freakoutcrazy

Blog des AK Psychiatriekritik der NFJ Berlin

Kategorie: Forschung

Pharma-funded Research

On August 20, 2014, Psychiatry Advisor published an article on its website.  The article was written by Leslie Citrome, MD, a professor of psychiatry at New York Medical College in Valhalla, NY, and a member of the Board of Directors of the American Society of Clinical Psychopharmacology.  The article is called Is Bias Against Pharma-Funded Research Fair?  This is an interesting title, because bias, by its very definition, is unfair.  So the very wording of the question begs the question – which strikes me as unfair.  But let’s put that aside. 

Dr. Citrome begins by introducing the term “pharmaism” (anti-pharma prejudice).  He tells us that:

“Pharmaism includes the implicit belief that people associated with pharmaceutical companies are more likely to be intellectually and morally dishonest than others.”

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Maternal antidepressant use and adverse outcomes: a cohort study of 228,876 pregnancies

by ajog

Objective

The purpose of this study was to describe antidepressant medication use patterns during pregnancy and pregnancy outcomes.

Study Design

We evaluated a cohort of 228,876 singleton pregnancies that were covered by Tennessee Medicaid, 1995-2007.

results

Of 23,280 pregnant women with antidepressant prescriptions before pregnancy, 75% of them filled none in the second or third trimesters of pregnancy, and 10.7% of them used antidepressants throughout pregnancy. Filling 1, 2, and ≥3 antidepressant prescriptions during the second trimester was associated with shortened gestational age by 1.7 (95% confidence interval [CI], 1.2–2.3), 3.7 (95% CI, 2.8–4.6), and 4.9 (95% CI, 3.9–5.8) days, when controlled for measured confounders. Third-trimester selective serotonin reuptake inhibitor use was associated with infant convulsions; adjusted odds ratios were 1.4 (95% CI, 0.7–2.8); 2.8 (95% CI, 1.9–5.5); and 4.9 (95% CI, 2.6–9.5) for filling 1, 2, and ≥3 prescriptions, respectively.

Conclusion

Most women discontinue antidepressant medications before or during the first trimester of pregnancy. Second-trimester antidepressant use is associated with preterm birth, and third-trimester selective serotonin reuptake inhibitor use is associated with infant convulsions.

Some Antidepressants Increased Risk of Death in ICU

by Clinical Endocrinology News

Patients on selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors when they were admitted to an intensive care unit were 73% more likely to die in the hospital, compared with ICU patients who were not on these antidepressants, a retrospective study found.

Dr. Katherine M. Berg and her associates analyzed electronic records from admissions to four ICUs in 2001-2008 to compare outcomes for 1,876 patients who were on a selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) and 8,692 control patients who were not taking an SSRI or SNRI before admission.

The mortality risk remained elevated at 1,000 days after ICU admission, she reported in a late-breaking poster presentation and discussion session at an international conference of the American Thoracic Society.

Certain subgroups were at even greater risk of dying in the hospital if they were on an SSRI or SNRI when admitted to the ICU. Patients who had acute coronary syndrome or had undergone cardiac surgery were more than twice as likely to die if they were on an SSRI/SNRI when entering the ICU, compared with controls, said Dr. Berg, a pulmonary/critical care fellow at Massachusetts General Hospital and Harvard University, Boston.

The increased mortality risk appeared to be associated mainly with medications that have higher degrees of serotonin reuptake inhibition. „Citalopram, which is a lower-potency drug, by itself did not incur a higher mortality risk, but sertraline, which is one of the more potent drugs, did. Even comparing the two drugs to each other, if you were on sertraline, your mortality risk was higher“ than if you were on citalopram, Dr. Berg said in an interview.

Fluoxetine, paroxetine, and sertraline were associated with significantly higher mortality, but no significant mortality differences were seen between patients on citalopram or escitalopram and control patients.

Of the 8,692 control patients, 7% died in the hospital, compared with in-hospital death rates of 10% in 286 patients on fluoxetine, 13% in 320 patients on paroxetine, and 15% in 426 patients on sertraline at the time of ICU admission. The remaining 844 patients were on other antidepressants.

The study adjusted for the effects of each patient’s age, Simplified Acute Physiology Score, and combined Elixhauser comorbidity score on in-hospital mortality risk.

Slight but statistically significant differences in the characteristics of the two groups included a greater proportion of women in the SSRI/SNRI group, compared with controls (57% vs. 40%), and a higher prevalence of diabetes (21% vs. 17%) or chronic obstructive pulmonary disease (11% vs. 7%) in patients on an SSRI/SNRI, compared with controls. Patients in the SSRI/SNRI group were more likely to have an infection than were controls (11% vs. 8%), but less likely to have acute coronary syndrome (8% vs. 10%) or cardiovascular disease (67% vs. 70%).

Further studies are needed to ascertain if this is a causal relationship or just an association between SSRI/SNRI use and mortality in ICU patients, she said. The findings are limited by the retrospective nature of the study, which also was unable to control for the effects of potentially important confounders such as smoking status or the presence of depression.

The data came from the Multiparameter Intelligent Monitoring in Intensive Care II database, a public collection of data with patient identifiers removed.

Antidepressants were the most commonly prescribed medication class in the United States in 2011, and SSRIs were the most common type of antidepressant, she said. SSRI use has been associated with increased risk of bleeding, falls, bradycardia, and stroke in previous studies, which also suggest a possible protective effect of SSRIs in patients with coronary artery disease.

Dr. Berg reported having no financial disclosures.

Playing Hide-and-Seek With Psychiatric Drug Studies

by Carl Elliott

If I were in charge of distributing NIH grant money, I’d be sending a lot of it to researchers like Erick Turner, a psychiatrist at Oregon Health and Sciences University and a former FDA reviewer.  You might remember Turner’s name from a terrific study of antidepressants he led a few years ago that wound up in the New England Journal of Medicine. The question he asked was simple. Does the published medical literature accurately reflect the available data on antidepressants? The methodology Turner and his colleagues used was equally simple (although exhaustively detailed and time-consuming to execute). They compared published studies of antidepressants with the studies listed in FDA drug approval packages. What did they find? Well, if a study was positive for the antidepressant, it was almost certainly published. But it the study came out poorly for the antidepressant, the study was probably never published — and when it was, the published version was given a positive spin.

This week, Turner and his colleague performed the same trick with second-generation antipsychotic drugs, this time for PloS Medicine. Although their results for the antipsychotics were not as pronounced as their results for the antidepressants, the pattern was similar. Of the 24 FDA-registered trials, 4 were never published, and, of course, those unpublished trials had all turned out poorly for the sponsor. (Three of them failed to show that the study drug was better than a placebo, and the other showed that the drug was statistically inferior to the control drug.) Fifteen of the 20 published trials were positive, however, and those that were negative showed evidence of bias in favor of the sponsor’s drug. “Some of what we found could constitute spin, some would fall into the category of shenanigans,” Turner told ABC News. “The take-home message is there are loopholes in the publication process by which doctors may be relying on information that’s incomplete or somehow skewed. The drug’s effects may be exaggerated or its safety concerns may be downplayed.”

Turner’s article adds to a growing body of evidence showing just how biased the medical literature on antipsychotic drugs has come to be.  An especially striking paper, published in 2006 in the American Journal of Psychiatry, was called “Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine.” (Or, to translate that title into brand names, “Why Zyprexa beats Risperdal, Risperdal beats Seroquel, and Seroquel beats Zyprexa.”) The researchers looked at head-to-head comparative trials of antipsychotic drugs and found that 90 percent of the time, the sponsor’s drug beat its competitors. If Lilly sponsored the trial, Zyprexa won. If Janssen sponsored the trial, Risperdal won. And if AstraZeneca sponsored the trial, Seroquel won.

Critics of the drug industry often point to studies like this as evidence that we can’t trust what we read in medical journals anymore. That’s probably true, but there is also a deeper ethical problem. All of these psychiatric drug studies involve human subjects, who are taking real risks when they sign up for clinical trials. How many of them would consent to a trial if they understood that the sponsor was going to bury or spin the results in order to market its drug?

Introducing RxISK.org

Why RxISK.org?

Prescription drug safety is an issue for us all.

Adverse side effects from these drugs are now a leading cause of death. And yet experts estimate that only 1–10% of “serious” adverse events (those that lead to hospitalization, life threatening, disability, congenital abnormality, and death) are ever reported. Not to mention the millions of “medically mild” adverse drug events that occur each year — ones that compromise a person’s concentration, functioning, judgment, and ability to care.

RxISK.org, the first free website (not sponsored by big pharma or advertising) for patients and their doctors and pharmacists to research, and more importantly, easily report drug side effects.

Why Should You Report?

No one knows drug side effects like the person who is taking a pill. Yet this voice is not heard. RxISK.org provides a megaphone to you and your healthcare team to change the way we see drug safety.

You may have been told there is no evidence linking the treatment you are on to the problems you are experiencing. One reason there may be no evidence is because you and your doctor have been silenced. Most of the data on prescription drugs is “owned” by the multinational pharmaceutical companies who run 90% of all clinical drug trials — and they’re not sharing data that may affect their bottom lines. And, as mentioned above, only 1-10% of serious adverse events are reported to the FDA.
There is definitely a gap in the data — and we need data for Data Based Medicine.
This is where you and your doctor and pharmacist come in.
We encourage you to use RxISK.org to research prescription drugs and their side effects. But please consider also reporting your side effects. Not only will you be helping yourself — by receiving your free RxISK Report™ to take to your doctor or pharmacist — but you will also be helping others, by adding your anonymized experience to the data on prescription drugs.
RxISK.org is your website to help make medicines safer for all of us.

Our Mission

“We’ve talked about it – and now we’re doing something about it.”
Our goal is the early identification of potential adverse drug events and other treatment-related effects through a unique approach to data collection and analysis.
We believe RxISK.org will succeed because of

  • patients’ desire to have their situation considered by a site backed by an expert team;
  • a commitment to the truth, with no bias;
  • the necessary level of expertise in designing and interpreting patient information as it expands beyond simple yes-no answers; and
  • a single focus — that is, effective adverse-drug-event reporting must be the main mission, not a secondary one.

This will result in a collection of patient and medical narratives, including economic and quality of life information, that will establish the nature of treatment-related effects, the best methods to manage them, and their potential to form a basis for new drug discovery.
Now that the truth about such medications as Vioxx and Avandia has reached the public sphere, the general public is suspicious of messages from drug companies. Appetite for a credible independent perspective based on the voice of the patient is strong.

Our Medical and Research Team

There are few professionals who have the profile and international reputation of Data Based Medicine’s founding team, which includes people who have risked their careers in speaking out about adverse drug events, such as David Healy and Nancy Olivieri, as well as international experts on pharmaco-vigilance such as Ralph Edwards from World Health Organization’s Uppsala Monitoring Center.

Dr. David Healy

Dr. David Healy, Chief Executive Officer and principal founder of Data Based Medicine Limited, is an internationally respected psychiatrist, psychopharmacologist, scientist, and author. A professor of Psychiatry at Cardiff University in Wales, David is a former Secretary of the British Association for Psychopharmacology, and has authored more than 150 peer-reviewed articles, 200 other pieces, and 20 books.

David has been involved as an expert witness in homicide and suicide trials involving psychotropic drugs, and in bringing problems with these drugs to the attention of American and British regulators, as well raising awareness of how pharmaceutical companies sell drugs by marketing diseases and co-opting academic opinion-leaders, ghost-writing their articles. His latest book, Pharmageddon, documents the riveting and terrifying story of how pharmaceutical companies have hijacked healthcare in America and the life-threatening results.
He also publishes through his blog DavidHealy.org and on Twitter @DrDavidHealy.

Dr. Derelie Mangin

Dr. Derelie Mangin is Professor and Director of Research in the Department of Public Health and General Practice in the University of Otago in New Zealand and an expert advisor to the NZ government on drug treatment funding priorities.

Dr. Kalman Applbaum

Dr. Kalman Applbaum is Professor of Medical Anthropology and Global Studies at the University of Wisconsin. He is a pharmaceutical industry expert and former marketing professor at the Kellogg School of Management.

Dr. Ralph Edwards

Dr. Ralph Edwards was Director of the Uppsala Monitoring Centre (UMC) from 1990 to 2009. UMC is a World Health Organisation (WHO) collaborating centre for international drug monitoring located in Sweden. Under his management, revenue grew to in excess of US$40m. He has been President of the International Society of Pharmacovigilance (2000-2004) and is among the world’s leading experts on pharmaco-vigilance.

Dr. Brenda Gallie

Dr. Brenda Gallie is Director of the Retinoblastoma Program at The Hospital for Sick Children, and Professor of Ophthalmology, Molecular Genetics, and Medical Biophysics at the University of Toronto. Her research has revealed basic molecular processes in cancer. She has developed a time-line for medical adverse events to enable patients and doctors to better understand how the adverse event might have evolved — this is incorporated into RxISK.

Robert Whitaker

Robert Whitaker is the founder of Centerwatch (in 1994), an early provider of market intelligence on pharmaceutical companies for investment analysts and others. He is the author of Mad in America and Anatomy of an Epidemic, which analyze the consequences of the indiscriminate use of medications. Robert also publishes through his blog, Mad in America, and on Twitter @WhitakerRB.

Dr. Joanna Le Noury is Senior Research Scientist in the North Wales Department of Psychological Medicine; she has analyzed several large pharmaceutical databases in the course of litigation.

Dr. Nancy Olivieri

Dr. Nancy Olivieri is a Senior Scientist at Toronto General Hospital, and a Professor of Pediatrics, Medicine, and Public Health Sciences at the University of Toronto. Her work explores the role of the pharmaceutical industry in society, and its influence on research and on the evidence base of medicine.

Our Business Team


Peter Wood, FCA, is an Ernst & Young retired partner with expertise in tax, corporate management, and leading-edge technology who has developed several successful web-based businesses. We are fortunate to have Peter leading our business team of operations, finance, marketing, technology, and design professionals.

Contact Us


To contact us, please email: Info@RxISK.org