Synthetic Pot Tied to Surge of Emergency Cases

Colorado patients were delirious, combative, had seizures and breathing problems

Doctors in Colorado are sounding an alarm about the dangers of synthetic marijuana after seeing a surge of emergency cases tied to its use. The products, sold under names like Black Mamba, Crazy Clown, K2 and Spice, sent at least 263 people for emergency treatment statewide over a one-month period last year.

“At the end of August, we started noting that patients were coming in with a very severe clinical illness,” said Dr. Andrew Monte, an assistant professor in emergency medicine at the University of Colorado School of Medicine in Denver. Monte said patients were delirious; they were fighting medical staff. Their pulses were racing and many went on to have seizures. Seven patients were put on ventilators in the intensive care unit after they developed trouble breathing. All survived. Monte said the cases they counted before the outbreak ended Sept. 19 were probably just a fraction of the total. “All these kinds of toxicologic outbreaks are far underreported, for a couple of reasons,” he said.

First, not everybody who got sick went to the hospital. Monte thinks most people would try to stay at home and wait out the bad reaction, especially if their symptoms weren’t as severe. Second, some patients probably weren’t asked about drug use or wouldn’t admit to it, making the final case count lower than it really was, he noted.

The surge in cases was reported in a letter published Jan. 23 in the New England Journal of Medicine and in the Dec. 13 Morbidity and Mortality Weekly Report from the U.S. Centers for Disease Control and Prevention.

Colorado isn’t the only state to see a rise in poisonings tied to synthetic pot.

According to an earlier report from the U.S. Substance Abuse and Mental Health Services Administration, the number of emergency department visits associated with use of synthetic pot more than doubled from 2010 to 2011, with the case count increasing from about 11,400 to more than 28,500 nationwide.

Synthetic marijuana is dried plant material that has been sprayed with laboratory-created psychoactive chemicals that mimic THC, the active ingredient in marijuana. It’s sold in gas stations and head shops as an herbal product. But experts say there’s nothing natural about it. “This is much closer to meth [methamphetamine] than it is to marijuana,” said Mike Van Dyke, chief of environmental epidemiology and occupational health at the Colorado Department of Public Health and Environment in Denver. “This is not a natural product. This is a chemical,” said Van Dyke, who was involved in tracking the outbreak.

What’s more, Van Dyke said, consumers never really know what they’re buying.

“It’s different from batch to batch. The whole chemical can be completely different from batch to batch, and you just don’t know what you’re getting when you buy these things,” he said. “It’s very dangerous.” Monte said most of the synthetic marijuana users treated in the ER last fall were men, and the majority were in their late 20s.

He said the typical user seems to be a person who needs to beat a drug test. The chemicals in synthetic marijuana aren’t easily detected in the blood or urine. For that reason, both experts said they didn’t think synthetic marijuana use would drop now that the real thing could be legally purchased in the state.

Although synthetic marijuana is illegal under Drug Enforcement Agency law, Monte said the drug makers get around that by changing the chemicals and packaging.

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FDA approves a powerful new opioid painkiller

Addiction experts protested loudly when the Food and Drug Administration approved a powerful new opioid painkiller last month, saying that it would set off a wave of abuse much as OxyContin did when it first appeared. An F.D.A. panel had earlier voted, 11 to 2, against approval of the drug, Zohydro, in part because unlike current versions of OxyContin, it is not made in a formulation designed to deter abuse.

Now a new issue is being raised about Zohydro. The drug will be manufactured by the same company, Alkermes, that makes a popular medication called Vivitrol, used to treat patients addicted to painkillers or alcohol. In addition, the company provides financial support to a leading professional group that represents substance abuse experts, the American Society of Addiction Medicine.

For some critics, the company’s multiple roles in the world of painkillers is troubling.

Dr. Gregory L. Jones, an addiction specialist in Louisville, Ky., said he had long been concerned about financial links between the group and the drug industry, adding that the Zohydro situation amplified those potential conflicts.

Dr. Stuart Gitlow, the current president of the American Society of Addiction Medicine, said he had been unaware until now of Alkermes’s involvement with Zohydro. Dr. Gitlow, who is affiliated with Mount Sinai Hospital in New York City, said that the group would seek more information from Alkermes about the situation and then decide what, if anything, to do next.

Officials of Alkermes appear to recognize the issue they face. In recent years, the company has been trying to increase sales of Vivitrol, a form of a drug called naltrexone, that is used to treat both alcoholism and opioid addiction.

In a statement, Rebecca Peterson, a spokeswoman for Alkermes, said the company was “evaluating its role with respect to Zohydro” as a result of the drug’s approval. She declined to elaborate.

The tie between Alkermes and Zohydro had not drawn attention because the company did not initially own the drug, nor was it apparently involved in the efforts to get it approved in the United States.

A small California-based company called Zogenix purchased the right to market Zohydro in the United States from another drug maker, Elan. Then a year later, in 2011, Alkermes bought a unit of Elan that included Zohydro, among other products, and inherited the existing agreement with Zogenix.

In their presentation to the F.D.A., officials of Zogenix said they would closely monitor the drug’s use for signs that it was being abused and quickly move to stop such problems. Agency officials said they had approved the drug to give doctors another long-acting opioid to use when treating patients with chronic pain. A few days after the drug’s approval, Zogenix announced that it had signed an agreement with another company, Altus Formulation, under which Altus would develop a formulation of Zohydro that was less vulnerable to abuse than the one just approved.

The development of drug formulations that are less prone to abuse can take years and are not always successful. Currently, drugs like OxyContin are designed so their consistency changes when they are crushed, making them difficult to inject or snort.

Zogenix began running a clinical trial of Zohydro in 2010. In a statement, the company’s president, Dr. Stephen J. Farr, said that the F.D.A. only recently laid out guidelines for the types of features it would like to see in opioid formulations that deter abuse. “Zogenix is fully engaged in efforts to bring an abuse-deterrent-form formulation of Zohydro,” to market, he said.

Dr. Andrew J. Kolodny, the chief medical officer of Phoenix House, which runs drug and alcohol treatment centers in 10 states, said he believed that the American Society of Addiction Medicine should not take money from a company whose product would most likely worsen this country’s drug abuse problem. In addition, Dr. Kolodny, who is a member of the group, said that while Phoenix House will continue to use Vivitrol when appropriate to treat patients, Alkermes officials will find the door closed. “Representative of Alkermes are not welcome,” he said.