Death Prompts Calls for More Drug Scrutiny

ByABC News

April 21, 2005 -- -- 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.

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."

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.

"Compounders will say that they fill unique market niches where products aren't in the marketplace," she said. "Maybe they're not in the marketplace because it's not safe for them to be in the marketplace."

And Sellers says there have been other instances where a compounded medication has gone awry.

"The cases that we do know of are considered tip of the iceberg by public health experts," she said.

In all, the government has documented over 200 incidents over the past 15 years, involving 1.4 million potentially tainted doses of medicine.

"Patients have a right to know the medications they are using, are not approved by the Food and Drug Administration," Sellers said.

However, Angelle, president of the International Association of Compounding Pharmacies, said while mistakes have been made, her industry's quality control standards are very high.

Angelle said the industry already is regulated by state boards of pharmacy.

But the industry does not test the effect of its compounds on patients, like the FDA requires for manufactured drugs.

The industry has lobbied hard against federal regulation. It says state regulation is sufficient, and that the Bergs' tragedy was not its fault.

"The practitioner that dispensed the medication is responsible for the consultation and education of that patient," Angelle said.

Because the tube was marked "for office use only," compounders say it was up to the spa's doctor to safely dispense the cream himself -- and only in his office.

Others disagree that the pharmacy shares no blame. "If you're going to promote a product in the marketplace, you have a duty to disclose that it is not produced according to strict federal standards," Sellers said.

One of those federal standards is an appropriate warning label. The tube of numbing cream that Berg used had no warning information.

But Angelle said, "That's where the role of the pharmacist and the compounding pharmacist is so important. We are trained to properly educate the patients."

Kirby points out that the Bergs' daughter received no "education" about the product.

The Bergs are now pushing to make more people aware of the risks their daughter faced -- so that she will be remembered for something more than just her death.

"She wanted to make a difference in the world. She wanted to be remembered," said Ron Berg. "One of the reasons we're doing what we're doing now … [is] because we somehow want to be the voice of Shiri."

The FDA and the North Carolina pharmacy boards are currently investigating the Berg case.

The spa's lawyer said the spa owners never knew that a prescription was needed for the gel, and they thought it was a safe and approved product. The spa has gone out of business, and its house doctor has been brought up on charges by the state medical board.

As for the compounding industry, it is beginning an accreditation program to improve compliance with industry standards.

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