Tag: Antipsychotics

Fox 5 Atlanta featured a back to school story about the growing percentage of preteens and teens being prescribed antipsychotic medication for ADHD.  They report:...

This column is partly a report on the marketing of Abilify, the atypical antipsychotic that has become America’s best-selling drug.   It’s also an appeal for advice and feedback from the RxISK and Mad in America communities, and a call for some brainstorming about strategy.  The plans laid out by drugmakers Otsuka and Lundbeck for Abilify’s future, and the cooperation they’re getting from leading universities, are alarming enough to me that reporting on them seems inadequate.  We need action, although I’m not sure exactly what kind.

With 1 in 5 Americans taking a psychiatric medication, most of whom, long term, we should probably start to learn a bit more about them. In fact, it would have been in the service of true informed consent to have investigated long-term risks before the deluge of these meds seized our population over the past thirty years.

As I wrote in Let’s All Support Stephen Sheller’s FDA Petition to Revoke the Pediatric Approval of Risperdal, Stephen Sheller's law firm, which represents hundreds of boys who were prescribed Risperdal and then grew breasts (gynecomastia) as a result, filed a petition with the Food and Drug Administration (FDA) to change the label and revoke its approval for use on children. During the course of discovery for litigation in its Risperdal cases, Sheller became privy to documents not provided to the FDA that showed Johnson & Johnson hid the problem. This is a very important case. If it is successful, it will give hope of forcing the FDA to follow its mandate to protect the public from harmful drugs.

In a well-researched, comprehensive article in today's Huffington Post Art Levine has brought to the attention of the mainstream media the government's complicity in the illegal psychiatric drugging of poor children, especially foster children, through Medicaid.  The article, Feds Pay for Drug Fraud: 92 Percent of Foster Care, Poor Kids Prescribed Antipsychotics Get Them for Unaccepted Uses is the only mainstream article I know about that has really pressed the federal government over its refusal to enforce Medicaid's coverage restrictions to "medically accepted indications."

The wait has been exhausting, but it is possible that a flicker of light may finally shine on the dark recent history of psychiatric research at the University of Minnesota. Given these upcoming investigations of psychiatric research at the University of Minnesota, the time is right to look back at some of the disturbing, unanswered questions that have emerged over the past several years.

Evidence based care is supposed to drive up standards, ensure uniformity, establish best practice, guide clinicians and protect patients. This should be celebrated. Instead, evidence-based mental health is openly disparaged, and when psychiatrists don’t get the results they want, they ignore them, suppress them, or denounce them. These attitudes have repercussions on the training of psychiatrists.

Professor Leigh Turner of the University of Minnesota Center for Bioethics blasts the Board of Regents for ignoring psychiatric research abuse.

Patient advocates and bioethicists have launched a call-in campaign demanding action on psychiatric research abuse at the University of Minnesota.

In 2004, a patient was given an experimental antipsychotic called bifeprunox and died of hepatorenal failure nine days later. But the sponsor apparently did not investigate the death for three years. In late 2007 the sponsor issued a safety alert and suspended all bifeprunox studies. This is where things get interesting.

I received the following question from a reader regarding the controversial CAFÉ – Comparisons of Atypicals in First Episode of Psychosis - study. (This was the study in which Dan Markingson committed suicide.) "It appears that there was no head-to-head with a control group taking a placebo pill. Nor was there a control group featuring 'old' types of 'antipsychotic'. If that was the case then it is very poor study . . . what on earth can you hope to show from the data?" I started to write a response, but the subject is complex, and my response became the following article.

Responding to a letter signed by 175 scholars asking for an inquiry into the death of Dan Markingson at the University of Minnesota, the Faculty Senate voted to investigate clinical research at the university. But the university president says the Markingson case will not be part of the investigation. What is he trying to hide?

For a scathing, 11-minute overview of the death of Dan Markingson at the University of Minnesota, and new allegations of coercion into psychiatric clinical trials, you can't do much better than this excellent investigative report by Jeff Baillon.

It took over twenty years for the state medical board to sanction a Minnesota psychiatrist who was responsible for the deaths and injuries of 46 patients. Today, in the Markingson case, it looks as if history is repeating itself. How many patients die while bureaucrats delay?

Dan Markingson was floridly psychotic and unable to give informed consent when University of Minnesota researchers coerced him into an industry-funded drug study. His mother, Mary Weiss, warned the researchers that Dan was in danger of killing himself, but she was ignored. Dan committed a violent suicide in 2004. Last week, after fighting the university and research regulators for nine years, Mary suffered a severe stroke. Her struggle for justice is in serious danger.

While a 2-year outcome study by Wunderink, et al. has been cited as evidence that guided discontinuation of antipsychotics for people whose psychosis has remitted results in twice as much “relapse,” a not-yet-published followup of that study, extending it to 7 years using a naturalistic followup, finds that the guided discontinuation group had twice the recovery rates, and no greater overall relapse rate (with a trend toward the medication group having more relapse.)

At the University of Minnesota, the answer is apparently $1,446. If harmless clerical errors were to blame for oddities like this, that fact should be easy to clarify simply by looking at the relevant documents.  But if there are systematic issues with the administration of clinical trials that makes it possible to bill for a visit with a dead subject, those issues would be important for other universities and private trial sites as well. 

Psychiatrists at the University of Minnesota forced a young man into a profitable study of antipsychotic drugs over the objections of his mother, who desperately warned that his condition was deteriorating and that he was in danger of killing himself. On May 8, 2004, Mary Weiss' only son, Dan Markingson, committed suicide. A petition to the governor of Minnesota now asks for an investigation.

The United States desperately needs good programs to help people withdraw from neuroleptic drugs. From all I have seen and heard, there aren’t any - none at least that can reputably claim to get good results on a fairly consistent basis. Again and again I find myself challenged to envision such a program, and in reply to the challenge I have broken down this hypothetical program into various components.

In the business of clinical trials, the most valuable commodities are the research subjects. Filling clinical trials is hard, and filling them quickly is even harder. That’s why in 2000 a clinical investigator told the HHS Office of the Inspector General that research sponsors were looking for three things from research sites: “No. 1—rapid enrollment. No. 2 — rapid enrollment. No. 3 — rapid enrollment.”

This is the second in my new series, “Haiku for social change”, the first having appeared on my own blog page. Since this piece is about pharmacology and psychopharmacology, I think MIA is a good home for it.

In early 2009, antipsychotic fraud was making headlines.  Eli Lilly had announced in January that it would plead guilty to charges that it had...

I do not understand how we can continue to avoid the conversation about psychiatric medications and their role in the violence that is affecting far too many of our children, whether Seung-Hui Cho, Eric Harris, Kip Kinkel, or Jeff Weise (all of whom were either taking or withdrawing from psychotropic medications) or the scores of children and adults they have killed and harmed. It is not clear what role medications played in the Newtown tragedy, though news reports are now suggesting there is one.

The recent research scandals out of the University of Minnesota’s Department of Psychiatry may be alarming, but they are not new. Back in the 1990s, when the university was working its way towards a crippling probation by the National Institutes of Health (for yet another episode of misconduct (this time in the Department of Surgery), the Department of Psychiatry hosted two spectacular cases of research wrongdoing, both of which resulted in faculty members being disqualified from conducting research by the FDA.

The suicide of Dan Markingson at the University of Minnesota has brought notoriety to the CAFÉ study and its site investigators, Stephen Olson and Charles Schulz. But the “corrective action” recently issued by the Minnesota Board of Social Work against the CAFÉ study coordinator, Jean Kenney, has raised another disturbing question.