August 2007

News from Attorneys General Offices

  1. Connecticut Attorney General Richard Blumenthal testified before the Senate Committee on the Judiciary, urging Congress to require the Federal Drug Administration (FDA) to mandate strong label warnings on OxyContin and classify as a federal felony any knowing distribution of a product that is defective and causes serious injury or death. Three years ago, General Blumenthal filed a petition with the FDA urging that the agency require stronger label warnings on OxyContin. The FDA has not yet acted on this petition.
  2. Florida Attorney General Bill McCollum announced the sentencing of former Panama City pain management physician, John Q. Durfey. Durfey pled guilty in May in federal district court to six counts of health care fraud and six counts of dispensing controlled substances outside the normal course of professional practice. He was sentenced to 20 years in prison and ordered to pay restitution in the amount of $466,723.03.
  3. Michigan Attorney General Mike Cox announced that his Health Care Fraud Division and the U.S. Attorney’s Office for the Eastern District of Michigan had negotiated a settlement of health care fraud allegations against Ciena Health Care Management, Inc., owner of 30 long-term care/skilled nursing home facilities. The settlement requires Ciena to a chain-wide, five-year corporate integrity agreement designed to improve the care provided by all of the Ciena facilities. Michigan and the federal government will share in the $1.25 million reimbursement.
  4. New Jersey Attorney General Anne Milgram announced that a state grand jury issued indictments against 19 individuals. They have been charged with racketeering and other crimes in connection with a Newark-based narcotics ring’s distribution of millions of dollars a year in illegal prescription painkillers such as OxyContin. Dr. Mario Comesanas pled guilty in March of this year to first-degree racketeering and second-degree distribution of narcotics for writing thousands of fraudulent prescriptions for the ring. The Division of Criminal Justice obtained a court order seizing $4.4 million in assets as proceeds of racketeering.
  5. Utah Attorney General Mark Shurtleff is partnering with the Utah Department of Health, the Division of Occupational and Professional Licensing, and the Utah Labor Commission to address the growing incidence of prescription drug overdoses in Utah. Last year, more Utahans died as a result of drug overdoses than died in automobile crashes. The state agencies will work together to develop best practice guidelines for health care providers in prescribing opiate pain medications, develop educational materials and a media campaign, and investigate causes and risk factors associated with prescription pain medication-related deaths.
  6. Vermont Attorney General William Sorrell announced that a licensed register nurse, Maureen Corbett, has pled guilty to two misdemeanor charges of diverting for personal use. She received a 6 to 18 months suspended sentence. Later in August, another registered nurse, Laurie Glynn, was arraigned on charges that she diverted drugs from her place of employment for her own use.

Judicial Developments

  1. The U.S. District Court for the District of Columbia issued its holding in Abigail Alliance v. Eschenbach. In an 8-2 decision, the court upheld the FDA’s decision to deny terminal patients access to medications that have passed safety tests but have not passed the full battery of tests to prove efficacy.
  2. In March, a New York state Supreme Court judge removed Daniel Devlin from acting as Al Devlin’s health care proxy. It then appointed Suzanne Devlin, Al’s wife, as guardian. Al Devlin had signed a health care proxy in July 2004 giving his brother, Daniel, the right to make health care decisions for him. Suzanne acted as witness to the document. Nonetheless, when her husband suffered brain damage during surgery in May 2005, Suzanne claimed that Daniel was not acting in her husband’s best interest when he continued to keep him on life support and to seek medical care for him. At the hearing, a doctor testified that Al Devlin was in a “persistent vegetative state.” In August, Suzanne removed her husband’s feeding tube and he died twelve days later.

Legislative Developments

  1. North Carolina Governor Mike Easley signed HB 634 which provides a more detailed version of the “do not resuscitate” form as well as providing a new form that state residents may use to appoint a health care agent.
  2. Tennessee has passed a state law that makes it a felony for TennCare patients to “doctor shop.” The new law amends section 71-5-2601(a)(1)(A). It states that patients may be prosecuted for deceiving medical providers in order to get a prescription for a controlled substance by failing to disclose that they have been given a similar prescription within the past month.
  3. The legislature in Utah passed the Pain Medication Management and Education Bill that directs state agencies to develop a program to investigate the causes of, and reduce deaths and harm from, the misuse and abuse of prescription pain medications.
  4. Singapore is considering new legislation called the Mental Capacity Bill which would permit documents similar to a durable power of attorney. The bill would allow individuals to appoint a person, called a “donee” to act in the event a person becomes mentally incapable of making decisions. An interesting aspect of the proposed legislation is that the bill includes a new criminal offense that would impose a jail term of up to 12 months and/or a fine of $7,000 if a donee is found guilty of ill treatment or willful neglect of his mentally incapacitated charges. A newly-created Office of Public Guardian would investigate complaints and supervise court-appointed guardians.

Pain Management

  1. The University of Wisconsin Pain & Policy Studies Group (PPSG) recently announced the retirement of its distinguished director, David Joranson. Under his leadership, the PPSG has been instrumental in educating states about regulatory and other barriers that prevented patients from receiving appropriate pain management. Joranson assisted the White House in organizing a national conference on the misuse, abuse, and diversion of prescription-controlled substances. He co-founded the National Association of State Controlled Substances Authorities and the Wisconsin Cancer Pain Initiative. Joranson was a member of the drafting committee of the National Conference of Commissioners on Uniform State Laws for revising the uniform controlled substances act, organized 12 workshops for state medical board members, and served on the task force of the Federation of State Medical Boards of the United States to draft model guidelines for the treatment of pain with controlled substances. He has advised the World Health Organization Programme on Substance Abuse, the International Narcotics Control Board, and several national governments. A recipient of a number of awards, he will also receive the American Cancer Society’s Distinguished Service Award in October. He will remain with PPSG in an advisory capacity.
  2. HealthCommunities.com has launched a new website, painchannel.com, which will provide chronic pain sufferers with free, up-to-date information and opportunities to share stories and discuss their pain management experiences with one another. The website also has a healthcare provider feature to help sufferers find practitioners that treat chronic pain.
  3. Lancet’s website featured an article by Dr. Joanne Wolfe of Dana-Farber Cancer Institute calling for increased research to address children’s differing physical, psycho-social, and clinical needs in regard to pediatric pain and palliative care issues.
  4. The use of functional magnetic resonance imaging (fMRI) for controlling pain was the subject in the August 26 issue of New York Times. The article features the attempts of Omneuron, a company that is commercializing fMRI, to help chronic pain patients visualize their pain and control it. In time, according to the chief executive, it is hoped that patients can control pain without the assistance of the machine.
  5. Several news outlets have carried a story regarding the use of synthetic snail venom, Prialt, for controlling chronic pain. The sea snail venom is found in Conus magnus snails, which lives primarily in tropical waters. The venom is a thousand times more potent than morphine. As many as 30 people have died from a Conus magnus snail strike.
  6. A research study examined the use of hypnosis in pain management among rural pain patients. The results of the study, published in Palliative and Supportive Care, concluded that hypnosis appeared to be a viable adjunct for pain management patients. However, trials are needed to examine the utility of hypnosis in end-of-life and palliative care patients.
  7. Dr. R. Gregory Lande discussed the indications for antidepressant use in patients with chronic pain disorders. Published at Abkhazia.com, the article stresses the need for a psychological assessment in the development of a chronic pain care plan for patients and notes that antidepressant therapy may be suggested for some patients.
  8. A study conducted by spine-health.com showed that 61 percent of those suffering from chronic back pain also suffer from bouts of depression. Many of those who were depressed were not diagnosed by a physician and some found that their doctor ignored their symptoms even after they reported the depression.
  9. Two articles in recent issues of the Journal of Pain may be of interest. The first reported the results of a survey of how people in pain seek relief. Seeking medical attention was the primary pain relief strategy, but 92 percent of pain sufferers had tried three or more alternative strategies. People who perceive that their pain is not understood by medical providers and those without health care insurance coverage are at the greatest risk for poor pain control. The other article reported the results of a study of 801 adults receiving daily opioid therapy from primary care practices in six health care systems in Wisconsin. The study found that the frequency of opioid use disorders was four times higher in patients receiving opioid therapy compared with general population samples. The study also provided quantitative data linking aberrant drug behaviors to opioid use disorders.
  10. Researchers in Minnesota surveyed medical residents’ beliefs and concerns about using opioids to treat pain in patients with cancer versus those with noncancer low back pain (NLBP). The results showed that residents had concerns that opioids cause significantly more abuse and addiction in patients with NLBP. The residents also expressed concern in terms of medication side effects, criticism from faculty, and sanctioning by the state board or legal system. The authors of the study, published in the Journal of Rehabilitation Research and Development, concluded that improved training is needed during residency concerning pain management for non-cancer patients.
  11. On October 5-6, Pain Expo 2007 will be held in Orlando, Florida. The expo will include information about the latest medical advancements in pain treatment as well as the benefits of non-medical approaches, such as spirituality, caregiver support, self-hypnosis, and fitness.
  12. The Washington Times carried a commentary critical of DEA’s contribution to “opiophobia” in doctors.
  13. The first study to determine the true economic cost of persistent pain in Australia is being conducted. It is anticipated that the study will be completed by the end of the year and that there will be recommendations that more government resources be funneled to deal with the issue of persistent pain.

Prescription Drug Diversion

  1. The federal government announced that 18 individuals were indicted on racketeering and related charges for allegedly operating an Internet business that generated more than $126 million in gross revenues from the illegal sale of prescription pharmaceuticals, both controlled and non-controlled. The defendants include three physicians. Affpower, a pharmaceutical distribution network, is based in Costa Rica. According to the indictments, computer servers were located in Cyprus, credit card payments were processed through a company in Israel, and revenues were placed in bank accounts in Cyprus.
  2. An article in the Philippine News tells of the indictment of Dr. Noel Chua on two counts of felony murder and on seventeen counts of violation of Georgia’s Controlled Substance Act. Dr. Chua is awaiting trial while incarcerated in the Camden County, Georgia, jail.
  3. An article that criticized the prosecution and conviction of Dr. Bernard L. Rottschaefer for drug diversion, written by Radley Balko, was published on the Fox News website.
  4. The New York Department of Health recently announced that the state’s new official state prescription form has generated $60 million in Medicaid fraud savings in the first six months of accounting oversight. Legislation in 2004 required that all prescriptions, not just those for schedule II controlled substances, be written on the tamper-proof forms. The program was fully implemented for physicians in April 2006 and for hospitals and non-profit diagnostic and treatment centers by April 2007.
  5. Many news outlets published the AP report on Internet prescribing and its contribution to prescription drug diversion. The article noted that about 95 percent of products sold by rogue online pharmacies are controlled substances in comparison to roughly 11percent of the dosages dispensed by legitimate pharmacies. The article also stated that Arkansas, Idaho, Kentucky, West Virginia and Wisconsin have passed laws aimed at blocking the importation of pharmaceuticals from rogue Internet pharmacies.
  6. Many news outlets, including USA Today, carried a story from the Associated Press noting the increases in the distribution of narcotic drugs from 2001 to 2005, particularly in the South. Tennessee and West Virginia saw three-digit rates of increase. The Tennessean carried the AP report, which garnered several responses from readers, as well as comments on it from Dr. Subhi Ali, the former president of the Tennessee Medical Association. Dr. Ali noted that, with Tennessee the number 1 state for prescription drug use, the state has launched the Tennessee Prescription Safety Program to curtail misuse and abuse of prescription narcotics while, at the same time, assure that patients have proper access to pain management. Janet Jones, president and CEO of Alive Hospice, also wrote an op-ed, noting the important role painkillers play in helping patients cope with chronic pain and in end-of-life care. An Arizona newspaper, in reporting the AP story, interviewed local pain management doctors who noted that pain in the elderly has been under-treated for many years. Doctors are now more willing to treat the elderly with opioids. Nonetheless, the doctors interviewed stressed that narcotics should be used only after other pain management methods have failed.
  7. An article in amednews.com discusses the difficulties states face in trying to implement the new federal law requiring tamper-resistant prescription pads for some Medicaid prescriptions. Eleven states already have laws requiring tamper-resistant prescription pads, at least for controlled substances.
  8. The California Medical Board has decided to abolish its current physician diversion program, which provides confidential drug and alcohol treatment for doctors, after a new study showed that the program failed to protect patients from impaired doctors and fell far short of rehabilitating physicians. One estimation is that approximately 15 percent of doctors who have been criminally and/or administratively charged with diversion of controlled substances are abusers.

Other Items of Interest

  1. An article, published online in July in Pediatrics, reviewed the results of a study involving the decisions on end-of-life care in critically ill newborns in the Netherlands. The article reports that the majority of deaths were immediately attributable to withholding or withdrawing treatment. In the majority of cases, the newborn had no chance to survive and, in the remaining cases, withholding or withdrawing treatment was based on quality-of-life considerations.
  2. This month’s issue of Qualitative Health Research included an article by two Wayne State University researchers that presented a comparative discourse analysis of end-of-life discussions that reached a consensus to change the goals of treatment and discussions that did not.
  3. The August 22 issue of the Journal of the American Medical Association (JAMA) featured an article by researchers from the University of California discussing palliative care for prison inmates. The August 15 issue included an article that discussed the tension between delivering high quality palliative care at hospitals and the use of mortality indicators that force hospitals to evaluate each death as a potentially poor outcome.
  4. A paper presented at the Sixth World Congress: Explorations in Health Economics in Copenhagen, Denmark, is available for download. Titled “The Value of Life Near its End and Terminal Care,” the authors attempt to provide the first rational and systematic analysis of the incentives behind end of life care.
  5. An article in the Pocono Record outlined Pennsylvania Governor’s Prescription for Pennsylvania plans for expanding palliative care training programs for health care providers and ensuring the use of palliative care specialists in state-regulated facilities. Part of the plan includes expanding the use of hospice services for end-of-life care.
  6. The tragic plight of 21 month-old Hailey Gonzalez has rekindled the debate over who should make decisions concerning withdrawal of treatment for battered children. Hailey was taken to the hospital in early August after her mother’s boy-friend allegedly slammed her head into a playpen. Her mother did not call for help for five hours. She was placed on life support; child welfare agents noted that only the mother could agree to the withdrawal of treatment without court intervention. The mother did eventually agree to withdrawal of treatment and Hailey died. The mother has been charged with second-degree manslaughter and her boy-friend has been charged with second-degree murder.

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