Death Prompts Calls for More Drug Scrutiny

Shiri Berg, 22, was just a young woman looking to look a little better. But earlier this year, she prompted more scrutiny of a little-known drug industry, and helped expose a system that puts lives at risk.

On Dec. 27, 2004, the North Carolina State University student was driving on route I-40 in North Carolina when she felt woozy and pulled over. She was later found inside her locked car, unconscious and having convulsions. She soon went into a coma.

Her father, Ron, says it was not drugs or alcohol. Bizarrely, Berg's lower body underneath her clothes was wrapped in cellophane, and her legs were covered in a strange gel.

One of Berg's roommates remembered that she had told him she was going for a laser hair removal session at a local spa to take care of unwanted hair on her legs.

Laser hair removal can be safe and effective, but Berg was concerned about pain associated with the procedure. As some clinics do to address the discomfort, the spa provided her with what they call a numbing cream.

Her friends say Berg was told to apply the cream right before her appointment and wrap herself in cellophane to intensify the anesthetic effect.

It was called Laser Gel 10-10, a prescription compound whose two major ingredients are serious anesthetics: 10 percent Lidocaine, 10 percent Tetracaine. It came with no warning about potential side effects, nor risk of coma.

Over the course of 10 days, Berg never regained consciousness. She died on Jan. 10.

Potent Combination

Dr. Howard Sobel, a New York dermatologist, says the combination of this strong medication spread over too large an area was too much for Berg's system.

Shiri Berg was apparently not the first to have this happen to her. Almost three years earlier, Blanca Bolanos went into convulsions in her car driving to a Tucson, Ariz., laser hair removal clinic. Bolanos was in a coma for two years before dying. Court papers say she used a cream of 6 percent Lidocaine and 6 percent Tetracaine.

David Kirby, the Berg family lawyer, says after Berg's coma hit the news, 20 other patients in North Carolina approached him. He says, like Berg, they used a highly potent Lidocaine-Tetracaine combination. He also says none received a prescription or saw a doctor.

Two of those patients went into cardiac arrest, but survived, Kirby told "Primetime."

Calls for Regulation

The Bergs blame the beauty spa and its doctor. But the cream that led to their daughter's death was not made by the spa.

It was mixed by something called a compounding pharmacy. Compounding pharmacies have been around for years and can do lots of good customizing medicines for patients.

Patsy Angelle, who owns and runs a small mom-and-pop compounding pharmacy in Baton Rouge, La., with a good safety record, gave "Primetime" an example of how her operation helped a child: "The child had a tonsillectomy. And his throat was hurting really bad. [His] physician contacted [us] and we prepared a medicated lollipop and the pain went away and the child was able to eat."

As long as they stay small, the FDA says it has left their regulation to individual states. But these days, mega-pharmacies are changing the industry, filling huge numbers of prescriptions for drugs that aren't regulated by the FDA.

A compounding pharmacy called Triangle mixed the cream given to Berg. It was a combination never reviewed -- or approved -- by the FDA. Critics like pharmacist Sara Sellers say that can be dangerous.

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