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    You have been sent this message from politicog@yahoo.com as a courtesy of washingtonpost.com Harvest Time By Hanna Rosin MILWAUKEE There is no summer in
    Message 1 of 10 , Jul 2, 2004
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      Harvest Time

      By Hanna Rosin

      MILWAUKEE

      There is no summer in Milwaukee this week; it's freezing and drizzly and gray. But then summer is not the ideal season for the Green Party National Convention. On a bright sunny day, one's thoughts might be distracted from the critical issues: corporate control, toxic air, racial injustice and the right of any animal not to be treated as property.

      Lost would be the many innovations of one Claude Vander Veen, local bicycle enthusiast and a man for all seasons.

      Vander Veen's helmet is not that spiffy aerodynamic kind, but a solid metal contraption taped up with a string of red lights reminiscent of Marvin the Martian. His gloves are big, thick, orange things, more like oven mitts. In general he prefers coveralls like the kind airline mechanics wear in the dead of winter when working for long hours in open hangars.

      The handful of Greens who've gathered for his session on alternative forms of commuting agree on the general principles: Keep those "Hummers" rotting in the garage. But as always with Greens, the strength of commitment lies in the purity of the details.

      "Sixty-five percent polyester?" asks Bruce Hunter, eyeing the coverall tag with suspicion. "Why is that?" Then they drift into discussion of a future of 12-foot-wide lanes reserved for "human powered only."

      Theoretically this could be a big breakout moment for the Greens. In the past four years the party has doubled in size. It has seeded a crop of scrappy local candidates with no money but big dreams who are running for city council-type seats and are actually winning. It has an administration hostile to one of its central concerns -- the environment. And it has a spiffy new logo!

      But deep at their core Greens are still Greens, the aging grad students who never left campus, earnest and agitated, endlessly fine-tuning among themselves. The big decision this year -- whether to endorse Ralph Nader for president -- is debated endlessly as the weekend progresses, in the elevators, in the bathroom, down the escalator, long after midnight. But so is everything else, whether to drive or walk to the Kinko's, order for here or to go, whether to sleep at the corporate hotel.

      "You're taking the elevator?" Janice Moore asks her friend. "Do you know who owns Otis stock?"

      What counts is the tribe and all its intricate unspoken rules: Ethnic food is always better, and leftovers are never thrown away. People should carry their own silverware. Bags are cloth, preferably obtained free at museums or libraries. Hair is pure, no coloring, no blow-dry. Braids are cool.

      Men should cede the microphone to women whenever possible. Women should cede it to lesbians. Lesbians to women from Third World countries, etc.

      Women who are not Palestinian dress like Palestinians down to the head scarves, known as "solidarity kaffiyehs." Head scarves used to symbolize female oppression but no longer do -- chiefly, it seems, because Laura Bush said the women in Afghanistan were oppressed and we had to liberate them, and everything Laura Bush says is wrong.

      Homeland is the Bay Area -- a place where true summer is also elusive.

      Convention organizers Adam Benedetto and Tim Condon are recent college graduates and emissaries from the MTV generation. Benedetto ran for sheriff in Dane County, Wis., two years ago on the Green ticket, shooting his own highly ironic ads involving Puff Daddy and Britney Spears. He lost to a Republican but made his point.

      "We just want to change what you think a Green Party person ought to be," says Condon, who shaves his head and wears a collarless black suit. "Us young people, we're from the packaging generation, where if it doesn't look good it can't be taken seriously."

      Behind him is a guy with matted hair whose feet are as black as his drugstore flip-flops. Three hippies in heated discussion. A woman who has turned herself into a Christmas tree of protest buttons.

      "I'm trying to figure out why a 19-year-old person who wants to vote doesn't even know the Green Party exists," Condon says. "There's a disconnect."

      The Green Party has been slowly building for 20 years but got its biggest boost when its members nominated Nader as their candidate in 2000. Nader's celebrity brought in thousands of converts; there are now 300,000 members and parties in 44 states. Young new stars emerged: Matt Gonzalez won 47 percent of the vote in the San Francisco mayor's race. Jason West became mayor of New Paltz and the first Green official elected in New York, and then one of the first in the country to issue marriage licenses to gay couples.

      But the association with Nader also caused hassles and trauma. Many Democrats blame Nader's candidacy for costing them the election and are shocked he would run again. Now the Greens absorb hostile questions about Nader the spoiler. He will pay for that here today.

      "I'm at the point where I'm embarrassed to be a Green in front of my family," says Green delegate Joan Strasser. "It's like saying we don't care if George Bush gets elected."

      For this budding young party the flirtation with presidential politics is akin to a theater actress who goes out with Ben Affleck and they break up. She leaves the experience starstruck and slightly bitter, her reputation soiled, her inferiority complex exacerbated by the brush with fame.

      Stories circulate about Nader's aloofness, his refusal to share his mailing lists with the Greens, his ignoring suggestions from staff. For a man who has dedicated his life to the nitty-gritty of consumer safety, Nader has stirred up a lot of strong passions.

      "Nader is an icon in the movement but he does not share my vision of grass-roots democracy," says Anita Rios, who co-chairs the party's diversity committee. "He doesn't understand about working with people, grabbing people by the hand one by one," she says, getting agitated. "We don't need some rich white guy with a Harvard education leading us."

      This year Nader decided not to come to the convention; he is running as an independent so he doesn't want the party's official nomination, only its endorsement. Nader chose Peter Camejo, a longtime Green activist who ran in the California recall race, as his running mate. But the no-show is taken as a sign of disrespect "Will he call?" one delegate asks Kevin Zeese, Nader's spokesman.

      "I can't promise that," says Zeese.

      "So I shouldn't go and tell people he'll call?"

      "No," says Zeese, adding, "They just want to know Ralph loves them, that he cares."

      After four years it's become clear that Nader and Greens may be a good ideological team but are mismatched in style. If pushed Nader can speak the PC, culture-wars idiom, but in his politics and personality he predates it; his love is consumer protection, after almost 30 years in public life he's said almost nothing about his personal life. He is a stranger to politics as a form of florid, personal self-expression, and all the intricate rules that grass-roots organizers love. "You can't run a presidential campaign by group consensus ," says Zeese.

      In a Hyatt meeting room, 20 or so have gathered for the women's caucus meeting. In this portion men are not allowed. The women begin with introductions; each gets to speak for a minute; rules are tightly enforced. What they say is not personal, in the usual sense, as in "I'm from California and have two kids."

      "I'm interested in how the system works to disenfranchise women" is a common intro. Medea Benjamin talks about how President Bush keeps women scared as a way to justify the war on terrorism. Terri Baum, who ran against Rep. Nancy Pelosi (D-Calif.), says, "As a lesbian I feel isolated."

      To be called on, people do not raise hands but twinkle their fingers. One woman requests to go beyond the agreed-upon minute. "Can we get consensus for one more minute?" someone asks. "A second?" "Any objections for another minute?" By that point three minutes have gone by. There are lots of "points of clarification for the minutes."

      Morgen D'Arc, who is running the meeting, prowls the room, her eyes shaded by masses of curls gone gray. The real drama seems to be taking place outside. There is, of course, a splinter group. Some women say D'Arc has usurped the group's leadership, that she has banned them. They have printed up fliers to this effect. "Not Enough Democracy!" they say, although there couldn't be more.

      The room is full now that men have been allowed to join. Sitting in the back, humbly obscured, is the Green Party's other candidate for president, David Cobb.

      "Hey, I know you," he says to another reporter. "You slept on my futon, man," and sits for an interview.

      Cobb is what counts in the Green Party as Clintonian; he grew up in a shrimping village on the Texas Gulf Coast in a house with no flush toilet. People here say he speaks like a preacher. He wears khakis, stained with coffee, and an open neck shirt; once this weekend he put on a tie.

      He describes himself as a "male feminist, white anti-racist ally." He reminds himself often that "white privilege exists and male privilege exists." For a running mate he considered only women, and chose Patricia LaMarche.

      Cobb ran Nader's campaign in Texas in 2000 and speaks highly of him. "Nader has done more to influence my life than any human being who's not related to me. He's a public icon and one of my personal heroes," says Cobb. "But it's a question of institutional self-respect."

      Cobb has developed a strategy he calls "smart growth." In safe states, those that are locked up for Bush or John Kerry, he tells Greens to vote Green. In battleground states, he says, "Vote your conscience," which is understood to mean hold your nose and vote for Kerry.

      "John Kerry is a corporatist militarist, but George Bush is a genuine threat to the planet," he says.

      Saturday morning in a conference center near the hotel the voting begins. It may be a convention but there are no balloons, no music, just a video of the ocean and a thumb stroking some flowers. There's one flag but it has a peace sign where the stars should be. About half of the guys onstage sport ponytails; none is wearing a suit.

      Over three days the fight between Cobb and Nader and all their proxies has gotten nastier. Cobb's people pointed out Camejo had once run on a Socialist Party ticket. Nader's camp accused them of red baiting. Each accused the other of secretly shilling for Kerry. Nader finally did call Friday night, and on a speakerphone broadcast to his supporters described the choice as one between "fear and fortitude."

      But on this final morning a truce has been reached. Whatever happens, both Camejo and Cobb promise to leave the convention hall "arm in arm."

      States come up one by one to announce their votes. The delegates introduce their states opposite from the usual way, listing points of shame instead of pride. "Tennessee, the first Superfund site." Or Utah, "where you can have multiple wives." Sometimes they mention obscure ecology projects in the works, to great applause. Someone in the Minnesota delegation votes for Eugene V. Debs, the socialist hero, also to great applause.

      In the first round no one gets a majority. In the second round, the candidates have narrowed and Cobb's votes are ticking up. California, the mother ship of the Green Party, gives him 22 more votes. That's when his supporters know and start cheering wildly. The honors are saved for Texas, his home state, which puts him over the top.

      The meaning is clear to everyone; the Greens have picked one of their own.

      "The Green Party has gotten out from under the shadow of the man who casts a larger shadow than any other American," says Cobb.



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    • politicog@yahoo.com
      You have been sent this message from politicog@yahoo.com as a courtesy of washingtonpost.com Federal Jobs for Disabled Drop By Christopher Lee The number of
      Message 2 of 10 , Jul 6, 2004
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        Federal Jobs for Disabled Drop

        By Christopher Lee

        The number of federal employees with severe disabilities has declined by nearly 20 percent over the last decade, challenging the long-held notion that the federal government is a haven of opportunity for such workers.

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      • politicog@yahoo.com
        You have been sent this message from politicog@yahoo.com as a courtesy of washingtonpost.com Personal Message: I tried this once already, and for some reason
        Message 3 of 10 , Oct 8, 2004
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          I tried this once already, and for some reason it didn't go through. Note that this story starts out talking about this legislation protecting gays and lesbians from hate crimes, but it would have included the disabled as well.

          Initiative on Hate Crimes Scrapped

          By Helen Dewar

          House Republican negotiators yesterday scuttled a Senate-approved proposal to strengthen the nation's long-standing hate-crimes law and extend its coverage to include crimes against gay men and lesbians.

          According to sources close to the talks, the proposal was rejected by House members of a conference with the Senate as the negotiators for the two chambers neared completion of work on the 2005 defense authorization bill. The defense bill had been amended by the Senate in June to include the bipartisan proposal to strengthen and update the civil rights-era hate-crimes statute.

          The Senate proposal, which was also rejected by House defense negotiators in 2000, would have added crimes based on sexual orientation, gender and disabilities to the existing law that allows federal prosecution of offenses based on race, color, religion or national origin. Financial support would have been provided for state and local investigations and prosecutions of hate crimes.

          The proposal would also have eliminated restrictions limiting hate-crime prosecutions to cases where the victims were engaged in federally protected activities, such as voting.

          Proponents, led by Sens. Edward M. Kennedy (D-Mass.) and Gordon Smith (R-Ore.), contended the expansion was needed to ensure protection of all hate-crimes victims. Opponents, including prominent House Republican leaders, argued that labeling something a hate crime punished thought rather than action.

          The Senate added the Kennedy-Smith proposal to the defense bill because the Senate GOP leadership would not schedule a vote on the hate-crimes initiative and the defense measure was the only vehicle available at the time to force a vote on the issue. The House voted 213 to 186 last month to instruct its negotiators to support the proposal, but the vote was nonbinding and the House conferees did not follow the instructions.

          Kennedy issued a statement blaming the White House and House GOP leadership for what he called "reprehensible" action in rejecting the hate-crimes initiative. "We will be back again and again, and we will continue to bring this legislation up every opportunity we can until it is signed into law," he said.



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        • politicog@yahoo.com
          You have been sent this message from politicog@yahoo.com as a courtesy of washingtonpost.com Court to Hear Marijuana Case By Charles Lane Local sheriff s
          Message 4 of 10 , Nov 30, 2004
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            Court to Hear Marijuana Case

            By Charles Lane

            Local sheriff's deputies and U.S. Drug Enforcement Administration agents disagreed when they converged on Diane Monson's house in Oroville, Calif., two years ago.

            The county cops accepted Monson's explanation for growing six marijuana plants: She had a doctor's permission to smoke it for back pain, so the pot was legal under the state's 1996 "medical marijuana" law.

            But the DEA agents insisted that growing marijuana is still against federal law. They seized the plants and destroyed them.

            Today that federal-state clash continues at the Supreme Court, where the justices will hear oral arguments on whether the Constitution permits the federal government to take action against those who use homegrown marijuana for medicinal reasons within states where it is legal to do so.

            The case is the third medical pot case to reach the Supreme Court since voters overwhelmingly approved California's Compassionate Use Act. But the legal issues this time give the case importance well beyond the 11 states, mostly in the West, that since 1996 have eased or eliminated penalties for medical use of marijuana.

            Among these states is Maryland, which last year set a maximum fine of $100 for medical users of less than an ounce of pot.

            It has wider implications because Monson claims that federal drug busts of people such as her exceed Washington's authority under the commerce clause of the Constitution, which gives Congress the power to regulate trade "among the several states."

            Last year, the San Francisco-based U.S. Court of Appeals for the 9th Circuit ruled 2 to 1 that Monson was right. If the Supreme Court agrees, it could limit the federal government's power over not just the cultivation and use of marijuana, but also other activities.

            Much modern government regulation exists because the Supreme Court articulated a broad definition of interstate commerce during the 20th century. This permitted the court to uphold, as exercises of Congress's commerce clause power, a wide range of national laws -- from the economic policies of the New Deal to the civil rights era ban on racial segregation in hotels and restaurants.

            Perhaps the key ruling came in 1942, when the court held that the Roosevelt administration could enforce acreage controls against an Ohio wheat farmer who claimed his crop was entirely for his own use.

            The court said that even subsistence farming could change the overall supply and price of grain; this "substantial effect on interstate commerce" triggered Congress's authority.

            But in more recent years, the court has tightened its definition of interstate commerce.

            In 1995, the court struck down a federal ban on gun possession within 1,000 feet of a school, ruling that Congress's claims that school gun violence had a "substantial effect" on the economy were implausible.

            And in 2000, the court struck down a federal law giving women a right to sue rapists in federal court, ruling that such violence was not, "in any sense of the phrase, economic activity."

            Monson and her co-plaintiffs -- Angel McClary Raich, an Oakland woman who suffers from a variety of painful chronic disorders, and two people identified as John Doe One and John Doe Two, who give Raich pot free of charge -- argue that these recent cases favor them, because using small amounts of marijuana they grow for themselves, or passing it along for "compassionate" reasons, cannot affect the broader market for the drug.

            "This case is and always has been about federalism and state sovereignty," Monson's lawyers argue in their brief.

            But the Bush administration counters that even small-scale use of a fungible commodity such as marijuana can affect price and quantity in the black market.

            "[E]xcepting drug activity for personal use or free distribution from the sweep of [federal drug laws] would discourage the consumption of lawful controlled substances and would undermine Congress's intent to regulate the drug market comprehensively to protect public health and safety," the administration argues in its brief.

            The federalism issue in the case has created unusual alliances. Three conservative Deep South states, Alabama, Louisiana and Mississippi, have filed a friend of the court brief supporting the marijuana users on states' rights grounds. "California is entitled to make for itself the tough policy choices that affect its citizens," the states' brief argues.

            Legal analysts say the likeliest supporter on the court for the marijuana users may also be its most conservative member: Justice Clarence Thomas, who, though a harsh critic of drug abuse, has also written that the court must narrowly define Congress's commerce clause powers.

            Meanwhile, a liberal environmentalist group, the Community Rights Council, filed a brief in support of the Bush administration, noting the group's interest in "ensuring . . . legislative flexibility to address national concerns."

            In two previous cases at the Supreme Court, medical marijuana advocates have a split record.

            In 2001, the court ruled 8 to 0 that there is no "medical necessity" exception to federal drug laws against producing and distributing marijuana, so California's "cannabis clubs" cannot escape prosecution by saying they save lives.

            But in 2003, the court refused to hear the Bush administration's appeal of a 9th Circuit ruling that said doctors have a right to discuss marijuana as a treatment option with their patients. That left the 9th Circuit ruling on the books.

            Thus, today's case is critical to the medical marijuana movement. With cannabis clubs unable to distribute pot legally, a doctor's right to recommend it would be meaningless unless users or their friends can grow it themselves.

            The case is Ashcroft v. Raich, No. 03-1454. A decision is expected by July.



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          • politicog@yahoo.com
            You have been sent this message from politicog@yahoo.com as a courtesy of washingtonpost.com Personal Message: I wonder if this would also apply to other
            Message 5 of 10 , Nov 30, 2004
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              I wonder if this would also apply to other ideological reasons to exclude recruiters, or if it would apply at the high school level.

              U.S. Loses Ruling Over College Bans on Military Recruiters

              By Michael Dobbs

              A federal appeals court yesterday prohibited the government from withholding funds from colleges and universities that refuse to cooperate with military recruiters because of the Pentagon's discrimination against gays in the armed forces.

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            • politicog@yahoo.com
              You have been sent this message from politicog@yahoo.com as a courtesy of washingtonpost.com FDA s Reliance On Unconfirmed Chiefs Is Faulted By Marc Kaufman
              Message 6 of 10 , Dec 20, 2004
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                FDA's Reliance On Unconfirmed Chiefs Is Faulted

                By Marc Kaufman

                The Food and Drug Administration, which regulates almost one-quarter of the U.S. economy, has been without a permanent chief for almost two-thirds of the time that President Bush has been in office.

                The agency also has had a high number of temporary appointees administering its centers, offices and divisions, including the key positions running the offices that evaluate new drugs and monitor the safety record of approved medications.

                To many agency observers, the absence of settled leadership has become a significant problem. The agency, they say, is less able to respond quickly and effectively to emerging problems and has been weakened in the face of political, industry and sometimes consumer pressures to stray from the agency's science-based public health mandate.

                In recent months, the FDA has been sharply criticized for its laissez-faire stance in the withdrawal of the arthritis drug Vioxx, its oversight of the company that was to provide half of the nation's flu vaccine this winter, and its handling of the sensitive issue of when and whether antidepressants should be prescribed for children. Friday's announcement that another popular arthritis drug, Celebrex, may also pose serious risks has raised the stakes further.

                The White House says the situation at the agency is no reason for concern, and FDA officials said their work has not been hampered by the lack of permanent leaders. Deputy Commissioner Janet Woodcock, who herself has served in an acting capacity for more than a year, said, "Our programs are set up to carry on. . . . Transitions for us are pretty frequent and inevitable."

                But others, including Sen. Charles E. Grassley (R-Iowa), who has held hearings into recent controversies at the FDA, are particularly concerned about the prevalence of "acting" leadership.

                "Recent events make it obvious there's no time to waste in securing stronger leadership at the Food and Drug Administration," he said. "Permanent people need to be appointed to these jobs posthaste. . . . Leadership is hampered by the term 'acting.' "

                While the FDA's top job has been filled by temporary appointments for months at a time in previous administrations, the duration of the situation under Bush is unprecedented in modern times. Of the 48 months in Bush's first term, then-Commissioner Mark B. McClellan's 17-month tenure was the only period during which the position was permanently filled.

                White House spokesman Trent Duffy acknowledged that the FDA had been without permanent leadership for a significant portion of the past four years. But Duffy said Bush believes that acting commissioner Lester M. Crawford is doing an "excellent" job and that he has all the "authorities and responsibilities" of a permanent commissioner. Duffy said the White House prefers having a permanent leader at the FDA, but there is no statutory or policy reason to rush the process.

                Some speculate, however, that there may have been political considerations. Edward M. Kennedy (Mass.), ranking Democrat on the Senate health committee, has said he would strongly oppose any nominee from the pharmaceutical industry; that stand may have made the administration less interested in filling the position before the election.

                Paul C. Light, a New York University professor who works on the Brookings Institution's presidential appointments initiative, said the absence of permanent FDA leadership may be in part intentional. "There are some in the administration and in the industry who would rather have vacancies at FDA than an aggressive regulator," Light said. "The theory is that it is better to have no one there than someone who favors a proactive stance that might slow down the industry or raise hard questions about profitable drugs."

                In four years, the Bush administration has sent only one name to the Senate for confirmation as food and drug commissioner -- McClellan's in October 2002. Early this year, he was shifted to oversee the Medicare program as it implements a new prescription drug benefit.

                Since then, Crawford, who was trained as a veterinarian and pharmacologist, has served as acting commissioner, taking on for the second time a role he and another FDA veteran filled for more than a year and a half before McClellan's confirmation. (Bush fired Clinton appointee Jane Henney immediately after taking office.) Naming permanent FDA commissioners became more complicated in 1988, when Congress required Senate confirmation as a way to make the job more powerful.

                Some argue that the additional burdens of the confirmation process have led to more and longer periods when the agency is run by temporary appointees. But others point out that the position was prone to high turnover and prolonged absences even before. When Frank Young became FDA commissioner in 1984, he noted that he was the fourth commissioner in seven years.

                The FDA has more than 10,000 employees, and most work on scientific issues that are supposed to be independent of politics and the agency's leadership. But at drug companies and consumer groups, there is concern that the absence of permanent leadership has enfeebled the agency.

                "Not having a permanent commissioner doesn't send a good message," said Arthur Aaron Levin, director of the Center for Medical Consumers in New York and a member of the FDA's advisory panel on drug safety. He worries that the agency is not doing enough to make sure drugs are safe.

                "Bureaucracies have a life of their own and need to feel their work is a high priority," Levin said. "But not having permanent leadership means you're not a high priority."

                Sam Kazman, general counsel of the Competitive Enterprise Institute, feels the lack of a commissioner is a problem for a different reason. In the aftermath of the Vioxx debacle, in which the FDA was widely seen as slow to react to safety concerns, he fears that the FDA will become gun-shy about approving new drugs.

                "When you have temps in high places at FDA, the agency's traditional tendency towards deadly overcaution becomes worse," Kazman said.

                Alan Goldhammer, associate vice president for U.S. regulatory affairs for the brand-name drug industry trade association, Pharmaceutical Research and Manufacturers of America, said the FDA is continuing to function normally but is weakened.

                "Even though Dr. Crawford has testified at a number of hearings and clearly is in charge of daily operations," Goldhammer said, "there is a difference when the person in charge has gone through the whole confirmation process. That person is in a better position to argue for the resources they need and to present the views of the agency."

                Goldhammer also said that having an acting commissioner in charge makes it more likely that other important positions will be filled by interim appointments. Decisions on naming potentially long-serving employees often await a permanent commissioner, he said.

                Among the acting appointees holding sensitive posts now are Steven Galson, acting director of the Center for Drug Evaluation and Research, and Paul Seligman, acting director of the Office of Drug Safety. Both have been in controversies that have called into question their ability to ward off political pressure.

                Galson came under strong criticism from many in the medical community for refusing to allow the emergency contraceptive Plan B to be sold as an over-the-counter drug, even though both FDA staff and an advisory panel had concluded decisively that the switch would be safe and valuable to consumers. Galson and Seligman have became embroiled in the Vioxx controversy and allegations that the agency sought to stifle dissent from drug safety officer David J. Graham.

                White House spokesman Duffy said the administration had no timetable for nominating a new permanent commissioner, but experience suggests the process may be time-consuming. Before McClellan got the job in 2002, at least three men prominent in the pharmaceutical community were quietly brought to the White House as serious contenders, and just as quietly were rejected.



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              • politicog@yahoo.com
                You have been sent this message from politicog@yahoo.com as a courtesy of washingtonpost.com White House Defends FDA as Drug Safety Debate Looms By Marc
                Message 7 of 10 , Dec 21, 2004
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                  White House Defends FDA as Drug Safety Debate Looms

                  By Marc Kaufman

                  The Bush administration and some of its critics squared off yesterday over whether the Food and Drug Administration is doing an adequate job overseeing drug safety, and whether the agency needs major reforms.

                  In a preview of the debate to come, White House Chief of Staff Andrew H. Card Jr. said the agency is doing a "spectacular" job and should "continue to do the job they do."

                  But Sen. Edward M. Kennedy (Mass.), ranking Democrat on the Senate Health, Education, Labor and Pensions Committee, shot back that the FDA's "record on protecting us from harmful prescription drugs is a catastrophic failure."

                  "Early action on bipartisan FDA reforms is possible in Congress, and I hope that the White House and congressional leadership will not stand in the way," Kennedy said.

                  The agency has come under intense scrutiny for its handling of drug safety questions involving the arthritis drug Vioxx, antidepressants for children and last week the painkiller Celebrex.

                  Vioxx was taken off the market by manufacturer Merck & Co. in September, the agency toughened guidelines on pediatric use of antidepressants in October after public and congressional criticism, and the fate of Celebrex remains uncertain.

                  The maker of Celebrex, Pfizer Inc., reiterated yesterday that it would not take the drug off the market after a clinical trial showed increased risk of heart attacks and strokes among users. Acting FDA Commissioner Lester Crawford said Friday that the agency is concerned about the finding and left open all possible regulatory responses.

                  Card made his comments about the FDA during ABC's "This Week," when he was asked whether he supported last week's call by Sen. Charles E. Grassley (R-Iowa), chairman of the Senate Finance Committee, for an investigation of the federal drug agency similar in scale to the Sept. 11 commission.

                  Card responded that "I don't know that we need a commission" and that "I've got great confidence in the FDA." He said news coming out about previously unaddressed safety risks associated with popular drugs on the market is "a testament to the FDA in how they do their job."

                  In the cases of Vioxx and Celebrex, the agency had little to do with the studies that identified the additional heart attack and stroke risks. According to FDA drug safety officer and whistle-blower David Graham, his research showing apparent dangers in Vioxx was suppressed by the agency.

                  Speaking later on the same news show, Pfizer chief executive Hank McKinnell defended the decision to keep selling Celebrex. "For many patients, Celebrex is the best option or, in some cases, the last option to live a normal life with the pain and inflammation of arthritis," he said.

                  McKinnell said that although one large and well-controlled study had found a significant cardiovascular risk with Celebrex, another large one in progress did not find the risk, and nor have about 50 other clinical studies of the drug. "So I'm not sure we really understand yet the relevance of this new data," he said.

                  A company official said yesterday, however, that direct-to-consumer advertising for Celebrex will be ended.

                  Graham, who also appeared on "This Week," said he wouldn't prescribe Celebrex "to my mother-in-law."

                  "The FDA wasn't concerned about Vioxx, and would not have removed it from the market if Merck hadn't, yet 100,000 patients had heart attacks because of Vioxx," Graham said. "The fact that the FDA now says that it's concerned about Celebrex to me is a very serious signal."

                  The FDA has lacked a permanent commissioner since March, and has had an acting leader for about two-thirds of President Bush's first term. Yesterday, Kennedy called for the quick nomination of a reform-minded commissioner while Card said acting Commissioner Crawford "is doing a very good job."

                  Congress has shown growing concern over the FDA's safety monitoring, and committees in both chambers are actively involved in investigating the withdrawal of Vioxx and the potential risks from Celebrex. On Friday, the House Energy and Commerce Committee asked Pfizer for scores of documents on Celebrex, including all communications with the FDA about its possible cardiovascular risks. Grassley's Senate Finance Committee has done the same with Merck and Vioxx.

                  Grassley has called for FDA reforms that would enlarge the agency's Office of Drug Safety and make it more independent, but has acknowledged there is not strong support for the idea.

                  The FDA announced early last month that it would take steps to improve safety reviews and make the agency more open to dissenting views from drug reviewers. It also asked the congressionally mandated Institute of Medicine to examine its entire approach to drug safety.

                  The new concerns regarding Celebrex came from a study run by the National Cancer Institute into possible new uses of the drug in the prevention of colorectal cancer. On Thursday, a data-safety monitoring committee studying the trial reported that subjects taking Celebrex were significantly more likely to suffer heart attacks and strokes than those on a placebo.

                  Those taking a high dose had a 3.4 times greater risk of cardiac problems than those on a placebo, and those on the lower dose had a 2.5 times greater risk. After the trial was stopped, the Cancer Institute reported there had been six cardiac events among those given a placebo, 15 for those on the lower dose of Celebrex, and 20 for those taking the higher dose.



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                • politicog@yahoo.com
                  You have been sent this message from politicog@yahoo.com as a courtesy of washingtonpost.com Warnings About Medications Risks Add Worry to Pain By Shankar
                  Message 8 of 10 , Dec 24, 2004
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                    Warnings About Medications' Risks Add Worry to Pain

                    By Shankar Vedantam

                    Paula Frazier's family is terrified that the Celebrex she has been taking for arthritis could kill her -- the homemaker from Denton, Tex., has a family history of heart disease, and a study last week suggested the drug may increase heart problems among some patients.

                    Jonathan Schaffer, an orthopedic surgeon at the Cleveland Clinic in Ohio, knows that many of his patients are panicked after the spate of recent warnings about popular pain-relieving drugs, but he is worried about himself, too: A tennis enthusiast who plays three nights a week, Schaffer takes nonprescription Aleve after each match. On Tuesday, he learned that federal researchers had halted a study because it indicated Aleve might increase the risk of heart attacks and strokes.

                    In the District, Linda Hannick says she has had trouble climbing down stairs since she was forced to go off Vioxx when the drug was withdrawn in September because of serious safety concerns. Hannick obtained a 10-day supply through a friend who had extra tablets and is now wondering whether she can get the drug overseas and bring it legally into the United States.

                    From coast to coast, warnings about several popular anti-inflammatory painkillers are triggering confusion and anxiety. Millions of people have come to depend on these medications, and the steady drumbeat of bad news has forced doctors to retreat from one drug after another. Some are frustrated and angry.

                    "People are saying the whole class of medicines should be thrown out," said David Borenstein, a D.C. rheumatologist. "Well, they should come and live in my shoes and see all the patients I have with arthritis. Going back to medicines we used a decade or two ago is not a step forward."

                    The safety concerns about the medications, which now include newer drugs known as COX-2 inhibitors and older nonsteroidal anti-inflammatory drugs, or NSAIDs, have come from a range of sources, and the data have sometimes been contradictory. The study finding an increased risk associated with Aleve, for example, found no increased risk associated with Celebrex.

                    "What does a 70-year-old person [taking anti-inflammatory drugs] to prevent Alzheimer's disease have to do with a 50-year-old person with rheumatoid arthritis who has pain every day?" Borenstein asked. "To say it applies in the same way and has the same risk is ludicrous."

                    But other medical experts disagreed and said the concerns about drugs such as Vioxx and Celebrex are serious.

                    "We never believed they were safer to prescribe than the older" drugs such as ibuprofen and aspirin, said Laura Marshall, a spokeswoman for Kaiser Permanente, a nonprofit HMO company that serves more than 8 million Americans. "If there is a lesson to be learned, it is that just because something is newer and costlier doesn't make it better."

                    Janet Woodcock, acting deputy commissioner for operations at the Food and Drug Administration, said the public had to be alerted about the risks, even if experts do not yet fully understand the biological mechanisms.

                    Woodcock said the agency is awaiting further analysis and will look into several other ongoing studies in which the drugs are being tested. The FDA has scheduled an advisory committee meeting in February to review the findings but will release information with public health implications before that, she said.

                    The drugs under suspicion, some sold by prescription and others over the counter, are used principally by people who have arthritis and other conditions that cause chronic pain. They are also widely used by athletes recovering from injuries -- or even a tough game of tennis.

                    "We are in a society where we are taught if you have an ache or a pain, take one of these," Schaffer said. The surgeon said his own analysis of the data told him the reported risks are real and have to be grappled with.

                    Judi Epstein of the District, who has run marathons and has led a very active life, said she is at a loss since the recall of Vioxx. Epstein, 58, was taking it for arthritis and chronic pain. She has been switched to Celebrex but said in an interview that it is not the same.

                    "I took it five solid years twice a day," she said of Vioxx. Now, "I'm just in a lot of aches and pains. I just went to cross my legs, and it is killing me."

                    John H. Klippel, president and chief executive of the Arthritis Foundation and a rheumatologist by training, cautioned against overreacting to the safety concerns.

                    Donna Sweet, a professor of internal medicine at the University of Kansas school of medicine in Wichita and a leader who spoke on behalf of the American College of Physicians, urged patients not to switch medications without consulting a physician.

                    "The Vioxx was bad enough, and then it led into Bextra and then the Celebrex study," she said. "Patients panic, and people are stopping medications when the risk-benefit ratio is in their favor."

                    Frazier, 40, the woman in Texas, said she had been bounced from drug to drug with each wave of bad news. She suffers from constant back pain as a result of osteoarthritis and intermittent pain in her hands and feet that doctors have not been able to diagnose.

                    Vioxx allowed her to function without pain and to lift her 4-year-old son, she said. When that drug was withdrawn, her doctor switched her to Bextra, another COX-2 inhibitor that has recently come under suspicion. Frazier stopped taking Bextra because it was not helping her, and her doctor switched her to Celebrex. Then came the study suggesting a possible increased risk for Celebrex.

                    "My family thinks I should stop taking it," she said. "They say the pain would come back but I'd be alive. They see it in black and white. What I understand better than my family is that with every benefit there is a side effect, but not everyone gets the side effect."

                    Frazier's doctor, Dallas rheumatologist Scott Zashin, said he will switch her to Lodine, an older drug.

                    "I am trying to get patients off medications, encourage aerobic exercise and also restorative sleep," said Zashin, who is the author of the book "Arthritis Without Pain." "If you sleep well, that may decrease your pain. Acupuncture is something I have done with some of my patients."

                    Hannick, 57, a bio-informatics analyst in the District, said she started taking Vioxx four years ago for arthritis. Then, two years ago, a motorist slammed into Hannick's car on a snowy day on the George Washington Memorial Parkway. Hannick saw him coming and turned her steering wheel to avoid hitting the car in front of her -- a gesture that saved the next car but caused her shoulder to take the brunt of the impact.

                    Surgery followed. Hannick grew even more dependent on her Vioxx. Her hips hurt after the accident, and she had trouble descending stairs. She was heartbroken when Merck withdrew the drug. Her doctor put her on another medication, but it was not as effective.

                    "I was back to square one," she said. "My shoulder hurt, my lower back flared up, and everything hurt," she said.

                    That is when a friend offered her a 10-day supply of Vioxx. That calmed down most of the pain, and Hannick's doctor then put her on yet another medication -- Arthrotec, a combination drug that includes an NSAID.

                    But Hannick is still in pain. If she had the chance, she would go back on Vioxx "in a minute," she said. "In fact, I am keeping my ears open to see if anybody has any more."

                    Staff writer Rob Stein contributed to this report.



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                  • politicog@yahoo.com
                    You have been sent this message from politicog@yahoo.com as a courtesy of washingtonpost.com NIH Revises Plan for Quick, Free Access to Study Results By Rick
                    Message 9 of 10 , Jan 18, 2005
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                      NIH Revises Plan for Quick, Free Access to Study Results

                      By Rick Weiss

                      An ambitious proposal to make the results of federally funded medical research available to the public quickly and for free has been scaled back by the National Institutes of Health under pressure from scientific publishers, who argued that the plan would eat into their profits and harm the scientific enterprise they support.

                      The initial plan, encouraged by Congress and hailed by patient advocacy groups, called for the results of NIH-funded research to be posted on a publicly accessible Web site within six months after they are published in a scientific journal. Most research results now are available only by subscription to the journal -- at a cost that often reaches into the thousands of dollars -- or on a pay-per-article basis that can cost $100 or more for two or three articles.

                      In the final version of the plan, however, the recommended six-month deadline for posting results has been stretched to a year. That change has angered many advocates of public access, who have argued it isn't fair that taxpayers must either wait or ante up to see the results of research they have already paid for.

                      A scheduled announcement of the policy was abruptly canceled last week by the Department of Health and Human Services, of which NIH is a part. Two sources within the department, speaking on the condition of anonymity because they are not authorized to speak for the department, said the announcement was delayed in order to keep it off the federal agenda until after today's confirmation hearings for Michael Leavitt, President Bush's nominee to become HHS secretary.

                      Sensitivities about the relationship between NIH and private industry are especially high these days. The agency has been pilloried in the past year by Congress and others for allowing many of its scientists to collaborate with drug and biotech companies in lucrative deals that raise conflict-of-interest issues. Several NIH-watchers said one reason for canceling the rollout of the new plan might have been to avoid calling attention to what could be perceived as another instance of the agency failing to stand up to moneyed interests -- in this case scientific publishers, the largest of which have enjoyed skyrocketing profit margins of 30 percent or more in recent years.

                      "There's been so much embarrassment flying around about transparency and the public interest at NIH, it's just coming to a head," said Bob Witeck, a spokesman for the Alliance for Taxpayer Access, a coalition of groups favoring easier access to publicly funded scientific findings.

                      Several business coalitions -- including the Association of American Publishers, whose president is Patricia Schroeder, a former congresswoman from Colorado -- had lobbied strenuously against the initial proposal, which they said would jeopardize many journals' existence by undercutting their paid subscriber base.

                      "The publishers were crawling all over the place," said Rick Johnson, director of the Scholarly Publishing and Academic Resources Coalition, an alliance of academic and research libraries trying to change the current system. He and others have argued that few scientists or libraries would cancel their subscriptions just because NIH-funded content was available free elsewhere, because such research represents only a fraction of the content of most journals.

                      Johnson also noted that the revised policy of asking scientists to post their results within 12 months of publication was a minimal request, because many journals already make their content freely available on the Internet after a year. (The policy has focused on getting scientists to post their results on a centralized, government Web site rather than trying to force journals to make their pages public, which raises copyright and other issues.)

                      NIH Director Elias A. Zerhouni denied that the agency had buckled under industry pressure. Zerhouni said in a telephone interview that there are so many different kinds of publishers -- including many nonprofit publishers run by scientific societies, which reinvest their profits in scientific and educational endeavors -- that it did not make sense to demand a six-month release deadline for all.

                      "I could not prove that a six-month deadline would not harm a significant part of the industry," Zerhouni said. "The new policy continues to call for release of information as soon as possible after publication, but it really leaves it in the hands of the scientists to decide when. What's important is that we're creating a precedent in which the agency that funds medical research is establishing a public database containing all its scientific output. I am certain that over time people will see this as a win-win."

                      Some advocates for public access agreed that even a voluntary policy encouraging release within 12 months could result in more access than is available today, if the NIH makes clear to its grantees that it is serious about wanting them to participate.

                      "The next year will tell if it's working. If a lot of people do it, it won't matter what the language is," said Michael Eisen, co-founder of the Public Library of Science, which publishes scientific journals freely accessible to the public. "What's important is for NIH to convincingly say they're behind it."



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