Compounding pharmacies have been linked to deaths, illnesses and safety failures for years

Founded in 2003, PharMEDium has four plants and annual sales of more than $100 million, officials said. The company says it uses only sterile, FDA-approved ingredients for the intravenous and epidural medications it supplies to more than 2,000 hospitals, including Johns Hopkins Hospital.

Company President Rich Kruzynski said the incidents are a fraction of the “tens of thousands of batches” provided to hospitals. The record, he said, demonstrates PharMEDium’s commitment to be the industry’s “gold standard” for quality, patient safety and regulatory compliance.

Graphic

Here are basic steps a compounder could follow to make a drug.

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ApotheCure

While many compounding pharmacies were focusing on hospitals, others were catering to physicians who practiced experimental medicine.

One of the rising stars was Texas-based ApotheCure, which was cited by celebrity Suzanne Somers in her 2005 bestselling book, “The Sexy Years,” which extolled the anti-aging benefits of customized hormone therapies.

About the same time, ApotheCure’s owner, Gary Osborn, was quoted in alternative magazines and wrote on his company’s Web site about the benefits of using gout medication for pain relief and using lipids in “fat-dissolving” solutions. He also promoted chelation therapy, which removes heavy metals from the body, as a treatment for autism.

As ApotheCure branched out, nearly doubling its $6 million in annual sales during the mid- to late 2000s, patients began getting ill after using some of its products. FDA records from a 2007 inspection show ApotheCure did not alert the agency about many of the incidents.

However, the FDA was notified by local health officials about a 2004 episode in which nine people in Pennsylvania got sick after receiving infusions of an ApotheCure solution that the pharmacy said would dissolve fat, records show. Symptoms included abdominal pain, nausea, vomiting and renal complications, according to state health records.

When FDA officials showed up to investigate the Dallas facility that had made the solution, owner Osborn turned them away, saying they needed an inspection warrant, FDA and court records show. They never returned with one, the records show.

FDA officials said that although they did not secure a warrant, they worked with Texas State Board of Pharmacy officials who inspected the facility. The state board did not take any disciplinary actions, said Allison Benz, the board’s director of professional services.

In 2005, a 5-year-old autistic boy died after being treated with ApotheCure’s chelation compound. Using this treatment for autism “is not evidence-based, and it has the potential for being very toxic and fatal,” said FDA’s Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research.

The company kept promoting chelation therapy, records show. Osborn did not make any public statements about the incident at the time and did not respond to The Post’s requests for comment.

Two years later, three patients at an Oregon pain clinic died after injections of ApotheCure-compounded colchicine, a medication for gout marketed by alternative compounding pharmacies for neck and back pain. The solution was eight times as strong as what was ordered by the treating physician, records show.

The Oregon state attorney general’s office investigated the company after the three deaths. David Hart, who prosecuted the case against ApotheCure for the attorney general’s office, said he thinks the FDA missed a critical opportunity in 2004 when it didn’t get the search warrant.

“Arguably, if action had been taken earlier by the FDA, this could have been prevented,” he said.

When the FDA was notified of the 2007 deaths, this time the agency got a warrant for the facility. The agency identified 13 deficiencies and Texas authorities found 80 deficiencies and violations, records show.

In its report, the FDA noted that products were not tested for potency prior to shipping — something that could have prevented the deaths. But that didn’t violate the law because testing for potency and sterility is not required of compounders, noted ApotheCure attorney James J. Doyle III in a written comment.

The agency’s and state board’s findings became the backbone for state complaints in Texas and Oregon and a Justice Department lawsuit filed against Osborn and his company, state and federal records show.

At the time of the fatal incidents, Osborn told the Associated Press that the colchicine mishap was due to “human error.” Osborn declined interview requests from The Post. His attorney, Lawrence J. Friedman, said he thinks his client was unfairly singled out.

“They decided to make an example out of ApotheCure,” Friedman said.

After the 2007 incident, Friedman said, his client hired consultants and “doubled, even tripled,” safety precautions.

However, a Dec. 20, 2010, internal audit of ApotheCure, obtained by The Post, showed that three years after the FDA investigated, the pharmacy was still riddled with unsanitary conditions.

Insect body parts were found in “clean rooms” where sterile products were compounded. A suspended ceiling, with exposed pipe, wiring and duct work, allowed “contaminants to flow over the sterile suite and fall through the suspended ceiling.”

The Texas pharmacy board returned last year and found a few minor problems. All of them have since been corrected, said Gay Dodson, the board’s executive director.

In 2012, Osborn pleaded guilty to misdemeanor criminal violations of the federal Food, Drug and Cosmetic Act for the colchicine-related deaths. Osborn was ordered to pay a combined $400,000 in fines to settle the DOJ, Texas and Oregon complaints directed at him and his company. The terms of settlements with victims’ families are confidential.

Osborn’s company — which has about $10 million in annual sales — is still in operation.

“People make mistakes, but there is nobody watching over these people,” said Christopher Long, whose 56-year-old mother died after receiving the toxic colchicine made by ApotheCure. “The regulatory piece of this, nothing has changed. I realize it takes a long time to rein things in, but my mother is dead, ApotheCure is still in operation and people have died again.”

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