The Drug Industry's Grip: Pharmageddon by David Healy

[Skyler]

Just when I thought there was nothing new.. outsourcing clinical trials to Asia. ~S

 

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Pharmageddon: The Drug Industry's Grip on Our Health and Lives

An interview with David Healy, an expert witness in homicide, suicide and birth defect legal actions involving psychotropic drugs.

 

David Healy is a Professor of Psychiatry at Bangor University. He is a former Secretary of the British Association for Psychopharmacology, and author of over 175 peer reviewed articles, 200 other pieces and 20 books, including The Antidepressant Era, and The Creation of Psychopharmacology from Harvard University Press,The Psychopharmacologists Volumes 1-3, Let Them Eat Prozac, Mania, & Pharmageddon. He has been involved as an expert witness in homicide, suicide and birth defect legal actions 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, ghostwriting their articles.

 

Rosenberg: Your new book, Pharmageddon, gives a bleak picture of the doctored data, skewed drug trials and rigged treatment guidelines that characterize today’s pharmaceutical industry. Many people will be shocked to learn the abuses are not limited to the US, where direct-to-consumer advertising is legal, but found in Europe.

 

Healy: The situation is identical. Pharma actually finds socialized health care systems easier to exploit. And despite direct-to-consumer advertising, more money is spent on marketing to doctors who are the real consumers. They are also pressured by the treatment guidelines process which is based on “evidence” that Pharma makes sure to keep secret so they are really in the dark, though they may not realize it.

 

Rosenberg: One example you give of Pharma’s reach and power is the eerie symmetry between the Texas Medication Algorithm Project (TMAP), conceptualized and funded by US Pharma, and Britain’s National Institute for Health and Clinical Excellence (NICE).

 

Healy: Despite their public/private differences, both organizations recommend the use of branded antipsychotics like Risperdal, Zyprexa and Seroquel before the use of older, affordable antipsychotics which of course enriches Pharma. One of the otherissues is this–there is a new bill aimed at speeding up the FDA approval process yet again–and also getting regulators to take into account the jobs that come with a strong pharmaceutical sector. Both America and Europe have been keen to keep their companies happy and have turned a blind eye to the outsourcing of clinical trials to Asia and Eastern Europe.

 

Rosenberg: In Pharmageddon, you chronicle how clinical trial oversight has gone from a hospital and university-based system to a for-profit system run by clinical research organizations or CROs.

 

Healy: The drug companies have outsourced all their operations from drug development and testing to clinical trials to scientific and academic writing so that they have become nothing but marketing organizations at their core. At each juncture where they have spun off a traditional responsibility, no one has objected and so it continues.

 

Rosenberg: There have been reports of risks to human subjects in overseas trials as well as bribes and protocol irregularities. Who oversees the ethics of outsourced trials and the quality of their data?

 

Healy: Clinical trials are overseen by private Institutional Review Boards, which are funded by the organizations they regulate–

 

Rosenberg: Like Moody’s and Standard & Poor’s are funded by their clients?

 

Healy: Yes. A recent large trial for the antipsychotic Abilify demonstrates the danger with outsourced clinical trials. On the basis of about 28 trials in the US, Abilify did not prophylactically stabilize mood as the manufacturer wants to claim. But when data from just two trials from Mexico were mixed in, it did. Read More

[Nikki]

Schuyler I get so confused these days over medications.

 

I believe doctors are being fed the wrong info from drug companies. Doctors are blindly prescribing drugs, over drugging people and mis-diagnosing wd and all the other horror stories we read here and have experienced.

 

On the other hand, I have seen and experienced medications help people (including me).

I have also experienced being harmed by ssri's and I too am stuck on the Merry-Go-Round of AD's.

 

I can't seem to get off of Celexa due to the humungus fear of WD. A very resonable fear. It haunts me every day.

 

If doctors would read more, listen more to their patients and researched more then maybe it would releas the drug industry's grip.

 

This problem is alot bigger than me......

 

Hugs

[Altostrata]

Yes, Nikki, sometimes medications can be helpful, doing what they claim to do.

 

The problem of not being able to trust medications is very bad in psychiatry. As David Healy said elsewhere, "psychiatry is completely bought out by pharma."

 

Thanks for posting this excellent article from alternet, Schuyler. (In the future, to honor fair use and inform SA readers, please also post the source of the article, author, and date of the article at the top of the post.)

[Skyler]

)

 

Oops, I edited too much out from the internal header. Will do. (I think, as in hope I got all that ).

[meistersinger]

Move this if needed. Pharma strikes again! These announcements via GRASP, posted without prrmission.

 

 

Autism Spectrum Disorder Studies

 

1. Vasopressin 1a Antagonist for Social Cognition in Autism

 

This is a clinical study of a drug called RO5028442 for the study of Autistic Disorder. Individuals with Autistic Disorder are defined by the DSM-IV as having difficulties with social interaction and communication, and presenting with repetitive behaviors. Many individuals with Autistic Disorder may also have associated symptoms such as irritability, aggression, and self-injury. The study will also help to see if the new drug is safe, tolerable and effective in reducing the symptoms of autism.

The study aims to:

● Explore the effects of a single dose of RO5028442 in adult high functioning autistic patients of exploratory biomarkers (ex. eye-tracking) of core deficits of the disorder

● Assess the safety and tolerability of a single dose of RO5028442 in adult high-functioning autistic patients

● Explore the correlation between AVPR1A polymorphisms and response to RO5028442 in high functioning autistic patients. In other words, we will explore whether or not certain genetic characteristics will predict patient response to the study drug, RO5028442.

Background

The study drug RO5028442 is a potent and highly selective antagonist of the human vasopressin type 1a (V1a) receptor. Vasopressin is thought to have a profound influence on higher brain functions such as emotional control and social behavior, or, the behaviors that comprise the associated symptoms of autism spectrum disorders. In non-human animals, vasopressin has been implicated in male typical social behaviors such as pair-bond formation and courtship, and vasopressin was also found to affect social recognition and interaction in rodents via its modulatory effect on olfaction (a sensory modality that may also be impaired in autism spectrum disorders).

Importance

Currently, there exists no reliable pharmacological treatment that selectively addresses behavioral problems for autism spectrum disorders. In addition, there is a dire need for intervention that can help clinical populations with associated behavioral disturbances of autism. This study is important in proving the efficacy, in a large-scale clinical trial, of a novel approach to threat the core deficits of autism spectrum disorders

If you or your child are interested in participating in this study, please contact Tara Kahn at (718) 653-4859 x226 or tkahn@montefiore.org

2. Milcanipran (Norepinephrine Reuptake Inhibitor) for Autism

 

Autism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders beginning prior to three years of age. There are three core symptom domains of ASD, including social deficits, repetitive behaviors and language deficits. Patients can also have associated symptoms of attentional deficits, disruptive behaviors and intellectual disability. There is currently no FDA approved treatment for the core symptoms of autism.

Focussing on the underlying brain circuitry of autism, we are interested in the relationship of the locus-coeruleus/noradrenergic (LC-NA) system and dramatic fluctuations in behavioral states in autism. Specifically, we are interested in observing how intrinsic and environmental stressors acting upon a substrate of genetic and epigenetic variations during a protracted maturational window of vulnerability developmentally dysregulate the LC-NA system. Dysregulation of the LC-NA system may be associated with compulsive behaviors and an absence in inhibition, as found in ADHD or symptoms of autism spectrum disorders.

The drug Milnacipran is said to play a role in the activation and normalization of certain brain circuits (the locus-coeruleus-noradrenergic system). If the LC-NA has been functionally deactivated at an early stage of development, as research suggests, it may be capable of being restored with a norepinephrione reuptake inhibitor such as Milnacipran. In this study, then, we use Milnacipran to regulate LC-NA system function and improve symptoms of autism such as attention, irritability, repetitive behaviors and social cognition.

In this study, we hope to:

1. Determine whether Milnacipran improves attention dysfunction in patients with autism

2. Determine whether milnacipran improves irritability, repetitive behaviors and social cognition in patients with autism

3. Determine whether Milnacipran normalizes motor impulsivity brain circuitry (right inferior frontal to subcortical circuirty) on functional MRI in response to the Motor Inhibition NoGo-Go Task

If you or your child are interested in participating in this study, please contact Tara Kahn at (718) 653-4859 x226 or tkahn@montefiore.org

3. An fMRI and Epigenomics Study in Adult Autism: Response to Intranasal Oxytocin and Placebo

 

Oxytocin, a nine-amino-acid peptide, is widely distributed throughout the peripheral and central nervous systems and has been found to affect affiliative behaviors, including sexual behavior, mother-infant and adult-adult pair-bond formation, separation distress, and other aspects of social attachment. Further, oxytocin has been shown to affect behaviors that show a striking similarity to the symptoms of autism; namely, oxytocin affects the expression of repetitive behaviors, stress reactivity and the regulation of affiliative behaviors. From these findings and preliminary findings from Dr. Hollander’s research, it is believed that oxytocin may be involved in the etiology of autism, and may be a valuable tool for the treatment of autism spectrum disorders. In this study, we seek to explore safety and therapeutic efficacy of intranasal oxytocin in treating repetitive behaviors and social functioning/cognitive deficits in adults with autism spectrum disorders.

Evidence is emerging that the three symptom domains of autism (i.e., the core domains of deficits in social functioning; deficits in expressive and receptive language and non-verbal communication; and repetitive behaviors and restricted interests) are expressed through discrete neuropathological brain circuits. In addition to treatment with intranasal oxytocin, we also administer fMRI and cognitive activation paradigms to explore the neural activation patterns of the social and repetitive behavior domains in subjects with autism and the mediating effect of oxytocin on such circuits.

In addition to oxytocin treatment and fMRI analysis, this study uses epigenetic findings to illuminate the underlying endophenotype of autism. We examine the oxytocin receptor gene (OXTR) which has recently been associated with hypermyelination of the gene promoter, and a reduction in mRNA expression. Epigenetic regulation of OXTR may be an important factor in the development of the disorder, and may potentially be helpful in predicting response to oxytocin treatment, and as a moderator of oxytocin treatment response.

If you or your child are interested in participating in this study, please contact Tara Kahn at (718) 653-4859 x226 or tkahn@montefiore.org

 

4. Trichuris Suis Ova and Autism

 

**note: this study is still pending**

The link between the symptoms of autism and the body's immune system is of great interest to our team. Specifically, we are interested in the febrile response in autism; symptoms of autism seem to dissipate in times of fever. The effects of febrile response in autism can be attributed to either an immune-inflammatory response or a direct effect of temperature on clinical symptoms. In this study, we seek to test a novel approach to ASD that will differentiate the two and would support the immune-inflammatory mechanism of the febrile response in ASD.

In this study, the eggs of Trichuris Suis Ova (TSO), a helmith porcine whipworm, are diluted into a liquid and given to patients for ingestion. In turn, the ova hatch in the small bowel and release larvae that mature into adult worms, however these worms cannot effectively multiply in the host and are not easily transmitted to others, hence they are not readily spread to other humans. Through an anti-inflammatory response, TSO regulates immune function and may, in turn, affect behavioral symptoms in individuals with autism.

Current pharmacological approaches to autism point to immunomodulatory effects in autism symptomatology; many FDA approved medications, prescribed for the symptoms of autism, act on the immune system. Risperidone, an FDA approved treatment for irritability and aggression in autism, has been found to have immunoregulatory effects through suppression of proinflammatory cytokines. Lithium has also been used in autism and studies of lithium have shown it also has immunoregulatory effects.

The autoimmune response triggered by the investigational agent may be effective in reducing repetitive behaviors, aggression, self-injury and impulsivity. The immunomodulatory pathways affected in ASD may not be influenced by the helminth TSO, and there is a possibility other tests and therapies for immune function may be a better fit for ASD. However, given its ability to inhibit the production of proinflammatory cytokines and restore balance to the Th1/Th2 system, and its success in treating other autoimmune disorders, it stands to reason that TSO may be a good test of the

immune dysfunction hypothesis in ASD.

If you or your child are interested in participating in this study, please contact Tara Kahn at (718) 653-4859 x226 or tkahn@montefiore.org

5. Hyperthermia and Autism

 

**note: this study is still pending**

The link between autism and immune function is of great interest to our team. Specifically, we are interested in the febrile response in autism; clinical symptoms, such as irritability, aggression and repetitive behaviors, seem to improve during fever. This fever induced amelioration of symptoms could be due to one of three possible causes:

1. The direct effect of temperature;

2. A resulting change in the immune inflammatory system function associated with the infection or fever; and/or

3. An increase in the functionality of a previously dysfunctional Locus Coeruleus-Noradrenerigic (LC-NA) system.

In this study, we seek to directly explore the effect of increased body temperature on autism symptomatology. Artificially increasing body temperature, we believe, may mimic the febrile response and yield an improvement in language function, social cognition and a decrease in disruptive behavior. The many parental reports received regarding the improvement of symptoms during febrile episodes warrant further investigation into the febrile hypothesis for the exploration of a possible etiology of ASD and potential treatments that may result. The hyperthermia hypothesis is a novel approach to simulating a febrile environment and has not been explored in a clinical research environment. Results from this study, whether positive or negative, will impact knowledge of autism spectrum disorders, as they will either provide a new avenue for treatment exploration, or rule out one of the three potential theories regarding the febrile hypothesis.

If you or your child are interested in participating in this study, please contact Tara Kahn at (718) 653-4859 x226 or tkahn@montefiore.org

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[aza]

Over the last servral evening's I have benn watching a documentary that strongly speaks to this forum, hopefully this is not a repeat, sorry if it is.

 

 

The Marketing of Madness freely available on Youtube!

 

This is the second movie documentary about bad medicine the other documentary wss (Doctored) released in 2012. An other well made documentary in part about Big Pharma.

[Altostrata]

Maclean's just named Pharmageddon as one of the best nonfiction books of 2012 http://www.sfgate.com/business/prweb/article/RxISK-Founder-Dr-David-Healy-Makes-Maclean-s-4305571.php

[aza]

Maclean's just named Pharmageddon as one of the best nonfiction books of 2012 http://www.sfgate.com/business/prweb/article/RxISK-Founder-Dr-David-Healy-Makes-Maclean-s-4305571.php

 

WOW! That was great! Did my Rxisk assesment on Gabapentin. You don't see that every day.

 

Thanks Alto