FEDS VS. MEDS

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, 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 44 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."Kafkaesque

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."