DEA discusses new frontier of designer synthetic drugs

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Since 2009, more than 200 different compounds and eight different structural classes of drugs have surfaced in U.S. abuser markets.

Designer synthetic drugs are flooding the United States at an unprecedented pace. Since 2009, more than 200 different compounds and eight different structural classes of drugs have surfaced in U.S. abuser markets, according to information reported by DEA during a November 13 media briefing. At the briefing, DEA described new trends in designer synthetic drugs, challenges, and efforts to combat this growing epidemic.

"It's a public health and safety challenge because these drugs—these compounds—are being marketed as legal alternatives to the controlled substances," said Alan G. Santos, Associate Deputy Assistant Administrator, DEA Office of Diversion Control.

Just since July 2012, DEA has seen more than 80 new compounds—that's a new compound every 5 or 6 days. "So our ability to keep up with this problem, even with the incredible resources we're throwing at it, is pretty difficult," said Santos. Given the extent of the problem, Santos said it wasn't hyperbole to call it a "new frontier of drug law enforcement and drug abuse."

Finished products, with packaging and names (such as "Smiles" or "Scooby Snacks") that are designed to appeal to the young, are showing up on U.S. drug abuser markets. But where are they coming from?

"During the drug-discovery process, drug manufacturers and scientists manufacture compounds, and many of these compounds—the vast majority of these compounds—just never make it to the final stages of being a medicine; they are abandoned for whatever reason," said Santos. Because of psychoactive properties, for example, these compounds may be discontinued early on.

"Then, we have a treasure trove of chemists out there who are scouring the scientific literature, and the only research they are doing is reasearching which compound can get people high," added Santos.

Santos reported that the drugs are being made in foreign environments, predominanty Southeast Asia and China, then shipped into the United States.

The compounds are being finished via a variety of different delivery mechanisms, including spraying or impregnating synthetic cannabinoids onto an inert plant material (in order to mimic the effects of marijuana), converting the compounds into powder form, or solubilizing the compounds.

As a result of the manufacturing process for these compounds being inconistent, Santos said, "For the drug abuser, you're really playing Russian roulette here, because you really don't know what you're taking."

In addition to the wide variation in the manufacturing process for these drugs, because they have not been tested for human consumption by FDA, knowledge of their long-term effects is lacking.

Interactions with other drugs also is lacking, but anectodal reports from local law enforcement and emergency department staff indicate a tremendous amount of adverse effects from the combined use of the drugs with alcohol and marijuana, for example. "If you want to really understand this problem," Santos said, "you need to talk to emergency room people and doctors."

DEA also reported seeing "hot spots" in terms of dosing. "We'll see a particular product out of a particular batch on the West Coast, which may have a particular compound in it, and the same batch of product will be seen on the East Coast, and it will have two or three other compounds in it," said Santos.

Designer synthetic drugs also are big business. "Conservatively," Santos said, "this is a multibillion-dollar-a-year industy."

Illustrating the epidemic: 'Molly' and 'N-bomb'

The problem surrounding drugs with the tag name "Molly" (also known as "Ecstasty"), which Santos said is a historical reference to the powdered form of 3,4-methylenedioxy-N-methylamphetamine (MDMA), illustrates the challenges that DEA is facing regarding designer synthetic drugs. Santos said that about six different compounds are being marketed as MDMA subsitutes.

These MDMA substitutes, Santos said, are being sold to "abusers who don't want to take a controlled substance or what they believe to be a controlled substance. ... We're also seeing it sold to people who want to be buying MDMA, but the person is actually selling them a compound that comes from a different origin. ... We're seeing about a half a dozen of these compounds, with methylone being a big one right now as a replacement."

While DEA seizures of MDMA-mimicking compounds are increasing, seizures for MDMA have decreased considerably in the United States since 2008 (Table 1).

Table 1. U.S. MDMA seizures since 2008

2008

2,438.8 kg

2009

3,073.6 kg

2010

2,079.4 kg

2011

943.8 kg

2012

432.7 kg

Source: DEA

DEA intelligence reports indicate that a kilogram of the MDMA replacement methylone can be purchased wholesale for about $1,500 to $5,000. However, after the methylone is put into individual dosage units and sold on the street, a very conservative estimate is $50,000 to $100,000 in profit, with wide variation depending on how the methylone is cut.

More information on MDMA/Molly appears in the sidebar below.

Santos also said that DEA is seeing an alarming situation surrounding a number of drugs encompassed under the phenethylamine class of drugs (also known as 25I-NBOMe or under the street name 'N-bomb'). The drugs have hallucinogenic effects similar to LSD, and Santos said DEA is seeing phenethylamine and related compounds as "almost an LSD replacement," with the drugs being impregnated on blotter paper or placed in dropper bottles.

"These compounds really scare us," said Santos, "because dosing is literally in micrograms, and we're seeing some overdose around the United States." In response, DEA is seeking to temporarily schedule three of these compounds.

DEA is taking a multifaceted approach to addressing this unique problem, including ramping up control, enforcement, and education efforts.

Temporary/emergency scheduling

Many states have taken action such as legislation, pharmacy board regulations, and consumer affairs department regulations. On the federal level, drugs can be scheduled through statute (i.e., Congress passes a law and drug is controlled) or the administrative process (i.e., DEA working with HHS to control a compound by moving it up, down, or out of the drug schedules).

Santos said that because of the lack of controls that were in place for these new comounds, DEA took unprecendented action in excercising its emergency scheduling authority. He explained that the attorney general, working with the DEA administrator, has the authority under the Controlled Substances Act "to temporarily or emergency schedule a compound if it's an imminent threat to public health and safety."

Controlling a compound ordinarily involves a complicated eight-factor analysis by DEA and HHS, which can take several years. However, in an emergency scheduling situation, the DEA administrator only needs to show that three of the traditional eight factors are met: history/current pattern of abuse, extent of the abuse, and risk to public health.

"With many of these synthetic compounds," Santos said, "those are fairly easy hurdles to get over, frankly." Regardless, despite the availability of this expedited, emergency scheduling process, Santos indicated that it remains time consuming and that only 14 of the more than 200 compounds in circulation have been temporarily scheduled thus far.

Additional measures are available to DEA under the Synthetic Drug Abuse Prevention Act of 2012. Ordinarily, after DEA and HHS decide to put a drug into an emergency schedule, DEA would have 12 months, with a possible 6-month extension, to prepare the research necessary to permanently schedule the drug. However, the Synthetic Drug Abuse Prevention Act doubled this time period, giving DEA 24 months with the potential for a 12-month extension.

"Any of these tools that Congress can give us to help control these compounds is really going to help us get ahead of the curve," said Santos. "The problem is, with a new compound coming in every 5 or 6 days, controlling our way out of this is going to be very difficult."

Enforcement efforts

Two large, coordinated enforcement efforts have taken place during the past year and a half: Project Synergy and Operation Log Jam. Santos said that these operations involved DEA cases as well as those through Homeland Security Investigations and other state and local law enforcement.

Santos reported that Project Synergy resulted in the arrest of more than 230 individuals; the seizure of thousands of pounds of product, including millions of small drug packages; and the seizure of $52 million during a 2-day period. Operation Log Jam resulted in another $42 million in seizures. Santos said DEA's hope is that these large-scale enforcement efforts eventually will lead to targeting the sources and major organizations that are trafficking the compounds in the United States.

Education/outreach: Pharmacists are key

During its outreach regarding the serious problems surrounding prescription drugs, DEA is conveying information on the serious threat of synthetic compounds to key stakeholders, including law enforcement prosecutors, public health officials, pharmacists, high school educators, and community groups.

"When we bring in the 5,000 to 6,000 pharmacists we had this year into our pharmacy drug awareness conferences, we're giving them a block on this," said Santos. "It's not that we think this stuff is being sold out of pharmacies, but these are people who are recognized as drug delivery experts in their communities ... so we want them to be educated on synthetic drugs."

DEA also is doing outreach to address what is a global problem. A survey by the United Nations Office on Drugs and Crime revealed that 80% of the nations surveyed reported having a psychoactive/synthetic drug problem in their country.

DEA is working with the United Nations Commission on Narcotic Drugs (CND) to adopt resolutions relative to synthetic drugs during the CND annual conference. "This is going to help in terms of raising global awareness," said Santos, "because if you are a signatory to the UN conventions, these resolutions actually put some responsibilities on nations in terms of sharing information."

Santos said the big push now is for early-warning systems. "We want to know if a particular compound has shown up in a Eurpoean nation that we haven't seen. We need broader sharing of intelligence between forensic experts."

Updated 'Molly' reporting

During Labor Day weekend 2013, two young partygoers attending a festival in New York City died from drug-related causes after allegedly ingesting “Molly,” which is generally described as a powder or crystalline form of Ecstasy and has led to the common assumption that Molly is MDMA (3,4-methylenedioxy-N-methylamphetamine).
 
Between October 2009 and September 2013, approximately 143 drug exhibits suspected of being MDMA/Molly were submitted to the Northeast Regional Laboratory by various DEA groups within New York State. Chemical analyses revealed that Molly was MDMA only 13% of the time. Even then, it’s not always 100% pure—one exhibit was MDMA along with 2C-C and Ritalin.
 
The most common substance believed to be Molly is 4-MEC (41% of exhibits) followed by methylone (20% of exhibits). A possible area of concern is that methylone may overtake 4-MEC soon, since methylone has only been reported by the National Exposure Research Laboratory since October 2012.
 
MDMA (Ecstasy) or 'Molly'?
  • MDMA (3,4-methylenedioxy-N-methylamphetamine) is a synthetic psychoactive drug possessing both stimulant and mild hallucinogenic properties.
  • Street terms include Ecstasy, XTC, E, X, Beans, and Adams.
  • Considered to be a “party drug” and obtained at “rave” or “techno” parties.
  • Abuse of MDMA can cause psychological and physical damage. Psychological effects include confusion, anxiety, depression, and paranoia. These effects may last weeks after ingestion. High doses of MDMA can interfere with the ability to regulate body temperature, resulting in a sharp increase in body temperature (hyperthermia), leading to liver, kidney, and cardiovascular failure.
  • MDMA is mainly distributed in tablet form and most often contains MDMA alone.
  • Many so-called Ecstasy tablets may contain other substances (e.g., MDA, methamphetamine, ketamine, caffeine, amphetamine), either alone or in combination with MDMA.
  • MDMA tablets are sold with logos, creating brand names for users to seek out.
  • MDMA also is distributed in capsules, powder, and liquid forms. Prices for a tablet at the retail level ranges from $25 to $40.
  • Synthetic cathinones are a central nervous system stimulant having psychoactive properties similar to amphetamine, cathinone, MDMA, and other related substances/analogs.
  • "Molly" is a synthetic cathinone that has been marketed as a powdered form of MDMA and is allegedly the purest form of MDMA.
  • While close in structure to MDMA, Molly is more closely related to “bath salts” and contains many of the same analogs as bath salts and can lead to labored breathing, rapid heartbeat, and elevated body temperature.
  • Laboratory analyses on drug seizures by DEA in New York and submitted as Molly between 2011 and 2012 revealed the exhibits were actually a variety of controlled and noncontrolled substances, such as: 3,4-methylenedioxymethcathinone (methylone), 4-methyl-n-ethylcathinone (4-MEC), 3,4-methylene-dioxymethamphetamine (MDA), and 3,4-methylene-dioxyprovalerone (MDPV) but not MDMA.
  • Most often, Molly exhibits are 4-MEC/4-MMC, methylone, MDPV, alpha-PVP, Pentedrone, MePP, or some combination of these and other chemicals.
  • Typically, Molly is found in powder form and packaged in capsules.
  • DEA investigations and intelligence reveals that a kilogram of bath salts ranges between $1,300 to $1,900. A capsule contains an average of 100 mg and retails for $10 to $20.

Source: September 2013 DEA (New York Division) informational bulletin

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