Tuesday, March 31, 2015

Twenty-Three Defendants – Including Nine Doctors – Charged With Enterprise Corruption in Massive $7 Million Medicaid Fraud

From this press Release from the BROOKLYN DISTRICT ATTORNEY'S OFFICE in the State of New York

Brooklyn District Attorney Ken Thompson, together with United States Health and Human Services Office of the Inspector General New York region Special Agent in Charge Scott J. Lampert, New York City Human Resources Administration Commissioner Steven Banks and the New York State Acting Medicaid Inspector General Dennis Rosen, today announced that nine doctors are among 23 defendants named in a 199-count indictment that alleges they participated in a massive scheme in which they lured people recruited from low-income neighborhoods, homeless shelters and welfare offices to corrupt medical clinics for unnecessary tests with the promise of free footwear such as sneakers, shoes and boots. District Attorney Thompson said, “These defendants allegedly exploited the most vulnerable members of our society and raked in millions of dollars by doing so. The many poor people who were allegedly targeted at homeless shelters, welfare offices and soup kitchens and referred to as ‘guinea pigs’ by the defendants were exploited for hours, if not days, just because they needed a pair of shoes. That so many doctors allegedly participated in this elaborate scheme to defraud a health care system designed to help the poor is truly disgraceful.” [...] In some cases, the patients were referred for psychiatric care or pain management. These referrals would then generate recurring visits for which they could bill. [...] It is further alleged that Herbert Meadow, MD, Renee Denobrega, NP, and physician’s assistant Matthew Jordan provided psychiatry services to patients, and charged inflated fees for abbreviated patient visits. They also referred patients to others in the enterprise for costly, frequent and unnecessary tests and procedures. Meadow was the owner of record for Community Medical Disorder P.C., and Vainer opened and was the sole signer of its bank account initially. Meadow is presently the sole signer, and both shared the profits generated by the billings.
This is a very large and complex investigation, and a lot of people were involved

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.

Thursday, March 26, 2015

GAO Finds Major Overuse of Antipsychotic Drugs by the Elderly

From the Illinois Nursing Home Abuse Blog

In late 2014 we blogged about the accusations levied against Dr. Michael J. Reinstein about his improper use of antipsychotic drugs prescribed to patients in abundance, as well as taking kickbacks from the drug maker to prescribe it, and making 140,000 or more false billing claims submitted to Medicare and Medicaid for those treatments. This activity landed him in both civil and criminal hot water, and in more recent news he pled guilty to criminal charges as well as settled civil claims with the Illinois and federal governments.

The companies accused of providing those kickbacks and receiving Medicare and Medicaid dollars from the business Reinstein generated by prescribing their antipsychotic drugs. Reinstein exemplifies a holdover of a slowly diminishing practice of using antipsychotic medications, which now is viewed more as the easy way out and a method of chemical restraint when there are other methods that could more humanely calm and care for a patient, particularly dementia and Alzheimer’s patients who have historically been the recipients of antipsychotic medications. Nursing homes historically used these especially when they kept low staffing levels and did not have the manpower to aid patients. Yet antipsychotic drugs can create a cycle of drug dependency, and can even lead to death.

Changing Tides?

While the movement to eliminate the use of antipsychotic medications has gained steam in recent years, the federal government reports that elderly Americans have been overusing psychiatric drugs such as clozapine (Dr. Reinstein’s apparent drug of choice), Abilify, and others. Such drugs are meant to calm down and sedate patients that are prone to violence or outbursts, which those suffering from dementia or psychosis may be particularly prone to exhibiting. The Government Accountability Office (GAO) has released a report stating that elderly adults who live outside of nursing homes and long-term care facilities overuse antipsychotic drugs which are prescribed to them by doctors, though residents in nursing homes also fell into such dependency and overuse, and efforts to curb over-prescription and overuse must continue there as well.

Notably, according to the report, about 86% of Medicare enrollees who suffer from dementia and live outside of nursing homes are prescribed antipsychotic medications, which is a staggering statistic. It is even more remarkable when considering that only approximately 6% of total Medicare enrollees living outside of nursing homes suffer from dementia. Thus the choice of treatment has predominantly been geared toward chemical intervention. For those in nursing homes, of the elderly dementia patients living in nursing homes for over 100 days in the year 2012, approximately a third of those patients were prescribed antipsychotic drugs (and 14% of those outside of nursing homes during 2012).

Part of the problem, according to the GAO report, is the lack of oversight by the government. Medicare and Medicaid specifically take responsibility for such oversight on behalf of the federal government, and states typically have Medicaid fraud units that look into not only financial fraud related to health care, but also investigate when issues include abuse or misuse of medications (which can result in unnecessary and excessive, and thus fraudulent, payments to providers and pharmaceuticals with federal dollars). Those agencies and offices, as well as the U.S. Department of Health and Human Services as the report notes, should be vital in promoting awareness of the dangers of antipsychotic drugs and reducing that use far more than the government has in the past.

Wednesday, March 25, 2015

Are pharmacists turning into salespeople? Internal company emails show push on pharmacists to keep ‘driving those numbers’

From an extensive report on CBC. While it is a general article, it is interesting to see how big pharmacy chains are transforming into your local corner drug pusher. worth reading.

Internal emails from top Canadian chain drugstores show the pressures that pharmacists say they get from companies to push billable services in order to boost revenue. The emails were shared with CBC’s Marketplace by pharmacists who are speaking out about increasing business pressures to perform extra services that can be billed to patients or to provincial governments. These services include medication reviews, flu shots, smoking cessation programs and food intolerance testing kits.

“I think as a pharmacist, it’s embarrassing,” Derek Jorgenson, a pharmacist and professor at the University of Saskatchewan’s College of Pharmacy and Nutrition, told Marketplace co-host Erica Johnson. “I think it makes you feel like you're not a health professional. It makes you feel like a door-to-door salesman or a used car salesman,” he said. “We as pharmacists didn't go into this profession to do that.”


The pharmacists approached Marketplace after the initial investigation to show how corporate pressures negatively affect their work.

“What we're becoming is salesmen,” one former Rexall pharmacist told Marketplace. Marketplace agreed to protect the identity of the pharmacists who spoke out because they fear retribution in the industry. “They want us to sell med checks, flu shots, Hemocode tests, A1C tests, things that don't cost the store anything, but make money for the store,” she said. The pharmacists shared internal emails from management that discuss daily targets for medication reviews.

Tuesday, March 24, 2015

Why All Those Testosterone Ads Constitute Disease Mongering

Snippet from a much longer article on Forbes.com

Archived link here

Documenting part of the much bigger pattern of disease mongering on the part of Big Pharma.


Over the last 10 years, testosterone prescriptions have risen 10-fold in the U.S. and 40-fold in Canada, according to an editorial published today in the Journal of the American Geriatrics Society. It’s likely no coincidence that the U.S. and Canada are two of only three countries (the other being New Zealand) that allow direct-to-consumer advertising of prescription drugs, say the authors, Thomas Perls, a professor at Boston University and geriatrician at Boston Medical Center, and David Handelsman, a professor at the University of Sydney in Australia.

Testosterone makers and some doctors “market the idea that men go through something similar to menopause, where they have these marked declines in testosterone and all these symptoms that we normally attribute to aging,” Perls says. “They say ‘If we give you testosterone, it will reverse the problem.’ It was a wildly successful ad campaign. We consider it to be disease mongering.”

Perls and Handelsman’s critique of testosterone marketing comes just weeks after the U.S. Food & Drug Administration issued tough new rules for the companies that market the hormone treatment. The agency demanded labels be revised make it clear the drugs are only for patients with diseases like hypogonadism or injuries that cause severely low levels of testosterone, and that replacement therapy may raise the risk of cardiovascular problems. Furthermore, the agency ordered testosterone makers to conduct post-marketing research to better elucidate testosterone’s risks.

But Perls and Handelsman argue that’s not enough. They’re calling for the agency to team up with the Federal Trade Commission and ban testosterone advertising for “contrived” conditions such as Low T or “andropause,” the term commonly used for male menopause. And they’re urging the FDA and Health Canada to require physicians to demonstrate—with legitimate hormone testing and the like—that any patient handed a prescription for testosterone actually has a disease that needs to be treated.


Long Island woman says psych ward doctors believed she was delusional for insisting Obama follows her on Twitter

From the New York Daily News

A Long Island woman’s insistence that President Obama follows her on Twitter made doctors at the Harlem Hospital psych ward think she was delusional and suffering from bipolar disorder — but she was actually telling the truth, a lawsuit charges. Kam Brock’s frightening eight-day “One Flew Over the Cuckoo’s Nest” ordeal at the mental facility included forced injections of powerful sedatives and demands she down doses of lithium, medical records obtained through her suit filed in Manhattan Federal Court show. They also indicate that doctors didn’t believe the leader of the free world followed her on Twitter — though @BarackObama follows over 640,000 accounts, including hers. They were also skeptical she worked at a bank, records show.

“I told (the doctor) Obama follows me on Twitter to show her the type of person I am. I’m a good person, a positive person. Obama follows positive people!” Brock, whose Twitter handle is @AkilahBrock, said.

A “master treatment plan” from Harlem Hospital backs up the Astoria Bank worker’s story.
“Objective: Patient will verbalize the importance of education for employment and will state that Obama is not following her on Twitter,” the document reads.

It also notes “patient’s weaknesses: inability to test reality, unemployment.”
Adding insult to insanity, the hospital hit Brock with a bill of $13,637.10, she charges in her suit seeking unspecified damages.

The bizarre experience began Sept. 12, when the NYPD seized her prized 2003 BMW 325Ci in Harlem because they suspected she was high on weed, her attorney, Michael Lamonsoff, said. Cops found no marijuana but confiscated her ride anyway, he said. The NYPD declined to comment.

The following day, Brock walked into the NYPD’s Public Service Area 6 stationhouse in Harlem to retrieve her car, her suit charges. Brock — an eccentric 32-year-old born in Jamaica with dreams of making it big in the entertainment business — admitted in an interview she was “emotional,” but insisted she in no way is an “emotionally disturbed person.” Nevertheless, cops cuffed her and put her in an ambulance bound for the hospital, her suit charges.

“Next thing you know, the police held onto me, the doctor stuck me with a needle and I was knocked out,” Brock said, tearing up. “I woke up to them taking off my underwear and then went out again. I woke up the next day in a hospital robe.”

Lamonsoff said race may have been a factor in the way Brock was treated. “How would you act if you were being told you were crazy?” he said. For eight days, she attended group therapy, endured injections of sedatives, and took lorazepam and lithium, medical records show, according to Lamonsoff.

When she was finally let go, the doctors didn’t tell her why she was being allowed to leave, Brock said. Harlem Hospital declined to comment. The city Law Department said the suit would be reviewed.

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

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

Sunday, March 15, 2015

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

Thursday, March 12, 2015

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.

Tuesday, March 10, 2015

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.

Monday, March 09, 2015

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

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.

Monday, March 02, 2015

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