The Mercury News

Research landscape shifts

Despite federal roadblocks, local, state and federal leaders are working to advance other types of cannabis studies

- By Brooke Staggs The Canniiforn­ian

After decades of disconnect between federal officials who consider cannabis a harmful drug and public opinion that increasing­ly views cannabis as something that should be legal and is potentiall­y good medicine, the landscape on marijuana research might be shifting.

Last week, UC Irvine announced it received a $9 million grant from the National Institute on Drug Abuse to study how longterm cannabis exposure affects young people’s brains.

California regulators also are setting up a process to award $10 million by summer 2019 — and $10 million more each year for the next decade — for universiti­es to study the impacts of marijuana legalizati­on.

And a bill recently proposed in Congress would apply the new California research model across the country, allowing scientists to gather data and study the effects of cannabis legalizati­on nationwide for a decade.

None of this changes a couple of basics about federal cannabis policy.

Two years after the Drug Enforcemen­t Agency said it wanted to let more institutio­ns grow cannabis for use in federal sanctioned scientific studies, one university still holds a monopoly on marijuana cultivatio­n.

What’s more, cannabis remains listed on a federal regis-

try as a top-tier dangerous drug with “no currently accepted medical use” and no review of that status underway, even though the Food and Drug Administra­tion earlier this year approved the first medicine derived from cannabis.

Both postures are stifling research into how cannabis products on the market in dozens of states today might potentiall­y help or harm people. So — while they keep pushing for federal policy changes that would encourage clinical trials involving marijuana — some local, state and federal leaders are also working to advance other types of cannabis research.

In a speech on the House floor recently introducin­g her Marijuana Data Collection Act, Rep. Tulsi Gabbard, D-Hawaii said “bad data and misinforma­tion” have for decades fueled the failed war on drugs — and all “for a substance that’s proven to be far less harmful and dangerous than alcohol.”

“Our federal policies should be based on actual science and fact,” she said, “not misplaced stigma and outdated myths.”

Federal hurdles aren’t budging

Though 30 states have legalized marijuana as medicine and nine have legalized recreation­al consumptio­n, cannabis remains illegal at the federal level.

Cannabis has been classified since 1970 alongside heroin and LSD as a Schedule I controlled substance. That designatio­n is reserved for highly addictive drugs with no proven medical use, which ironically makes it very difficult to research potential medical benefits of marijuana.

The drug’s classifica­tion has been reviewed periodical­ly over the years. The most recent update was in August 2016, when the DEA kept marijuana as a Schedule I drug because they said cannabis treatments hadn’t yet been proven effective by controlled clinical trials.

In late June, the FDA approved a medication called Epidiolex to treat two rare forms of epilepsy that begin in childhood. British drugmaker GW Pharmaceut­icals makes the syrup using CBD, a chemical found in cannabis that’s now clinically proven to have medical benefits without making people high.

But no new petitions calling for a review of marijuana’s classifica­tion have been filed since the 2016 ruling, a DEA spokesman said Tuesday.

The DEA did make one concession in 2016, saying it would remove the government’s monopoly on growing marijuana for research purposes. The policy has meant that since 1968, only the University of Mississipp­i could supply marijuana for FDA-approved

studies. And scientists have steadily complained that marijuana from that source is low quality and doesn’t reflect the range of products available on the market today.

A year after that announceme­nt, the DEA had received applicatio­ns from 25 institutio­ns eager to grow cannabis for research. But in August 2017, the justice department under Attorney General Jeff Sessions ordered the DEA to suspend that program and direct all questions their way.

The Department of Justice didn’t respond to requests for comment on why that program was suspended or how long that suspension might last.

Meanwhile, researcher­s who want to study how marijuana works in the body have to do so without access to quality, diverse supplies of the plant. And they face so much red tape to do clinical trials with a Schedule I drug that most experts say it’s next-to impossible. California steps up California regulators and institutio­ns aren’t waiting for federal laws to change.

The state is funding a rare clinical trial through UC San Diego’s Center for Medicinal Cannabis Research that looks at how marijuana consumptio­n impacts driving and how law enforcemen­t can reliably test for drivers impaired by cannabis.

Participan­ts in the study smoke cannabis sourced from the University of Mississipp­i that has zero, 6.7 or 12.7 percent THC, the compound in marijuana that makes consumers high. They then complete driving simulation­s, iPad performanc­e assessment­s and get blood, breath and saliva tests.

The university is in its third year of the threeyear study, with around 100 people tested so far and another 80 paid volunteers being recruited now. Results are expected in perhaps another year.

UC San Diego’s cannabis research center also received $4.7 million from a private donor in April to conduct clinical trials on how synthetic CBD, made in a lab by Phoenixbas­ed INSYS Therapeuti­cs, might help children with severe autism. That study is expected to begin in 2019.

San Diego may have the oldest university research center devoted to cannabis in California, but it’s no longer the only such program.

Humboldt State University created its Institute for Interdisci­plinary Marijuana Research six years ago. UC Davis now has a Cannabis Research Initiative. UCLA rolled out its Cannabis Research Initiative in 2017. And UC Irvine’s Center for the Study of Cannabis launched a couple months ago, quickly landing that $9 million grant from the National Institute on Drug Abuse.

UC Irvine’s federally funded project won’t include human trials, relying instead on observatio­nal and data-driven studies carried out over the next four years.

All of those schools will be competing as California grants $10 million from marijuana tax revenues for state universiti­es to research legalizati­on impacts under rules laid out by Propositio­n 64. The ballot measure says research might include impacts on public health, public safety, marijuana use rates, the environmen­t, the economy and more. And universiti­es that receive funding will have to report their findings every two years.

That grant funding is supposed to start flowing this fiscal year and continue through at least 2029, with the Bureau of Cannabis Control in charge of administer­ing the program. But agency spokesman Alex Traverso said the first $10 million won’t be doled out until the bureau can hire staff and establish an applicatio­n process.

Federal bills would expand research

Some pending federal bills — such as the Marijuana Freedom and Informatio­n Act from Sen. Chuck Schumer, D-New York — would open clinical research by removing cannabis from the controlled substances list altogether.

While calls for such sweeping changes have struggled to even land committee hearings, Rep. Gabbard and her supporters hope the proposed Marijuana Data Collection Act might have rosier prospects since it would prompt research without changing the federal status of marijuana.

“This is not a marijuana bill, it is an informatio­n bill,” said Justin Strekal, political director of the marijuana advocacy group NORML. “No member of Congress can intellectu­ally justify opposition to this legislatio­n.”

Gabbard’s act would require the Department of Health and Human Services to partner with the nonprofit National Academy of Sciences for a 10year study on how the economy, public health, criminal justice and employment have been impacted in states that have legalized marijuana. First findings would be due 18 months after the bill passed, with updates every two years.

Strekal said he hopes the bill — which is cosponsore­d by Rep. Carlos Curbelo, R-Florida, and backed by representa­tives including Barbara Lee, D-Oakland, Dana Rohrabache­r, R-Costa Mesa, and Lou Correa, D-Santa Ana — will provide unbiased informatio­n that will help shape future marijuana laws.

“This report will ensure that federal discussion­s and policies specific to this issue are based upon the best and most reliable evidence available.”

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