Lifewatch: Clinical Trials

Reported by Claire Hosmann - email
Posted by Debra Worley - email

(WECT) - There are 40,000 clinical trials currently taking place across the nation.  More than a million people are taking part in them, but do the risks of joining a trial outweigh the benefits?

It costs on average $802 million to develop a new drug, but not every drug makes it to the market.

Many are stuck in clinical trials and could take more than a decade to get approved.

Critics claim the FDA takes too long to give the go-ahead to life-saving medications and therapies, but others say it's better to be safe than sorry.

Abigail Burroughs lost her battle with neck cancer.  In the last 7 months of her life, she not only fought her disease, but the Federal Government as well.

"I wish that they would just sit down and get to know me and then be able to sit down and look me in the eye and tell me, 'No,'" said Abigail.

The FDA refused Abigail access to a drug that may have prolonged, or even saved, her life.

After she died, the drug she was fighting for, Erbitux, was approved.

Abigail's father created the Abigail Alliance to take her fight to Capitol Hill. The Access Act, before the House and Senate right now, allows terminally-ill patients who have exhausted all other options access to investigational drugs.

The society for clinical trials opposes the access legislation, calling it a "bad law."

"Statistics show that 90 percent of all drugs that pass phase 1 testing are ultimately shown to be ineffective or too toxic," said Dr. Colin Begg.

It typically takes pharmaceutical companies six years after discovering a promising molecule to gather enough data to begin clinical trials. Completing a trial takes another seven years.

The FDA says the trial duration is time well spent.

Although it is too late for his daughter, Burroughs says he will push forward.

"I work every day for her, but I work every day for a lot of other people," said Burroughs.

The Access Act also pushes for placebo-free drug trials.

The hope is more people will get involved in clinical trials if they know they will be receiving the drug in question.