San Diego City Beat: Feds v. Meds

San Diego City Beat
January 5, 2005

Originally appearing here.

The San Diego City Beat published a discussion and analysis of a recent legal challenge to the HHS to change how marijuana is scheduled, with the legal challenge relying on a 2002 law, the Data Quality Act, originally crafted to benefit the tobacco industry and other corporate interests.

by Dean Kuipers

A little-known law may finally challenge the feds’ 30-year stall in recognizing medical marijuana. But it also raises a big question: Who decides what is medicine?

By now, America has heard a lot about Oakland, Calif., medical marijuana patient Angel McClary Raich. In arguments Nov. 29 before the U.S. Supreme Court, Raichpossibly the most sympathetic party to ever come before the High Court, a 38-year-old mother of two with a list of ailments including an inoperable brain tumor, wasting syndrome, uterine fibroid tumors, scoliosis, paralysis, endometriosis, and moregot her chance to nail outgoing U.S. Attorney General John Ashcroft et al. for trying to take away the only medicine that has helped her. Her case has pitted California’s Compassionate Use Act of 1996, which legalized limited medical use of marijuana, against the federal Controlled Substances Act, under which all marijuana is illegal. For Raich, cannabis is the only treatment (out of 35 medicines tried) that has allowed her to keep her weight up, and her doctor says that losing it would be a death sentence.

The case is a mighty test of states’ rights, which this court has favored, but the barrage of questions with which the justices peppered Raich’s lawyer, Boston University professor Randy Barnett, revealed more than the possible end of their so-called “federalist revolution.” They revealed the interior machinations of a kind of regulatory fever dream in which no government agency will confront the increasingly embarrasing mass of scientific evidence in favor of pot’s accepted use as medicine.

Justice Stephen Breyer highlighted the problem in his questioning, suggesting this wasnt a matter for the courts. If Raich et al. were unhappy with the federal Drug Enforcement Administration kicking down their doors and throwing them in jail, possibly to die, he argued, why didn’t they go to the Food and Drug Administration (FDA) “and take marijuana off the list that would be the obvious way to get what they want.” In other words, it should be left to the regulatory agencies. “Isnt medicine by regulation better than medicine by referendum?” he quipped.

“They don’t let you answer any of the questions in any detail, so I basically pointed him to our amicus brief, which chronicles the obstructions that the government has put in the way of medical cannabis research,” says Barnett. Holding up both this and a 1999 report by the Institute of Medicine, commissioned by drug czar John Walters at the White House Office of National Drug Control Policy, which goes into some detail about marijuana’s therapeutic effects and the way research has been stymied for political reasons, Barnett stood in the courtroom and stared at an impossible tautology: the courts don’t want to rule on medical pot because it should be a regulatory matter, and the regulatory agencies refuse to review it, forcing it repeatedly into the courts. Meanwhile, the lives of otherwise law-abiding citizens hang in the balance.

For more than 30 years, activists and federal regulators have been locked in a slow and outlandishly tortuous legal struggle over the medical use of marijuana and who, if anyone, has the authority to change marijuana’s status under the 1970 Controlled Substances Act from a Schedule I narcotic, meaning it has “no accepted medical use,” to one of four less-restrictive categories. Even though comments like Breyer’s make it seem as though there is a clear procedure for this, and a DEA judge even ruled in 1988 that it would be illegal not to reschedule given the preponderance of evidence, the DEA has dug its heels in and. defying logic, science, and, apparently, the law, mutely refused to budge.

Three months ago, however, a new challenge to this chronic obstruction was filed under a little-known 2002 law called the Data Quality Act (DQA) that may turn out to be the pry bar that gets the feds to act. The act is designed to force regulatory agencies to base decisions on the best available science. Although it’s not part of the Raich case and has received relatively little notice in comparison, it may turn out be her salvation.

“I hope that what this does is wake them up to doing a fair review of the current [rescheduling petition],” says Hilary McQuie, campaign director for Americans for Safe Access, who filed the Data Quality Act petition. “Because I don’t feel like I should have to take a regulatory agency to court. I feel like they should do a full scientific review.

“When everyone’s saying the FDA should just do this, do they not know that the DEA is in the way of the FDA doing this?” adds McQuie. “It shouldn’t be this hard. It shouldn’t be law enforcement agencies that make medical scientific decisions. But right now it is set up that way.”

“Their gimmick is that they won’t let researchers have cannabis for research,” says Barnett. Though the FDA’s recommendations regarding drugs can allegedly force the DEA to at least consider rescheduling marijuana, the two agencies work together to make that impossible. Every potential avenue is only a loop. No legal pot, no research; no research, no legal pot. “That’s the game that’s played: if you object to the regulatory process, they say, ‘Yeah, but there’s judicial review.’ If you get to judicial review, they say, ‘Oh, well, look back at the regulatory process; they’re the experts, not us.'”

Signed by President Bill Clinton on his way out the door as part of the Paperwork Reduction Act, the DQA was a corporate gimme that was meant to help industries fight meddlesome regulations. Written by former U.S. Office of Management and Budget head Jim Tozzi and backed by a load of big-tobacco money, it was meant to thwart or delay decisions that cost industries money. Manufacturers, for example, could use the DQA to delay environmental regulations that were based on the Precautionary Principle, protecting people before the scientific testing of toxins or whatnot were complete, which could take years. The act was designed to risk public health while it saved industry a lot of hassle and money.

But the idea that regulatory agencies can only act on the best science, which made many environmental and consumer groups nervous, was also easily turned to activist purposes. In 2003, Americans for Safe Access began studying the law for the potential to force the U.S. Department of Health and Human Services (HHS) – the FDA’s parent agency – to change its statements about pot having no accepted medical value. The group filed its petition with HHS on Oct. 4 and, by way of press conference, staged a civil disobedience at the doors of the HHS building on Oct. 5, where 14 patients and advocates chanted “Schedule I to Schedule III, cannabis is helping me” and promptly got arrested.

“It certainly seems like a novel approach,” says Paul Armentano, spokesperson for the National Organization for the Reform of Marijuana Laws (NORML). “In theory, it presses all the right buttons. But when you’re talking about marijuana, there’s ‘in theory’ how these things should work and then there’s ‘in practice’ how they do work. But I believe it’s the first time that the DQA has been used in such a manner.”

The Data Quality Act’s key provision, which makes it an improvement on the Administrative Procedures Act that predated it, is that the DQA is time-limited, so there’s less foot-dragging allowed. HHS has 60 days from the date of filing to give an answer, or at least file for a limited extension to make a decision. That date was Dec. 6. It also provides for judicial reviewyes, ’round and ’round and then back in the courts. But this time, it’s back to the ASA’s home court, the 9th Circuit in California, which is perceived as a friendly court.

This is the court that ruled in favor of Angel Raich, and that made medical marijuana legalagainin California.

At least, that’s what they think will happen. No one’s really totally sure. No Data Quality Act case has ever gotten that far.

A Legal Quagmire

The Dec. 6 deadline came and, as expected, HHS asked for a 60-day extension, which is evidently the most they can get before the legal wrangling begins. Americans for Safe Access Executive Director Steph Sherer met with representatives for HHS Secretary Tommy Thompson, and was informed of the extension and that the petition is under review by the FDA in consultation with National Institute of Health’s National Institute on Drug Abuse (NIDA).

Spokespersons for both the FDA and NIDA declined to comment, saying they hadn’t been briefed on the petition. Activists say that NIDA’s involvement is a bad sign, however, as the petition didn’t ask for a refutation of pot’s potential for addiction (which is what NIDA monitors), and NIDA has been one of the most active agencies trying to keep pot on the list of the most dangerous drugs.

It’s a stall, but under the DQA, the stall can only last so long. Frustrating though it may be, this slog is infinitely speedier than any of the attempts at rescheduling that have come before.

Consider the first petition, filed in 1972. Only two years after marijuana was lumped with LSD, heroin and mescaline in Schedule I, NORML filed the first petition with the Bureau of Narcotics Enforcement, the predecessor to the DEA, which stalled for three years, and then denied to hear the petition. A court forced them to hear it, then the DEA (formed in 1973) killed it without any hearings. A higher court of appeals again forced them to hear it, but it was easily killed off once more. Finally, in 1986, after another exhaustive, grinding court fight, the DEA caved in and assigned the investigation to its own DEA administrative law judge, Francis L. Young.

Young spent two years hearing the testimony of scores of scientists, doctors, medical marijuana patients, law enforcement officers, agents, corrections officials and the like, and in 1988 came back with a stunning verdict. In one of the most celebrated documents in the history of pot activism, Young issued a 100-plus-page ruling, saying not only that the DEA must move pot to Schedule II, to have controlled medical use like cocaine and opium, but that “the evidence in this record clearly shows that marijuana has been accepted as capable of relieving the distress of great numbers of very ill people, and doing so with safety under medical supervision. It would be unreasonable, arbitrary and capricious for the DEA to continue to stand between those sufferers and the benefits of this substance in light of the evidence of this record.”

“And he’s one of them!” cries Joe Elford, staff attorney for Americans for Safe Access, the chief author of the group’s DQA petition. “Anyone who does administrative law generally thinks of it as a kangaroo court. It’s one of their boys ruling on one of their issues, and you basically expect to lose, and hopefully you might get some relief from a real court down the line. But it was absolutely astounding that a DEA administrative law judge would make such findings and certainly to make ’em so forcefully.”

Of course, the DEA swept it all under the rug. It decided that Young had applied the wrong standard, that the testimony of doctors and patients didn’t show “a currently accepted medical use.” The record had to show controlled scientific testingwhich neither the FDA nor the DEA would allow by law.

That decision went through five appeals before it was finally dead, in 1994, 22 years after the petition had been filed. But the movement to reschedule marijuana saw cracks in the feds’ armor and picked up steam. Dr. Jon Gettman, then the director of NORML, filed a new rescheduling petition in 1995. This was finally denied in 2001it only took seven years this timebut the reasons why it was denied were more specific and attackable. The phrase “arbitrary and capricious” began to resonate. It’s a magic set of words among lawyers, epecially those fighting regulatory agencies. The FDA, for instance, has to set criteria to define “currently accepted medical use,” and if it departs from them, it has abused its discretion, which is against the law.

That’s where the DQA comes in. The new petition filed by Americans for Safe Access invokes the DQA to charge that the FDA abused its discretion on three of its five criteria in denying Gettman’s 1995 rescheduling petition. Whenever the FDA deviates from its own criteria, it seems they made an arbitrary and capricious decision. That’s the legal basis for the case. Plus there’s more.

“That process requires, by statute, a full and scientific medical review,” says Gettman, who now has a new rescheduling petition before HHS as part of a coaltion. “That review is supposed to cover both the scientific evidence in the petition and everything else that’s relevant. Now, what ASA is doing with the Data Quality Act, as I understand it, is that they’re arguing that HHS’s review of this 1995 petition of mine was inadequate and that it didn’t cover all the available information.”

For instance, how could the FDA have reviewed the 1999 Institute of Medicine study, which found marijuana useful “for pain relief, control of nausea and vomiting, and appetite stimulation,” and still deny accepted medical use? It’s the White House’s own study. Not to mention the massiveand growingraft of other medical evidence available before 2001, like the discovery of the receptor sites in the brain that show exactly how tetrahydrocannabinoids work to relieve pain.

If the FDA is shown to have abused its discretion, this should require the DEA to consider a new rescheduling procedure.

At least, in theory. “It gets complicated, and the trouble is that the courts are still sorting it out,” says Elford. “The law’s only a couple of years old. There have been, at this point, only a handful of published decisions dealing with this case.”

Indeed, in a ruling that came down on Dec. 3, a U.S. District Court judge found that Data Quality Act challenges were not judicially reviewable. Publishing on that ruling, Sean Moulton, senior policy analyst at good-government group OMB Watch, says, The activists “are facing an uphill battle at this point. It’s not outside the realm of possibility to get a precedent overturned, depending on where they’re going to file. But I think that a lot of the points that [this judge] made about standing would apply to many other DQA cases that might get filed in court.”

Joe Elford knows he’s in for a long fight. He expects both HHS and the DEA will try every available dodge. It will take months. There’s no set procedure for judicial review. But if it all goes through, it could go to the 9th Circuit.

“We’re going to get a much better shake in the Northern district of California,” he says a little dreamily. “And from there to the 9th Circuit Court of Appeals, and then from there, possibly the U.S. Supreme Court. But I’m certainly not holding my breath.”

Scheduling the Rescheduling

With another month to stew while the FDA and NIDA look at their petition, Americans for Safe Access Executive Director Steph Sherer says they’ll be turning up the heat, trying to keep this moving, badgering members of Congress, running a nationwide sign-on campaign to join the 7,000 doctors who’ve already endorsed ASA’s effort. You might want to look at that number of doctors again: 7,000. That’s a potential blizzard of prescriptions. Sherer, who’s recently been working Capitol Hill relentlessly, can feel HHS beginning its long stall.

“The bureaucrat’s favorite game is the stalling game,” says Sherer. “And we don’t have time for that. We have patients who are facing jail; we have patients who are living in fear of arrest. If they’re not going to accept the petition, they need to deny it quickly so we can move on to the next step.”

“Just delaying it doesn’t help anybody,” says the ASA’s McQuie. “It’s particularly ironic after Justice Breyer’s comment that this should be in the hands of regulators, and that Angel Raich should have just taken this to the FDA and then challenged them in court if they denied it. That’s exactly what we’re trying to do, but they just make it as difficult as possible.”

The government players: Who’s who?

Drug Enforcement Administration (DEA)

Agency that has the final say on whether marijuana has acceptable medical use. Researchers wanting to test the medical validity of marijuana must first get permission from the DEA, which is rarely granted. For example, in December, the DEA rejected University of Massachusetts Amherst Professor Lyle Craker’s 2001 request for a license to grow marijuana for FDA-approved research.

Department of Health and Human Services (HHS)

Arm of the government responsible for writing up the opinions that tell the DEA which drugs should be considered controlled substances.

Food and Drug Administration (FDA)

An HHS underling agency whose Center for Drug Evaluation and Research runs clinical studies to determine which drugs are “safe and effective” for consumer use. CDER has said it supports independent research into the medical benefits of marijuana, but that those researchers must go to the NIDA to obtain that marijuana.

National Institute on Drug Abuse (NIDA)

The go-to place for supplies of marijuana to be used for research. Unfortunately, researchers claim that NIDA provides low-potency marijuana and is prejudicial in its decisions on whom to dole it out to. And if researchers want to grow their own marijuana, they must get permission from the DEA (see above).

Read more about MAPS’ support of medical marijuana research.