FDA-Approved Medical Marijuana Research Blocked Under New Federal Guidelines

On December 6, the U.S. Department of Health and Human Services (HHS) prevented a privately funded, FDA approved medical marijuana study from taking place by refusing to allow the researcher to purchase marijuana from a legal source.

HHS's rejection of Dr. Ethan Russo's request to purchase marijuana from the National Institute of Drug Abuse (NIDA) came just five days after HHS implemented its new medical marijuana research guidelines amidst widespread criticism that the guidelines are still "too cumbersome."

Last week, a coalition of doctors, patients, medical groups, members of Congress, and other concerned citizens delivered a statement to HHS Secretary Donna Shalala, arguing that "many of the new guidelines would still be too cumbersome to enable research to move forward as expeditiously as possible."

The statement was signed by Susan Sarandon, Richard Pryor, scientist Stephen Jay Gould, Ph.D., former Surgeon General Joycelyn Elders, National Review senior editor Richard Brookhiser, AIDS Action Council, New York State Nurses Association, National Black Police Association, Reagan administration official Lyn Nofziger, and hundreds of other patients, doctors, medical organizations, and concerned citizens. (The statement and a critique of HHS' guidelines are online at www.mpp.org/guidelines

Secretary Shalala responded to the statement last Tuesday on C-SPAN's Washington Journal, vowing to "defend" the guidelines, claiming that they enable "the kind of rigorous research that everybody else is required to do on drugs... We need to do what we do for every drug."

Chuck Thomas, director of communications for the Washington, DC-based Marijuana Policy Project, charged, "In fact, the new federal guidelines actually place a much greater burden on medical marijuana researchers than on drug companies that develop and study newly synthesized pharmaceuticals. HHS proved our point by rejecting Dr. Russo's request to purchase marijuana for a privately funded, FDA-approved study. A privately funded researcher wishing to study a newly synthesized pharmaceutical would have been allowed to begin the research as soon as FDA approved the study design."

"The special HHS review panel told me, via telephone, that they 'didn't like' my study, but they have yet to put their concerns in writing," said Dr. Russo, a neurologist in Missoula, Montana. "The FDA and a local Institutional Review Board had already approved my study design. That's good enough for pharmaceutical companies, so it should be good enough in my case. The Clinton administration has no business micromanaging my study after FDA approved it as is. It is to be privately funded, and I am willing to purchase the marijuana from the federal government, so there is no financial justification for requiring extra reviews. They apparently do not want to risk that clinical research will allow the FDA to approve natural marijuana as a prescription medicine."

The Murder Of A Medical-Marijuana Law
FILED 12/10/99

'Initiative 59, approved by the electors of the District of Columbia on November 3, 1998, shall not take effect.'--Public Law No.106-113

In a late-November move that elicited disdain among drug reformers, yet little surprise, Congress and President William Jefferson Clinton quietly committed electoral homicide. The victim: Initiative 59, the District's beleaguered medical-marijuana bill.

The Murder Weapon Nineteen words is all it took for Congress to overturn a fair and democratic election: "Initiative 59, approved by the electors of the District of Columbia on November 3, 1998, shall not take effect."

So says Section 167 (b) of H.R. 3194, the "District of Columbia Appropriations Act," now Public Law Number106 -113. Reformers maintain that this is the first time Congress has overridden a law passed by ballot initiative.

Though unique, Congress' decision to override the will of the 75,000-plus District residents who cast their enfranchised votes for the measure last November was hardly unexpected. Since the outset of the I59 initiative campaign by DC's ACT-UP anti-AIDS coalition three years ago, proponents had found Congress implacably hostile toward any plan that would allow DC patients access to medical pot. Republican hate-monger Bob Barr (R-Ga.) even took time out during a House Congressional hearing to characterize audience members adorned in I59 t-shirts as "walking testimonials to drug use."

The Corpi Delectae Fight Back One of the people smeared by Barr's meretricious doping accusations that day was ACT-UP's Wayne Turner, leader of the I59 campaign. Despite the Congressional smothering of the law which I59 succeeded in creating, Turner remains optimistic that District residents will one day have legal access to medical cannabis. "An overwhelming vote of the people is very strong, and very difficult to ignore," he points out.

In the meantime, however, Turner says that I-59 proponents will continue to pursue "both legal and legislative strategies to implement safe, legal, and accessible medical marijuana in the District of Columbia. Ultimately, democracy can't be stopped."

One option for activists is a lobbying campaign to persuade the DC City Council to enact legislation similar to I-59 this spring, suggests Rob Kampia, Executive Director of the Marijuana Policy Project: "Ideally, the measure would be passed early in 2000, so that Congress would not be able to use the annual appropriations process to overturn it."

DC Political Football: Time to Punt on I59? NORML director R. Keith Stroup, Esq., offers a different view. "My suggestion would be that we continue to work at the state level, where Congress does not have the power to override policy, and move away from the District as a battleground" for the time being, he suggests. "At some point we will win enough states that a majority of the Congress will support the medical use of marijuana, and then we can come back to DC and win the issue."

Stroup pointed out the simple fact that Congress frequently overrides legislation passed by the D.C. City Council, the only municipality in the nation whose budget is controlled by Congress. DC municipal regulations on abortion rights, anti-AIDS needle exchanges, medical pot and plenty of other, even more mildly controversial issues, predictably become political footballs for opportunistic, headline-seeking congressmembers like Bob Barr, and Stroup does not see much remedy for that larger problem. He specifically cautioned that new I59-like local legislation would likely fall victim to future Congressional homicide, just like the new medical-pot law itself.

Although few journalists have addressed Congress' arrogant and cowardly attack on I59, the Washington POST's Steve Twomey is an exception. "The real issue is not drug legalization," he warns. "The real issue is how this democracy continues to justify depriving several hundred thousand citizens of the same rights and status as all other citizens, even as they pay the same taxes and fight the same wars. How can anyone, Clinton, Barr, [and] the rest, defend on moral grounds having an island of authoritarian rule from which residents must escape, like Third World refugees, to taste the ideals of their own nation?"

The Usual Suspects For Georgia Republican Bob Barr, prime Congressional crusader against DC home rule, the District's residents apparently lack the intellectual validity to be afforded basic democratic rights. Recently, when questioned about his decision to quash the enactment of DC's medical-marijuana law, he mocked voters there (largely African-American) by insulting their choice of mayors: "Is there any legitimate speculation to think, given Marion Barry's history and the liberal leanings of DC voters, that they've decided to fight drugs?."

Barr, whose comfortable relationship with white supremacist organizations around the South was a matter of some comment during his leadership of the Clinton impeachment inquisition just last year, is fond of relaying the line, "It would be a travesty for Congress to stand by and allow a handful of activists to overturn federal narcotics laws with an argument that is, medically speaking, the worst kind of quackery."

Several additional members of Congress afforded lip service to Barr's ultra-moralistic crusade, including District Oversight Subcommittee head Rep. Thomas M. Davis III (R-VA), Sen. Kay Bailey Hutchinson (R-TX), and House Appropriations Chairman Ernest Istook, Jr. (R-OK). Rep. Istook appeared particularly concerned about I59's potential impact on late-night television monologues, actually displaying hypothetical concern for DC's voters when he warned that the victory of I59 "threatens to re-ignite the national ridicule of DC that erupted when Marion Barry was arrested." Istook is also a Caucasian Congressmember.

In fact, though, Jay Leno and David Letterman have not delivered any amusing one-liners on the throttling of the will of DC's voters. Virtually no major media outlets, for that matter, have even mentioned the fate of I59 at the hands of 535 men and women who clearly see themselves as far more knowledgeable than the voters who put them them in Washington. But columnist Twomey certainly notes the irony: "If some junta in some banana republic canceled an election, you can bet that the networks, the news weeklies, and the big and famous newspapers would be all over that puppy, reporting the shocking insult to basic human rights."

Clinton and Barr, Together Again President Clinton's collusion with Bob Barr, his erstwhile chief impeachment tormentor, in the radical abortion of I59, demonstrates that Drug War politics still remain the ultimate unifier among Washington cronies. Although Clinton in November vetoed several earlier DC appropriations bills on the basis of the GOP's obstructive "social riders"--specifying the bans on I59 and needle exchanges as intolerable infringements of DC "home rule"--Clinton abruptly changed his tune when Republicans back-pedaled on the issue of free needles. Section 150 (b) of the revised DC budget bill still prohibits any federal funds to be used toward the implementation of needle-exchange programs by the District's health organizations. However, it now quietly states that DC health groups will remain eligible to receive federal funds, as long they use private money to implement anti-AIDS programs like needle exchange. Apparently, Clinton traded away the rights of DC voters on medical pot for an opportunity to salvage an almost equally hot-button political football: needle exchange.

Historically, Barr and Clinton have proven to be a formidable team when it comes to thwarting medical marijuana legislation. Last year, right on the eve of the Nov. 1998 elections, the President okayed budget legislation that contained a Barr provision forbidding District officials from spending the $1.64 necessary to even supervise and count the I-59 vote. And for nine months after that, while reformers were asking a federal judge in DC to rule that this ballot-censoring ban was illegal and unconstitutional, Clinton-led Justice Department lawyers were defending Barr's measure at taxpayer expense, calling it "sensible." Eventually they lost, when the judge ruled that it indeed was illegal and unconstitutional, and finally it was revealed that 69 percent of DC's voters had known better than Barr and Clinton's DoJ attorneys put together.

"Clinton is not now, nor has he ever been, and ally in the battle for medical marijuana," NORML's Stroup concluded. Something about Clinton's famous history of never ONCE inhaling the stuff, presumably.

The Magic Of Marijuana Applause At the start of the Y2K Presidential race, Democratic hopeful Bill Bradley acknowledged on ABC's "This Week" that he frequently used marijuana throughout his career as a champion basketballer with the New York Knicks. Bradley joined a growing club of former marijuana-toking political heavyweights that includes the President, Vice President, and several members of Congress. Rep. Dana Rohrbacher (D-CA), for example, recently joked about his pot-smoking past on ABCs "Politically Incorrect," wisecracking, "I did everything but drink the bongwater"--to delighted applause from the studio audience.

That delighted applause may have been a factor in Rep. Rohrbacher's decision to break away from the majority of his colleagues and join 134 others who voted to oppose H.R. 3194. Unfortunately, however, far too many of our other elected officials choose to ignore compassion, and their own experiences with marijuana, when asked to decide on the medical-pot issue. And they really have no moral basis to even address the issue. If the political elites can rationalize their own recreational pot-smoking as nothing more than youthful, fun-seeking impropriety--and even youthful coke snorting is not held against Republican hopeful George W. Bush, Jr--then how dare they claim to wield the moral authority to deny a proven medication to all the seriously ill patients who aren't even getting any fun out of it?

Paul Armentano - Special to HT News