California lawmakers could soon clear a governmental logjam that has held up dozens of studies related to addiction treatment, psychedelics or other federally restricted drugs.

The holdup revolves around the Research Advisory Panel of California, established decades ago to vet studies involving cannabis, hallucinogens and treatments for “abuse of controlled substances.”

It has been a critical hurdle for California researchers exploring possible uses of psychedelics or seeking new ways to combat addiction. Scientists cannot move forward with such research projects without the panel’s blessing.

The panel had long met behind closed doors to make its decisions, but concerns arose last year that it was supposed to fall under the Bagley-Keene Act, a state law requiring open meetings. Holding those meetings in public, however, raised alarm about exposing trade secrets and other sensitive information.

So the panel stopped meeting at all. It has not convened since August. Meetings ordinarily scheduled for every other month have been canceled since October.

The result has been a ballooning backlog: As of early May, there were 42 new studies and 28 amendments to existing projects awaiting approval, according to state officials.

Ziva Cooper, director of the UCLA Center for Cannabis and Cannabinoids, said she had submitted one study to the California panel over a year ago — one already approved by the National Institutes of Health, the Food and Drug Administration, and an institutional review board. That research will assess the health risks of cannabis for seniors and young adults ages 18 to 25, two groups whose cannabis use has been on the rise, she said. Cooper said the panel sought a small change: adjusting two words in a consent form for study participants. But because the panel has not been meeting, she has been unable to proceed.

The holdup has also snarled two other studies her UCLA center had submitted to the panel — one examining whether cannabis could be used as an alternative to opioids for pain relief, another on whether a psychedelic compound found in mushrooms, psilocybin, could help treat people struggling with cocaine addiction.

And Cooper said she hasn’t even bothered to submit three more studies, including research on the effects of high-potency cannabis. The holdup has left Cooper and other researchers fearing they could lose funding for planned studies or be forced to lay off staff.

The idea of having to study something different because “in California I can’t do the research that I’m trained to do … is demoralizing,” Cooper said. It aggravates her “to not be able to answer the questions that are desperately needed right now” as the range of cannabis products on the market has grown.

The standstill “has broad implications, costing researchers money in expired grants and contingent grants, shortened patents on new drugs, lost wages for research personnel, lost talent, and lost costs of research drugs for human use that will expire before use,” according to an analysis prepared for a state committee.

That long hiatus could soon end: Under Assembly Bill 2841, the state panel would be able to hold closed sessions to discuss studies that involve trade secrets or other proprietary information. The bill, proposed by Assemblymember Marie Waldron (R-Valley Center), would go into effect immediately if signed by the governor.

“We are focused on reactivating the large amount of research studies that have been on hold for over a year now,” Waldron said in a statement. “This is the quick and urgent solution needed to address that problem.”

The bill is supported by the nonprofit Veterans Exploring Treatment Solutions, which supports research into the possible benefits of psychedelics for treating depression and other conditions among military veterans and helps them obtain such treatment abroad.

“Psychedelic research has ground to halt in California — including numerous VA studies, “ said its director of public policy, Khurshid Khoja. If the Legislature does not act swiftly, the state will see “a rapid exodus of skilled researchers from California universities and research institutions to pursue their critically important work elsewhere — not to mention capital flight by funders who’ll deploy research dollars outside the state.”

“AB 2841 is an urgently needed response to address this crisis,” Khoja said.

To many researchers, however, AB 2841 does not go far enough. Dozens of scientists have called for the panel to be eliminated, arguing that even when it was meeting regularly, it was an unnecessary obstruction to research already being scrutinized by other government and institutional reviewers.

In a letter to Gov. Gavin Newsom, a coalition of researchers argued that undergoing the state review could delay a study by at least five months, resulting in more than $100,000 in “unnecessary staff expenditures” in that time. Because other states don’t have that hurdle, they argued, California researchers are losing out on competitive funding — and Californians miss chances to participate in local trials for emerging treatments.

UCLA psychologist and addiction researcher Steven Shoptaw called it “an unequal burden on addiction research” compared with other scientific studies.

The California panel has been vetting not only studies that involve federally restricted drugs, but also those assessing any kind of medication to treat addiction, said Dr. Phillip Coffin, a UC San Francisco professor of medicine who has called to eliminate the panel.

“If I’m testing Prozac for depression, or Prozac for any other disease, I can do my research without waiting” for the committee, he said, but “If I’m testing Prozac for addiction, I have to wait.” By maintaining such barriers, Coffin argued, “we are seriously harming any chance California has of responding to the addiction crisis.”

Short of eliminating the panel, some have also argued for amending the law to exempt any researchers who have gotten federal approval to do such research.

Others have argued that the panel has a valuable role, even for studies that have undergone review by the FDA or other entities. An analysis of AB 2841 prepared for the Assembly Committee on Health said state data from the Department of Justice show that the Research Advisory Panel regularly catches issues with drug safety, consent forms missing important information about safety and privacy, and other potential problems.

The panel “has a record of providing an extra level of protection, which is important given the volume of controlled substance research that occurs in California,” the analysis said. In addition, the committee analysis said the panel is “the only one which ensures that studies conducted in California comply with state law.”

Coffin disputed such arguments, saying that in his experience and that of many other researchers, its feedback had not “improved patient safety or remotely justified the extreme delays.”

If it is truly finding problems that have escaped other reviewers, he argued, “then all research — not just addiction treatment and controlled substances — should be forced to go through this panel.”

In November 2017, days after her daughter Mallory Smith died from a drug-resistant infection at the age of 25, Diane Shader Smith typed a password into Mallory’s laptop.

Her daughter gave it to her before undergoing double-lung transplant surgery, with instructions to share any writing that could help others if she didn’t survive.

The transplant was successful, but Burkholderia cepacia — an antibiotic-resistant bacterial strain that first colonized her system when she was 12 — took hold. After a lifetime with cystic fibrosis, and 13 years battling an unconquerable infection, Mallory’s body could take no more.

In the haze of grief and pain, Shader Smith found herself looking through 2,500 pages of a journal her daughter had kept since high school. It chronicled Mallory’s hopes and triumphs as an ebullient, athletic student at Beverly Hills High School and Stanford University, and her private despair as bacteria ravaged her systems and sapped her considerable strength.

In the years since, the journal has become a source of solace for Shader Smith as she has traveled the globe speaking about the growing threat of antimicrobial resistance. It is also now the inspiration for two new projects she hopes will spark greater understanding of the public health crisis that ended her daughter’s life prematurely and could claim millions more.

On Tuesday, Random House published “Diary of a Dying Girl,” a selection of Mallory’s journal entries. The same day saw the launch of the Global AMR Diary, a website collecting the worldwide stories of people battling pathogens that can’t be defeated by our current pharmaceutical arsenal.

An estimated 35,000 people die in the U.S. each year from drug-resistant infections, according to the U.S. Centers for Disease Control and Prevention. Worldwide, antimicrobial resistance kills an estimated 1.27 million people directly every year and contributes to the deaths of millions more.

Despite the mounting toll — and the prospect of an eventual surge in superbug fatalities — the development of new antibiotics has stagnated.

Shader Smith is acutely aware of what we stand to lose when medicine can no longer save us.

“I don’t want to live in a post-antibiotic world,” Shader Smith said. “Until people understand what’s at stake, they’re not going to care. My daughter died from this. So I care deeply.”

Over the last 50 years, opportunistic pathogens have evolved defenses faster than humans can develop drugs to combat them.

Misuse of antibiotics has played a large part in this imbalance. Bugs that survive antibiotic exposure pass on their resistant traits, leading to hardier strains.

Crucial as they are, antibiotics don’t have the same financial incentives for developers that other drugs do. They aren’t meant to be taken over the long term, as are medications for chronic conditions such as diabetes or high blood pressure. The most powerful ones have to be used as rarely as possible, to give bacteria fewer opportunities to develop resistances.

“The public does not understand [the] scope of the problem. Antimicrobial resistance truly is one of the leading public health threats of our time,” said Emily Wheeler, director of infectious disease policy at the Biotechnology Innovation Organization. “The pipeline for antibiotics today is already inadequate to address the threats that we know about, without even considering the continuous evolution of these bugs as the years go on.”

Despite the global nature of the threat, Shader Smith said, the response from public health officials is curiously disjointed.

For one, no one can agree on a single name for the problem, she said. Different agencies address the issue with an “alphabet soup” of acronyms: the World Health Organization uses AMR as shorthand for antimicrobial resistance, while the CDC prefers AR. Medical journals, doctors and the media refer alternately to multidrug resistance (MDR), drug-resistant infections (DRI) and superbugs.

“It doesn’t matter what you call it. We just have to all call it the same thing,” said Shader Smith, who works as a publicist and marketing consultant.

Since Mallory’s death, Shader Smith has made it her mission to get the people and organizations working on antimicrobial resistance to talk to one another. For the Global AMR Diary, she enlisted the help of a dozen agencies working on the issue, including the CDC, WHO, the European Center for Disease Prevention and Control (the European Union’s equivalent of the CDC), the Biotechnology Innovation Organization and others.

Antimicrobial resistance can “feel abstract given the scale of the problem,” said John Alter, head of external affairs of the AMR Action Fund, one of the organizations involved with the project. “To know there are millions of families at this very moment going through struggles similar to what Mallory experienced is simply unacceptable,” he said.

“Not only does this firsthand experience help others who might be going through something similar, but it also reminds those tasked with creating solutions and care who they are working for. They aren’t just test tubes or charts,” said Thomas Heymann, chief executive of Sepsis Alliance, another contributor.

The stories in the online diary are often harrowing. A 25-year-old pharmacist in Athens had to put her cancer treatment on hold when an extremely resistant strain of Klebsiella attacked. A veterinarian in Kenya suffered permanent disability after contracting resistant bacteria after hip surgery. Around the world, routine outpatient procedures and illnesses have rapidly become life-threatening when opportunistic bugs take hold.

Mallory was 12 when her doctor called to confirm that her cultures were positive for an extremely resistant strain of cepacia, a form of bacteria found widely in soil and water. The pathogen can be deadly to people with underlying conditions such as cystic fibrosis, a genetic disorder that impairs the cells’ ability to effectively flush mucus from the lungs and other body systems.

Life expectancies for people with cystic fibrosis have grown since Mallory’s diagnosis in 1995, with many people of them living into their 40s and beyond. The cepacia curtailed that possibility for her.

“This is all we’re ever going to have,” Mallory wrote in June 2011, at the end of her freshman year at Stanford, “so if you’re not actively pursuing happiness then you’re insane. And I don’t think I would have this perspective if I didn’t have resistant bacteria that will likely kill me.”

A shrine to Mallory Smith. She fought a drug-resistant bacteria from age 12 to 25, all through high school, then at Stanford. (Genaro Molina / Los Angeles Times)

Mallory’s intuition that her journal could be valuable to others was prescient. “People can easily understand and relate to actual experiences,” said Michael Craig, director of the CDC’s Antimicrobial Resistance Coordination and Strategy Unit. “The Global AMR Diary takes this approach and expands on it with a global lens — increasing the potential to get these critical messages to more people around the world.”

An earlier version of Mallory’s diaries was published in 2019 as “Salt in My Soul: An Unfinished Life.” The new book includes entries that Shader Smith said she wasn’t ready to grapple with in the immediate aftermath of Mallory’s passing: ones addressing depression and private despair, concerns about relationships and body image issues complicated by chronic illness.

It also includes a coda about phage therapy, a promising advance against AMR.

As cepacia overwhelmed Mallory’s system in the weeks after her transplant, her family secured an experimental dose of phage therapy. Widely used to treat infection before the advent of antibiotics, phages are viruses that destroy specific bacteria. The treatment arrived too late to save Mallory’s life, Shader Smith writes in a last chapter of the book, but her autopsy revealed that the phages had started to work as intended.

The systems that bring new drugs to patients move slowly, Shader Smith said, and “Mallory might have been saved if they had moved faster.” Her mission now is to make sure that they do.

“Mallory died six years ago. Six years is a long time, day in and day out,” she said. “And I’ve never taken my foot off the pedal.”

Ernesto Londoño’s engrossing and unsettling new book, “Trippy: The Peril and Promise of Medicinal Psychedelics,” is part memoir, part work of journalism. It tells of how Londoño sought relief from depression with mind-altering drugs. It also investigates the current fad of “medicinal” psychedelics as a treatment for those struggling with depression, trauma, suicidality and other conditions.

Like other psychedelic enthusiasts, Londoño — a journalist who reported in conflict zones such as Iraq and Afghanistan and served as the New York Times’ Brazil bureau chief — wants us to like psychedelics. They relieve him of depression and suicidality. He then continues to “trip” to engage in self-exploration: escape reality, journey into himself and return with an expanded view of the world.

Calling street drugs and hallucinogenics such as psilocybin, MDMA/ecstasy, LSD and ayahuasca “medicine” is problematic. Psychedelic psychiatry has had a resurgence in the past decade, though only among a minority of medical professionals. Mainstream psychiatry largely abandoned psychedelics by the 1970s, for a variety of reasons.

The renewed interest in psychedelics as a treatment seems to arise more from hope than science — a wish that medicinal psychedelics will be effective because our current treatments are inadequate. Antidepressants known as SSRIs and other approaches are often ineffectual, but that doesn’t mean psychedelics, which can be damaging to many in acute distress, should be tried.

Londoño is more balanced in discussing the benefits and dangers than Michael Pollan and others. Pollan’s bestselling book-turned-Netflix-series “How to Change Your Mind” proselytizes medicinal psychedelics in a way that “Trippy” thankfully doesn’t.

Londoño brings a healthy dose of skepticism. Psychedelics aren’t romanticized with examples of the counterculture movement of the 1960s or hyped by listing celebrities currently using them. The author often questions how much of what he’s part of is “a cult” and if what he’s taking is “voodoo,” not medicine.

Ernesto Londoño, author of “Trippy.”

(Jenn Ackerman)

“Trippy” is a fascinating account of the world of medicinal psychedelics. We attend psychedelic retreats in the Amazon and Latin America. We drink ayahuasca, a syrupy, foul-tasting psychoactive tea that induces vomiting and hallucinations. Ayahuasca calls back “memories” — some real, others false — that participants take as the cause of their emotional ill health.

We visit a ketamine clinic, where Londoño feels a “blissful withdrawal,” retaining “strong powers of perception” but losing “any sense of being a body with limbs that can move at will.”

We watch MDMA (a German pharmaceutical from 1912 now best known as the street drug called ecstasy or molly) being administered at a veterans hospital to treat post-traumatic stress disorder. At a “treatment center”/church/spiritual refuge in Austin, Texas, we witness tobacco being blown into a man’s nostrils, extract from an Amazonian plant squirted into his eyes, and toad venom burned into his forearms under the guise of spiritual salvation.

Unlike the unbridled enthusiasts, Londoño exposes the predatory nature of the psychedelic industry and how it exoticizes the use of hallucinogens as Indigenous medicines. We’re privy to some scandals in this field, specifically sexual abuse and harassment and taking advantage of vulnerable people looking for help.

It’s an engaging memoir of one man’s experiences with psychedelics. Londoño’s little asides, like when he’s talking about meeting the man who would become his husband, endear him to us: “I saw the profile of a handsome man visiting from Minnesota for the weekend. He was a vegetarian and veterinarian. Swoon!”

But as a work of mental health journalism, “Trippy” isn’t, as the book jacket suggests, “the definitive book on psychedelics and mental health today.”

Much is overlooked and left out. Londoño fails to stress that these treatments best serve the “worried well,” those struggling with relatively mild complaints, but can be extremely unsafe for those with serious mental illness, meaning severe dysfunction. Such a person has typically been diagnosed with bipolar disorder, major depressive disorder with suicidality, post-traumatic stress or schizophrenia. They can’t hold a job or live independently, often for years.

Most people Londoño interviews in “Trippy” seek “bliss,” not lifesaving measures to give them a chance at basic functioning. The retreats are less mental health centers than gatherings of spiritual seekers.

Full disclosure: I read “Trippy” with an open mind and as someone who spent 25 years in the American mental health system with serious mental illness. Those years passed the way they do for so many: a string of hospitalizations endured, countless therapeutic modalities tried, numerous mental health professionals seen and myriad psychiatric medications taken (yes, in the double digits).

“Medicinal” psychedelics never came up as a potential treatment. I recovered before fringe psychiatry’s renewed interest in psychedelics became a fad in the past decade.

It’s unsettling that Londoño doesn’t mention the recovery movement and what we know can lead to mental health recovery. He doesn’t mention the five Ps, which are based on the four Ps that Thomas Insel, former head of the National Institute of Mental Health, writes about in “Healing: Our Path from Mental Illness to Mental Health.” To heal, we need people (social support), place (a safe home), purpose (meaning in life), payment (access to mental health care) and physical health (a clean diet and, ironically, no drugs or alcohol).

In this, Londoño fails to explore whether his recovery had as much to do with the changes he made as a result of his first treatment/trip as with psychedelics themselves: changes in diet, renewed purpose, finding love, moving into a new home, leaving his stressful job. If two centuries of psychiatric research has taught us one thing, it’s that there is no magic bullet for mental health recovery.

The book’s most compelling explorations into psychedelics as mental health treatments come when Londoño discusses their use in treating trauma, particularly that which war journalists and veterans experience.

He also explores the pervasiveness of mental health issues and the particular challenges LGBTQ+ people can face.

“Trippy” raises seminal questions we need to be asking as the psychedelic industry reaches further into mental health treatment:

What is “medicine” and what is an illicit drug?

Are we trying to treat those in crisis or simply help anyone escape the suffering that’s part of the human experience?

Should we continue to try more and more extreme treatments?

Or should we finally pay attention to and change systemic issues that are the root cause of so much mental and emotional distress?

Sarah Fay is the author of the bestselling memoirs “Pathological: The True Story of Six Misdiagnoses” and “Cured.”