Feds Vs Meds
December 08, 2004
By now, America has heard a lot about Oakland, California medical marijuana patient Angel McClary Raich. In arguments November 29 before the U.S. Supreme Court, Raich – possibly 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 more – got 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. Her doctor says losing it would be a death sentence.
The case is a mighty test of states' rights, which this court has previously favored. But the barrage of questions the justices fired at 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 embarrassing mass of scientific evidence in favor of pot's accepted use as medicine.
Justice Stephen Breyer highlighted the problem in his questioning, suggesting this wasn't 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 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. "Isn't medicine by regulation better than medicine by referendum?"
"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 over 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 One 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 in its heels and – defying logic, science, and, apparently, the law – mutely refused to budge.
Two 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 moves the feds. 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 the U.S. Deptartment of Health and Human Services [HHS] up to doing a fair review of the current [rescheduling petition]," says Hilary McQuie, campaign director for Americans for Safe Access (ASA), 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, 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 sacrifice public health to save 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 – the FDA's parent agency – to change its statements about pot having no accepted medical value. The group filed its petition with HHS on October 4 and, by way of a press conference, staged a civil disobedience at the doors of the HHS building on October 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, or 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. The 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 last Monday, December 6. It also provides for judicial review – yes, '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 venue.
"If they don't answer us on the 6th, that would almost be even better," says McQuie. "My understanding is that, if it reverts for judicial review, it's in the 9th Circuit, which would be favorable for us."
This is the court that ruled in favor of Angel Raich. And which made medical marijuana legal (again) in 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
Monday's deadline came and, as expected, the 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, or 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 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 ruling of over 100 pages, 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 ASA, and 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 carpet. 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 testing – which 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 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 2001 – it only took seven years this time – but the reasons why it was denied were more specific and easily attacked. The phrase "arbitrary and capricious" began to resonate. It's a magic one among lawyers, especially 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. Wherever 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 the HHS as part of a coalition. "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 IOM study, which found marijuana useful "for pain relief, control of nausea and vomiting, and appetite stimulation," and still denied accepted medical use? It's the White House's own study. Not to mention the massive – and growing – raft 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 December 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, "They're [ASA] 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 the HHS and the DEA to 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."
So, what if pot is moved to Schedule II? It would still be illegal in most circumstances, just like cocaine. But the hundreds of patients who hold a doctor's prescription would not risk having the DEA kick down their doors at dawn. And Michael Teague, for one, would not be in prison.
Like Angel Raich, Michael Teague is not the guy who comes to mind when you imagine a dangerous drug user wanted by federal authorities. On April 2, 2003, Orange County Sheriff's deputies searched his garage in Tustin and found 102 to 108 marijuana plants, about half of them only one-inch high clones. Teague was then 33 and the modestly successful owner of Aqua Chemical, a pool-cleaning service, and the Sheriff's Department treated this as a big score.
At least, until he pulled out his prescription for medical marijuana. Teague had injured four vertebrae in his back while wrestling in high school, and as he went through years of treatments it was discovered that he was allergic to aspirin, ibuprofen, muscle relaxers – in fact, most synthetic pain killers. His doctor then got him on pot, and it worked.
"I never smoked until they told me I needed it," says Teague, speaking by phone from a halfway house in Garden Grove, where he is finishing the last month of what has turned out to be an 18-month sentence. "I didn't get stoned every day. I don't even drink alcohol. I only smoked a few times a week at night so I could sleep on the pain. I've never done anything wrong in my life."
In fact, Michael Teague's whole family is full up with cops. His mother is retired from the police department, and his brother is a deputy sheriff. They supported his idea to grow his own medicine once a doctor said it was the way to go. His mother, who was diagnosed with cancer, considered taking marijuana, too, until Michael was arrested. "I understand why this medical marijuana needs [federal approval]," she says. "I'm in chronic pain, and there's nothing they can give me." They all believed they were obeying the law to the letter.
State prosecutors agreed, finding Teague's plants were under the limit allowed by law and that he was abiding by Proposition 215, refusing to charge him. Irritated, the Sheriff's office and U.S. Bureau of Alcohol, Tobacco and Firearms convinced the U.S. Attorney's office to pick it up as a federal case.
Then the weirdness began. Convinced he had a great case for federal appeal, Teague chose a bench trial, freely admitting he had grown the plants. The judge gave him assurances that this would guarantee his rights to an appeal, and Teague expected to be out on bail, since he was not a flight risk or a danger to the community. Instead, the judge sentenced him to 18 months and remanded him to federal prison that day. Seventeen months later, despite the efforts of multiple lawyers, Michael Teague has never had a hearing regarding his appeal, never got into a promised drug treatment program (which would cut his time in half), never even received the transcripts of his trial, which are guaranteed by law. On January 9, 2005, he will have served his full sentence in Terminal Island, while other medical marijuana patients like Bryan Epis and Keith Terry Alden were very quickly bailed out pending a decision on Raich et al. v. Ashcroft et al., which will affect all of their appeals.
"Once you get into Bureau of Prisons custody, it pretty much takes an act of God to get anything else done," Teague says with a sigh. "I had to sell my house, I couldn't afford it," he adds. "I had to sell my company because they locked me up so fast. I ran it for 12 years, started from scratch. I've owned three businesses, and I've always been successful. I am a law-abiding citizen. I knew that what I was doing was edgy – I'll be honest – but I never knew that they were going to take my company and my house and put me in prison."
Teague says now his fantasy is to leave the United States, since it's turned out that the legal system has failed him. Another fantasy would be that pot gets rescheduled.
"The judge said it's a Schedule One narcotic. I might as well have had heroin, or crack; according to the federal government, it doesn't matter," he says. "And it's still Schedule One, that's why I can't use it now. The judge just made it clear that this is an issue that needs to be taken up by a higher court."
Scheduling the Rescheduling
With another 60 days to stew while the FDA and NIDA look at their petition, ASA's 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 the HHS beginning its long stall.
"My feeling is, this is information they've been looking at since 1972. They know we're going to court if we're denied, and they definitely have a strategy of stalling it to keep us out of court," Sherer says. "The bureaucrat's favorite game is the stalling game. And we don't have time for that," she adds. "We have patients who are facing jail; we have patients who are living in fear of arrest. Our objective is to get this taken care of as quickly as possible. 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."