A National Public Radio segment more than 13 years ago catalyzed Dr. Harry Lever’s investigation into the underregulation of food and drugs sourced internationally.
“I got interested in this problem on May the 25th of 2007,” Lever said. While driving to work, the director of the Cleveland Clinic’s Hypertrophic Cardiomyopathy Center heard some unsettling specifics.
Lever recalls being frightened upon hearing tea leaves were being dried in China by truck exhaust, much of the United States’ garlic came from China and was contaminated with fungus and vitamin C was not made in this country.
“They were doing all kinds of stuff in China I just didn’t know about,” Lever told the Cleveland Jewish News on July 24. Through a quick Google search, he learned many generic drugs in the U.S. were coming from China.
“I said, ‘There’s a potential problem,’” Lever recalled.
Over a decade full of research and letters to the U.S. Food and Drug Administration later, Lever spoke about his findings in a July 28 Zoom program, “Dr. Harry Lever: The Dangers of Generic Drugs,” with fellow members of B’nai Jeshurun Congregation in Pepper Pike.
The cardiologist said one generic drug that is not always the same as its name brand counterpart is Heparin, a blood thinner used to treat and prevent blood clots caused by certain medical conditions or medical procedures. It is also used before surgery to reduce the risk of blood clots.
During his initial investigation into generic drugs in 2007, Lever said he called the Cleveland Clinic pharmacy, inquiring about the source of its Heparin. He remembers being told it was from “a good American company” called Baxter International Inc.
Lever later discovered Baxter outsourced its Heparin contract to a venture capital firm in Wisconsin that had it made in China.
“At that time, there was a shortage of pigs in China and Heparin comes from the small intestine of a pig,” Lever explained. He said the manufacturers had to find something else to mix their Heparin with, settling on oversulfated chondroitin sulfate, which worked to thin blood in a test tube.
“Then somebody in upstate New York tested it in rats and every rat died,” Lever told the CJN. “The paper on the test tube stuff was published, but they didn’t publish the rat one because they all died.”
He then mentioned the case of an infectious disease doctor in St. Louis, Mo., who was taking care of four children on dialysis who all got very sick.
“She got very suspicious,” Lever said. He explained she got in touch with the FDA, who turned it over to the Centers for Disease Control and Prevention.
“It took them about five months but they found out that there was this chemical in the Heparin that they contaminated it with,” Lever said.
Over the years, Lever said patients in his practice have had correlations with generic drugs and suddenly not feeling well.
He said he often deals with hypertrophic cardiomyopathy, a disease in which the heart muscle becomes abnormally thick, and has noticed issues with a drug called Metoprolol Succinate when manufactured in India by a company called Wockhardt.
“I started seeing people coming into my office (where their) heart rate wasn’t controlled and they were having chest pain and shortness of breath,” Lever said. “When I would find out what they were taking I’d keep the dose the same and change the manufacturer, because I didn’t have any way of testing the drugs – we just didn’t have something like that at the time – and I would notice that people would get better.”
Lever added, “I said, ‘There’s something going on here.’”
He said he wrote a letter to the FDA in 2012 detailing his findings, and within three hours got a response saying that they would look into it. But it took 16 months for them “to tell me they didn’t find any problems.”
Lever does not believe there was a proper investigation.
Noting 80% to 90% of active ingredients for generic drugs come from China and 40% of finished drugs come from India, Lever said the problem drugs mentioned in this article are only a couple examples from a long list.
He said he was working with a group of people around the U.S. to fix issues in the generic drug industry when the COVID-19 pandemic began. He said these issues have impacted the handling of COVID-19 as well.
Mentioning the initial delay in testing, Lever said the liquid used for COVID-19 tests comes from China. He also said there have been problems with N95 respirator masks coming from China.
“Many of them would not work and they were recalled,” he said of the masks. “So we really have a lot of problems that need to be fixed and, unfortunately, a lot of people aren’t aware of it.”
The COVID-19 pandemic has created another “extraordinarily frightening” reality, Lever said. “There are no longer any inspections in China or India right now, because they’re afraid to go over there; they don’t want to expose the inspectors.”
He said people must be careful to choose quality drugs from reputable manufacturers.
“Everybody’s assumed that the FDA has done everything that they should do,” Lever said. “The fact of the matter is, unfortunately, either they’re understaffed or underfunded or whatever and it just hasn’t happened.”