Thursday, December 20, 2012

"At the end of the day, drug companies own medicine"

Another excellent report by the Milwaukee Journal-Sentinel's John Fauber, this time on treatment guidelines.  (If only we could get this kind of sustained reporting here in the Twin Cities.)

Haven't we seen this story before?

Another German politician, another plagiarized doctorate.

Wednesday, December 19, 2012

"A suicide draws attention to the ethics of psychiatric drug testing"

Maggie Koerth-Baker blogs on the Dan Markingson case at BoingBoing.net.

The legal threat against Mary Weiss revisited

On Twitter there has been renewed discussion of the legal action against Mary Weiss by the University of Minnesota demanding $57,000 in 2008.  It seemed like a good time to revisit this blog post, "When University Attorneys Play Hardball," from the Chronicle of Higher Education.

Tuesday, December 18, 2012

Monday, December 17, 2012

A message to Twitter allies on the Markingson case

Because of the blog posts by Judy Stone and Matt Lamkin, the case of Dan Markingson has been getting renewed attention in other places, mainly on Twitter. But it's not clear that the message is getting through to university officials, such as the president of the university, Eric Kaler. So if you tweet about the case -- or, in fact, if you re-tweet posts from the weekend -- be sure to include his Twitter handle, @PrezKaler, so that he sees it.  

Is Pfizer too big to fail?

Sure looks that way.  Have a look at what Howard Brody has to say on the Hooked blog.

"There is a sense of it being David against Goliath. But it was, of course, David who won."

The always-interesting Richard Smith, former editor of the BMJ, reviews Ben Goldacre's Bad Pharma.

Cosemtic stem cells will make bone grow in your eyelids?

Man, this sounds really unpleasant. I'll stick with wrinkles.

Thursday, December 13, 2012

"The thing that I am most appalled by in reviewing this tragic case is that nothing—absolutely nothing—has happened to Drs. Olson or Schulz, the IRB responsible for overseeing the trial, or the University of Minnesota."

Read Part 2 of Dr. Judy Stone's series of Scientific American blog posts on the case of Dan Markingson. (Part 1 is here.)

A Kiwi mother meets the excecutive whose drug killed her son

Maria Bradshaw is a New Zealander whose son committed suicide after taking an antidepressant.  On the Mad in America blog, she writes about her recent encounter with the manager director of the company whose drug caused her son's death.  It did not go well.

Tuesday, December 11, 2012

Scientific American on informed consent and the death of Dan Markingson

Dr. Judy Stone writes, "The suicide of Dan Markingson, a 26 year old man participating in a psychiatric trial, has again made the news, and will serve us for a life-time of study and discussion of research ethics, along with the TeGenero and Jesse Gelsinger cases." The first of her series of posts on the case has just come out on the Scientific American blog network.

Monday, December 10, 2012

Wednesday, December 5, 2012

A step-by-step guide to filing a complaint to the Minnesota Board of Social Work about Jean Kenney



If you are considering filing a complaint to the Minnesota Board of Social Work about Jean Kenney and the CAFÉ or CATIE studies, here is a guide to how you might proceed, based on Mike Howard’s successful complaint.

Start by gathering records from Fairview Hospital and/or the Ambulatory research Center.  If past experience is an indicator, however, chances are that they will refuse your request.  Don’t be bullied; you have a right to these records.  Contact the Minnesota Attorney General’s office and have them send a letter ordering the release of the records to you.

You should ask for all records pertaining to your or your family member’s medical care and the study in which they were enrolled, but here are some special requests that you should specifically include: 

- Jean Kenney’s handwritten case notes

- All CAFÉ or CATIE study visit logs

- Signed consent forms for the CAFÉ or CATIE study

- Medical records from Fairview Hospital if the patient was hospitalized

- Records from any outside caseworker or therapist who may have been involved

- Records of any interaction with Stephen Olson, with special attention to how often the patient was seen by Olson

- Records of any family meeting with the study team

- Records of Kenney’s phone logs and any emails involving the CAFÉ or CATIE study between Kenney or Olson and AstraZeneca, Quintiles, the University of North Carolina or the National Institutes of Mental Health
 

Second, read the depositions by Jean Kenney and Stephen Olson from the lawsuit by Mary Weiss.  Many of the things that are discussed in those depositions may be relevant to your case. 

Third, look at the Minnesota statutes governing social work and see if any of them were violated in your case.  If they were, cite the statutes in your letter.  Statutes that might be especially relevant include the following:






In addition, see this:

When you begin writing the complaint, here are some general areas you might cover.

Topic 1: Medical competence

Mike Howard’s complaint successfully challenged Kenney’s competence.  The “corrective action” found that Kenney was medical unqualified to do many of the tasks she was assigned as study coordinator, such as dispensing study drugs and assessing  their side effects.  You should start by looking through the records with an eye towards answering these questions. 

Did Kenney dispense a study drug to you or your family member?

Did Kenney take a medical history or sign off on any medical history forms?

Did Kenney sign off on any “adverse event” forms?  (The phrase “adverse event” is medical jargon for anything that goes medically wrong for a subject in a research study, such as a side-effect from a drug or an abnormal laboratory finding.)

Did Kenney sign off on any “rating scales” for psychiatric symptoms or drug side-effects?  Examples might include the Barnes Akathisia Rating Scale, the Simpson-Angus Scale, the Positive and Negative Syndrome Scale (PANSS), or the Clinical Global Impressions (CGI) scale.

Did Kenney make any mistakes about your or your family member’s medical diagnoses, medications or dosage?

Topic 2: Informed consent

All of the atypical antipsychotics used in the CAFÉ and CATIE studies have been linked to hyperglycemia, diabetes, and weight gain.  During the period when the CAFÉ and CATIE studies were in progress, the drugmakers issued warnings about these problems to doctors and clinical investigators.  All subjects in the CAFÉ and CATIE studies should have been told about these new risks and offered the opportunity to drop out of the study or continue.  If they decided to continue, the subjects should have been asked to sign a new consent form which included the risks of hyperglycemia, diabetes and weight gain.

So look carefully at the informed consent form.  Note whether it includes these risks.  If it doesn’t -- and if it is the only consent form in the chart -- this suggests that you or your family member was never informed of the new risks.  This is a serious ethical breach.  As the Board of Social Work “corrective action” points out, the failure to inform subjects of these risks would effectively invalidate their consent.

Topic 3: Privacy

The sponsors of the CAFÉ and CATIE studies did not have a legal right to see the medical records of anyone they planned to recruit into a research study unless that person gave them authorization by signing a HIPAA form.  (HIPAA, or the Health Information and Accountability Act, is a federal law protecting the privacy of health information.)  But the depositions from Olson and Kenney in the lawsuit brought by Mary Weiss suggest that Olson and Kenney may not have always asked subjects for authorization.

So be sure to look through the medical records for a signed HIPAA form.  Examine the signature carefully and make sure that it matches that of your family member.  If there are irregularities, make a note of this in your complaint.

Topic 4:  Falsified study entries and fraudulent initials and/or signatures.

The “corrective action” noted that Kenney had signed clinical documents with the initials of a physician, presumably Stephen Olson.  Look carefully through the records of study visits and any other relevant documents to see if there is evidence of falsification.  Look at any documents that your family member should have signed (informed consent form, HIPAA authorization, etc.) and make sure that his or her signature is genuine.  Be sure that the records of any study visits, family meetings, etc. match up with your own records or recollections of what happened.

Topic 5: Standard of practice for a clinical social worker


The “corrective action” for Kenney noted a number of instances where Kenney failed to meet minimal standards of practice for a social worker, such as failing to respond to warnings by family members, and the failure to document any treatment goals.   Look carefully through the study records for anything that strikes you as inadequate medical care and make a note of them in your complaint.

Pharmageddon

David Healy's most recent book, praised by Donald Light, in Health Affairs.

Why we should all be alarmed about the recent off-label marketing ruling

Tamara Piety explains on Pharmalot.

As she lay dying

An ER doc tries to save his dying mother from her doctors.

Monday, December 3, 2012

How to file a federal complaint about research subject protection at the U



In the weeks since the “corrective action” against Jean Kenney was issued by the Minnesota Board of Social Work, I have been contacted by the families of several patients who were harmed or mistreated in psychiatric studies at the University of Minnesota.  Some of them plan to file their own complaints to the Board of Social Work.  This is an excellent idea, which is why I posted Mike Howard’s complaint  to the Board about Kenney, so that others can use it as a model.

But the Board of Social Work is not the only place to file a complaint.  If a person has evidence that wrongdoing has occurred in a federally funded study, he or she has another avenue: the federal Office of Human Research Protections (OHRP).  OHRP has jurisdiction over research funded by federal bodies such as the National Institutes of Health, and it has genuine power.  In fact, in 1990s, its predecessor office, the Office for Protection of Research Risks, temporarily suspended medical research at major medical centers such as Duke and Johns Hopkins after serious ethical wrongdoing was revealed.

Judging from the alarming problems outlined in the “corrective action” against Kenney, I believe there are grounds for complaints to OHRP about the CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) study.  The University of Minnesota was a site for the CATIE study as well as the CAFÉ study, and Kenney was the study coordinator for both.  The principal investigator, Stephen Olson, was recruiting subjects for both studies in 2003.

I would be glad to help anyone interested in filing a complaint.  I am ashamed of the way that my university has handled the egregious ethical violations in the CAFÉ study, and I am willing to do whatever I can to make sure that justice is done. You can find me here, and I can be reached at my gmail address, ellio023.

Carl Elliott