A new report on illicit US drug markets from researchers at the University of San Francisco has found that that the spread of fentanyl, a powerful synthetic opioid implicated in nearly 29,000 overdose deaths last year alone, is tied to enforcement-driven shortages of heroin and prescription opioids, as well simple economics for drug distributors -- not because users particularly desire the drug.

Illicit fentanyl has swept through American drug markets in waves -- the super strong "China white" heroin of the 1970s was actually a heroin-fentanyl mixture -- most recently in the past decade after rising levels of opioid addiction and the spread of "pill mills" prompted multifaceted moves to restrict opioid prescribing.

From a drug distributor's perspective, fentanyl is a most excellent substitute for heroin or prescription pain pills. Produced entirely in labs or chemical factories, it is far more powerful and cheaper to produce than heroin. Because it's more potent, it is easier to smuggle -- often coming into the US via postal and delivery service parcels, not by the semi load. And it doesn't require months of growing time and period of intense peasant labor in lawless regions of weak states.

Fentanyl is typically sold deceptively -- marketed as heroin or prescription drugs such as OxyContin or Xanax -- and users and street-level dealers often don't even know that the drugs they are using or selling contain fentanyl, the researchers found. Fentanyl is making its way into the supply chain at the wholesale, not the retail level. That, the researchers said, suggests that demand is not the key driver in the drug's spread.

"Fentanyl is rarely sold as fentanyl," said Sarah Mars, PhD, a researcher in the Department of Family and Community Medicine at UCSF. "The dealers selling fentanyl directly to the users often don't know what's in it. Not only is this particularly dangerous, but it also means penalizing low-level dealers isn't going to make any difference in the fentanyl poisoning epidemic."

According to Mars, users are split on fentanyl, which produces a more sudden and powerful high than heroin, but one that fades faster. Some said fentanyl brought back the euphoria they had lost the ability to feel with long-term heroin use, but others said they feared fentanyl and found its effects too harsh.

"Whether or not they prefer fentanyl, users don't have any influence over what drugs are being sold," Mars said. "Without accurate information about these drugs, they can't make an informed choice about what they are buying. Also, very little drug slang has developed to describe fentanyl, which lends support to the notion that this is not a demand-driven epidemic."

The presence of drugs adulterated with fentanyl is uneven, Mars said.

"Most of the illicit fentanyl has been in the Northeast and Midwest," she specified. And that's where opioid overdose death rates are the highest.

Another contributing factor to the fentanyl overdose toll is that it has dozens of analogs with wildly varying potency. Some, like carfentanil, are amazingly powerful, as much as 10,000 times as potent as morphine. Some are so new they have not yet been made illegal.

"We believe it's the fluctuation in the potency of the drugs containing fentanyl that makes them so dangerous," said Daniel Ciccarone, MD, MPH, a professor of family and community medicine at UCSF and senior author of an ongoing National Institutes of Health-funded study, Heroin in Transition. "You might have one dose that had hardly any fentanyl in it or none at all. Then, you might have one with a different fentanyl analog, of different potency, or even mixtures of multiple fentanyls and heroin."

Here is the paradox of drug prohibition: Trying to crack down on drugs tends to lead not to less drug use but to more dangerous drugs, and in the case of opioids, tens of thousands of dead drug users. There is an inexorable logic at play: The more law enforcement comes down on a drug, the greater the tendency for suppliers to make it more potent and compact -- and dangerous.

Perhaps that's why we now see mainstream calls for a radically different approach, such as the one from Washington Post columnist Megan McArdle earlier this week. In her column "The Incredibly Unpopular Idea That Could Stem Heroin Deaths," McArdle argues that current drug policy is only running up the overdose death toll and that we need "to start talking about ways to make safe, reliable doses of opiates available to addicts who aren't ready to stop."

That would involve increasing access to opioid substitutes such as methadone and buprenorphine, "but lowering the death toll may require a more drastic step: legalizing prescriptions of stronger opiates," McArdle writes.

"Prescription heroin?" she continues. "Remember, I said you might not like the solution. I don't like it, either -- and frankly, neither do the drug policy researchers who told me it may be necessary. But when fentanyl took over the US illicit drug markets, it also got a lot of addicts as hostages. We'll never be able to rescue them unless we can first keep them alive long enough to be saved."

There is a better way to deal with the opioid crisis than relegating tens of thousands of American opioid users to early, preventable deaths. We know what it is. Now it's a matter of implementing smarter, more humane policies, and that's an ongoing political struggle -- one where lives are literally at stake.

Dr. Robert Newman died earlier this month after being struck by an automobile earlier this summer. He was 80 years old.

If any one man can be credited with carving out a space for the use of methadone as a treatment for heroin addiction, he is that man. Working as a New York City public health doctor in the 1960s, he was given the task of ensuring that heroin addicts who wanted treatment could get treatment with methadone. His boss, city health department head Gordon Chase, told him he would be known as "Mr. Methadone."

While he did not achieve the goal of providing treatment to everyone who wanted it, Newman oversaw the rapid expansion of the city's fledgling methadone program in the early 1970s. The number of patients on methadone went from a handful to more than 10,000 in two years, and 35,000 by 1975.

And he stood up for those patients. When the NYPD wanted Newman to turn over patients' methadone records, he refused. Instead, he took to the courts to defend his patients' right to privacy -- and he won.

After that, he devoted his career to advocating for evidence-based treatment, traveling the country and the world and picking up a second moniker, "the methadone pope," as he advanced harm reduction ideas decades before they became popularized.

He faced opposition from abstinence and 12-step proponents, as well as from elected officials like New York City Mayor Rudy Giuliani, who in 1998 tried to shut down the city's methadone program on the moralistic grounds that it merely substituted one addiction for another. The diplomatic Newman didn't challenge Giuliani head on but instead used interviews to make his case that methadone treatment allowed addicts to lead productive lives.

Newman also advocated for a humane approach toward addicted mothers and pregnant women, supporting groups such as National Advocates for Pregnant Women in their fight against the demonization and criminalization of those women. He was a drug policy reformer who served for decades on the board of the Drug Policy Foundation and then its successor the Drug Policy Alliance.

As this century's opioid epidemic deepened, Newman was cautiously optimistic that the work he had begun decades earlier would help further destigmatize addiction. "I'm hoping that pragmatism will win out," he said. "As more and more Congresspeople, people in the general community and physicians have children who develop a problem with prescription drug use and can't get treatment for it, I think it will make people more receptive to opening doors to treatment."

Newman was not only an influential physician in addiction issues, he was a giant in the hospital world as a whole. He served as President of Beth Israel Medical Center in New York, and then of the entity that acquired Beth Israel along with other facilities -- and then of the entity that acquired that entity. But one could still talk him at a drug policy conference, or send him an email, and you'd get an email back.

Dr. Robert Newman's contribution to an enlightened approach to addiction cannot be overstated. He will be missed, but his legacy lives on.

(Read Bob Newman's 1998 interview with this newsletter here.)

The FDA has issued new draft guidance aimed at expanding the use of medication-assisted treatments (MATs) for opioid addiction, Pennsylvania's governor says the state isn't ready for legal weed, the Oklahoma medical marijuana fight isn't over yet, and more.

Marijuana Policy

Pennsylvania Governor Says State Not Ready for Marijuana Legalization. Gov. Tom Wolf (D) said during a radio interview on Tuesday that he doesn't think the state is ready to legalize marijuana. "There are, what, six states that have legalized recreational marijuana in the United States," Wolf said. (The actual number is nine.). "I don't think the citizens of Pennsylvania are ready for it, and so the answer I would say is no… I don't think Pennsylvania's actually ready for recreational marijuana." The position puts Wolf at odds with two neighboring Democratic governors, Phil Murphy of New Jersey, who is strongly pushing legalization, and Andrew Cuomo of New York, who just signed off on the notion.

Los Angeles Won't Vote on Raising Pot Tax in November. The city council has reversed a decision to place a 1% marijuana tax increase on the November ballot. The city estimated it would raise approximately $30 million per year from the tax increase, but faced immediate blowback from industry groups who said pot taxes were already too high and are driving consumers to the black market.

Medical Marijuana

Oklahoma Agencies Still Have "Concerns" Over Legal Medical Marijuana. Interim health commissioner Tom Bates told lawmakers Wednesday that the Health Board still has concerns about how medical marijuana will be implemented and that a special session of the legislature may be needed to see the program properly implemented. The board wants lawmakers to amend the law so that, among other changes, commercial grows are indoor only, patient home grows are prohibited or require a special license, smokable marijuana is prohibited, THC levels are limited to 12% or less, a pharmacist is required on-site at dispensaries, and that a list of qualifying conditions for patients be created. Some of the changes are among those recommended in the Health Board's first try at setting interim rules, which were retracted in the face of loud public opposition. Any effort to re-adopt them is certain to lead to renewed clamor.

Heroin and Prescription Opioids

FDA Seeks to Expand Use of Medication-Assisted Therapies for Addiction. The Food & Drug Administration (FDA) on Monday released new draft guidance aimed at promoting the creation and more widespread use of medication-assisted therapies (MATs) for opioid use disorder. The guidance adjusts how FDA evaluates new treatments for opioid addiction. Instead of only determining whether a treatment lowers opioid use, the agency will now assess whether the medication could help lower overdose rates and limit the spread of infectious disease. "We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission," said Scott Gottlieb, FDA commissioner.

A bill ostensibly aimed at reducing opioid overdoses passed the House last month, but rather than cheering it on, drug treatment and recovery advocates are lining up to block it in the Senate. That's because instead of being aimed at reducing overdoses, the bill is actually a means of removing patient privacy protections from some of the most vulnerable people with opioid problems, including people using methadone-assisted therapy to control their addictions.

And that, advocates say, is likely to increase -- not decrease -- opioid overdoses by pushing users away from drug treatment out of fear the information they reveal could be used against them. The fear is real: Unlike other medical conditions, drug addiction leaves patients open to criminal prosecution, as well as stigmatization and other negative social consequences if their status as drug treatment or maintenance patients is revealed.

This bill, H.R. 6082, the Overdose Prevention and Patient Safety Act, would remove drug treatment patients' ability to control the disclosure of information to health plans, health care providers, and other entities, leaving them with only the lesser privacy protections afforded to all patients under the Health Insurance Portability and Accountability Act (HIPAA) of 1996.

"The confidentiality law is often the only shield between an individual in recovery and the many forms of discrimination that could irreparably damage their lives and future," said Paul Samuels, President/Director of the Legal Action Center. "Unfortunately, there is a very real danger of serious negative consequences for people whose history of substance use disorder is disclosed without their explicit consent."

The Legal Action Center is spearheading the effort to block this bill with the Campaign to Protect Patients' Privacy Rights, which counts more than a hundred organizations, including the American Association for the Treatment of Opioid Dependence, AIDS United, Community Catalyst, Faces and Voices of Recovery, Facing Addiction, Harm Reduction Coalition, National Advocates for Pregnant Women, National Alliance for Medication Assisted Recovery and the, National Council on Alcoholism and Drug Dependence.

The current patient privacy protections, known as 42 C.F.R. Part 2 ("Part 2"), were established more than 40 years ago to ensure that people with a substance use disorder are not made more vulnerable to discriminatory practices and legal consequences as a result of seeking treatment. The rules prevent treatment providers from disclosing information about a patient's substance use treatment without patient consent in most circumstances. The bill's plan to replace Part 2's confidentiality requirements with HIPAA's more relaxed standards would not sufficiently protect people seeking and receiving SUD treatment and could expose patients to great harm, the advocates charge.

"They should call this the Taking Away Protections Act," said Jocelyn Woods, head of the National Alliance for Medication-Assisted Recovery. "People will be afraid to go into treatment. I'm getting emails from people who want to leave treatment before this happens. If I were going into a program and they can't tell me my information will be safe, I would think about turning around and walking out," she said.

"Many of us would not have gone to treatment or accepted services if we thought that our information would have been shared with other entities without our permission. We would not have put our careers, reputation or families at risk of stigma and discrimination if we were not assured that information about our substance use disorder was safe and would only be shared with our consent," added Patty McCarthy Metcalf, executive director of Faces and Voices of Recovery.

The push for the bill is being led by health information software companies and behavioral health providers, such as Hazelden and the Betty Ford Center, and it prioritizes convenience over patient privacy.

"This is because the behavioral health people see complying with the privacy requirements as a pain in the ass," said Woods. "They're going to have to fix their computer systems to block out any treatment program licensed by the federal government -- not just methadone programs -- and they don't want to do that. One of the software companies, Netsmart, complained that they don't want to mess with their programming," she said.

"We need Part 2," Woods continued. "It keeps police out of the program. Without it, police can walk right in. They already sit outside methadone clinics and bust people for DUI on the way out. If this passes, they will walk right in. If the police see anyone they think has a warrant or committed a crime, they're gone."

While the bill has made its way through the House, advocates are hopeful it will stall in the Senate.

"The House pushed this through because they wanted to look like they were doing something and because the behavioral health people were pushing for it," Woods said, "but my sense is that it's moving slowly in the Senate. We have this crazy president, and there's immigration, and the congressional break, and then campaign season. My hope is we can push this past the elections and a blue wave in November will give us a fighting chance."

But the campaign isn't taking any chances and is mobilized to fight on the Hill in the next few months to block the bill. As Mark Parrino, President of the American Association for the Treatment of Opioid Dependence warned: "In the midst of the worst opioid epidemic in our nation's history, we cannot afford to have patients fearful of seeking treatment because they do not have faith that their confidentiality will be protected."