Published findings of legitimate work on mind-altering chemicals keep unscrupulous chemists in business and a step ahead of the law

Dilemma illustrates where bioethics ends—and law enforcement begins

 

When the renowned chemist David Nichols expressed his dismay recently over the designer drugs, and fatal overdoses, that trace back to the psychoactive compounds he developed in his laboratory, he was clearly responding to growing concerns about whether his research is ethical.

 

His personal essay in Nature on Jan. 6 was prompted by a lengthy Wall St. Journal article that featured a “laboratory-adept European entrepreneur” named David Llewellyn, who sells psychoactive powders and pills that are all but identical in make up to the compounds that Nichols and other scientists have developed for possible use in psychotherapy.

 

In the Oct. 30, 2010 story, Llewellyn specifically mentioned Nichols as an inspiration. Scientists in academia and industry publish their work so others can replicate or refute their findings. But, as the news article pointed out, the tradition of publishing has also had the unintended effect of giving illicit drug makers step-by-step recipes.

 

Readers subsequently sent e-mails to Nichols, saying he should stop his research, he stated in his essay. Reporters called up bioethicists to ask whether Nichols—one of the top experts in psychoactive compounds—was conducting legitimate, or irresponsible, research.
Generally, society has avoided putting any intentional restrictions on research to prevent the results from being used by rogue opportunists, Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics, told Live Science. “Basically, we live with a certain amount of acceptance that any piece of knowledge has some potential to be used toward, if you like, the dark side,” Faden said.

 

And actually, there isn’t much more that a bioethicist can say. Ultimately, what determines whether research on psychoactive chemicals is ethically defensible is if the potential for the eventual drug’s benefit outweighs the risk of harm—and whether the benefit can be scientifically demonstrated.

 

The creation of mind-altering chemicals for medicinal purposes is well established, according to Peter Rabins, a professor of psychiatry at the Johns Hopkins University School of Medicine, and a core faculty member at the Berman Institute. He starts with the premise that, in America and many other cultures, compounds that have a meaningful effect on a person’s mental life are legal and widely accepted—whether the drug is caffeine or alcohol, or those available only by prescription.

 

“The desired outcome of psychotherapy is ‘My life is better,’” Rabins explains. “So, if someone says, ‘Gee, I have insights that I didn’t have before.’ Do we want to call that psychotherapy? Probably yes.”

 

Modern research into the therapeutic benefits of psychoactive substances seems to stem from the self-experimentation conducted by Swiss chemist Albert Hofmann in the 1940s. He was the first person to synthesize LSD (lysergic acid diethylamide), while working for Sandoz Laboratories. After accidentally absorbing a small amount of the acid through his fingertips, he wrote about sinking “into a not unpleasant intoxicated-like condition, characterized by an extremely stimulated imagination.”

 

When Hofmann ingested LSD again three days later, with the intent of scientifically observing and determining its true effects, he did not immediately return to that dreamy, psychedelic state. He took what he thought was the threshold dose, and within an hour, experienced intense anxiety, believed his next-door neighbor to be an evil witch, and said he felt as if he had been poisoned.

 

But eventually, Hofmann reported, the horror subsided and the blissful, kaleidoscopic play of shapes and colors in his mind returned. Sandoz (now Novartis) brought LSD to America in 1949 for possible clinical use, and throughout the 1950s, medical centers and their students conducted experiments, and the mainstream press fixated on the drug’s potential for the field of psychiatry.

 

Restrictions on more widespread use in the general population began during the 1960s, with the government outcry against recreational drug use. The Drug Enforcement Administration was formed, and LSD was deemed a substance with a “high potential for abuse,” without any medically accepted therapeutic value.

 

“If you can’t scientifically demonstrate a benefit, and there are clear harms, then a drug should rightfully be restricted,” Rabins says. “It’s ethical as well as legal to say that drug should not be available.”

 

However, just as states throughout the country adopted bans on LSD in the late 1960s, use of the drug began to rise. According to statistics from the U.S. Substance Abuse and Mental Health Services Administration, first-time users increased for the next five years, then declined by the late 1970s.

 

The term “designer drug” was coined during the 1980s, to describe the seemingly novel substances concocted in underground labs and sold on the streets. Most of those drugs were first synthesized by professionally trained chemists and then later copied by do-it-yourselfers for distribution on the black market, according to a 2008 article in the University of Pennsylvania Law Review.

 

The article cites the observations of Robert Seidenberg, a celebrated psychologist who died last July. In a letter to the editor published in the New York Times in May 1986, Seidenberg commented that virtually all “designer drugs” are either legitimate pharmaceutical products on the market or potential products that were first synthesized in medical research and development.

 

The D.E.A. lists LSD as a “Schedule I” controlled substance, the same designation given to cocaine, heroin and hallucinogenics such as MDMA and psilocybin (a.k.a. “magic mushrooms”). Meanwhile, methamphetamines and opiate analgesics such as OxyContin fall under Schedule II, with many common drugs, such as Tylenol, listed under Schedule III. The D.E.A. has five schedules for controlled substances, with the first comprising drugs that come with the most severe penalties for possession, distribution and use.

 

Chemicals with “substantially similar” structures to controlled substances fall under the Federal Analog Act in the United States. These include the “legal highs” made by Llewellyn and other clandestine chemists. In addition to mimicking the molecular makeup of a controlled substance, a chemical must have a hallucinogenic or stimulant effect, or be said to have that effect, in order to fall under the analog act.

 

The practice of designer-drug makers plundering academic and industry research became especially problematic when Nichols and Alexander Shulgin, a pharmacologist at Dow Chemical, started separately publishing their individual work on MDMA in the 1980s. This gave rise to the popularity of “Ecstasy” on the streets, and spinoff substances in which amateur chemists manipulated molecules to stay ahead of the law.

 

They still are: “Forensic laboratories began to send me requests for samples of drugs that they suspected were appearing on the black market, but which were so new that there are no analytical standards,” Nichols wrote in his essay.

 

So, on one side, scientists are free to pursue possible therapies and publish their discoveries as long as the potential for benefit outweighs the risk of harm. But when those scientific findings resurface as harmful substances made by unscrupulous individuals such as Llewellyn, police and regulators have the responsibility of intervening.

 

As far as Rabins is concerned, that arrangement is entirely appropriate. “Sometimes, people are going to pass laws, and it goes beyond the bounds of bioethics to say whether that’s right or wrong,” Rabins asserts. “Ethicists can tell us to look at the risk-benefit ratio. And then, as a society, people can collectively decide what’s acceptable. Ethics isn’t going to sort that out.”

 

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