WASHINGTON -- November 29 -- As Americans get ready for Thanksgiving meals around the country, the Food and Drug Administration has acknowledged that contamination of the food supply by genetically engineered crops is inevitable, but its new proposed guidance to the industry does little to protect consumers. The FDA draft guidance published today in the Federal Register simply encourages producers of new genetically engineered crops to voluntarily consult with the agency earlier in the process of development. [SNIP]

"We're not really in the business of encouraging or discouraging use of any particular drug," Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said at a news conference. "There was absolutely no political pressure on this. This was a science-based decision, and the way this decision was made was typical of any decision at the FDA having to do with the review of drugs." The FDA has come under fire in the last several weeks for its alleged failure to act more quickly on other drugs, such as Vioxx and antidepressants in children, that studies had shown to cause harm.

12/02/2004 07:49:00 PM|W|P|Doc|W|P|Joe Conason | Working for Change | from the The New York Observer | 12.01.04 Cowards in Washington ignore pot's benefits No worse example exists of the moral cowardice of the federal government -- implicating all three branches -- than the continuing prohibition of marijuana for medical therapy. Despite copious evidence that pot has helped to ameliorate the lives of thousands of patients suffering from cancer and AIDS -- and despite burgeoning voter support for legal reform -- Washington officialdom persists in its lethal devotion to prohibition. Even when a blameless woman comes before them to plead for her life, the constituted authorities seem unable to think beyond a law, more than three decades old, that has long since been superseded by science and common sense. On Nov. 29, Angel McClary Raich appeared at the U.S. Supreme Court with her attorneys to defend her right to grow cannabis for her own medical use. Tormented for most of her life by a horrifying catalogue of ailments, including uterine fibroids, scoliosis and an inoperable brain tumor, Ms. Raich nevertheless has survived while raising two children. The 39-year-old mother and her physicians attribute her ability to overcome seizures, nausea, wasting syndrome and severe pain to the almost continuous ingestion of natural marijuana in various forms. According to Ms. Raich, she resumed walking after three years in a wheelchair because of the relief afforded by that regimen. She now benefits from the assistance of two fellow Californians, identified only as her "caregivers," who annually cultivate about eight pounds of marijuana for her. Yet to the authorities, her worst offense is not using the forbidden herb, but actively fighting their attempts to prosecute her and others for the act of medicating themselves. That is how Ms. Raich ended up in the Supreme Court, two years after suing Attorney General John Ashcroft and Drug Enforcement Administration chief Asa Hutchinson. Seeking to assert the supremacy of federal law over the state referendum that legalized medical-marijuana use in 1996, those two worthies had ordered federal agents to raid California's cooperatives and private gardens in search of marijuana plants. Ms. Raich answered that aggressive enforcement with legal papers -- and eventually won an injunction against the raids in the Ninth Circuit Court of Appeals. What is most remarkable about this problem is how impervious our politicians (and most of our judges) are to human compassion and scientific data. To enforce marijuana prohibition, they would willingly endanger the health and lives of innocent citizens -- and even cast aside principles they profess to hold deeply. Messrs. Ashcroft and Hutchinson are devout Christians of a fundamentalist stripe. Both claim to be "pro-life," but they see no contradiction in depriving Ms. Raich and many other patients of the substance that keeps them alive. Both claim to promote "family values," but they are determined to destroy any family with a member who needs this drug. Both would insist on "states' rights" as a cornerstone of constitutional law, but they won't allow any state to experiment with marijuana reform. Tellingly, the Justice Department hasn't even tried to argue that Ms. Raich doesn't need her daily tokes. The government position seems to be that her need to live doesn't matter as much as enforcing the Controlled Substances Act, passed by Congress in 1970. [zombienote: Note these are ALL REPUBLICANS, including Nixon, whose adminstration gave us the CSA, which is simply a glorified memo. This is what my blog focuses on: the clear Culture War aspect of cannabis prohibition. It is a rightwing Republican jihad.] On this issue, there is a pervasive bipartisan blindness, epitomized by the Supreme Court justices during oral argument in Ashcroft v. Raich. More than once, they urged the Raich lawyers to petition Congress and the Food and Drug Administration to change marijuana's legal status so that it is more easily available for research and compassionate use. Work through the system, said the justices. [zombienote: Will never happen. This is just a diversion to more footdragging. The call for "more studies" is equally as dishonest.] Had the robed sages bothered to read the papers submitted to them, they might realize that the system doesn't work. Dedicated scientists and advocates have been pursuing legal remedies for many years, with little result. The prejudice against pot remains sufficiently powerful to thwart reform at the federal level. (In fact, cocaine and heroin are treated with greater latitude.) Few in Congress possess the courage to demand change, while the F.D.A. and other federal agencies actively obstruct crucial research that is instead proceeding in other countries. Years ago, the government's own scientists urged that the United States make marijuana more widely available to both patients and researchers. Democrats and Republicans alike callously ignored that plea. [zombienote: He is most likely referring to the Shafer Commission Report. And yes, Democrats went right along with the Republicans, adding to that bit about "not a dime's worth of difference. This is why Dems MUST take this up as a main issue and get their heads out of their collective ass to become a real opposition party.] In a society that still promotes alcohol and tobacco, as well as many narcotics and pharmaceuticals with severe side effects, the draconian regulation of marijuana is both illogical and cruel. That is why Americans across red and blue states from Arizona to Maine have voted repeatedly to reform those laws for the sake of the seriously ill. In law, the validity of those state reforms will depend on an interpretation of the Constitution's commerce clause. Before the Supreme Court rules on Ashcroft v. Raich next year, however, Congress and the Bush administration ought to consider the damage that an inhumane, outdated and stupid statute does to respect for the law and to the reputation of law enforcement. [zombienote: Inhumane, outdated and stupid pretty much describes Bush/Neocon/GOP values.] Joe Conason writes for the New York Observer and Salon.com, and is the author of Big Lies: The Right-Wing Propaganda Machine and How It Distorts the Truth. Smirking Chimp Discussion Thread|W|P|110203526583741372|W|P|War on Drugs? Or war on common sense?|W|P|xxdr_zombiexx@yahoo.com12/01/2004 04:23:00 PM|W|P|Doc|W|P|By Steven Wishnia |AlterNet | Posted November 30, 2004.

"I need to medicate. I'm not feeling well," Angel McClary Raich says outside the Supreme Court on Monday, Nov. 29.

Raich, who has dark hair, pale olive skin and rimless oval glasses, is reed-thin – she struggles to keep her weight over 98 pounds. And no wonder she's thin; the 39-year-old Oakland, Calif. woman suffers from scoliosis, endometriosis, severe headaches, chronic nausea, unexplained seizures and episodes of paralysis, uterine fibroid tumors, a brain tumor too deep in her head to be removed, and a mysterious wasting syndrome where she loses life-threatening amounts of weight. She has taken more than 30 different medications to deal with her conditions, including Vicodin, methadone, Tegretol, Paxil, Depakote, Dilantin, Promethazine, Marinol and cannabis. Cannabis is the only one that's been effective. She has to consume more than two ounces a week, in smoke, vaporization, food and cannabis-oil balm, but she no longer needs a wheelchair and can spend time with her two teenage children. "Cannabis gave me back my limbs," she says. Another California woman, Diane Monson, 47, of Oroville, uses cannabis to control her painful back spasms, which did not respond to a decade of conventional medications, including Vicodin, Vioxx and the muscle relaxant Flexeril. But medical use of cannabis, while legal under California's 1996 law, is illegal under federal law. In August 2002, DEA agents raided Monson's garden and destroyed her six marijuana plants, after a three-hour stand-off with local police. "They were getting quite chesty with the federal guys," she recalls of the sheriff's dept. officers. Two months after that raid, the two women petitioned the courts for an injunction to bar the federal government from interfering with their medical-marijuana use. A federal district court in California said no, but in December 2003, the Ninth Circuit Court of Appeals ordered the lower court to issue a preliminary injunction. The Justice Department appealed to the Supreme Court, which heard arguments on Nov. 29. A ruling is expected sometime in summer 2005. The Commerce Clause The key legal issue in the case, Ashcroft v. Raich, is how far the federal government can stretch its constitutional power to regulate interstate commerce. Federal drug prohibition justifies its usurpation of what are normally state police powers on the grounds that the illegal drug traffic is interstate commerce. But Monson grows her pot herself, and Raich gets hers donated by two local growers (who are anonymous parties to the suit). Therefore, they contend, as their marijuana never crosses a state line and no money changes hands, it is neither interstate nor commerce. The two women also argue that preventing them from using medical marijuana would cause them "irreparable harm," severe pain and even death. "There are no other treatments I can reasonably recommend for Angel," Raich's physician, Dr. Frank H. Lucido of Berkeley, wrote in a deposition. "It could very well be fatal for Angel to forgo cannabis treatments." "Death constitutes irreparable harm," the patients' lawyers argue. The case represents California pot patients' second effort to break the legal yoke that the federal Controlled Substances Act holds around state laws that let sick people use cannabis if they have a valid recommendation for it from their doctor. In the first case, U.S. v. Oakland Cannabis Buyers Cooperative in 2001, patients argued that "medical necessity" trumped the federal law, much as ambulances are allowed to break the speed limit. (Raich's husband, Robert, was one of the Oakland co-op's lawyers.) The Court unanimously rejected that claim for sale and distribution of marijuana, but left it unresolved for individual medical use. The Justice Department's case relies mainly on a 1942 Supreme Court decision, Wickard v. Filburn, in which an Ohio farmer, Roscoe Filburn, was fined $117 for violating New Deal agricultural regulations by growing 460 bushels of wheat, twice his allowed quota. Filburn claimed that the wheat was for his family's personal use, so it was neither interstate nor commerce. The Court held that if enough farmers followed his example, it could substantially affect the interstate commerce in wheat. [zombienote: And we couldn't have that, now could we?] Cannabis is illegal, the Justice Department adds, and the courts have said that the government has the right to ban personal possession of marijuana in order to stifle the trade in it, just as it does with machine guns, child pornography and purloined OxyContin. [zombienote: Of all the bullshit comparisons.... Marijuana does not kill people, it doesn't shoot bullets or explode, it does not exploit children, and it is safe as hell compared to oxycontin. The same federal government will tell you Depleted Uranium is safe.] And the Controlled Substances Act classifies pot as a Schedule I substance, a dangerous drug with no valid medical use. [zombienote: The CSA is, is essence, a glorified memo and can be nixed with another glorified memo. Oh.. it's a treaty, you say? Like Kyoto, or SALT. or Non-nuclear proliferation? Or the Geneva Convention. Bush and HIS federal government have seen fit to blow those off like they are nothing, but we still pay $40 billion a year to maintain the unpopular demonization of a harmless and useful plant>] Homegrown Questions Responding to questions from Justices Sandra Day O'Connor, John Paul Stevens, and David Souter, Acting Solicitor General Paul D. Clement repeatedly insisted that it would be impossible to allow medical use of marijuana while banning recreational use. Because marijuana is fungible, he said, police would need an "almost unnatural ability" to prevent medical herb from being diverted into the black market, and anyone arrested would claim they were a medical user. [zombienote: After all, nobody would ever steal or fake prescriptions for "regular" pharmacuetical chemicals... not ever. (Noel Bush, Rush Limbaugh)] "Any little island of lawful possession poses a real challenge to the statutory regime," Clement told the Court. Medical marijuana, he told Justice Stevens, "is an oxymoron." There is no such thing as medical use under federal law, he contended, and even if there were, there's no legal framework to regulate it. [zombienote: I thought Supreme Court Judges have to have "brains". Clements has clearly got shit for brains. Or maybe he just has not hear of Guy Pharmaceuticlas in England.. Or both.] The case will likely turn on the questions of whether Monson and Raich's home gardening constitutes "economic activity" and whether it has a substantial effect on the interstate marijuana market. Clement told the Court that it would, that marijuana is a $10.5 billion market nationally and that there are 100,000 medical users in California. The Justice Department maintains that there is no separation between private marijuana use and interstate commerce, that by possessing even homegrown pot Raich and Monson are stimulating the illicit drug market by increasing the marijuana supply. That is an oddly paradoxical claim; medical users tout growing their own as an alternative to the illegal market. On the other hand, Clement argued that moving medical users out of the illegal market would depress prices, thus stimulating demand for pot – but if medical users bought weed on the street, that would also increase demand. The Justice Department's brief also avers that by taking cannabis instead of prescription drugs, medical users are undermining the market for legitimate pharmaceuticals. By that logic, the patients' lawyers respond, home rose gardeners could be accused of undermining florists, and people who take care of their own kids could be accused of undercutting professional day care. "Prostitution is economic activity. Marital relations aren't," Boston law professor Randy E. Barnett, the patients' attorney, told the Court. The law involved in the Wickard case, the patients' brief notes, exempted small farms, those growing less than 300 bushels of wheat. Two recent Supreme Court decisions have limited the government's use of the interstate-commerce justification: U.S. v. Lopez from 1995, striking down a law banning possession of a gun near a school, and U.S. v. Morrison in 2000, invalidating a law letting women sue their abusers in federal court. Clement contended that these cases are irrelevant, because they did not involve economic activity; Barnett responds that if the Court does not back Raich and Monson, there will be no limits on the concept of affecting interstate commerce, and federal law could reach "any activity at all." Court and Spark Finding a majority on the Court to support the right to use medical marijuana may be difficult, though. Justices O'Connor and Ruth Bader Ginsburg appeared most sympathetic, with Stevens and Souter also possible allies – though Souter and Anthony Kennedy both expressed concern about medical homegrown's effect on the market. The Court's conservative bloc, Justices Antonin Scalia, Clarence Thomas and the ailing William Rehnquist (who was absent, but announced that he would participate in the decision) is considered most sympathetic to restricting the use of the Commerce Clause, but conventional wisdom is that their distaste for drug use will trump that. [zombienote: In other words, once all the arguments are in they plan to say no anyway.] Justice Stephen Breyer seemed markedly skeptical. He questioned whether marijuana can help patients, suggested that they should get the Food and Drug Administration to approve medical marijuana instead of going through the courts, and declared that "medicine by regulation is better than medicine by referendum." [zombienote: The FDA is only interested in drugs that kill people. MArijuana is an herb and beyond their scope. And they work for Big Pharma, anyway. Deferring to the FDa or to "more studies" is just footdragging.] The marijuana legalization movement has tried several times to get the DEA to reclassify pot, to move it out of Schedule I. In 1988, after more than 15 years of litigation, DEA administrative law judge Francis Young called cannabis "one of the safest therapeutically active substances known to man." The DEA rejected his conclusions, and it has also nixed subsequent claims that new scientific evidence warrants rescheduling. [zombienote: And they got rid of him. Can't have judges making the wrong decisions...] In 2001, a University of Massachusetts researcher applied for permission to grow cannabis for use in clinical studies, but the DEA has been sitting on that request for three years, says Rob Kampia of the Marijuana Policy Project. (The federal government's medical pot, grown on a farm in Mississippi and distributed to approved researchers and the seven surviving legal patients, is to West Coast medical-grade homegrown as rancid wine cooler is to prime Napa Valley cabernet.) Federal Raids Meanwhile, medical marijuana has been a top law-enforcement priority for the Bush administration. California NORML lists about 35 federal raids on medical growers since 2001. Some have been on massive cultivation operations well beyond state legal limits – California grower Eddy Lepp, busted in August, claimed that his 32,000 plants were earmarked for more than 2,000 individual patients – but the DEA has also hit small gardens like Monson's: 25 plants in San Diego, 27 plants in Mendocino County, 12 plants in South Central Los Angeles. In November 2003, the DEA seized three plants from a 57-year-old Colorado cancer patient without pressing charges. The Justice Department's answer to medical marijuana users is simple: Take Marinol, capsules of synthetic THC dissolved in sesame oil. "It's wrong to assume that there's any inherent hostility to these substances," Clement said, noting that the DEA had moved Marinol from Schedule II (cocaine, OxyContin) to Schedule III (codeine). (That decision came just after the 1998 election, when four states approved medical marijuana initiatives.) Yet many medical marijuana users dislike Marinol. Its effects take two to three hours to come on, while smoking is almost instantaneous, an essential trait for controlling nausea or taming migraines. And Marinol is expensive, selling for $17 a pill on the Internet. As with eating marijuana, it's difficult to control the dose; one 10-mg capsule can be as disorienting as overindulging in hash brownies. Asked by Ginsburg what possible defense there would be for a patient like Raich, who says Marinol made her vomit, Clement said there is none, just that it was unlikely she would be prosecuted. That's scant consolation for patients like Raich. "If they decide I have the right to live, I can spend the rest of my life with my family," she said after the hearing. A negative ruling, she added, would be "a death sentence." Either way, she says, she's not going to stop medicating. Steven Wishnia is the author of “The Cannabis Companion” (The Running Press) and "Exit 25 Utopia." See also: Dude, Where's My Integrity? |W|P|110193645074223581|W|P|The Supremes Debate Medical Pot |W|P|xxdr_zombiexx@yahoo.com