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).

Five arrested in East Cove Psychiatric Services investigation

As seen here

Agents with the North Carolina State Bureau of Investigation executed search warrants Tuesday morning at a Kinston psychiatric facility. That afternoon, authorities arrested East Cove Psychiatric Services’ owners and operators Joanna Wolicki-Shannon and Walter Shannon. Shannon, 64, faces 12 felony counts of obtaining a controlled substance by fraud or forgery and received a $180,000 bond. Wolicki-Shannon, 50, received charges of six felony counts of obtaining a controlled substance by fraud or forgery and took a $90,000 bond. According to the SBI, “The doctors wrote bogus prescriptions for phentermine, hydrocodone, Percocet, Adderall, vyvanse and Ritalin using their psychiatric practice employees and members of the office staff’s families to submit them to pharmacies to be filled. The employees picked up the prescribed drugs and delivered them to the doctors.” Agents arrested three others in connection to the case. Lisa Renay Lankford, 53, faces 18 felony counts of obtaining a controlled substance by fraud or forgery and received a $279,000 bond. Candice Raegan Hill, 35, and James Howington, 31, were charged with 10 felony counts each of obtaining a controlled substance by fraud or forgery along with 10 felony counts of trafficking opium. Hill received a $650,000 bond, while Howington received a $659,000 bond. Hill and Lankford are both former office managers at East Cove, and Howington is Hill's boyfriend. East Cove’s main office is located in the 1300 block of North Queen Street, while an additional facility is open Thursdays on Limehouse Road in Kenansville. East Cove serves Eastpointe region clients who require mental health, developmental disability and/or substance abuse services. State agents are being assisted by the FBI in the case. Throughout the day Tuesday the Lenoir County Sheriff’s Office also lent assistance at the scene. The suspects should make their first appearance in Lenoir County District Court on Wednesday.

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

British Psychiatrist Adam Osborne is suspended AGAIN... over 'serious misconduct' with female patient

From this Report in the Daily Mail

Adam Osborne, 38, who has a private practice in Central London, last week had his licence suspended by the General Medical Council (GMC) after being accused of having a two-year sexual affair with a highly vulnerable woman patient who has psychiatric issues, is married and has two children. The news comes five years after he was suspended by the GMC for ‘dishonest and misleading’ behaviour in prescribing drugs to his cocaine-addicted prostitute lover. The latest blow means he cannot practise in any capacity as a doctor until an investigation into the new allegations has been concluded. The suspension will prove highly embarrassing for (his brother) the Chancellor (George Osborne), coming as he prepares for Wednesday’s crucial Budget, the last before May’s General Election. If the investigation results in a Fitness To Practise hearing, which is held in public, Dr Osborne could face further sensitive personal information being revealed. And if the allegations are upheld, he could be struck off. In the wake of the hearing, Dr Osborne’s personal website was taken down. His Linkedin page states that he has a special interest in adult attention deficit hyperactivity disorder, personality disorders, depression and anxiety. Dr Osborne currently runs Devonport Psychiatry, which is based in Marylebone, Central London, but is officially registered to his home address in Shepherd’s Bush, West London, which he shares with his wife Rahala Noor, a plastic surgeon. His suspension in 2010 stemmed from a series of allegations surrounding his use of prescription drugs, which centred on allegations of a relationship with a prostitute. The GMC said that his ‘relationship’ with the woman had ‘clouded his judgment’ and led him to prescribe powerful anti-psychotic drugs, dishonestly use a false name and fail to inform her GP. Dr Osborne was also disciplined for prescribing contraceptive pills to his then girlfriend, Rahala, a strict Muslim who would become his wife, and an anti-smoking drug to an unnamed family member. The GMC hearing was told that Dr Osborne had been in a relationship with the prostitute, referred to as Miss B, from 2007 to 2008 while he was separated from his girlfriend and he was a trainee psychiatrist in Manchester.

More Details and Photos at the Daily Mail

The Corrupt Relationship Between Big Pharma and Doctors

A Editorial by Jessica Smith News Editor of the Western Herald Excellent Writing, worth checking out the original article in full

While watching one of my new favorite satirical news shows, “Last Week Tonight with John Oliver” on HBO, Oliver delivered a humorous rant with serious undertones on the questionable and unethical relationship between doctors and pharmaceutical representatives.

What I find unethical about these relationships is many doctors are being paid by the same drug companies whose medicine they prescribe, according to a ProPublica investigation conducted in 2013.

In that same “Last Week Tonight with John Oliver” segment, Oliver discussed how some pharmaceutical sales reps “use sex appeal and free food to peddle drugs.”

It’s no secret that Big Pharma is a business looking reap profits off of consumers. However, the distance that pharmaceutical companies are willing to go remains shady.

Oliver said $329.2 billion was spent on prescription drugs in 2013. Oliver also mentioned drug companies spend “an estimated $24 billion marketing directly to doctors.” He compared the companies to “high school boyfriends” and quipped, “they’re much more concerned with being inside you than being effective once you’re in there.”

All jokes aside, this is a highly unethical action and a reality the public should be aware of.

As a social work student, I am obligated to abide by the National Association of Social Workers Code of Ethics. The American Medical Association (AMA) also has a Code of Medical Ethics, which doctors are supposed to abide by.

In the AMA’s Code of Medical Ethics under Opinion 8.06 - Prescribing and Dispensing Drugs and Devices, it states, “(2) Physicians may not accept any kind of payment or compensation from a drug company or device manufacturer for prescribing its products. Furthermore, physicians should not be influenced in the prescribing of drugs, devices, or appliances by a direct or indirect financial interest in a firm or other supplier, regardless of whether the firm is a manufacturer, distributor, wholesaler, or repackager of the products involved.”

By this standard, doctors receiving payments or compensation from a drug company or device manufacturer are in violation of the AMA Code of Medical Ethics.

Some doctors receive perks such as lunches, and dinners. While some make hundreds of thousands of dollars consulting or speaking at medical conferences, sponsoring a large pharma company.

I find this practice to be unethical and not in the best interest of their patients treatment.

[..]

I believe some doctors are overprescribing or inaccurately prescribing medications to their patients due to their relationship with large drug companies.

A lack of insight about what these medications may be doing to the human condition, due to government deregulation of the FDA’s ability to research new drugs without Big Pharma financiering research of their own drug, has led to hastily prescribed patients.

Drug companies are now required to disclose any perks they give to doctors, which are posted to a federal website. If you are interested in finding out if your doctor is receiving perks, I strongly encourage you to visit http://OpenPaymentsData.CMS.Gov.

Johnson & Johnson pleads guilty, pays $25M tied to metal-tainted Children's Tylenol

Via this report on the Fierce Pharma Website

Johnson & Johnson's ($JNJ) McNeil Consumer Healthcare may have cleaned up its act over the past 6 years, but the company is again being bit in the behind by the problems that sprung from the mess that its OTC plant in Pennsylvania once was. The company has pleaded guilty to a federal misdemeanor charge and will pay a $20 million fine and forfeit another $5 million for allowing Infants' Tylenol, Children's Tylenol and Children's Motrin products into the market that were tainted with metals.

The plea agreement announced by Justice Department and FDA officials today stemmed from a complaint that McNeil's plant in Fort Washington, PA, received May 1, 2009, that there were black specks in some of its children's pain medicines. But instead of starting an investigation to find out why, Johnson & Johnson ($JNJ) let it slide, according to the DOJ release.

The particles were later determined to be "nickel/chromium-rich inclusions" and not ingredients that should have been in the products taken by children throughout the world, court records indicate. The FDA would later get from McNeil a list of 30 OTC drug batches with "non-conformances for particles" that occurred in roughly a year's time. In April 2010, McNeil recalled all lots of certain unexpired OTC drugs made for infants and children that it had shipped worldwide.

The Myth of the Chemical Cure: The Politics of Psychiatric Drug Treatment

Video presentation by UNE Center for Global Humanities and its founding director, Anouar Majid, host Joanna Moncrieff on "The Myth of the Chemical Cure: The Politics of Psychiatric Drug Treatment." Just under 1.5 hours

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.

FDA Finds Prozac in USPlabs Supplement, but Company Claims it’s a Counterfeit

From this extended article

A dietary supplement firm long on the US Food and Drug Administration's (FDA) enforcement radar is again in the agency's sights after regulators claim they found fluoxetine, the active ingredient in Prozac, in one of the company's former fitness products.

[...]

In December 2012, FDA sent the company a Warning Letter regarding three of its products: Jack3D, Super Cissus and Oxy Elite Pro. The company's manufacturing operations did not meet federal regulations for good manufacturing practices (GMPs), FDA said. In addition, the company's Super Cissus product was cited by regulators as being marketed for claims restricted for approved pharmaceuticals, and was therefore misbranded.

In April 2013, the company's Jack3D and Oxy Elite Pro supplements were again the target of an FDA Warning Letter after the agency said they contained dimethylamylamine (DMAA), an ingredient linked to cardiovascular adverse events.

[...]

Now USPlabs is again facing FDA scrutiny after agency regulators said they found an undeclared drug ingredient in the since-discontinued product.

On 28 February 2015, FDA issued a "public notification" that USPlabs' Oxy Elite Pro containing fluoxetine, the active ingredient in Prozac, and should not be used by consumers.

"This product was identified by FDA during an examination of international mail shipments," FDA wrote in its notice.

In a statement, USPlabs said the product in question was counterfeit, and that, “Media reports saying that a company product contains Prozac are false.

Salix Pharma (SLXP) Discloses SEC Probe into Possible Securities Law Violations

From This Report from StreetInsider.com

Salix Pharma (NASDAQ: SLXP) disclosed the following in its 10-K filed after markets closed Monday:

The Audit Committee of the Board of Directors of the Company has retained outside counsel and is conducting an internal investigation of disclosures of inventory amounts in the distribution channel and related issues in press releases, on analyst calls, and in the Company’s various SEC filings. That investigation includes certain accounting issues identified during the course of the investigation, including returns of Giazo, marketing fees paid to a wholesaler, and the Company’s practices for recognizing revenue for shipments made to another wholesaler on or after October 1, 2013, and resulted in our restating our financial results for 2013 and the first three quarters of 2014. The Audit Committee has notified the SEC Enforcement Staff that it is conducting this investigation, and has had meetings with the SEC Enforcement Staff with respect to the Audit Committee’s investigation. Moreover, counsel to the Audit Committee has voluntarily provided relevant documents to the SEC Enforcement Staff, and is cooperating with the SEC Enforcement Staff in the SEC’s investigation. The Company has received information requests from the SEC and the Company expects to receive subpoenas for documents and testimony during the course of the SEC’s investigation.

We cannot predict the outcome or the duration of the SEC investigation or any other legal proceedings or enforcement that may arise out of the SEC investigation. We also could be subjected to other lawsuits and could become the subject of other regulatory inquiries or investigations in addition to the SEC investigation now underway. If we are subject to adverse findings in any proceedings, we may be required to incur costs, or pay damages or penalties or have other remedies imposed upon us which could have a material adverse effect on our financial condition and results of operations.

Responding to the SEC investigation could divert management’s attention from managing our day-to-day operations. Additionally, expenses that may arise from responding to the SEC investigation, management’s review of responsive materials, any related litigation or other associated activities may be significant. Current and former employees, officers and directors may seek indemnification, advancement or reimbursement of expenses from us, including attorneys’ fees, with respect to the current investigation or future proceedings related to this matter, if any such investigation or proceeding involves such employees, officers and directors personally. In addition, the SEC investigation may adversely affect our ability to obtain, or increase the cost of obtaining, directors’ and officers’ liability and other types of insurance. These events could adversely affect our financial condition, results of operations and the price of our common stock

Sydney’s shameful asylums: The silent houses of pain where inmates were chained and sadists reigned

This is an important article tracing the disturbing history of psychiatry in Sydney, Australia from the mid 1800s to the present day.

Well worth the read, plenty of photos



The video is the usual nonsense of "without the benefit of modern drugs to keep patients quiet" sort of thing

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.

[...]

California Lawmakers blast overuse of psychiatric drugs on foster kids

from this report in the Tribune in San Luis Obispo

California lawmakers on Tuesday blasted the overuse of psychiatric drugs on the state's foster children and pledged to improve the lives of thousands of vulnerable teens after more than a decade of government inaction.

"We can't let another decade go by without creating a system of care, a system of care that is capable of helping kids heal from the challenging experiences they have lived through or protecting them from further harm," said Sen. Mike McGuire, D-Healdsburg, in opening a joint Senate Human Services Committee and Senate Select Committee on Mental Health.

Advocates said the state's foster children are being prescribed psychiatric drugs at three times the rate of other youth. Since 2006, the use rate of psychotropic medications has nearly doubled, McGuire said. He noted that it's costing taxpayers millions of dollars through the state's low-income health program Medi-Cal.

Iris Hoffman, a member of the California Youth Connection in Sonoma County, told lawmakers how she spent her childhood in juvenile homes, group homes and treatment centers while heavily medicated on the anti-psychotic drugs Abilify and Seroquel. She and other foster children were fearful of retribution if they refused drugs that made them drowsy in class, Hoffman said.

"When you're in those situations, there's all kinds of punishments and things you have to be fearful of if you are to refuse medications prescribed to you by a psychiatrist that only meets with you for an hour a month," she said.

Democratic lawmakers are proposing several pieces of legislation to improve oversight after an investigation by the Bay Area News Group found that thousands of vulnerable teens in foster care are being prescribed antipsychotics that could trigger diabetes, tics, weight gain and drowsiness.

Sen. Jim Beall, D-San Jose, said Tuesday that the hearing at the Capitol is only a step in determining whether the drugs are being administered as part of a therapeutic regimen or "being used as a chemical straitjacket solely to control their behavior."

Beall and Sen. Holly Mitchell, D-Los Angeles, have proposed SB238, which would alert caretakers when drugs are overprescribed and warn of dangerous drug interactions.

Beall also plans to introduce two other bills — one calling for public health nurses to oversee the medical monitoring of children's medication, and the other to establish treatment protocols and oversight in group homes.

Lawmakers on Tuesday heard from medical professionals, child welfare directors, family service advocates, foster youth and officials from California's health and social services agencies.

The use of psychiatric drugs has increased even though the state's foster care population has dropped. As a result of reforms that emphasize keeping children with their families whenever possible, the number of children in foster care has dropped from 103,000 in 2000 to about 55,000 in 2013.

Lawmakers say nearly a quarter of adolescents in California's foster care youth system are prescribed powerful psychotropic drugs. According to the National Center for Youth Law with data provided by the state, 36 percent of them are taking multiple medications that carry harmful side effects.

Antipsychotics, antidepressants, ADHD drugs, anti-anxiety medications and mood stabilizers are some of the psychotropic drugs.

Judge: State of Alaska can't hold foster kids at mental hospital for indefinite stretches

From a report in the Alaska Dispatch News

More details at the link

Facing allegations that it improperly warehoused foster children at North Star psychiatric hospital in Anchorage, the Alaska Office of Children’s Services has been ordered by a state Superior Court judge not to keep children at the facility for indefinite periods of time.

The order is part of a preliminary injunction issued by Superior Court Judge Erin Marston that said a minor, admitted to the acute psychiatric hospital during an emergency, cannot remain there longer than 30 days without court approval.

But that length of time may change. As a next step, the judge has asked parties in the case to offer recommendations on the appropriate period of time a minor should be kept at the hospital before a court can weigh in.

The case was brought a year ago by the Southwest Alaska tribal governments of Hooper Bay and Kongiganak on behalf of the tribes’ children.

Alaska Legal Services, representing the tribes, argued that the state was improperly placing and holding children in the hospital. It provided examples of three Alaska Native teenage girls from two foster families who had been held at the hospital for at least four weeks without a judge’s approval, though their admission was based on questionable evidence.

One of the girls, a teenager referenced as C.A. for her initials, was held at the hospital for about a month, though a hearing judge later found there was no evidence supporting the decision to send her there, wrote Marston.

“OCS decided to send C.A. to North Star, although the reason for this decision is unclear,” Marston wrote.

Marston’s Feb. 12 preliminary order said that indefinite stays by children at North Star may violate U.S. constitutional rights and lead to “irreparable harm.”

“Continuing treatment of foster children without a judicial hearing raises the question of a violation of the fundamental right to due process,” he wrote.

The hospital provides a secure, locked facility where 24-hour services are given under the care of psychiatrists to children with severe emotional and behavioral disorders, he wrote.

But long, unnecessary placement at a mental hospital is not good for adolescents, said Jim Davis, the attorney arguing the case for Alaska Legal Services.

“This is not to say North Star is ‘One Flew Over the Cuckoo’s Nest,’ but a mental hospital is not a good place for kids” with typical teenage behaviors, said Davis. “It can disempower and otherwise undermine a kid’s sense of self if they don’t really have a mental illness requiring them to be there.”

North Star Behavioral Health System was a defendant in the case along with Christy Lawton, OCS director. Like OCS, North Star must change its practices because of the preliminary order, Davis said.

Officials representing and working for North Star did not return phone calls seeking comments.

Though the case is not settled, the judge’s preliminary order is in part a victory for the tribal governments.

[...]

The state’s policy was insufficient because it proposed no timeline, leaving that up to the scheduling of the courts, Davis said. Getting a hearing can take far too long, sometimes leaving a child in the mental hospital long after they should have been released, said Davis.

The girl had caused alarm after it was believed she had overdosed on antidepressants, leading to a trip to the hospital emergency room in the hub city of Bethel. There, the girl showed no physical signs of overdosing and the girl’s foster mother found the bottle of pills the next day.

[...]

D.S. was held for 38 days, while J.S. was held for 47 days, Davis said. They were released after a Superior Court judge said they shouldn’t be there, he said.

“The process isn’t working when it takes weeks and weeks to have a hearing,” Davis said.

In his order, the judge wants the parties by March 12 to recommend the appropriate length of time to hold minors before a court can weigh in.

Davis said he will argue that minors, just like adults, should not be involuntarily held longer than 72 hours without a court’s input. That is more than enough time to determine whether a minor is being improperly held at the hospital, he said.

Bookman, of the OCS, said a child admitted by a guardian is in a situation different from that of an involuntarily admitted adult, so 72 hours may not be appropriate. He said he would “talk to OCS about it, do some research and come up with a position.”

Psychiatrist Settles Pleads Guilty and Settles Civil Claims

As seen on the Illinois Nursing Home Abuse Blog

Background

A few months ago, an Illinois psychiatrist was suspended indefinitely from practicing because of his alleged abuse of an antipsychotic drug called clozapine. Dr. Michael J. Reinstein prescribed clozapine to more than half of his patients at nursing homes as well as mental health facilities. Clozapine is used to keep patients sedated when they become irritable or violent – many of them suffer from dementia or other ailments, and antipsychotic drugs such as clozapine are used to hold them down. Such drugs can be considered an unacceptable form of chemical restraint that advocates have fought against in recent years in favor of more humane methods that avoid drug dependency.

Constant drug use by patients as prescribed can put them in a stupor and can hasten their mental and/or physical demise. Clozapine adversely affects the immune system by diminishing white blood cells, and can cause heart inflammation, seizures, and problems with the blood, as well as dizziness and lightheadedness. As we profiled earlier in this space, clozapine itself is one of the most dangerous types of antipsychotic medications, and is considered “a risky drug of last resort.” Historically, Dr. Reinstein was alleged to have prescribed more clozapine in a single year (2007) than all medical providers in the large state of Texas combined, and has had patients die in the past while on substantial doses of clozapine.

Charges, Guilty Plea and Settlement

Reinstein was also accused of taking about $350,000 in kickbacks, including gifts (like travel and dinners) from a clozapine manufacturer, Teva Pharmaceuticals, which is against the law. Teva already settled with the government over those kickback allegations. The government also sued Reinstein for taking kickbacks to prescribe clozapine, and for submitting possibly more than 140,000 false claims (overbilling) for reimbursement for these treatments from the federally funded programs Medicare and Medicaid. This type of Medicare/Medicaid fraud is prosecuted civilly and criminally under the False Claims Act, and such allegations are very serious. In recent news, Reinstein, already dealing with a suspended license and a civil suit from the government for taking kickbacks and committing medication fraud, has been charged criminally by the United States for taking kickbacks from the clozapine drug maker.

As reported by the Chicago Tribune, the criminal charges have been brought on a single kickback worth $2,000, but the government was reportedly looking to take back approximately $600,000 worth of “ill-gotten gains stemming from clozapine prescriptions.” Just days ago, Reinstein pled guilty to the federal charge of accepting kickbacks for prescribing clozapine against the Medicare and Medicaid Anti-Kickback Statute. His sentencing date is as yet unscheduled, but the please agreement includes a recommendation of 18.5 months behind bars. Along with the guilty plea, Reisnstein settled the civil case with both the Justice Department and the State of Illinois (which later joined the federal government in that suit) for $3.79 million, settling claims that he accepted kickbacks to prescribe clozapine and then submitted an astounding amount of false claims for reimbursement.

Takeaway

This case demonstrates the importance of cracking down on Medicare and Medicaid fraud, as well as companies and medical providers engaging in kickback schemes. This is an illegal way to “get rich” at the expense of patients who are not prescribed what they need or do not receive the appropriate treatment because doctors are prescribing medications as part of the kickback scheme. This case also highlights the abuse of federal taxpayer dollars through reimbursement claims. And above all, it puts the spotlight on the abuse of medications for chemical restraints, and how we must continue moving toward alternative methods.

"They said if I kept making noise, they would drag me into the mental-health ward and diagnose me as having mental illness."

As reported by the CBC, with much more including a video report and documentation at the link

You can also see the video here

Another case of a person being diagnosed as mentally ill for the convenience of the doctors, not to help the patient. Apparently they wanted to put here on anti-psychotics to shut her up.

Alice Zhang says she's being denied a life-saving kidney transplant because doctors at Vancouver General Hospital have decided she is mentally ill.

The 45-year-old mother of two, who speaks only Cantonese, and her family say she has no history of mental illness, and that she was only removed from the transplant list for complaining about her treatment in the hemodialysis unit.

"That's what started this whole situation" Zhang, speaking through an interpreter, told CBC Investigates.

She said doctors threatened to admit her involuntarily under the Mental Health Act.

"They said if I kept making noise, they would drag me into the mental-health ward and diagnose me as having mental illness."

Zhang said that is where she ended up on two occasions.

Polycystic kidney disease

Zhang has polycystic kidney disease. She shares custody of her boys, aged nine and 11 years old.

She needs hemodialysis three times a week, and has been on the kidney transplant list since 2009.

She said a sudden diagnosis of delusional disorder came right after she filed written complaints that nurses were too rough on her injection site.

"They said, 'Right now, we are going to temporarily stop the transplant process,'" said Zhang. Hospital documents confirm that the process was halted.

"Because I complained about them, they said that to me."

According to a psychiatrist’s handwritten notes, Zhang was paranoid.

Difficult but not delusional, says family

Zhang's husband, from whom she is separated, believes doctors are misinterpreting her actions.

"If they don't even understand what she's saying, how can they say she has a mental illness?" said Lea Kwong Chow.

"This person doesn't really have great social skills. Just because of that, you can't say they have a mental illness."

Chow said that in the nearly 20 years he has known Zhang, she has never shown any signs of paranoia.

While a translator attends most appointments, Chow and Zhang said there are many informal interactions without one.

In October, the psychiatrist's handwritten note to Zhang raised concern that she was following a nurse.

"You were asking about her last name. This was interpreted as concerning behaviour," the note said.

The notes show Zhang tried to explain she had been asked to find out the nurse's last name by her lawyer, something he confirmed in a letter to Vancouver Coastal Health.

The same psychiatrist wrote, "The fact that you believe that the nurses are trying to harm you tells me that you have a mental illness ... the nurses are starting to feel threatened by you. Some of this has to do with your complaints about them."

But Zhang — who refused to take prescribed anti-psychotic drugs — said she has never said anyone tried to hurt her on purpose.

"I have never been the suspicious type," she said. "I believe they have violated my human rights."

Big Pharma Is America’s New Mafia

We just came across this well documented column in the Daily Beast

Here's a snippet:

“Much of what the drug industry does fulfills the criteria for organized crime in US law,” Dr. Gotzsche said in a recent interview. “And they behave in many ways like the mafia does, they corrupt everyone they can corrupt, they have bought every type of person, even including ministers of health in some countries… The drug industry buys the professors first, then chiefs of departments, then other chief physicians and so on, they don’t buy junior doctors.”

Gotzsche isn’t the only one accusing pharmaceutical companies of wrongdoing beyond the marketing malfeasance they’re famous for. In Australia, during the Vioxx class action suit brought against Merck, company emails were released revealing that Merck employees planned to “neutralize” and “discredit” doctors who criticized the drug. “We may need to seek them out and destroy them where they live,” a Merck employee wrote, according to The Australian. Apparently, uncooperative physicians were targeted to lose academic appointments and research funding for telling the truth about the negative side effects they observed.

This is troubling—but even more so in light of the fact that it’s now widely accepted that prescription drugs can be dangerous and over the years dozens have been recalled. “Our prescription drugs are the third leading cause of death after heart disease and cancer. Our drugs kill around 200,000 people in America every year, and half of these people die while they do what their doctors told them—so they die because of the side-effects,” said Dr. Gotzsche in his recent interview. “The other half die because of errors—and it’s often the doctors that make the errors because any drug may come with 20, 30 or 40 warnings, contraindications, precautions…and then the patients die.”

This is a hard pill for any of us to swallow. We should be able to trust our doctors, who should in turn be able to trust “the science.” As amusing as Oliver’s “epic takedown” of doctors was, the trouble isn’t physicians prescribing a new drug because a drug rep brings us a platter of tacos, the problem is whether the drugs we have to choose from are truly safe and effective in the first place.

Excited Man Only Two Therapy Sessions Away From Resolving Issues [Satire]

A classic bit of Satire from the Onion on the ability (or inability) of psychiatrists to actually cure someone of anything

After over seven years of weekly meetings with his psychiatrist, 35-year-old Chris Vaughan told reporters Friday he is thrilled to be just two 45-minute sessions away from completely resolving all of his problems.

Patient at Cavan hospital given ECT without proper medication

From a Report in the Irish Times

Inspectors at a psychiatric unit in Cavan General Hospital investigated a “serious” incident where a patient was administered electro-convulsive therapy (ECT) without the required muscle relaxant medication.

An unannounced inspection was carried out at the acute psychiartirc unit of the hospital on June 3rd and 4th 2014 .

Inspection of one individual clinical file found a detained patient had consented to a course of electroconvulsive therapy treatment.

The anaesthetist failed to administer the required muscle relaxant medication before one of the treatment sessions.

The medical record stated that the patient has complained of joint stiffness and that the consultant psychiatrist would inform the patient of the drug administration error.

“However, there was no record in the patient’s clinical file that this adverse incident has been discussed with the patient,” the report said.

At the request of the inspectors, a review report in relation to the incident was provided.

Inspectors said there was no record in the of the event entered in the incident log or reviewed by all relevant clinical personnel and the manager.

“The clinical governance in response to this incident appeared to be lax” the report said.

The Inspectorate Mental Health Services immediately requested a report on the incident from the clinical director and notified the Mental Health Commission of this “matter of serious concern”.

[..]

While it is good news that ECT is on the the decline, it is shocking that not only is it still practiced in Ireland, but that they cannot even follow their own safety rules

Lawsuit describes string of sex assaults at Seattle Children's Hospital - Hospital staff failed to help girl abused in psychiatric ward

From a report in Seattle PI

Much more information at the link

A former patient at Seattle Children’s Hospital has sued, claiming hospital staff failed to notice as she was repeatedly, sexually assaulted by another patient.

Attorneys for the young woman claim at least three other children have been sexually abused at the Laurelhurst neighborhood facility in recent years. Despite assurances of reform from hospital managers, they contend too little is being done to protect children there.

Writing the court, attorneys Steve Berman and Marty McLean said their client was just one of an unknown number of children abused while locked in Children’s inpatient psychiatric unit.

“Sadly, (she) is not the first child-patient who was sexually victimized while admitted,” Berman said in the lawsuit, which was filed earlier this week. “Publically available records confirm that (she) was at least the fourth patient in a five-year span to have been sexually victimized while under (Children’s) care and custody.”

Berman, a nationally prominent attorney specializing in class-action lawsuits, went on to say he believes “there are more children who have been victimized, as well.”

A spokeswoman for Seattle Children’s declined to comment on the lawsuit. Attorneys for the University of Washington-affiliated nonprofit have not yet responded to the allegations in court.