D., MI) sent a letter to President elect Obama urging him not to appoint anyone currently at the FDA, including Dr. Janet Wodcock, who is rumored to have met with the Obama transition team to talk about the position.

I know that I am just one person and my personal opinions have little value to what will eventually happen, but I strongly urge that the Obama team listen to Mr. Stupak’s concerns. “Something is rotten in Denmark” and something is also rotten at the FDA.

President elect Obama ran his campaign on making change. The appointment of a new FDA Commissioner, from the outside, is a great place to begin making change. It is very clear in my mind that Dr. Woodcock’s nomination would be more of the status quo. She is a career bureaucrat well entrenched in the FDA and has a long history with being very cozy with big pharma.

The new FDA commissioner should be an individual without ties to lobbyists, special interest groups, and especially to big pharma. The commissioner and all of the top officials need to be individuals with fresh ideas and the willingness to evaluate new therapies with a better understanding of the critical needs of the community.

The FDA has fallen into a rut of blindly applying a form of statistical purity when they should be asking whether the statistical evidence demonstrates efficacy using a reasonable medical probability standard.

Under the current administration too many life-saving drugs are delayed in gaining approval, allowing numbers of people to suffer and die needlessly. The cost of developing drugs and getting them approved has skyrocketed so that only big pharma are now the only ones who can develop drugs, stifling grassroots innovation. Today, fewer drugs are being developed and far fewer drugs are being approved despite their demonstrated good safety profiles.

Safety and efficacy must be viewed in context of the type of condition being treated. Statistical purity when evaluating efficacy for drugs treating end stage disease does nothing to help people. Safety does remain important, but when treating people who are near death a post approval safety monitoring system can fill in the gaps.

The new commissioner of the FDA should be someone who understands that the FDA’s role in evaluating efficacy has grown out of control, ignores Congress’ intent, and more importantly poorly serves patients. There is no reasonable excuse to delay the approval, even if it is a provisional approval, of safe drugs that have been shown clear potential to be effective in prolonging life in late stage diseases.

There is no better example of my concern than the drug Provenge, the potentially first immotherapy for advanced prostate cancer. I have written a lot about Provenge, so I will not repeat myself giving you the background (you can read about Provenge by searching this blog).

Since the FDA failed to approve Provenge, despite the FDA’s own review committee’s positive safety profile evaluation and the committee’s finding that it demonstrated substantial evidence of efficacy (the congressionally mandated standard), men with advanced prostate cancer continue to die sooner than they might otherwise. This was the first time in history the FDA overturned a positive FDA expert advisory panel recommendation to approve a drug for an end stage disease.

Under the current administration, the FDA has a complete lack of transparency and accountability. After the FDA failed to approve Provenge. There had been many inquiries by advocates, media, and others to the FDA asking why it was not approved; to date nobody has received a specific reason why the FDA had over ruled their own advisory committee.

Many advocates in the prostate cancer community have adapted Dr. Mark Thornton’s, a well respected oncologist, characterization of the day the FDA failed to approve rovenge as “Black Wednesday.” Even today, there are a number of men who were in the initial clinical trial of Provenge who remain alive, well beyond their life expectancy.

The FDA’s failure to approve Provenge has cost many men their life and each day the FDA continues to delay because of their obsession on statistical purity more men will die.

On October 6, 2008, Dendreon, the manufacture of Provenge sent out a press release detailing results of the IMPACT trial (the current on-going trial required by the FDA to gather additional data) which has been blinded to Dendreon. The results confirmed that Provenge saves lives. The Independent Data Monitoring Committee (IDMC) reported a 20% decline in the death rate in the Provenge arm compared to the placebo.

Even after this data was released, the FDA has remained unimpressed. They are sticking to their strict requirement for statistical purity over saving lives and demanding a 22% extension of life. Yes, you read that correctly. Twenty-two percent versus 20% statistical requirement in a group of men with advanced stage prostate cancer. Where is the common sense and compassion in that?

Joel T Nowak MA, MSW