While I will defend to the hilt Mr. Walker’s right to express his opinion, and I entirely agree with the Abigail Alliance’s desire to find ways to expand access to investigational drugs for patients who have run out of other options, I also profoundly disagree with Mr. Walker’s opinions about the FDA in general and his characterizations of Dr. Pazdur in particular.

Thanks for writing in Steven.

The truth is that Dr. Pazdur has been a lethal disaster for cancer patients, making a plethora of serious mistakes that have resulted in the premature deaths of more than a million Americans. Those Americans with cancer died waiting as numerous effective drugs have been (and continue to be) unnnecessarily delayed or rejected by Dr. Pazdur.

It was recently reported that cancer drug development and approval times have been 1.5 times longer than the process for drugs intended to treat other less serious diseases over the last 15 years. Much of that slowdown is the direct consequence of Dr. Pazdur’s 9 years of rigid, narrow-minded policies and decisions. Dr. Pazdur has also intentionally (by his own admission and most compellingly by his actions) effectively eliminated the accelerated approval pathway for cancer drugs put in place by Congress in 1997. The pathway was created because FDA was stalling progress against a variety of life-threatening diseases, including cancer. Congress’ directive to speed up development and approval of drugs for terminal diseases was starting to take hold at FDA until Dr. Pazdur arrived at the agency and took over the cancer drug division in 1999.

In 2003, he decided to really put the brakes on progress against cancer when he unilaterally decided to effectively eliminate the accelerated approval pathway as a workable pathway for approval of canxcer drugs. He didn’t just make a policy, he personally, authoritatively enforced it. It did not make cancer drugs better or safer, it just slowed down their delivery, increased the cost of cancer drug development, and killed people – hundreds of thousands of them – prematurely, as they found themselves left out of the progress he refused to deliver to the clinics.

he is still doing it today. Look in to his role and decisions reagrding Provenge, the life-extending, extremely safe therapeutic vaccine for men with terminal, hormone refractory prostate cancer. how is Dr. Pazdur helping them by refusing them access to a safe, life-extending therapy with essentially no side effects at all?

Much of the FDA “bashing” carried on the pages of the WSJ regarding FDA’s role as a barrier to progress against terminal diseases has been right on target, which makes it anything but bashing. When it is correct and well supported by facts (and it has been in the case of Dr. Pazdur), it is legitimate criticism of a deeply failing federal agency and bureaucrat that have quite literally killed countless people with their incompetence and unresponsiveness.

As for Iressa, Dr. Pazdur’s real mistake was pulling it off the market, not approving it in the first place. The drug remains approved in multiple advanced countries around the world that are not burdened with Dr. Pazdur. Patients in Japan and Switzerland, for example, can get it. It works, dramatically, for about 10 percent of non-small cell lung cancer patients, and the patients likely to respond can be identified in advance of treatment; a fact Dr. Pazdur chose to ignore in favor a his bilnd adherence to the results of statistical analysis. His approaches don’t work for evaluating targeted drugs like Iressa, and Dr. Pazdur is not an open minded man. He resists change and has used his power as FDA cancer czar to impose his own, misguided and archaic views on the entire field of cancer drug development, clinical trial design and approval standards.

Consider that Americans with terminal lung cancer can’t get Iressa solely because of Dr. Pazdur. Who do you suppose is better off – terminal lung cancer patients who can get Iressa, or those who can only get Dr. Pazdur’s platitudes about the sanctity of statistical analysis and a meaningless statistical metric called a p-value?