5 Incredible Hawaii Medical Stories
(page 3 of 6)
The Transplant Surgeon Who Went Out On A Limb
Getting a dangerous supplement off store shelves took urgent action by the FDA, the CDC—and one local liver transplant surgeon.
Dr. Linda Wong.
Photo: Rae Huo
By the end of last summer, Dr. Linda Wong knew something was terribly wrong after seeing four cases of acute liver failure in as many months. That was more suddenly crashing livers than Wong, the head of Hawaii’s only liver transplant program, would ordinarily expect to see in a year.
These weren’t, however, ordinary cases. The patients weren’t chronic alcoholics, they hadn’t overdosed on Tylenol, they didn’t have hepatitis B or C or any of the other illnesses associated with the life-threatening shutdown of the liver. Most of them were young, and they were either bodybuilders or people trying to lose weight.
The only thing Wong found that they all had in common was the use of a certain dietary supplement advertised as both a muscle builder and fat burner: OxyElite Pro.
On the night of Sept. 3, 2013, Wong saw a fifth patient, a young bodybuilder who had been rushed to Honolulu by air ambulance from the Big Island, his skin as yellow as a highlighter pen. When asked if he took supplements, he said he used just one, OxyElite Pro. The man was so sick, Wong expected he would soon die without a liver transplant.
“I thought, this is crazy,” she recalls. “I can’t watch people die like this.”
That night she phoned her hospital’s chief and told him the public needed to be warned about OxyElite Pro. The chief listened with interest, but cautioned her about jumping to conclusions. He suggested she write a scientific paper. Wong worried that in the time it would take to get a paper published, the human toll would soar. She decided that if the hospital wouldn’t sound the alarm, she would have to do it on her own. She told the chief she wanted to go to the newspaper. She would speak only for herself, a concerned surgeon, and she wouldn’t drag the institution into it. If OxyElite Pro’s manufacturer wanted to sue somebody, she would take the hit.
“The chief was skeptical,” Wong says. “But he didn’t say no. I took that as a green light.”
On Sept. 5, the story appeared in the the Honolulu Star-Advertiser, buried on page B5 of the business section. It was followed by neither feedback nor fallout. No reporters called for more information. No hints of pending lawsuits came her way. “I don’t think anybody read it except business people, and they probably aren’t the ones who take these supplements,” she says.
Wong had stuck her neck out, sounded the alarm, and nobody seemed to notice.
It wasn’t until Sept. 9 that Wong figured out her next move. By then she had seen seven liver patients who had taken OxyElite Pro. Two needed liver transplants or they would die. One was too sick for a liver transplant, and she did die.
It took an offhand comment from a Medicaid billing clerk to point Wong in the right direction. The clerk phoned to inquire about the sudden surge in requests for liver transplant evaluations. Wong explained, and the clerk asked, Does the Health Department know about this?
Calling the state Department of Health had not occurred to Wong, or to any of the colleagues with whom she had conferred. “When you think of the Department of Health, you think about infectious things, you think about mumps, measles, some kind of exposure,” Wong says.
But Wong’s phone call to the Health Department made all the difference. The state epidemiologist, Sarah Park, quickly launched an investigation, which soon included medical detectives from the U.S. Food and Drug Administration and the national Centers for Disease Control and Prevention. On Oct. 8, with 24 cases of liver failure in Hawaii now linked to OxyElite Pro, the Health Department asked local retailers to remove the product from their shelves. On Nov. 10, the Texas company that makes OxyElite Pro, USPlabs, issued a voluntary recall, under the threat of legal action by the FDA.
By then both local and national media were all over the OxyElite story. Two class-action lawsuits have since been filed against USPlabs, and a call for regulatory reform of the supplement industry has been issued.
Altogether, the CDC has identified 97 people in 16 states who suffered liver damage linked to OxyElite Pro, including the woman who died. Undoubtedly, this human toll would have been higher had it not been for one concerned liver transplant surgeon in Hawaii who knew she had to act.
Dangerous dietary supplements: They’re still out there
A recent article in The New England Journal of Medicine, which praises Dr. Linda Wong as “an astute liver-transplant surgeon in Honolulu,” lambastes the FDA for its delayed response in removing OxyElite Pro from store shelves and calls for sweeping reforms in how the agency monitors the safety of dietary supplements.
“This dietary supplement was recalled, but nothing has been done to prevent another supplement from causing organ failure or death,” writes Pieter Cohen, an assistant professor of medicine at Havard Medical School. “Nor have any changes been made to improve the FDA’s ability to detect dangerous supplements.”
Cohen proposes the creation of a database to document the ingredients, and other information, of every supplement sold in the U.S. He also recommends the formation of a multidisciplinary response team, which would be alerted immediately when consumers or physicians report problems with supplements.