Showing posts with label death. Show all posts
Showing posts with label death. Show all posts

Wednesday, August 05, 2015

My son died in a mental health facility. If we keep protecting dangerous hospitals, he won’t be the last.

From the Washington Post. Full article at the link

On Nov. 23, I received the call no parent wants to get – my only son was dead. My beautiful, 24-year-old boy was gone. It is a nightmare I have yet to wake up from; one I will never wake up from.

I could barely hear the words from the other end of the line; my cries were drowning them out. I was driving when I received the call, and had to pull over to call my son’s father. Then I had to drive home to deliver the news to my daughter, Paris. How I made it home without getting in a wreck is a mystery to me.

Two-and-a-half months prior, my ex-husband, Kristoff St. John, and I had placed our son, Julian, at Telecare’s La Casa Mental Health Rehabilitation Center in Long Beach, Calif. on a 72-hour involuntary psychiatric hold. Julian had been diagnosed with paranoid schizophrenia when he was 17 and had become suicidal while off his medication and on a powerful substance – meth. The staff upgraded him to a 14-day hold, and then lengthened it again for an indefinite period, to give him adequate time to get off of meth.

Like many parents of children with mental health issues, our goal was to find help for our son who suffers from a horrific illness for which there is no cure. We knew that, with proper medication and therapy, Julian had a chance of living a comfortable life. So we sought help from Los Angeles County’s Department of Mental Health, which referred us to Telecare’s facility. The county says it pays Telecare $17 million per year to contract 190 beds at La Casa. We had hoped that the facility would help him withdraw from meth and get back on his meds, and that within the year, Julian would come home – alive.

But we made a fatal mistake placing our son in the care of La Casa, one of many mental health facilities in this country that contracts with state and local governments. Like many before him, Julian didn’t make it out alive.
Of course, the problem is that these people are trusted to do things the are not capable of doing.

Tuesday, May 26, 2015

Patient killed by 'massive overdose' of anti-psychotic drug after nurse 'mistakenly gave him 21 times what he needed'

From a much longer report in the MIRROR.

A patient died from a massive overdose of anti-psychotic drugs after being given 21 times the medication he needed by a nurse, a court has heard.

Joshua Gafney was handed 4,200mg of clozapine instead of just 200mg by Amanda Young after the nurse visited him at his home.

Mr Gafney, 22, was handed a glass containing six bottles of the drug by 40-year-old Young when he needed just under a teaspoon-worth, just hours before he died on February 8 2012.

Bristol Crown Court heard how the nurse claimed she "did not see" crucial labels on Mr Gafney's medication, causing her to confuse the dosage.

She mistakenly believed each 14 ml bottle contained 50 mg of the powerful drug - when in fact this figure was per millilitre meaning there were actually 700 mg in the bottle.

His mother immediately raised concerns, which Young, from Summerlands Hospital, Somerset, attempted to resolve by putting some water in the solution.

Just two hours after the nurse left the family home in Yeovil, Somerset, Joshua was found unresponsive in bed by his mother, Tina Marren.

In spite of desperate attempts by his sister, Jasmine Gafney, and paramedics, to save Joshua, he was declared dead that evening.

A postmortem examination found Mr Gafney had died as a result of acute clozapine toxicity - an overdose.

Friday, May 01, 2015

Psychiatrist Dr. William Lewek given max sentence for burying body in his own back yard

Taken from a Report From the Democrat and Chronicle. there is more informtion and a video at this link.

Monroe County Court Judge Christopher S. Ciaccio cited Arendt on Friday as he sentenced a Rochester psychiatrist to up to four years in prison for burying a body in a Park Avenue neighborhood backyard.

While William Lewek has numerous substance abuse and physical and mental health issues, Ciaccio said, none of those are adequate explanation for why he kept Matthew Straton's body hidden for nearly three months, even as police and increasingly frantic family and friends looked for him.

Instead, Lewek "simply put his needs and fears above others'," Ciaccio said as he gave Lewek the maximum sentence on the felony charge of tampering with physical evidence.

That physical evidence was the body of 32-year-old Straton, who died in October 2013 at Lewek's Rowley Street house and who Lewek then dragged outside and buried. The county Medical Examiner's Office was never able to ascertain what killed Straton, though during sentencing Friday there were numerous references to it very likely being of a drug overdose.

"Matt had been thrown out like a bag of garbage," Straton's mother, Kym, told the court prior to sentencing, as she described the family's frantic efforts to try to find him for more than two months. "I have nightmares of what Matt looked like when he finally was discovered."

{...]
We also have this video from the initial arrest

Saturday, April 25, 2015

Florida Psychiatrist Mark Agresti sued over treatment of West Palm Beach woman who killed daughter and herself

Here is the Local TV WPBF News Reports



with this related report

Bradley Brooks was so concerned about his 10-year-old-daughter Alexandra, on Sept. 12, 2013, he asked the police to check the home she shared with her mother Pamela Brooks. Police went to the home located at 139 Gregory Place and found Alexandra and Pamela inside, both stabbed to death. Pamela Brooks was found with 130 self-inflicted stab wounds. Her daughter was found with 30 stab wounds. Police ruled the case a murder-suicide.

The girl's father is now suing a psychiatrist and a substance abuse counselor who were treating Pamela Brooks.

According to the lawsuit, Pamela Brooks had a lifetime of alcohol abuse. Beginning in 1999 her alcohol abuse began causing problems in her life. The lawsuit also states, Bradley Brooks filed an emergency request for custody of their daughter back in May of 2013, just weeks after her mother was arrested for DUI. The lawsuit states, Pamela Brooks was ordered to a comprehensive psychological evaluation and was seen several times by the doctor. Her next scheduled appointment was for Sept. 13, 2013. She and her daughter were found dead inside their home Sept. 12, 2013.

According to the lawsuit filed last week, Brooks doctor is accused of "Failing to clearly communicate that Pamela Brooks was at risk of inflicting harm to herself or to others," and "Failing to refer Pamela Brooks to a physician trained in the management of patients suffering from severe depression," the suit states.

Both the doctor and counselor are accused of negligence.
And as reported in the Palm Beach Post
A psychiatrist and a substance abuse counselor who were treating a West Palm Beach woman who killed herself and her 10-year-old daughter in September 2013 have been sued in connection with the deaths that stunned the community. In the lawsuit filed last week in Palm Beach County Circuit Court, family members of Pamela and Alexandra Brooks blame Dr. Mark Agresti and counselor David Dashev for the murder-suicide.

The two “knew or should have known that Pamela Brooks was at risk of inflicting harm to herself, or to others,” according to the lawsuit filed by attorney Glenn Crickenberger, who works for the Stuart law firm of famed lawyer Willie Gary. “However, (they) failed to refer Pamela Brooks to a physician trained in the management of patients suffering from severe depression.”

Brooks, 48, was found dead in the living room of her Gregory Place home with 130 self-inflicted stab wounds. The body of her daughter was found in the kitchen with 30 stab wounds, the suit says. The deaths so shocked the community that the city’s then police chief took the unusual step of calling a press conference to announce they had been ruled a murder-suicide. The grisly scene was discovered by Brooks’ ex-husband, Bradley, who broke into the home because he was concerned about his daughter, a King’s Academy student.

Dashev, former chief operations officer of the Mental Health Pavilion at what is now West Palm Hospital, declined comment on the suit. Agresti couldn’t be reached.

Pamela Brooks had been ordered to seek treatment from Agresti and Dashev by Circuit Judge Thomas Barkdull in May 2013 after Bradley Brooks filed an emergency request for custody of the couple’s daughter. The request came weeks after Pamela Brooks was arrested for driving under the influence.

The lawsuit, filed on behalf of Bradley Brooks and his ex-wife’s parents, Martin and Evelyn Hewson, details Pamela Brooks long struggle with alcohol abuse. It also indicates she initially responded to treatment by Agresti and Dashev. Treated daily with Antabuse, a drug designed to reduce cravings for alcohol, medical records in June and July 2013 showed she was “compliant and that her spirits were good,” the lawsuit says.

In August, the tenor of the notes changed. They indicate she had resumed drinking. Questions were raised about whether she needed residential care. “There was a discussion with Ms. Brooks regarding depression and the presence of suicidal ideation,” the suit says.

From Aug. 16 to Sept. 6, 2013, she was seen about 10 times by Agresti and Dashev. “During several of these visits Pamela described her overall condition as being characterized by anxiety and tension,” the suit states. “She described herself as feeling overwhelmed, angry and upset stemming from her DUI and all the changes in her life that the DUI has caused.” A day before her next appointment, she killed herself and her daughter.

The suit accuses Agresti and Dashev of negligence. It seeks an unspecified amount in damages.

Monday, March 30, 2015

Congressional hearing reveals 4 more deaths at Tomah, Wisconsin, VA Hospital

Selections from this report on the Reveal website

Four more veterans died under suspicious circumstances than previously reported at the U.S. Department of Veterans Affairs hospital in Tomah, Wisconsin, under the leadership of its chief of staff, psychiatrist Dr. David Houlihan. The deaths, revealed in a rare congressional field hearing today in the small Wisconsin town, bring to 33 the number of unexpected deaths The Center for Investigative Reporting has found occurred during Houlihan’s decade at the helm. The medical center became known as “Candy Land” for the ease with which narcotic painkillers were prescribed.

They include Kraig Ferrington, a 45-year-old Army veteran and union plasterer who died of an overdose of seven medications prescribed by Houlihan in 2007, and three veterans that a VA pharmacist told lawmakers died in the VA parking lot in 2008 and 2009.

“We are doing everything we can to make sure these tragedies don’t happen to others,” Sen. Ron Johnson, chairman of the Senate Committee on Homeland Security and Governmental Affairs, told a packed audience of 400 veterans and family members at the Cranberry Country Lodge. The hearing brought together many of the people who had suffered and complained for years about Houlihan’s practices to no avail. Members of Congress from both parties made the trip to the rural community, which had until recently been more famous for cranberries and cheddar cheese than notorious for narcotic painkillers.

[...]

Today’s hearing marked the sixth congressional hearing where overmedication and abuse of authority at the Tomah VA have been discussed since CIR revealed the problems in a story published Jan. 8.

[...]

Within a week of that story’s publication, Houlihan and Frasher were removed from their positions pending the completion of an internal investigation.

On March 10, they were placed on administrative leave after a preliminary review found that Tomah patients were 2.5 times more likely than the national average to receive high doses of opiates. On March 20, the VA told Congress that Houlihan’s boss, Tomah hospital Director Mario DeSanctis, had been “reassigned to a position at the Great Lakes Health Care System network office, a position outside of the medical center.”

The VA Office of Inspector General, the Wisconsin Department of Safety and Professional Services and the U.S. Drug Enforcement Administration also have opened fresh investigations of Houlihan and the Tomah VA.

Throughout the three-hour hearing, lawmakers expressed exasperation that few alternatives to narcotics are being offered. Rep. Tim Walz, D-Minn., an Army veteran, said he had been pressing the VA to adopt a more nuanced approach to pain management since 2008. [...]
Witnesses included Ryan Honl, a Gulf War veteran and West Point graduate; Noelle Johnson, a pharmacist who was fired in 2009 after she refused to fill prescriptions for high doses of morphine that she believed were unsafe; and family members of those who died, including Heather and Marvin Simcakoski, the widow and father of Jason Simcakoski, a 35-year-old former Marine who died of an overdose in the Tomah VA psychiatric ward in August.

Monday, March 23, 2015

University of Minnesota suspends psychiatric drug studies enrollment due to reaction to student death

A report in Science Magazine based on a press release form the University of Minnesota

The University of Minnesota has halted patient enrollment in all psychiatric drug studies after a state report criticized the school’s handling of a suicide during a clinical trial in 2004. The report, released last Thursday by Minnesota’s Office of the Legislative Auditor, says the university’s reaction to both the death of 27-year-old Dan Markingson and subsequent calls for investigation have “seriously harmed” its credibility and reputation. The report also argues that the Markingson case “raises serious ethical issues and numerous conflicts of interest, which University leaders have been consistently unwilling to acknowledge.” Markingson had been enrolled in a trial for antipsychotic drugs while committed involuntarily to a university hospital. One of the trial leaders was his treating psychiatrist.

The university’s president, Eric Kaler, announced that his school would suspend enrollment in current and upcoming drug studies in the Department of Psychiatry until they could be reviewed by an outside institutional review board (IRB). The school’s IRB came under fire last month after a separate review suggested the panel was not examining trials as closely as it should be.

Although the two reports are very different, their authors express at least one overlapping worry: that the school has not responded well to criticism. In the words of the auditor’s report: “A primary problem uncovered by our review is past and current University leadership that is defensive, insular, and unwilling to accept criticism about the Markingson case either from within or outside the University. However, we do not have a recommendation that would change attitudes. … We can only suggest that the Legislature make the issue—and need for change—a more important consideration in selecting people to serve on the University Board of Regents.” The report recommends that the state legislature enact new laws that would allow the legislature to more closely monitor participation in psychiatric drug studies at the university.

The Board of Regents will meet this Friday to discuss the report.

Saturday, March 21, 2015

Numerous news reports on the Scandal of the Death of Dan Markingson

A list of resources related to the death of Dan Markingson who was a psychiatric research subject who died during an experiment.

  1. "Student dies at Rochester in MIT-based study,” Massachusetts Institute of Technology News Release, April 10, 1994.
  2. In the Matter of the Civil Commitment of Daniel Markingson, State of Minnesota, County of Dakota, Court File PX-03-10465, November 17, 2003.
  3. House Research Bill Summary, File Number H.F. 3553, Authors: Pugh, Whelan, and Bernardy; Subject: Clinical drug trials; oversight, Analyst: Lynn Aves, April 4, 2016.
  4. Aftercare agreement for Dan Markingson, December 8, 2003.
  5. "The Academic Health Center Responds to Carl Elliott’s Media Outreach," September 1, 2010.
  6. “Once-Secret Drug-Company Records put U on the Spot,” Star Tribune (Minneapolis), March 19, 2009.
  7. In the Matter of the Civil Commitment of Dan Markingson, Respondent, State of Minnesota, County of Dakota, File No. PX-O3-10465, November 20, 2003.
  8. Aaron Friedman, “University of Minnesota research case is not a scandal,” Star Tribune (Minneapolis), May 16, 2013.
  9. Alex Friedrich, “U's handling of drug study suicide earns an 'F' among peers,” Minnesota Public Radio News, April 23, 2015.
  10. Alexandros Stamatoglou, “The Physician Payment Sunshine Act: An Important First Step in Mitigating Financial Conflicts of Interest in Medical and Clinical Practice,” 45 John Marshall Law Review 2012, pp. 963-990.
  11. Alicia Mundy, “Sting Operation Exposes Gaps in Oversight of Human Experiments,” Wall Street Journal, March 26, 2009.
  12. Andy Mannix, “Charles Schulz under Scrutiny for Seroquel Study Suicide,” City Pages, February 2, 2011.
  13. Andy Mannix, “Dan Markingson's 2004 suicide: 'Corrective Action' issued to former U of M employee,” City Pages, November 13, 2012.
  14. Arne Carlson,“Markingson case: University of Minnesota can't regain trust under current leadership,” Star Tribune (Minneapolis), April 13, 2015.
  15. Association for the Accreditation of Human Research Protection Programs. An External Review of the Protection of Human Research Participants at the University of Minnesota with Special Attention to Research with Adults Who May Lack Decision-making Capacity, February 23, 2015.
  16. Board of Regents of the University of Minnesota and Institutional Review Board, Notice of Taxation of Costs and Bill of Costs and Disbursements, State of Minnesota, County of Hennepin, Court File 27 CV-07-1679, April 29, 2008.
  17. C. Fred Alford, Whistleblowers: Broken Lives and Organizational Power (Cornell University Press, 2002).
  18. C.M Michael, S.J, Nass, G.S. Omenn (eds), Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials; Board on Health Care Services; Board on Health Sciences Policy; Institute of Medicine; Evolution of Translational Omics: Lessons Learned and the Path Forward, Washington (DC): National Academies Press (US); 2012.
  19. Carl Elliott, "The Deadly Corruption of Clinical Trials." Mother Jones, September/October 2010, 54-63.
  20. Carl Elliott, “The University of Minnesota’s Medical Research Mess,” New York Times, May 26, 2015.
  21. Carl Elliott, "Getting by with a Little Help from Your Friends." Hastings Center Bioethics Forum, October 18, 2013.
  22. Carl Elliott, “The Best-Selling, Billion-Dollar Pills Tested on Homeless People,” Matter, July 27, 2014.
  23. Carl Elliott, Matt Lamkin, “Restrict the Recruitment of Involuntarily Committed Patients for Psychiatric Research, JAMA Psychiatry 2016; April 1; 73(4):317-8.
  24. Charlotte Haug, “What Happened to Dan Markingson?” Journal of the Norwegian Medical Association, 133, pp. 2443-2444.
  25. Chris Hansen, “The Hansen Files: Drug Trials,” Dateline NBC, March 4, 2012.
  26. Clinical Research and Compliance Consulting, "University of Minnesota Department of Psychiatry Assessment Report," December 31, 2015.
  27. David Evans, Michael Smith, and Liz Willen, “Big Pharma's Shameful Secret,” Bloomberg Markets 14 (2005): 36–62.
  28. Debra Dykhuis, Human Research Protection Program, letter to Robert Huber, May 6, 2015.
  29. Debra Dykhuis, Human Research Protection Program, letter to Carl Elliott, June 5, 2015.
  30. Duff Wilson, “For $520 Million, AstraZeneca Settles Case Over Marketing of a Drug,” New York Times, April 27, 2010.
  31. Eden Almasude, “A Medical Student’s Call for Action Against Research Misconduct,” Bioethics Forum, June 3, 2014.
  32. Emily Kaiser and Tom Webber, “Arne Carlson: U needs leadership overhaul after Markingson case,” Minnesota Public Radio News, April 13, 2015.
  33. Ezekiel J Emanuel, Trudo Lemmens, Carl Elliott, “Should Society Allow Research Ethics Boards to Be Run As For-Profit Enterprises?” PLoS Medicine, July 25, 2006.
  34. Gardiner Harris, “Report Assails F.D.A. Oversight of Clinical Trials,” New York Times, September 28, 2007.
  35. Gina Kolata, “Johns Hopkins Admits Fault in Fatal Experiment,” New York Times, July 17, 2001.
  36. J. Jacobson, Report of Examiner. Dakota County Court File No. PX-03-10. November 19, 2003.
  37. J.P. McEvoy, J.A. Lieberman, et al. "Efficacy and tolerability of olanzapine, quetiapine, and risperidone in the treatment of early psychosis: a randomized, double-blind 52-week comparison, American Journal of Psychiatry. 2007 July; 164(7):1050-60.
  38. Jeanne Lenzer, “Drug Secrets: What the FDA Isn’t Telling,” Slate.com, September 27, 2005.
  39. Jeff Baillon, “Nurse questions integrity of U of M drug researchers,” Fox 9 News (KMSP), May 19, 2014.
  40. Jeff Baillon, “Nurse questions integrity of U of M drug researchers," Fox 9 News, KMSP, November 25, 2014.
  41. Jeff Baillon, "U of M Drug Study Criticism Grows." Fox 9 News. KMSP. May 19, 2014.
  42. Jeff Baillon, “Another Ethics scandal for the University of Minnesota Department of Psychiatry,” Fox 9 News, KMSP, July 15, 2014.
  43. Jennifer Couzin-Frankel, “A Lonely Crusade,” Science, May 23, 2014;344(6186):793-7
  44. Jennifer Couzin-Frankel, “Human subjects protections under fire at the University of Minnesota,” ScienceInsider, March 2, 2015.
  45. Jeremy Olson, “Review finds lapses at University of Minnesota psychiatry department,” Star Tribune (Minneapolis), February 11, 2016.
  46. Jeremy Olson, “Auditor to review U's drug trial suicide,” Star Tribune (Minneapolis), June 19, 2014.
  47. Jeremy Olson, “U psychiatry chief steps down in wake of research criticism,” Star Tribune (Minneapolis), April 13, 2015.
  48. Jeremy Olson, “Minnesota House, Senate Unanimously Pass Limits on Researchers’ Use of Mentally Ill Patients,” Pioneer Press (St. Paul), May 8, 2009.
  49. Jo Zillhardt, Office of the Ombudsman for Mental Health and Mental Retardation, Medical Review Subcommittee, letter on death of Dan Markingson, June 17, 2005.
  50. Jo Zillhardt, Office of the Ombudsman for Mental Health and Mental Retardation, Medical Review Subcommittee, letter on death of Dan Markingson, June 17, 2005.
  51. Judy Stone, “A Clinical Trial and Suicide Leave Many Questions: Part 6: The Run-Around, or Why I Now Call for an Independent Investigation of University of Minnesota,” Scientific American Molecules to Medicine blog, March 26, 2013.
  52. K. Geister, Report of Pre-petition Screening Team Re: Daniel Markingson, Respondent. November 17, 2003.
  53. Katie Thomas, “A Drug Trial’s Frayed Promise,” New York Times, April 17, 2015.
  54. Kia Farhang and Marion Renault, “Faculty push for independent research review," Minnesota Daily, December 09, 2013.
  55. Laura Stark, Behind Closed Doors: IRBs and the Making of Ethical Research (University of Chicago Press, 2011.)
  56. Laws of Minnesota 2009, chapter 58; codified as Minnesota Statutes, 253B.095, subdivision 1(d)(4) and (e).
  57. Leigh Turner, “The U of M should thoroughly investigate issues in the Markingson case,” MinnPost, March 11, 2014.
  58. Mark Yarborough, Kelly Fryer-Edwards, Gail Geller, Richard R. Sharp, “Transforming the culture of biomedical research from compliance to trustworthiness: insights from nonmedical sectors,” Academic Medicine 2009 April; 84(4):472-7.
  59. Mark Yarborough, Kelly Fryer-Edwards, Gail Geller, Richard R. Sharp, “Transforming the culture of biomedical research from compliance to trustworthiness: insights from nonmedical sectors,” Academic Medicine 2009 April; 84(4):472-7.
  60. Matt Lamkin, “Will the U review or whitewash a research subject’s death?” Star Tribune (Minneapolis), December 18, 2013.
  61. Matt Lamkin, Carl Elliott, “University of Minnesota research lapses show self-reform is failing,” Star Tribune (Minneapolis), February 11, 2016.
  62. Meghan Holden, “Kaler talks Markingson case, bowl game,” Minnesota Daily, December 11, 2013.
  63. Minnesota House of Representatives, Higher Education Finance and Policy Committee, April 13, 2016 (testimony on audio recording at 20 minutes.)
  64. NMS Labs, Toxicology Report, Patient name: Dan Markingson, Minnesota Regional Medical Examiner’s Office, February 14, 2008.
  65. Office of the Inspector General, U.S. Department of Health and Human Services, Institutional Review Boards: A Time for Reform, June, 1998.
  66. Office of the Legislative Auditor, State of Minnesota, A Clinical Drug Study at the University of Minnesota Department of Psychiatry: The Dan Markingson Case, March 19, 2015.
  67. Paul Tosto and Jeremy Olson, "The death of subject 13." Pioneer Press (St. Paul), May 18, 2008.
  68. Peter Aldous, “Why Are Dope-Addicted, Disgraced Doctors Running Our Drug Trials?” Matter, July 28, 2014.
  69. Public Citizen, Health Research Group, Public letter to President Eric Kaler, June 16, 2014.
  70. Richard Smith, “Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies,” PloS Medicine, May 17, 2005.
  71. Robert Klitzman, The Ethics Police: The Struggle to Make Human Research Safe (Oxford University Press, 2015), p. 79-80.
  72. Roberto Abadie, The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects (Duke University Press, 2010.)
  73. Sabriya Rice, “Policing the ethics police: Research review boards face scrutiny as feds propose new rules,” Modern Healthcare, December 12, 2015.
  74. Sharon Matson. FDA Establishment Inspection Report, Stephen Olson MD. Report no. FEI 3004927371. July 22, 2005.
  75. Shirley Wang and Avery Johnson, “AstraZeneca Papers Raise Seroquel Issues,” Wall Street Journal, February 27, 2009.
  76. State of Minnesota Board of Social Work, Agreement for Corrective Action in the Matter of Jean M. Kenney, November 8, 2012.
  77. Susan Perry, “U of M Suspends Enrollment in Psychiatric Drug Trials in the Wake of Scathing Report on Markingson Case,” MinnPost, March 20, 2015.
  78. Susan Perry, “U of M Suspends Enrollment in Psychiatric Drug Trials in the Wake of Scathing Report on Markingson Case,” MinnPost, March 20, 2015.
  79. Trudo Lemmens and Paul Miller, “The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives,” Journal of Law, Medicine and Ethics Fall 2003; 31: 3, pp. 398-418.
  80. U.S. Department of Health and Human Services, Office for Human Research Protections, Institutional Review Board Guidebook, Cognitively Impaired Persons, Chapter 6(D), 1993.
  81. William Heisel, “The Markingson Files: Conflicts of interest in clinical trials should be transparent,” Reporting on Health, June 06, 2011.
  82. Zachary Schrag, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 (Johns Hopkins University Press, 2010).

Tuesday, March 17, 2015

Crime, Drugs And Dead Amish Baby: How A Criminal Underground Is Linked To Harmful Prescriptive Practices At A Wisconsin Veterans Affairs

An excellent report by Benjamin Krause of DisabledVeterans.org

Investigative reporter Aaron Glantz just released the results of his damning investigation into harmful Veterans Affairs prescriptive practices linked to the death of a little Amish baby.

Glantz’s investigation revealed the story of little Ada Mae Miller. A stoned veteran driving home following treatment at Tomah VA struck her and her Amish family. The family was driving to the store in their buggy when struck by Marine Corps veteran Brian Witkus.

Baby Ada Mae and her mom were thrown from the buggy by the impact. Ada Mae was crushed under the weight of her mother, who landed on her. Her autopsy listed the cause of death as “crush injury to the chest.”

Witkus was a known drug addict receiving treatment from Tomah VA and the now infamous psychiatrist named Dr. David Houlihan. Witkus hit the Miller family while stoned on painkillers and tranquilizers from the Tomah VA. He was convicted and served three years in prison following a conviction for homicide.

The death of Ada Mae is but one example of criminal conduct linked to harmful prescriptive practices at VA that gave rise to crimes such as drug dealing, vandalism, burglary and more. Local law enforcement knew men and women committing these crimes by the nicknames “Turtle,” “Airman,” “Black Mark” and “Detroit.” On the inside, these patients of the Tomah VA facility were known as “Houlihan’s Hooligans.”

The scope of the drug problem in the sleepy town of Tomah, Wisconsin is truly shocking. According to Glantz’s report:

“In recent years, hospital staff have discovered younger veterans stealing from elderly patients and others dealing VA-prescribed painkillers and shooting OxyContin and heroin on hospital grounds. Inside the hospital, VA police reports document the fallout: strung-out veterans tossing wheelchairs across rooms and a trash can out of a window, setting fire to magazines, wielding a meat cleaver.

“A search of Tomah police records by The Center for Investigative Reporting and the La Crosse Tribune found that employees at the Tomah VA had called 911 more than 2,000 times in the past five years, seeking local law enforcement help with cases of battery and burglary, an attempted kidnapping and 24 unexpected deaths.”

This report is a must read for any veteran advocate or veteran concerned about doping practices at Veterans Affairs facilities across the nation. Glantz covers the soup-to-nuts implications of the harmful practices at the Tomah VA facility and digs deep into the criminal underbelly of Tomah, Wisconsin.

READ IT: The death of baby Ada Mae and the tragic effects of addicted veterans

Thursday, March 05, 2015

How the American opiate epidemic was started by one pharmaceutical company

An extended article investigating a corrupt pharmaceutical company Here are some snippets. Well

The state of Kentucky may finally get its deliverance. After more than seven years of battling the evasive legal tactics of Purdue Pharma, 2015 may be the year that Kentucky and its attorney general, Jack Conway, are able to move forward with a civil lawsuit alleging that the drugmaker misled doctors and patients about their blockbuster pain pill OxyContin, leading to a vicious addiction epidemic across large swaths of the state.

A pernicious distinction of the first decade of the 21st century was the rise in painkiller abuse, which ultimately led to a catastrophic increase in addicts, fatal overdoses, and blighted communities. But the story of the painkiller epidemic can really be reduced to the story of one powerful, highly addictive drug and its small but ruthlessly enterprising manufacturer.

On December 12, 1995, the Food and Drug Administration approved the opioid analgesic OxyContin. It hit the market in 1996. In its first year, OxyContin accounted for $45 million in sales for its manufacturer, Stamford, Connecticut-based pharmaceutical company Purdue Pharma. By 2000 that number would balloon to $1.1 billion, an increase of well over 2,000 percent in a span of just four years. Ten years later, the profits would inflate still further, to $3.1 billion. By then the potent opioid accounted for about 30 percent of the painkiller market. What's more, Purdue Pharma's patent for the original OxyContin formula didn't expire until 2013. This meant that a single private, family-owned pharmaceutical company with non-descript headquarters in the Northeast controlled nearly a third of the entire United States market for pain pills.

[...]

Starting in 1996, Purdue Pharma expanded its sales department to coincide with the debut of its new drug. According to an article published in The American Journal of Public Health, “The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy," Purdue increased its number of sales representatives from 318 in 1996 to 671 in 2000. By 2001, when OxyContin was hitting its stride, these sales reps received annual bonuses averaging over $70,000, with some bonuses nearing a quarter of a million dollars. In that year Purdue Pharma spent $200 million marketing its golden goose. Pouring money into marketing is not uncommon for Big Pharma, but proportionate to the size of the company, Purdue’s OxyContin push was substantial.

[...]

The state of Kentucky's lawsuit against Purdue Pharma is not the first legal trouble the company has run into. In 2007, in United States of America v. The Purdue Frederick Company, Inc., Purdue and its top executives pleaded guilty to charges that it misled doctors and patients about the addictive properties of OxyContin and misbranded the product as "abuse resistant." Prosecutors found a "corporate culture that allowed this product to be misbranded with the intent to defraud and mislead." Purdue Pharma paid $600 million in fines, among the largest settlements in U.S. history for a pharmaceutical company.

[...]

Kentucky is filing a total of 12 claims against the company, including false advertising, Medicaid fraud, unjust enrichment, and punitive damages. In total the suit could cost Purdue Pharma $1 billion (which is just one-third of its annual revenues from OxyContin).

No state has been more devastated by the nationwide opiate problem than Kentucky. Much of the eastern part of the state and the Appalachians has watched as men, women, and teenagers fell victim to the potent pain pills. There were several different gateways — back injuries, operations, parents' medicine cabinets — but all of them led to an implacable addiction that rivals that of the hardest street drugs. And that’s the rub. Because there was simply so much OxyContin available for over a decade, it trickled down from pharmacies and hospitals and became a street drug, coveted by teens and fiends and sold by dealers at a premium (prices often shot up well over $1 a milligram, pricing the popular 80mg tablets at over $100 for a single pill).

Whatever the gray areas on OxyContin's many paths to perdition, the statistics on the first decade of this century bear out a staggering epidemic. From 1999 to 2010, the sale of prescription painkillers to pharmacies and doctors' offices quadrupled. In the exact same time span, the number of overdose deaths from prescription painkillers also quadrupled, rising to almost 17,000.

To call this a coincidence would be analogous to declaring no connection between loosening enforcement on drunk driving laws and observing a sudden increase in deaths caused by drunk driving. It goes almost without saying that these figures dovetail seamlessly with the release of OxyContin and Purdue's marketing timeline, which hit hardest in the early 2000s.

Wednesday, February 25, 2015

Prashant Tiwari's family files $12.5M lawsuit after suicide in Brampton, Ontario hospital

As reported by the CBC

Many more details at the link

Members of a Brampton, Ont., family have launched a $12.5-million lawsuit after a 20-year-old man was found dead in the bathroom of the hospital where he was supposed to be on suicide watch.

Prashant Tiwari committed suicide last June at Brampton Civic Hospital while under treatment, the lawsuit alleges, adding he had been admitted to the psychiatric ward after he had started cutting himself.

Rakesh Tiwari alleges his son was left unattended in a hospital bathroom for three hours. During that time, the 20-year-old used his hospital gown and a chair to hang himself, his father said.

"He volunteered himself to the hospital. He knew he had some problem, and he was fighting and he needed help," said Rakesh Tiwari.

"He was not to die."

Tiwari believes staff were supposed to check on his son every 15 minutes.

"My son should not have been unattended," he said.

A lengthy statement of claim — filed at Brampton's Superior Court of Justice on Wednesday — names the hospital and numerous employees as defendants, and lays out a timeline of what happened to Prashant Tiwari in the hospital.

[...]

After his death, the statement of claim alleges, 12 people accessed Prashant’s medical records without proper authorization for unknown reasons.

[...]

Friday, February 20, 2015

Psychiatrist William Lewek Pleads Guilty to Hiding Matthew Straton's Body

As reported by Time Warner Cable News in Rochester, NY.

A guilty plea today from the Rochester psychiatrist accused of hiding the body of Matthew Straton in his backyard.

William Lewek, 62, pleaded guilty to tampering with physical evidence and driving while ability impaired.

Lewek was arrested in January of 2014 after investigators found the body of Matthew Straton partially buried in the backyard of his Rowley Street home. Straton dissappeared in October of 2013. Today's plea follows months of legal proceedings including an application for Lewek to enroll in a Judicial Diversion Program for drug treatment.

The trial was scheduled to begin Monday.

Thursday, February 19, 2015

Third patient death in 13 months at boutique psychiatric rehab center Sierra Tucson

From an extended report from the Arizona Daily Star

Sounds like this boutique psychiatric center for the well to do has a history of grabbing for the money and cutting corners for fun and profit.

Many more details at the link

A third patient in 13 months has died while in treatment at the Sierra Tucson center north of Tucson, an autopsy report says.

The report from the Pinal County Medical Examiner’s Office released last week says a 55-year-old Pennsylvania man hanged himself with a belt in his room at Sierra Tucson on Jan. 23.

According to the report, the man had been on suicide watch and he left a suicide note inside a tote bag next to his bed. Witnesses told investigators that he was discovered in his room, “unconscious but still breathing,” two hours after staff began looking for him, the report says.

The suicide is the third patient death at Sierra Tucson since January 2014 and the fourth since August 2011.

Autopsies determined two of the patient deaths to be suicides and two as undetermined. The deceased patients, all male, ranged in age from 20 to 71.

[...]

The upscale, nationally known Sierra Tucson facility is situated on a 160-acre site at 39580 S. Lago del Oro Parkway along the Pinal/Pima County border. It has 124 beds, plus 15 acute level beds.

In the latest case a married father of two, who had checked into Sierra Tucson on Jan. 4 for severe depression and chronic pain due to neuropathy, was found dead in his room at 12:41 p.m. Jan. 23.

[...]

The facility has programs to help patients with addictions, mood disorders, chronic pain, eating disorders and trauma through its “Sierra Model” of integrating therapies such as massage, yoga and acupuncture with traditional psychiatry. Most patients are in their late 30s and early 40s. A majority of patients self-pay at a cost of about $1,300 per day.

[...]

The state has reprimanded Sierra Tucson numerous times since 2009 for failing to follow its own policies on patient care

Tuesday, February 10, 2015

In 2013 The Wall Street Journal discovered a cache of files that revealed the U.S. government lobotomized over 2000 veterans against their will after WW2.

The veterans were lobotomized for reasons such as PTSD, depression, schizophrenia, and occasionally homosexuality.

Here is the Link to Part 1 of this important investigation: The Lobotomy Files

Here is the introduction to this important story

Roman Tritz’s memories of the past six decades are blurred by age and delusion. But one thing he remembers clearly is the fight he put up the day the orderlies came for him.

“They got the notion they were going to come to give me a lobotomy,” says Mr. Tritz, a World War II bomber pilot. “To hell with them.”

The orderlies at the veterans hospital pinned Mr. Tritz to the floor, he recalls. He fought so hard that eventually they gave up. But the orderlies came for him again on Wednesday, July 1, 1953, a few weeks before his 30th birthday.

This time, the doctors got their way.

The U.S. government lobotomized roughly 2,000 mentally ill veterans—and likely hundreds more—during and after World War II, according to a cache of forgotten memos, letters and government reports unearthed by The Wall Street Journal. Besieged by psychologically damaged troops returning from the battlefields of North Africa, Europe and the Pacific, the Veterans Administration performed the brain-altering operation on former servicemen it diagnosed as depressives, psychotics and schizophrenics, and occasionally on people identified as homosexuals.

The VA doctors considered themselves conservative in using lobotomy. Nevertheless, desperate for effective psychiatric treatments, they carried out the surgery at VA hospitals spanning the country, from Oregon to Massachusetts, Alabama to South Dakota. Roman Tritz talks about the scars from his lobotomy.

The VA’s practice, described in depth here for the first time, sometimes brought veterans relief from their inner demons. Often, however, the surgery left them little more than overgrown children, unable to care for themselves. Many suffered seizures, amnesia and loss of motor skills. Some died from the operation itself.

Saturday, January 31, 2015

Medical malpractice is not limited to surgery, and the case of Paul Lozano illustrates this better than any other example.

Item #2 from the List Verse Article 10 Horrible Cases Of Medical Malpractice

Medical malpractice is not limited to surgery, and the case of Paul Lozano illustrates this better than any other example. Lozano had been sexually abused by his mother as a child, and his psychiatrist, Margaret Bean-Bayog, decided to try a form of therapy known as “reparenting”, where the psychiatrist simulates the different stages of lifespan development in an attempt to “reprogram” the patient. She coddled him, read him stories, called him “baby”, made him call her “mother”, and made him learn cue-cards off by heart. One such card read “I’m your mom and I love you and you love me very much. Say that 10 times”. Other cards were more sexual, and more notes were found that appeared to be erotica featuring Lozano and his doctor. It was also reported that they did in fact have sexual relations. After about five years, he committed suicide.
When Bean-Bayog's graphic love notes were discovered, two other therapists informed state authorities. But no investigation was launched until Lozano's suicide made newspaper headlines. Even then, other psychoanalysts circled the wagons, claiming their colleague was the victim of the affair.

Friday, January 30, 2015

Judge ponders psychiatrist's admission that he helped bury the body.

From a Report from New York's Democrat and Chronicle

Much more information and video at the link

Monroe County Court Judge Christopher Ciaccio has postponed a decision on the admissibility of statements Dr. William Lewek gave to Rochester police.

The psychiatrist is awaiting trial on accusations that he buried the body of Matthew Straton, 32, in the backyard of Lewek's home on Rowley Street in October 2013. Lewek, a certified addiction counselor, allegedly told Rochester police that Straton, 32, died in the home.

At issue in court Wednesday was the admissibility of statements Lewek, 63, gave to police. Police investigator Nicholas Mazzola previously testified that Lewek led police into his backyard on Jan. 15, 2014, pointed out a mound of debris and dirt and said that beneath that mound was the dead body of Straton.

Wednesday, January 21, 2015

Smoking Cessation Drug Suspected in 30 Suicides in Canada

From a Report in the Vancouver Sun

Champix is suspected of playing a major role in the deaths of 44 patients — 30 of them by suicide — since the popular stop-smoking drug was approved in Canada in 2007, a Vancouver Sun investigation has found.

The Pfizer drug has also been linked to more than 1,300 incidents of suicide attempts or thoughts, depression, and aggression/anger across the country in the past seven years.

The drug is the most popular of those offered by B.C.’s quit smoking program, which traditionally sees a jump in participation every January as people renew new year’s resolutions to butt out.

Numbers on the deaths and other side-effects come from a Health Canada database where doctors, pharmacists and drug companies report bad side-effects experienced by patients taking pharmaceuticals.

But Health Canada admits on its website that side-effects are under-reported, and experts say the database could represent as little as one per cent of the patients who suffer complications.

“A small proportion of the adverse reactions that have occurred on this drug in Canada would be in the adverse reaction database. Essentially it is spontaneous, voluntary reporting,” said Barbara Mintzes, a pharmaceutical drug expert at the University of B.C.

Even the incomplete numbers, though, are a concern, she said. When someone taking an anti-depressant attempts suicide, it’s initially not clear whether that’s caused by the pre-existing depression or the drug; but in the case of Champix, people are taking the drug to stop smoking — not for a mental health condition.

“You are looking at a lot of deaths, suicides and attempted suicides, and suicidal ideation in a population that you would have no reason to think would be otherwise at high risk of suicide,” said Mintzes, an associate professor in the Faculty of Medicine’s School of Population and Public Health.

The Sun downloaded data from the Health Canada site for Champix and Zyban, the two drugs covered by Pharmacare as part of the province’s Smoking Cessation program.

Champix is the subject of a class-action lawsuit, which more than 200 Canadians have joined, alleging psychiatric side-effects. One of the plaintiffs is the mother of a B.C. woman who killed herself while she was on the drug.

In recent years, Champix has been slapped with the toughest safety warnings in the U.S. and Canada, and France stopped covering the drug through its public Pharmacare system.
Much more information at the lihnk

Sunday, January 18, 2015

VA to look into overmedication reports at Tomah center

From an AP Report in the San Francisco Chronicle

The U.S. Department of Veterans Affairs is launching an investigation into reports of overmedication and retaliatory management practices at the VA Medical Center in Tomah, the agency said Thursday.

Veterans Health Administration specialists plan to visit the western Wisconsin facility within two weeks to review medication prescription practices, the federal agency said in a statement Thursday afternoon. They also plan to send representatives from the Office of Accountability Review to look into allegations of retaliatory behavior.

"My sense is that this isn't just unique to Tomah," U.S. Rep. Ron Kind, a Democrat whose district includes Tomah. "We have a system-wide issue that needs to be addressed when it comes to pain management with our veterans."

Kind and other Wisconsin lawmakers had sent requests to Veterans Affairs Secretary Robert McDonald this week seeking an investigation

Tomah VA spokesman Scott Farley said in a statement the medical center will fully cooperate with the investigation.

A recent story from The Center for Investigative Reporting noted the number of opiates prescribed at the Tomah VA had more than quintupled between 2004 and 2012, even as the number of veterans seeking treatment there has declined. Health care professionals have complained about the medical center's practices for several years.
Here is more info from The Center for Investigative Reporting Looks like the main culprite is, of course, another damn psychiatrist Dr. David Houlihan
Politicians from both parties and government bureaucrats are rushing to look into allegations of rampant overmedication, retaliatory management practices and preventable overdose deaths at the U.S. Department of Veterans Affairs Medical Center in Tomah, Wisconsin, that The Center for Investigative Reporting revealed last week.

In the story’s wake, the VA has begun “actively reviewing allegations of retaliatory behavior and overmedication at the Tomah VA Medical Center,” said agency spokesman James Hutton. He said the facility’s chief of staff, psychiatrist Dr. David Houlihan, has been temporarily reassigned to the VA regional office while an internal investigation takes place.

But the problems disclosed should not have surprised politicians or federal officials: Health care professionals at the hospital have complained for at least five years about Houlihan’s prescription practices and his retaliatory management style – filing numerous reports with those in charge of oversight.

“It’s about time,” said Robin Weeth, a former social worker at the hospital who wrote to the VA inspector general in 2012 with a long list of allegations, including that “veterans are overmedicated and have been driving while impaired, fallen asleep while smoking and set themselves on fire.”

Today, Weeth reports that he never heard back from the inspector general.

The CIR story reported that the number of opiates prescribed at the Tomah VA had more than quintupled between 2004 and 2012, even as the number of veterans seeking care at the hospital declined. It included details of the August death of a 35-year-old Marine Corps veteran, who overdosed while in the hospital’s inpatient psychiatric ward.

[...]

The VA inspector general had closed an investigation into the Tomah VA before Baldwin even got in touch, in March 2014. The inspector general’s report noted that Houlihan’s narcotic prescriptions were “at considerable variance compared to most opioid prescribers” and “raised potentially serious concerns” that should be brought to the attention of the federal agency’s leadership. But the report suggested no punishment.

Weeth said he believed that Jason Simcakoski, the 35-year-old former Marine who fatally overdosed in the Tomah VA psychiatric ward in August, still would be alive today if the inspector general had come down harder on Houlihan.

[...]
Much more information at the links

Friday, January 16, 2015

Life Care Of Greeneville, NC Named In Wrongful Death Lawsuit

As reported in the Greenville Sun

Many more Details are available at the link

A wrongful death civil lawsuit has been filed against a Greeneville nursing home and several other defendants alleging wrongdoing in the care the facility gave an elderly dementia patient.

In the complaint, filed Dec. 2, 2014, in Greene County Circuit Court, the plaintiff, Robin Tweed Keller, of Virginia, alleges that medical battery and negligence by Life Care Center of Greeneville resulted in the suffering and eventual death of her father, Bobby Glenn Tweed, on Nov. 19, 2013, at the age of 79.

The suit identifies Keller as Tweed's only daughter and his next-of-kin -- and the person he had designated his Tennessee Healthcare Durable Power-of-Attorney in September 2009.

She is also identified as the court-appointed representative of his estate.

Defendants named in the lawsuit are:
  • Life Care Center of Greeneville, 725 Crum St.;
  • Life Care Centers of America Inc., based in Cleveland, Tenn., the parent company of Life Care Center of Greeneville and more than 100 other similar centers in the nation;
  • Wayne E. Tasker & Associates Inc., of Morristown, doing business as Green Tasker & Associates Inc., and Tasker Green & Associates Inc., a firm which Keller believes provides services to Life Care Centers in connection with the mental health of patients;
  • Dr. William C. Diebold, a medical doctor and board-certified psychiatrist with Takoma Regional Hospital's Center for Outpatient Behavioral Health and Senior Care, who, the lawsuit states, treated Tweed at one point during the last months of his life;
  • Stephen L. Haile, an advanced-practice registered nurse who the plaintiff believes to be an officer or employee of the Tasker firm; and
  • Dr. Kenneth Nickle, a physician with Summit Medical Group, who, the lawsuit states, served as medical director of Life Care Center of Greeneville during the last three months of Tweed's life and, in that capacity, treated Tweed for two-and-a-half to three months.
Also cited as a defendant is an unnamed female who, the complaint states, was employed at Life Care Center of Greeneville. The lawsuit alleges that she was involved in the care and treatment of Tweed and administered certain "atypical anti-psychotic drugs" without obtaining the legally-required informed consent from Keller.

The Greeneville Sun has made attempts to seek comment from each defendant listed in the complaint. Each defendant contacted has declined comment on the pending case at this time.

WHAT LAWSUIT CLAIMS


The suit alleges that, for a few days in August 2013 at Takoma Regional Hospital and then continuing until mid-October 2013 at Life Care Center of Greeneville, Tweed was administered powerful drugs that were inappropriate for his medical condition: dementia and Alzheimer's disease (but not mental illness).

The drugs mentioned in the lawsuit -- Seroquel, Geodon and Depakote -- are described in the suit as "extremely powerful psychotropic medications" classified as "atypical anti-psychotic drugs."

Seroquel and Geodon, the suit alleges, "and other atypical anti-psychotic drugs" have been shown to increase death in elderly patients who are suffering from dementia.

Because of that increased risk of death, the U.S. Food and Drug Administration (FDA) has required the manufacturers of Seroquel and Geodon to include "black box" warnings about the danger of using those drugs with elderly patients who are suffering from dementia, the suit alleges.

The suit describes Depakote as "an anti-epileptic drug, which is used to treat a variety of epilepsy seizure types as well as acute manic symptoms in patients with bipolar disorder."

But, the suit continues, "It has not been approved by the FDA for use with Alzheimer's disease or dementia."
Many more Details are available at the link

Wednesday, January 14, 2015

FDA warns Pfizer's antipsychotic Geodon and generic versions of the drug could cause a fatal skin reaction

As Reported by Reuters

Pfizer Inc's antipsychotic Geodon and generic versions of the drug can trigger a potentially fatal skin reaction, the U.S. Food and Drug Administration warned on Thursday.

A new warning has been added to the drug's label to describe the condition - known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) - which may start as a rash and spread all over. (1.usa.gov/1Gh2I8p)

Other symptoms include fever, swollen lymph nodes and organ inflammation.

Geodon, known generically as ziprasidone, is used to treat schizophrenia and bipolar I disorder by reducing hallucinations, delusions and other psychotic symptoms.

While no deaths have been reported, the regulator reviewed six cases in whom the signs and symptoms of D.R.E.S.S. appeared between 11 and 30 days after ziprasidone treatment was initiated.

Last year, 2.5 million prescriptions for oral formulations of ziprasidone were dispensed, the agency said.

Patients on the drug who have a fever with a rash and/or swollen lymph glands should seek urgent care, the regulator said, advising doctors to halt treatment if they suspect D.R.E.S.S.