A Long And Deadly Wait

Forbes.com

Matthew Herper, 09.30.09, 06:00 AM EDT

Sabril could help babies with brain-destroying seizures. So why did it take so long to approve?

Timothy Zirkel will never forget the seizures that assaulted his 4-month-old son, Jake. “You could see the pain in his body as it happened,” says Zirkel. “I just remember always wanting to trade places with him.”

Every seizure was damaging Jake’s brain. Infantile spasms, a rare form of epilepsy, strike 2,500 babies in the U.S. every year. Unless the seizures are stopped early, permanent neurological problems result. These children may never walk or talk. Some have IQs of less than 50.

After a first treatment failed, Jake was helped by an experimental medicine called Sabril that carried the risk of destroying his peripheral vision.

It was “a no brainer” to take the chance, says Zirkel. “Within the first day of taking it, his seizures stopped and they have never come back.” That was in 2005.

The drug had languished since 1998 when its original maker abandoned it because of the vision side effects. A tiny biotech, Ovation Pharmaceuticals, picked it up in 2003, and fought for six years to get it approved. Its path to patients was the longest of any medicine on record–14 years.

MORE…

Comment from Leslie

Is it possible that the infants would not experience and suffer from  seizures if they did not receive dirty vaccines?  Treating a drug reaction with another drug….that is what the pharmaceutical industry is all about.

Also how many parents have been accused of SBS when a neurological problem is causing the infnat’s seizures….that is another whole sad issue that too many families have had to face.

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.