The Bottleneck for New Drugs is the FDA

Let's face facts: The FDA is a bureaucracy that is still a-glow in the protection of many Americans during the Thalidomide baby birth defect debacle. That protection came, ironically, by a bureaucrat stalling on doing anything in approving the drug. After this woman sat on her hands for months and months, the world learned of the terrible birth defects occasioned by Thalidomide.

The FDA has taken that lesson to heart. Do nothing is the wisest and safest course. If you approve a drug or device, such as Vioxx or breast implants, and there is even the hint of health problems, you will be hounded by lawyers forever. And the drug companies, which put out largely a safe product, will be tarred by the negative publicity surrounding the drug.

As part of the massive deficit spending by this administration, some money is supposed to trickle into cancer research. As the following editorial points out, the last time money was poured into reaseach, it all 'disappeared into a thousand tiny holes.'

The author of the following piece argues that the FDA has to do better this time. Instead of waiting years and years for drug efficacy to be demonstrated by over-all survival, it needs to accept surrogates for effectiveness, such as progression-free survival (PFS) as good enough to move a drug forward.

The Next Front in the War on Cancer
Faster clinical trials are critical if we are to save more lives.

By MARK THORNTON

On Tuesday, President Barack Obama announced a massive initiative against cancer. "Our recovery plan will launch a new effort to conquer a disease that has touched nearly every American, including me," he said in his speech to the nation, "by seeking a cure for cancer in our time."

Specifically, the president was referring to a provision in his stimulus bill that will direct a tranche of funding to the National Cancer Institute (NCI). The money will come from the $10 billion that's being steered to the National Institutes of Health, and it will, for the next two years, match the surge in spending on cancer that occurred between 1999 and 2003.

But despite the lofty goal set by Mr. Obama, it appears that the NCI is not mapping out a specific plan or strategy on how to most effectively use its new money. It is simply going to pour more money into the cancer research community.


In 1998, a new day was dawning in cancer research. The genomic codes of cancer were being broken, and an explosion of new vulnerabilities was being discovered that had the potential to reveal hundreds of new "drugable" targets. The hope then was that this would quickly produce a cure.

The dream was that this dramatic funding increase would break the back of cancer.

It didn't. Now that the money has disappeared, the diagnosis of cancer is no less fearful in 2009 than it was in 1999.

Read the rest at:

http://online.wsj.com/article/SB123569839480689223.html

Our lives depend on doing a better job, folks!