When federal authorities indicted an alleged Pikesville crime ring on charges of trafficking millions of dollars' worth of smuggled cigarettes, they also accused the group of moving an unusual piece of contraband: a medication sold over the counter in Russia.
Valocordin, a muscle relaxant and sedative also known as Corvalol or Corvalolum, is commonly bought by Russians in pharmacies to treat heart ailments, high blood pressure and anxiety. The clear syrup, mixed into a glass of water, is considered to be as harmless as most over-the-counter cough medicines are in the United States.
But U.S. Food and Drug Administration officials say Valocordin can be addictive and deadly in large doses — issues highlighted in this month's indictments detailing the alleged smuggling operation and the role of a Pikesville pharmacy.
The alleged distribution of Valocordin at Healthway Pharmacy offers a look at immigrants' cultural health practices, which can run afoul of American regulations. Experts say immigrants in the Baltimore area and across the United States often turn to foreign drugs as trusted alternatives in the face of rising costs for doctors' visits and prescription drugs.
Adam Burke, director of the Institute for Holistic Health Studies at San Francisco State University, said foreign medicines and practices often find their way to the United States because immigrants turn to them "for cultural reasons, for linguistic reasons, for financial reasons, for convenience reasons, for access to care." Herbalists in Chinatowns are another example of immigrant populations continuing known regimens rather than turning to Western health practices.
"People have their traditions, and if they grew up with them, they're use to those traditions," Burke said. "If you were to go to Ghana or somewhere they have different health practices, you'd probably be uncomfortable and want to do what you're accustomed to."
A number of drugs routinely used overseas are prohibited by the FDA. Rohypnol, for example, is widely available in more than 60 countries to treat insomnia and as an anesthetic but was banned in the United States because it was linked to sexual assault cases and became known as the "date rape drug."
In mid-December, federal prosecutors unsealed an indictment that targeted 11 individuals in the "Yusufov organization," which allegedly trafficked more than $6.6 million in contraband cigarettes. Members of the organization living in northwestern Baltimore County and New York bought cartons of cigarettes in Maryland and then sold them for a profit in New York, where cigarette taxes are nearly twice as high, according to the court documents.
Part of the alleged conspiracy involved Healthway Pharmacy, where prosecutors said owner Salim Yusufov, 43, received and distributed 130 milliliters of Valocordin on five occasions between July 2010 and July 2011. The indictment said his pharmacy "illegally imported unapproved prescription drugs from Russia and sold them to customers."
Federal court records do not list a lawyer for Yusufov. A message left with a phone number listed in his name was not returned and relatives could not be located.
Two other suspects sometimes paid for contraband cigarettes with prescription and counterfeit prescription drugs, federal prosecutors alleged in indictments. The group also illegally distributed oxycodone and sold drug samples, prosecutors said.
Valocordin has also been illegally circulating in New York, according to that state's Office of Alcohol and Substance Abuse Services.
"This medication is very popular among Russian and Eastern European immigrants in the United States," New York state health officials said in an online health warning. "Corvalolum is reported to be available over-the-counter in primarily Russian and Polish communities in New York City despite the fact that the FDA has banned it from the U.S."
New York state officials said the drug is typically brought into the country in tourist bags as personal heart medication or purchased online, where it's advertised as a herbal remedy. It comes in liquid form, ready to mix with water, sometimes with sugar.
"My grandma used to take this medication," said Alex Poberesky, a Pikesville criminal defense attorney who works with Eastern European immigrants and is not involved in the recent indictments. "Every Russian knows this medication because it's over-the-counter and usually given in the case of high blood pressure to get it down right away."
Valocordin is on the FDA's import alert list and is banned because it contains the controlled substances bromisovalum and phenobarbital. Bromisolvalum is a depressant. Phenobarbital, a barbiturate, acts as a central nervous system depressant, causing mild sedation to anesthesia, New York officials said.
Overdoses can lead to death or permanent disability, and the FDA has labeled Valocordin a health hazard since July 1997.
"Drugs must meet FDA standards for safety, efficacy and quality and be approved by the agency to be sold in the U.S.," agency spokeswoman Tara Goodin said in a statement. "If the product being used is unapproved, we can't be certain of what's in it, which creates risk for consumers. Also, drugs from foreign sources don't have FDA-approved labeling with our instructions for use."
G. Caleb Alexander, an associate professor at the Center for Drug Safety and Effectiveness at Johns Hopkins' Bloomberg School of Public Health, said he has treated two patients from Russia or Eastern Europe who have told him that they take Valocordin intermittently at home.
"Although the drug has a barbiturate in it and has a sedative effect, I don't think it's high on the [Drug Enforcement Administration] level or the FDA priority level of drugs that are abused," he said.
But Alexander said that doesn't mean the drug or its alleged distribution in Pikesville was safe.
"In what context was this drug being provided to individuals in the community?" he asked. "They certainly weren't coming in with prescriptions from their doctors? That's an important question: How was this drug given out?"
Although Alexander understands why patients might turn to foreign medicines — in light of prescription drug prices — he discourages their use because he doesn't know enough about the medicines or how they were made, stored or transported.
Sometimes patients facing death from an illness such as cancer turn to an overseas drug the FDA hasn't approved, said Marvin Shepherd, president of The Partnership for Safe Medicines and director of the Center for Pharmacoeconomic Studies at the University of Texas at Austin.
In such cases, he said, the FDA gives people some leeway to bring those drugs into the country.
The FDA referred all questions about the issue to the federal indictments and its website, which includes rules for some allowances on bringing foreign drugs into the country.
Variances allowed by the FDA include treatment for a serious condition for which effective treatment isn't available in the United States. The drug can't be marketed or promoted to other residents and it must not represent an "unreasonable risk." The treatment must start in the foreign country where the drug originated and the amount allowed into the country is limited.
For drugs that are considered controlled substances in the United States, just 50 units are allowed in the country, Shepherd said.
Importing drugs for sale remains illegal — no matter what the consumer and cultural demand, Shepherd said. And that's often where pharmacies go wrong with drugs such as Valocordin.
"I think since it's available overseas and over the counter overseas, I think people figured they'd just bring it over here," Shepherd said.