Corruption at Its Finest

For those of us who have followed the Provenge saga and have been fighting this injustice since May 9 2007, most, if not all the information contained here will not be news to us. Nevertheless, since I have been offered a platform to express my views and opinions, I leaped at the chance to do so. My main concern and motivation for this blog stem from what appears to be FDA corruption and the lack of urgency by Congress to rectify the situation.

I have written to my Senators and Representative so many times, I have lost count. If I am lucky enough to receive a response, the communication exchange usually ends the same way. The Senators and Representative forward my concerns to the FDA. The FDA changes the recipient’s name and sends their already prepared form letter to the Senators and Representative, which is then forwarded to me. The FDA’s response is a blatant disregard for authority. Who is the boss of whom? The FDA is seriously out of control. What is even more disturbing is that Congress has allowed the FDA to get away with thumbing their nose at the boss (Congress). If this was any other employer/employee relationship, the employee would have been shown the door a long time ago. My perception is that FDA officials have become so cocky and removed from the mandate set by Congress, they feel they answer to no one. I apologize for the rant. However, this situation is beyond ridiculous and I am beyond frustrated.

A Walk Down Memory Lane

The trail of FDA corruption dates back for decades. I will not go back to when the corruption began because I would literally have to write a novel. Drug approval and the pharmaceuticals are big money. In the recently passed Prescription Drug User Fee Act Reauthorization bill, pharmaceutical companies will pay the FDA approximately $393 million in user fees in fiscal year 2008, compared with $305 million in FY 2007. Congress and the media are not immune to this dangling lucrative carrot. Pharmaceutical companies spent $855 million from 1998 to 2006 lobbying congress, more than any other single industry, according to the non-partisan Center for Public Integrity. In 2006, the pharmaceutical industry spent a whopping $5.3 billion on advertising. With all this temptation, the iron man would find it difficult to resist. Hence, the walk down memory lane begins.

1977

“Rumsfeld was president of Serle corporation in 1977, maker of aspartame, then, part of Reagan transition team, and got aspartame ‘legalized’ by appointing a defense department contractor [??] (Hayes) as head of FDA! In January 1981 Rumsfeld told a sales meeting, according to one attendee, that he would call in his chips and get aspartame approved by the end of the year. On January 25th, the day the new president took office, the previous FDA commissioner’s authority was suspended, and the next month, the commissioner’s job went to Dr. Arthur Hull Hayes. Transition records do not show why the administration chose ***Hayes, a professor and Defense Department contract researcher.*** In July Hayes, defying FDA advisors, approved aspartame for dry foods — his first major decision. In November 1983 the FDA approved aspartame for soft drinks — Hayes’ last decision. In November 1983 Hayes, under fire for accepting corporate gifts, left the agency and went to Searle’s public-relations firm as senior medical advisor. Later Searle lawyer Robert Shapiro named aspartame NutraSweet. Monsanto purchased Searle. Rumsfeld received a $12 million bonus. Shapiro is now Monsanto president. …..Former White House Chief of Staff Rumsfeld owed a debt of gratitude to former White House confidante and Rumsfeld friend Donald Kendal, Pepsi’s chairman. The Pepsi announcement and aggressive marketing (millions of gumballs, a red and white swirl, tough contracts) made NutraSweet known in every home. ….From 1985 to 1995, researchers did about 400 aspartame studies. They were divided almost evenly between those that gave assurances and those that raised questions about the sweetener. Most instructively, Searle paid for 100% of those finding no problem. All studies paid for by non-industry sources raised questions. By James S. Turner.”

Retrieved November 12, 2007 from Whale.to

1996

“On November 25, 1996, David Kessler, Commissioner of the U.S. Food & Drug Administration (FDA) announced his resignation. It is common knowledge among insiders that Kessler lied before Congress when he testified under oath at the FDA Oversight hearings last year. There has been talk about the possibility of subcommittee members asking the Justice Department to prosecute him for perjury. He overcharged for dozens of cab rides, illegally used his government credit card to get a discount plane ticket for his wife, and committed other similar transgressions.”

Hamell, J. (March 1997). FDA Commissioner David Kessler Resigns. Life Extension Magazine. Retrieved November 12, 2007 from Lef.org

2001-2004

“At a major meeting on cancer last May, ImClone Systems announced that its experimental cancer drug, combined with another medicine, shrank tumors in 22.5 percent of the patients in a study, for whom existing treatments had failed. ImClone executives were ecstatic, saying they would immediately seek government approval. In another room at the same conference, Dr. Richard Pazdur, director of the Food and Drug Administration’s cancer drug division, was delivering a different message. Though he did not mention ImClone or any other company by name, Dr. Pazdur said in a panel discussion that the agency wanted to discourage companies from seeking regulatory approval for drugs based on clinical trials designed like ImClone’s.”

Pollack, A. (February 8, 2002). Imclone Rejection Focuses Debate on Testing of Cancer Drugs. The New York Times. Retrieved November 12, 2007 from Nytimes.com

“ImClone founder Sam Waksal has admitted selling his shares after he was tipped that the FDA report would be negative. Advance word on the report, according to records and sworn testimony, was initially provided by an FDA official. Richard Pazdur, a cancer specialist at the FDA, told a Washington lawyer that ImClone would soon receive a letter rejecting its application to market Erbitux, a promising cancer drug.”

Barrett, D. (January 24, 2004). Stewart Trail Winds From Doorstep to FDA. Associated Press. Retrieved November 12, 2007 from Latimes.com

2005

Former FDA Commissioner, Dr. Lester Crawford resigns “just two months after his approval by the Senate. On October 17, 2006, he pleaded guilty “to conflict of interest and false reporting of information about stocks he owned in food, beverage, and medical device companies he was in charge of regulating.”

Retrieved November 12, 2007 from Wikipedia

Fast Forward to 2007

Here we are fast approaching 2008 and nothing has changed. The more things change, the more they stay the same. FDA still lacks accountability. To date, Congress is still looking the other way. The media still considers the shenanigans of Britney Spears, O.J. Simpson and Paris Hilton more newsworthy than 82 men dying each day from prostate cancer. Big pharm still reigns. Dr. Richard Pazdur is still wreaking havoc. The only difference this time is a new immunotherapy treatment for late-staged prostate cancer called Provenge (the sordid story found at CareToLive.com) is the political casualty of the FDA, along with 30,000 new victims each year.

Melody Davis, RN, BSN