Deaths put spotlight on drug compounders

BACKSTORY • Woman’s demise led to discovery of bad drug batch

By peter korn

The Portland Tribune, May 8, 2007, Updated Oct 30, 2009 (2 Reader comments)

L.E. Baskow / Portland Tribune

Deputy state medical examiner Christopher Young helped make the connection between the improperly mixed colchicine and the dead patients.

Margrit Long drove herself to Providence St. Vincent Medical Center on Friday, March 30. She’d told a friend she was feeling sick, a little nauseous, but she wasn’t the type to complain. And besides, she hated hospitals.

But by the time Long arrived at St. Vincent, according to her son, Thomas Long, the pain must have gotten worse. She left her purse in the car.

“My mom has never left her purse anywhere,” Long said.

Fifty-seven years old with three adult children, a woman who took in injured rabbits, ferrets and birds and had begun classes at Portland Community College in hopes of starting a new career, Long told her friend she thought she might be getting sick.

Long was not getting sick. She had been poisoned. And she was not the first victim of the bad medicine that soon would kill her. Authorities are hoping she was the last.

Southwest Portland resident Long was one of three people who died in late March and early April from a toxic, improperly mixed batch of a controversial medicine that was delivered to a Portland clinic, the now-closed Center for Integrative Medicine.

A second patient received intravenous colchicine from the center and, like Long, died within days. A third death resulted when a nurse from the center had some of the same batch of colchicine sent up to Yakima, Wash., so her mother could get relief from the chronic back pain she suffered.

The bad medicine thought to have killed all three came from Texas drug supplier ApothéCure Inc. Toxicology tests would later reveal that the drug from ApothéCure was 10 times the potency stated on the label, potent enough that just one injection – a standard dose that Long had been receiving on and off for years – would kill.

On the surface, Long died because a drug supplier made a mistake. But some medical experts believe the story goes deeper, that responsibility for the three deaths should be apportioned to an entire industry – large “compounding pharmacies” – that produce large amounts of drugs and distribute them nationally, yet escape federal drug regulation because they identify themselves as pharmacies rather than drug manufacturers.

“We’ve got a shadow drug industry in this country with little or no regulatory oversight,” said Larry Sasich, an Erie, Pa., pharmacist and consultant for Public Citizen, a nonprofit consumer watchdog group.

• • •

A shadow drug industry wasn’t something Christopher Young was giving thought to back in March. But in another week, the world of drug suppliers would become part of his life.

Unusual deaths, on the other hand, are nothing new to Young, who has served as Oregon deputy state medical examiner for two and a half years. Violent, sudden and suspicious deaths define the types of cases Young’s office investigates.

On a typical day at least three bodies will arrive at the medical examiner’s office in Clackamas. Over the course of a year Young and colleagues will perform about 1,000 autopsies.

But late on the morning of April 4, Young answered the telephone and heard deputy medical examiner Gene Jacobus describe a possible case of colchicine overdose that had come in from St. Vincent. By afternoon Jacobus had obtained the medical records for the case and had faxed them to Young.

Young didn’t know what to make of the records. He was used to seeing cases of overdoses by drug abusers. He wasn’t used to seeing drug overdoses caused by medical professionals.

The next day, deputy medical examiner Julie Wilson went to talk to the providers at the Center for Integrative Medicine. Wilson conducted interviews with staff.

Young thought it possible that Long had been given too much colchicine at the center, but Wilson’s interviews took a turn when she was told that a patient in Yakima had died 15 days earlier after receiving an injection of colchicine that had been sent from the same Portland clinic.

The possibility of a dosing error at the Portland clinic now seemed more remote. Now, with two deaths and two locations, another possibility had to be considered – a toxic batch of colchicine.

Young had Wilson confiscate the remaining vials of the drug from the center, about 70 in all. Eighteen days later he would have the results of tests on those vials, and confirmation that toxic medicine was to blame.

Wilson’s interviews at the Center for Integrative Medicine yielded one more nugget – another Portland patient had received colchicine from the clinic days before Margrit Long.

And he too had died, at Legacy Good Samaritan Hospital & Medical Center. The initial cause of death had been listed as heart failure. But colchicine deaths cause organ failure, and can easily appear to be heart failure if nobody is looking for an alternate cause. The Good Samaritan patient had died and been buried – it was too late to test for the poison.

Young said he’ll never be completely certain that colchicine was responsible for the death of the Good Samaritan patient. But he’s decided to reissue the death certificate to say the cause of death is just that.

The lack of certainty doesn’t sit well with Young, but he is convinced he’s done everything he can to find out as much as he can. And that, Young said, is his job.

“We’re the last doctors these people get to see,” he said.

• • •

The deaths immediately thrust Texas drug supplier ApothéCure into a national spotlight. Multiple federal and state investigations are looking into how the fatal batch of colchicine was compounded, and how it came to be used at the Center for Integrative Medicine. Several calls to ApothéCure from the Portland Tribune in the past two weeks have not been returned.

The source of the problem, according to health advocate Nancy Sander, is that ApothéCure is a drug manufacturer in every way but name.

Sander, president and founder of Allergy and Asthma Network/Mothers of Asthmatics, a nonprofit organization that focuses on medication issues, said that drug manufacturers masquerading as compounding pharmacies are endangering patients in their search for greater profits.

Drug manufacturers are regulated by the federal Food and Drug Administration. Compounding pharmacies, on the other hand, are licensed only by state boards of pharmacy, which provide much looser oversight.

“It’s happening in women’s hormones, in steroids and growth hormones. It’s happening in so many different and insidious ways – pharmacies that claim they are compounders but really are mass manufacturers,” Sander said.

“Whiskey is legal, moonshine is not. There’s a reason. These companies (large compounding pharmacies) are not concerned at all about patient safety or safe outcomes. If they were they would become legal manufacturers.”

But not even critics of the lack of regulation of the large compounding pharmacies like ApothéCure – there may be dozens like ApothéCure nationwide – know how many people may be dying or injured because of their products. There is no national agency keeping track of the injuries, and no rules that say pharmacy compounders must report injuries caused by their drugs.

Most compounding pharmacies are exactly what they sound like – small, neighborhood shops dispensing manufactured medications and compounding, or mixing, formulations that are not available from manufacturers.

Often these formulations are simply about changing form –for instance, turning a manufactured capsule into a liquid so a child can swallow it. Sometimes compounded products are medications not widely used and thus not produced by drug manufacturers. That is not always the case.

But even though drug compounders are not regulated by the FDA, they are still required to be licensed in every state in which they sell drugs.

According to Gary Schnabel, executive director of the Oregon Board of Pharmacy, ApothéCure is not licensed to sell drugs in Oregon.

In addition, Schnabel said, federal law prohibits compounders from selling drugs that are available in the same form and dosage from manufacturers. Also, when Julie Wilson from the medical examiner’s office confiscated the remaining colchicine from the Center for Integrative Medicine, she collected approximately 70 vials of the drug.

But the labels on those drugs presented another issue.

In Oregon, Schnabel said, only drug manufacturers can produce large batches of medication for general office use by a health practitioner. Compounders are limited to supplying drugs for individual patients with individual prescriptions. The vials seized from the Center for Integrative Medicine were not labeled with patient names.

And as for Schnabel’s criteria – individual prescriptions versus office-use supply – well, even as he looks into those 70 vials, Schnabel said that his office does not usually discipline Oregon compounding pharmacies that provide drugs for office use. The reason? Virtually all compounders do it, Schnabel said.

In fact, on both the national and state level, enforcement of compounders seems to be a wink-and-nod sort of affair.

Schnabel calls the practice “discretionary enforcement.”

“Technically it (a drug from a compounding pharmacy) should be individualized,” Schnabel said. “But more recently some discretion has allowed small amounts to be compounded for clinic use.”

Schnabel could not offer a precise definition of “small amounts,” but said the 70 vials of colchicine confiscated from the Center for Integrative Medicine did not appear to fit the definition.

Stephanie Kaplan, a naturopath at A Woman’s Time clinic in Northwest Portland, said that limiting compounded medicine to individual prescriptions would make an important part of her practice nearly impossible.

For example, Kaplan said, she uses a compounded antioxidant called glutathione, which she delivers intravenously to four or five patients a month as part of regular therapy for multiple sclerosis. Kaplan needs the glutathione on hand when the patients arrive, so every month she orders a vial of 50 milliliters.

Kaplan said she purchases her compounds from one of a handful of local compounding pharmacies. “I have no concerns,” she said. “I actually am more confident that the pharmacist I have a relationship with locally is going to do a more careful job than a manufacturer,” she said.

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