Healthy Skepticism Library item: 783

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Publication type: news

Shimron Y, Gardner A.
Cream's safety wasn't tested: 'Compound drugs' lightly regulated
The News & Observer Publishing Company 2005 Jan 29

Full text:

The death of N.C. State student Shiri Berg after an apparent reaction to a potent anesthetic cream is drawing new scrutiny to compounded drugs and the little-regulated industry that produces them. Compounded medicines are custom-prepared by pharmacies in nonstandard doses. They do not receive the same safety testing that other pharmaceuticals require before they can be sold.

North Carolina’s medical and pharmacy boards have each begun an investigation, as has the U.S. Food and Drug Administration.

A 2003 FDA study found that one-third of compounded drugs failed to meet the basic standards of quality. And in 2002, the U.S. General Accounting Office concluded that the FDA was aware of 200 adverse reactions caused by compounded drugs since 1990, including three deaths and 13 hospitalizations.

Berg, 22, an N.C. State senior, applied the numbing cream to her body before driving to a Dec. 28 appointment at Premier Body of Raleigh for a laser hair removal procedure. In her car, she had seizures and fell into a coma. She died Jan. 5 at Rex Healthcare. The cause of death listed on her death certificate as “elevated blood lidocaine level.”

The cream she used, sometimes known as 10/10 Laser Gel Plus, is a combination of two prescription-strength anesthetics — 10 percent lidocaine and 10 percent tetracaine. It is widely used in area spas.

The cream is produced by several compounding pharmacies that make drugs in small-scale quantities from raw ingredients. No FDA approval or clinical tested is required.

Any pharmacy is allowed to compound drugs, but most compounding is done at pharmacies that specialize in it. The compounding industry has about 3,000 member pharmacists across the nation, according to its trade association.

State pharmacy boards are supposed to regulate compounders. But David Work, executive director of the state pharmacy board, said it has insufficient funds to fully monitor the industry or randomly test compounded drugs.

“We have seven people including a supervisor who are trained investigators,” Work said. “We haven’t the resources to do sufficient oversight.”

Work said his board will ask the state legislature for permission to increase its fees so it can hire more investigators.

If either the medical or pharmacy board finds evidence of criminal wrongdoing, it would forward that information to Wake County District Attorney Colon Willoughby. Willoughby said it was too early for his office to get involved.

Increasingly, compounding pharmacies are adopting mainstream drug manufacturers’ tactics by hiring sales representatives to visit doctors’ offices and sell their products, said Sarah Sellers of Barrington, Ill., a member of the FDA’s staff of advisers and consultants.

Two Raleigh doctors who oversee spas say they were approached by a sales representative from Triangle Compounding Pharmacy of Cary, the company that made the cream Berg used before her laser hair-removal appointment.

“They came in one day to demo the product,” said Dr. Tim Kwiatkowski, medical director of SonaMedSpa in Raleigh. “We declined to use their product.”

Dr. Adam Stein of Iatria Day Spa in Raleigh said he, too, was solicited by Triangle Compounding and was given some samples. He said he prefers to use a less concentrated solution.

Compounding pharmacies have operated in a regulatory vacuum since 2002, when the U.S. Supreme Court wiped out nearly all federal law addressing the practice. (Compounders challenged restrictions on advertising claiming they violated their 1st Amendment free-speech rights. The high court agreed.)

Often compounders prepare medicines for customers who require a special dosage or method of taking a drug that is not standard. For example, they make dye-free cough syrups for patients who are allergic to the coloring found in commercial products.

But they have increasingly found lucrative markets for patients wanting alternative medicines for hormone replacement, sexual impotency, and now cosmetic procedures such as laser hair removal and chemical peels.

The absence of regulation presents some risks to patients, FDA consultant Sellers said.

“This industry is making untested, unvalidated, unapproved drugs that are not manufactured under federal standards,” she said. “These drugs are experimental, and patients need to understand that.”

An industry representative said that compounding pharmacies provide a needed service, and that their marketing efforts reflect that.

“They sell the concept of what they can provide and try to fill a niche of what’s underserved by commercially available products,” said Patricia Paget, spokeswoman for the International Academy of Compounding Pharmacists of Sugar Land, Texas.

Production halted

Triangle Compounding said it has ceased production of the 10/10 cream until investigations into Berg’s death are complete.

So has Medicine Park Pharmacy of Sanford, which also has made the cream.
“If we have been lax in any way, we won’t be anymore,” said Billy Cameron, owner of Medicine Park.

So far, there has been no suggestion that the cream Berg used was tainted, but the pharmacy board is having the cream tested for potency, purity and contamination.

However, by law a prescription should have been written specifically for Berg. David Kirby, a lawyer hired by her family, said she did not have a prescription. Three other women interviewed after Berg’s death said they were sold the cream by Premier Body with no prescription either. Spa officials have declined to comment on the matter.

“They basically told me I had to use it,” said Maureen MacNeill of Raleigh, referring to Premier’s office staff. “They said, ‘Use the entire tube. Cover both sides with a thick layer and put Saran Wrap on it.’ “

Like MacNeill, Joanne Scannell of Holly Springs said she was sold the cream by a salesperson, not a doctor or a nurse. “It was sold to me when I signed the contract,” she said. “I never saw a doctor.”

Lidocaine is available over the counter at up to 4 percent strength. Anything above that requires a doctor’s prescription. Many spas have taken to using prescription-strength creams to make the procedure more comfortable for their patients.

Skin and Aesthetic Solutions of Raleigh is one such spa. Unlike Premier Body, which has a doctor “on call,” this office is owned by a dermatologist, Fernando Puente, who practices medicine down the hall.

Puente said he writes a prescription for each client who uses the cream. And he holds a dispensing permit from the N.C. Board of Pharmacy that allows him to purchase the cream from a compounding pharmacy and sell it directly to his clients. Puente said he doesn’t allow clients to take more than 10 grams, about the size of a travel toothpaste tube, home with them before their laser treatment.

“Sometimes the patient doesn’t apply it correctly or they miss areas. And of course there’s a chance that they use too much,” he said. “We feel better if we do it ourselves.”

Sellers, the drug-safety consultant, said compounders should be required to label their products as untested and unapproved.

“It should be disclosed to the patient that they’re getting a compounded product,” Sellers said. “It’s really about informing consumers about the risks.”