Additionally, "On June 30, another FDA advisory panel recommended reducing a single adult dose of any acetaminophen from 1,000 milligrams to 650 milligrams - and making Tylenol available by prescription only." The recommendations resulted both from the panel's concerns about the prescription pain relievers' addictive properties as well as the effect of one of their active ingredients, acetaminophen, on users livers.However, the doctors with whom Medill, an arm of Northwestern University, seem relatively united against the recommendations, questioning both the panels' major concerns: addiction and liver damage.Activist and president of a pain patient advocacy group, the Pain Relief Network, Siobhan Reynolds has "filed a complaint with the Justice Department alleging prosecutorial misconduct in a grand jury investigation of her role" in an ongoing legal battle involving Dr. Reynolds is being assisted by both her own organization and the American Civil Liberties Union, which filed an amended motion to quash a March 2009 subpoena that the parties claim infringes upon Reynolds' right to free speech and represents a gross misuse of the grand jury system. As CNN reported on June 30, 2009 ("FDA Advisors Vote to Take Vicodin, Percocet Off Market"), an FDA advisory panel voted in favor of "eliminating prescription drugs that combine acetaminophin with narcotics -- such as Vicodin and Percocet -- because of their risks for overdose and severe liver injury." The panel also "advised the FDA to lower the maximum daily dose of acetaminophen in over-the-counter and prescription medications, and to address the formulations and dosing recommendations for children." Among other recommendations, the panel suggested that, if the FDA chooses not to remove the aforementioned medicines from pharmacy shelves, it could "lower the amount of acetaminophen" in drugs that combine acetaminophin and narcotic painkillers and "take some action to ensure that subscribers and patients are aware of the potential liver damage posed by taking these products." Although it typically follows advisory committee recommendations, CNN informs readers that it "is not required" to do so.Stephen Schneider and wife Linda Schneider, "who were indicted in December 2007 on 34 counts [...] of unlawfully prescribing painkillers and overbilling for services at their clinic in [a] Wichita[, KS] suburb," the Associate Press reported on July 10, 2009 ("DOJ Eyes Kan. The latest in a series of related legal filings, Reynolds' July complaint alleges "possible ethics violations by Justice Department employees," primarily Assistant U. Attorney Tanya Treadway, who - as discussed below - has relentlessly pursued Reynolds over the last few years in hopes of either slapping her with an obstruction of justice charge or using her personal information to gain insight into the Schneider defense team's case. However, as Ohio newspaper the Columbus Dispatch reported on July 20, "Confusion and concern have followed news that the [FDA] is considering" the changes discussed above ("FDA Inquiry into Painkiller Perplexes Patients").The Chronicle feature provides a more detailed account of the case's history - particularly where Reynolds' and Treadway's involvements are concerned.Many of the legal documents - including Treadway's Reynolds-aimed subpoena, Reynolds' initial motion to quash the grand jury subpoenas, and the ACLU's amended motion to quash them - are also available for public online viewing. Brinkema was a setback for federal prosecutors, who were seeking a life sentence for William E. Hurwitz, 61, a former pain specialist based in Mc Lean, was a key target of a far-reaching investigation into doctors, pharmacists and patients suspected of selling potent and addictive painkillers. District Court in Alexandria convicted Hurwitz on 16 counts of drug trafficking in April.But prosecutors said that Hurwitz prescribed excessive amounts of Oxycodone and other potentially dangerous narcotics -- in one case, more than 1,600 pills a day -- to addicts and others, some of whom sold the medication on the black market. Brinkema seemed to lean toward the patient advocate side when she imposed her 57-month sentence yesterday.' He crossed the line from a healer to a dealer,' Assistant U. Although she said she agreed that Hurwitz had gone from being a doctor to someone who gave 'drugs to people for illicit means,' she said that the 'overwhelming majority' of his patients were legitimate and that Hurwitz had tried to help them.
Moreover, Christo states that "The prevalence of any addiction is about 10 percent" - even for those who have never had problems with licit or illicit drug abuse.
Brinkema also recalculated federal sentencing guidelines in ways that lowered the sentence, accepting the defense's argument that Hurwitz was not completely at fault because his patients had duped him." A federal judge is challenging the plea agreement entered into earlier in 2007 between prosecutors and Purdue Pharma, the manufacturer of Oxy Contin.
The Roanoke Times reported on June 20, 2007 ("Oxycontin Agreement Challenged By Judge") that "A federal judge is raising questions about a plea agreement that calls for 4.5 million in fines -- but no jail time -- for the illegal marketing of Oxy Contin, a powerful painkiller that doubles as a street drug.
ACLU attorneys claim that the prosecution's actions "constitute an abuse of the grand jury process [and] would have 'a chilling effect' on Reynolds' constitutionally protected speech." Additionally, the ACLU contends that the subpoena represents further "misuse of the grand jury process because it is aimed at invading the defense camp of the Schneiders." In lay-speak, Reynolds' ACLU advocates have argued not only that the defendant simply exercised her right to free speech in her Schneider-related advocacy efforts but also that the prosecution is attempting to illegally snoop around for clues about the Schneiders' legal strategy.
Although the "motion was heard on Tuesday (5/12)," according to the Chronicle, "there is no word back from the judge yet," and because "[p]roceedings were conducted 'under seal' at Treadway's behest," the parties are barred from publicly discussing the matter.