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Pain Activist Facing Fines in Free Speech Case

The government's war against pain doctors hit a new low last spring, when federal prosecutor Tanya Treadway, busy prosecuting Kansans Steve and Linda Schneider, subpoenaed pain control advocate Siobhan Reynolds for information on the Pain Relief Network's (PRN) public advocacy in support of the Schneiders. Despite ACLU efforts to quash the subpoena as an attempt to shut down free speech, judge US District Judge Julie Robinson allowed it. Friday, according an update from Jacob Sullum on Reason, Robinson imposed a $200/day civil contempt fine on both Reynolds and PRN, to begin in 10 days if she does not comply with the subpoena. An appeal is planned -- stay tuned. Earlier in the week, Boston-based civil liberties attorney Harvey Silverglate criticized Treadway in a column in Forbes magazine. We reprint a few paragraphs, also via Sullum:
When Reynolds wrote op-eds in local newspapers and granted interviews to other media outlets, Assistant U.S. Attorney Tanya Treadway attempted to impose a gag order on her public advocacy. The district judge correctly denied this extraordinary request. Undeterred, Treadway filed on March 27 a subpoena demanding a broad range of documents and records, obviously hoping to deter the peripatetic pain relief advocate, or even target her for a criminal trial of her own. Just what was Reynolds' suspected criminal activity? "Obstruction of justice" is the subpoena's listed offense being investigated, but some of the requested records could, in no possible way, prove such a crime. The prosecutor has demanded copies of an ominous-sounding "movie," which, in reality, is a PRN-produced documentary showing the plight of pain physicians. Also requested were records relating to a billboard Reynolds paid to have erected over a busy Wichita highway. It read: "Dr. Schneider never killed anyone." Suddenly, a rather ordinary exercise in free speech and political activism became evidence of an obstruction of justice.
Location: 
Wichita, KS
United States

Medical Marijuana: Veterans Administration Says Positive Marijuana Drug Screening Will Not Void Pain Contracts for Vets with Doctors' Recommendations

The Veterans Affairs watchdog group VA Watchdog reported last week that the VA will not remove veterans with medical marijuana recommendations who test positive for pot from its pain management programs. Just don't bring your medicine to a VA facility.

In recent years, vets who use marijuana medicinally have been thrown out of VA pain management programs as "drug abusers" after testing positive for marijuana. This policy shift will provide some solace, but only to those vets residing in states where medical marijuana is an option.

The VA has clarified its policy. While restating that it remains illegal to use or possess marijuana at VA facilities because of federal law, the agency will now accept medical marijuana use in states where it is legal:

"[I]t is acknowledged that testing positive for marijuana in a patient, based upon a random drug screening, will not serve as a breach of the current pain management agreement if the patient submits documentation in support of the marijuana being prescribed and dispensed in conformity with Michigan law," wrote Gabriel Perez, director of the Lutz Veterans Affairs Center in Saginaw, Michigan.

According to VA Watchdog, the policy appears to be the same in all states where medical marijuana is allowed under state law. But the VA has not released an official policy statement on the matter.

Free Speech: ACLU Backs Pain Activist's Effort to Quash Subpoena Issued in Kansas Case

The American Civil Liberties Union (ACLU) has joined pain activist Siobhan Reynolds and the Pain Relief Network (PRN) in her effort to block a bare-knuckled federal prosecutor from compelling her to produce documents about her contacts with Kansas pain doctor Steven Schneider and his wife, as well as friends, relatives, employees and attorneys.

http://stopthedrugwar.org/files/siobhanreynolds.jpg
Siobhan Reynolds at 2004 Congressional briefing
The federal grand jury subpoena marks the second time US Assistant Attorney Tanya Treadway has gone after Reynolds for her advocacy for the Schneiders as they face federal charges they unlawfully prescribed pain medications.

The Schneiders were arrested and their pain clinic and home raided by federal agents in December 2007. Reynolds, a tireless advocate for chronic pain patients and the doctors who prescribe for, went to Kansas to support the couple, whom she sees as being hounded by overzealous federal drug warriors. There, with her criticism of the prosecution's case, she became a thorn in Treadway's side.

Last July, Treadway sought a gag order barring Reynolds and the Schneiders from talking to the press and another order barring Reynolds from talking to "victims" and witnesses in the case. The judge hearing the case, US District Court Judge Monti Belot, denied that motion to stifle dissent.

At the time, Treadway said in court documents that Reynolds had a "sycophantic or parasitic relationship" with the Schneiders and alleged that she was using the case to further the Pain Relief Network's political agenda and her own personal interests.

Then, in March, Treadway hit Reynolds with the subpoena, which demands that Reynolds turn over all correspondence with attorneys, patients, Schneider family members, doctors, and others related to the Schneider case. Treadway's subpoena is supposedly part of an obstruction of justice investigation aimed at Reynolds. She also demands that Reynolds turn over bank and credit card statements showing payments to or from clinic employees, patients, potential witnesses and others, including virtually every attorney Reynolds knows.

That meant that in order to defend herself, Reynolds had to write and submit her own motion to quash the subpoena, which she filed on April 9. Now, the ACLU has ridden to the rescue, filing an amended motion to quash the subpoena that strongly argues the subpoena should be withdrawn because it threatens Reynolds' First Amendment rights and amounts to little more than a "fishing expedition" aimed at finding out information about the Schneiders' defense.

"These subpoenas constitute an abuse of the grand jury process," the ACLU argued. They would have "a chilling effect" on Reynolds' constitutionally protected speech. The subpoena directed at Reynolds is also "a misuse of the grand jury process because it is aimed at invading the defense camp of the Schneiders. On its face, AUSA Treadway's fishing expedition appears to have the impermissible purpose of obtaining information about the Schneider's defense. Therefore the subpoenas should be quashed as an abuse of the grand jury process."

The motion was heard on Tuesday (5/12), but there is no word back from the judge yet, who took it under advisement. Proceedings were conducted "under seal," at Treadway's behest, prohibiting the involved parties from publicly discussing it.

Free Speech: Grand Jury Subpoenas Prominent Pain Relief Advocate Who Has Criticized the Prosecution of a Kansas Physician

Siobhan Reynolds, head of the pain patient and doctor advocacy group the Pain Relief Network, has been targeted for a grand jury investigation of obstruction of justice for her role in supporting a Kansas physician and his wife in their legal battle against federal prosecutors who accuse them of unlawfully prescribing pain relief medications at their clinic.

http://www.stopthedrugwar.org/files/siobhanreynolds.jpg
Siobhan Reynolds at 2004 Congressional briefing
Reynolds, a tireless activist for the cause of adequately treating chronic pain, publicly questioned the government's case against Steve and Linda Schneider and worked to support their defense. That must have aroused the ire of Assistant US Attorney Tanya Treadway, who is prosecuting the case, because this isn't the first time Treadway has tried to shut Reynolds up.

Last July, Treadway sought a gag order barring Reynolds and the Schneiders from talking to the press and another order barring Reynolds from talking to "victims" and witnesses in the case. The judge hearing the case, US District Court Judge Monti Belot, denied that motion to stifle dissent.

At the time, Treadway said in court documents that Reynolds had a "sycophantic or parasitic relationship" with the Schneiders and alleged that she was using the case to further the Pain Relief Network's political agenda and her own personal interests. Reynolds and the Pain Relief Network advocate against federal prosecutions of pain relief doctors, whom they see as victims of overzealous federal prosecutors and DEA agents who know little about proper medical care standards.

Now, Treadway is at it again. In a subpoena made available to the Associated Press, she demands that Reynolds turn over all correspondence with attorneys, patients, Schneider family members, doctors, and others related to the Schneider case. She also demands that Reynolds turn over bank and credit card statements showing payments to or from clinic employees, patients, potential witnesses and others.

The feisty Reynolds has no intention of complying. Instead, she has filed a motion seeking to throw out the grand jury subpoena. In that motion, she argues that forcing her to turn over such information would destroy her work as a political activist and violate her First Amendment rights to free speech and association.

She told the AP she would go to jail before turning over any documents. "This is an attempt to silence and intimidate me. I am going to fight it as far as I need to," she said. "If I were to give in here, lawful advocacy against the United States in court will effectively be brought to an end. So... a lot is at stake here."

Pain Management: FDA to Tighten Regulation of Extended-Release and Patch Opioid Meds

The Food & Drug Administration (FDA) is beginning a "massive new program" to reduce overdoses, diversion, and inappropriate use of powerful opioid pain relievers, especially targeting extended-release and patch formulations of fentanyl, methadone, morphine, oxycodone, and oxymorphone. On Monday, the FDA announced it had sent letters to 16 drug companies who produce the 24 listed products informing them they would now have to create a Risk Evaluation and Management Strategy (REMS) "to ensure that the benefits of the drugs continue to outweigh the risks."

That means physicians are likely to face new procedures in prescribing the drugs, and patients are likely to face more hurdles in obtaining them, an FDA official said at a Monday press conference. But pain patients already face serious obstacles in obtaining relief. The FDA action comes in the context of a campaign by the DEA to crack down on doctors it deems to have improperly prescribed large amounts of opioid pain medication -- even though prescribing what at first glance appear to be extremely large amounts is well with standard pain relief practice. Physician's fears of being prosecuted have contributed to what pain patient advocates describe as a crisis in chronic pain relief.

"Pain patients aren't drug abusers looking for a prescription fix," said Gregory Conko, senior fellow at the Competitive Enterprise Institute, which teamed up with the Pain Relief Network last May to create the Politics of Pain campaign to fight for patients' access to sufficient pain medications. "It's a genuine tragedy that the DEA often treats them and their doctors as if they were. It's as though the agency just doesn't care whether its single-minded waging of the war on drugs imposes collateral damage."

The Politics of Pain campaign has collected personal stories from physicians and patients who have explained firsthand how difficult it can be to either offer or find sufficient treatment for pain conditions. In one video interview, Gulf War veteran James Fernandez and his wife tell their story of how he, once a robustly healthy US Marine, is now virtually confined to his home because of severe, ongoing pain that has been under-treated for years.

In another interview, Dr. Alexander DeLuca, a board-certified specialist in addiction medicine, describes the obstacles faced by a physician trying to deliver the "standard of care" called for by his own medical training. According to DeLuca, virtually no patients in the country today receive proper treatment for chronic pain.

Still, there are a lot of pain pills out there. Last year, US pharmacies dispensed 21 million prescriptions for the 24 medications listed to 3.7 million patients. "This is a very extensively used group of medications," said Dr. John Jenkins, director of the FDA's Office of New Drugs at its Center for Drug Evaluation and Research. "This will be a massive new program."

Jenkins said that abuse, misuse, and accidental overdoses involving those products had been on the rise over the last decade, and the agency is concerned about doctors inappropriately prescribing them for patients who are not suffering moderate or severe chronic pain.

"We continue to see case reports where someone with a sprained ankle receives a fetanyl patch or extended-release opioid," Jenkins said.

Dr. Bob Rappaport, director of FDA's division of anesthesia, analgesia, and rheumatology products, told the press conference the agency was also deeply concerned with the rising non-medical use of the opioids. He cited a Substance Abuse and Mental Health Services Administration (SAMHSA) report released Monday that showed some 5.2 million people said they had used prescription opioids for non-medical purposes in the past month, and that the figure among 18-to-24-year-olds had increased from 4.1% in 2002 to 4.6% in 2007.

"This is an ongoing problem, and it's getting worse," Rappaport said.

Forcing the drug manufacturers to submit REMS plans is "our attempt to ensure the benefits outweigh the risks," Jenkins said. The agency will seek to find an "appropriate balance between legitimate patient need for such drugs and the threats caused by the abuse and misuse," he added.

But tighter regulation isn't going to happen right away; a series of meetings with various stakeholders over the coming months are being set up to arrive at final regulations, said Jenkins. They will include patient advocates, health care professionals, the pharmaceutical companies, and law enforcement. The first meeting with manufacturers is set for March 3. Hopefully the concerns of patient advocates get heeded and successfully addressed, but it's not clear whether that is even possible with a venture of this nature given the current enforcement climate.

Pain Relief: FDA Panel Urges Ban on Darvon, Related Drugs

Acting on a petition from the public interest group Public Citizen, a Food & Drug Administration (FDA) advisory panel last Friday voted narrowly to recommend that a widely used opioid pain medication be removed from the market. The drug is prophoxyphene, which has been in the pharmacopeia for more than a half century, and is most widely prescribed under the brand names Darvon and Darvocet.

http://stopthedrugwar.com/files/darvon65mg.jpg
65 mg Darvon pills (usdoj.gov)
Prescribed for the relief of mild to moderate pain, prophoxyphene is used in dozens of generic pain medications, too. According to a briefing paper prepared by Xanodyne Pharmaceuticals, the manufacturer of Darvon and Darvocet, some 26 million prescriptions for the pain-fighting pair were written in 2005.

The FDA approved new Darvon formulations as recently as 2003 and a generic phophoxyphen pain medication in 2005. The drug has also passed a number of FDA reviews in the past half-century, including one occasioned by another Public Citizen petition in 1978. The FDA can ban a drug if it is proven unsafe or ineffective when taken as directed.

The agency collected reports of more than 1,400 deaths in people who had taken the drug since 1957, though experts stressed the figure does not prove the drug was the cause of death in all cases. Nor does it seem an exceptionally large figure for an opioid drug prescribed millions of times a year for more than 50 years.

The panel also relied on a Florida Medical Examiner Commission report on 2007 drug-related deaths that showed 87 deaths linked to prophoxyphene.

"If that's not a risk, I don't know what is," said Dr. Sidney Wolfe, head doctor for Public Citizen.

There may be a risk, but it's relative. That same report listed 476 deaths caused by alcohol poisoning, 743 from tranquilizer overdoses, and 843 from cocaine. Among opiate-caused deaths, methadone led with 785, then Oxycontin with 705, hydrocodone with 264, morphine with 255, Fentanyl with 117, and heroin with 93 -- all greater than the number of deaths attributed to Darvon and its generic equivalents. Even the tranquilizer Meprobamate killed more people with 88 deaths listed. (Cannabis was listed as the cause of death in zero deaths.)

Still, despite weak evidence to justify removing Darvon and its brothers from the pharmacopeia, the FDA advisory panel voted to recommend that 14-12 last Friday. A final decision will come in a few weeks.

"It's not a very clear-cut picture," Sharon Hertz, MD, deputy director of the agency's analgesia drugs division, said at a press briefing after the decision. "It's not straightforward that it should or shouldn't come off the market."

Some panel members saw little benefit in keeping Darvon on the market. "I would say, little 'b', big 'r' for this drug. That's little benefit and lots of risk. And that's unsettling," said Ruth Day, PhD, who voted to remove the drug.

It "looks like it offers placebo benefits with opioid risks," saids Sean Hennessey, PhD, a panel member and epidemiologist from the University of Pennsylvania.

But other panel members warned that banning prophoxyphene could leave pain patients in the lurch. It could also drive them to other pain, more potent pain medications, like Oxycontin, they warned.

"Every drug you're talking about that's going to deal with pain has difficulty," said Mary Tinetti, MD, a professor of medicine at Yale University. "There is the possibility that the drugs that would take its place would cause at least as much harm in some people."

Xanodyne hopes it can keep the drug on the market. "I'm hoping to do everything we can to keep this product available to the 22 million people who need it," the company's vice president for clinical development and medical affairs, James Jones, told WebMD.

The Drug War's Dangerous Distortion of Medical Standards

We haven't reported lately on the issue of under-treatment of pain, so this weekend day seemed like a good time to link to a couple of the sites whose people labor in trenches of the pain struggle every day. First, the war on pain doctors continues, with the latest major battle being that of Wichita-area Dr. Stephen Schneider and his wife Linda Schneider. The Schneiders were charged with the deaths of 56 patients by over-prescribing pain medications, but the judge has now limited the case to just four. My guess is that most of these patients passed due to the medical issues that led them to seek treatment, just as one would expect to happen in any medical practice that takes on seriously ill patients; and that a few might have needed the drugs for pain but misused them (as one would also expect to happen sometimes). I haven't examined the case closely enough for that to be more than a guess, but it's an educated guess, as that is usually what is going on in these pain doctor trials. Visit the Pain Relief Network news update page for info. How have things come to this? Big topic, but Dr. Alex DeLuca has a post last week on his "War on Doctors / Pain Crisis" blog, "The Distortion of Medicine and Confusion of Standards," that goes into some of it. A key part of the problem is that while modern pain management textbooks recommend "titration to effect" -- e.g. "gradually increasing the opioid dose until the pain is relieved or until untreatable side effects prevent further dosage increase" -- most doctors just don't do that. And so patients in ongoing, serious pain go without adequate treatment. This makes the typical standard of pain care below medical standards. But it also means that doctors who wrongly believe they shouldn't be relieving a patient's pain are available to testify in trials for the prosecution -- hence the Schneider trial and many others. Even when the defense brings in experts to testify as to what the expert view really is, it creates confusion that can lead to false convictions. This is in fact what happened in the famous William Hurwitz case. DeLuca goes into this in more detail in an interview filmed by the Competitive Enterprise Institute, linked to in his post, so check it out. Another physician victim of the pain wars, Dr. William Mangino, recently submitted a Reply Brief in the appeal of his case. He is imprisoned in Pennsylvania, and he wrote the brief himself. It paints a pretty terrible picture of the what the government is doing in these cases. Dr. Mangino sent us a copy, via one of his friends, and we've posted it here.

Pain Treatment: Millions Suffer Unnecessarily From Lack Of Medications, Human Rights Watch Says, Drug Control Part of the Problem

Millions of people worldwide are suffering unnecessarily from treatable pain, Human Rights Watch said in a report released last Friday. The report came one day before the annual observance of World Hospice and Palliative Care Day, which, not surprisingly, seeks to increase the availability of hospice and palliative care around the world. This year's theme was "Hospice and Palliative Care: A Human Right."

Tens of millions of people worldwide suffer from severe pain due to cancer, HIV and AIDS, and other health conditions. Although most pain can be treated effectively with inexpensive medications, government inaction or obstruction denies its victims access to pain treatment in many countries, Human Rights Watch said.

Governments around the world, including those in low- and middle-income countries, where the availability of pain relieving opioid medications is limited, must take urgent action to stop the unnecessary suffering, the group said. "Allowing millions of people to suffer unnecessarily when their pain can be effectively treated violates their right to the best possible health," said Diederik Lohman, senior researcher in the HIV/AIDS program of Human Rights Watch. "Policymakers worldwide can and should address this."

Low- and middle-income countries are home to half the world's cancer patients and 95% of HIV sufferers, but account for just 6% of worldwide morphine consumption. Morphine is considered by the World Health Organization (WHO) to be a safe and effective drug and one that is absolutely necessary for the treatment of severe pain. Still, some 80% of the world's population does not have access to adequate pain treatment. As Human Rights Watch noted: "This is often due to overzealous drug control efforts and poor training for health care workers."

International drug control conventions and human rights treaties mandate that countries ensure the availability of opioid drugs for pain treatment. But many countries have failed to respond, despite entreaties from the UN and the WHO. The Human Rights Watch report specifically mentioned the reluctance to treat AIDS sufferers' pain in India, the unavailability of pain relievers in Colombia, and the apparent belief by some Kenyan doctors that patients were supposed to die in pain.

"Failure of leadership is a chief cause of the pain treatment gap," said Lohman. "We know how to treat pain and the key drugs are cheap to produce and distribute. What is lacking is the will and commitment to improve access. Governments must not stand by while people suffer."

The report cited the following common problems:

  • Many countries do not recognize palliative care and pain treatment as priorities in health care, have no relevant policies, have never assessed the need for pain treatment or examined how well that need is met and have not examined the barriers to such treatment.
  • Narcotic drug control regulations or enforcement practices in many countries impose unnecessary restrictions that limit access to morphine and other opioid pain relievers. They create excessively burdensome procedures for procurement, safekeeping, and prescription of these medications and sometimes discourage health care workers from prescribing narcotic drugs for fear of law enforcement scrutiny.
  • In many countries, medical and nursing school curricula do not include instruction on palliative care and pain treatment, meaning that many health care workers have inaccurate views of morphine and lack the knowledge and skills to treat pain adequately.

Human Rights Watch noted that the Commission on Narcotic Drugs, the lead UN agency on international drug policy, is in the midst of a review process, which it called an "opportunity to set ambitious and measurable goals to improve access to pain treatment." That would be a good first step, the group said.

"Human Rights Watch calls on all countries to develop and carry out palliative care and pain treatment policies, if they have not already done so, to review their narcotics regulations to ensure that they do not interfere with medical use of morphine and other opioid medications, and ensure that palliative and pain treatment are included in training curricula for doctors and nurses," the report concluded.

My First Year Of Freedom: Richard Paey Speaks Out

Open to the public; sponsored by Floridians for Criminal Justice Reform, Families Against Mandatory Minimums (FAMM), November Coalition and Pain Relief Network. Richard Paey, serving 25 years in prison for "illegal prescriptions", was granted a full pardon by Gov. Charlie Crist of Florida and the Florida Clemency Board on September 20, 2007. For more info & to RSVP, contact John Chase at chaseng@mindspring.com or 727-787-3085. For more about Paey, see: http://www.google.com/custom?q=Richard+Paey&client=pub-5913590882762306&...
Date: 
Sat, 09/20/2008 - 11:00am
Location: 
4730 West Spruce Street
Tampa, FL
United States

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