Drug safety affects all of us

via Today in Science History:
"It is not enough that you should understand about applied science in order that your work may increase man's blessings. Concern for man himself and his fate must always form the chief interest of all technical endeavours... in order that the creations of our minds shall be a blessing and not a curse to mankind. Never forget this in the midst of your diagrams and equations." Albert Einstein Address to students of the California Institute of Technology, Pasadena, California (16 Feb 1931). In New York Times (17 Feb 1931), p. 6

via ALLIANCE FOR HUMAN RESEARCH PROTECTION:

 

The Alliance for Human Research Protection (AHRP) is a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to minimizing the risks associated with such endeavors and to ensuring that the human rights, dignity and welfare of human subjects are protected www.ahrp.org

Advancing Honest and Ethical Medical Research 

Vital drug safety information should never be hidden as a “trade secret.”  Drug manufacturers who obtain a public license to market their drugs should have to provide access to vital safety information.

After much debate, an important public safety program begun in 2010 by the European Medicines Agency (EMA) provided access to physicians and the public to the data from clinical trials that drug manufacturers used to gain marketing approval for their new prescription medicines in Europe.

The program was hailed by American, and European researchers--indeed by researchers around the world--as a major step towards improving drug safety.

Prior to the EMA disclosure program, the only way access to clinical trial data was gained was through lawsuits.

But by the time any legal action had been taken against a drug manufacturer for failure to disclose serious adverse effects, the companies had amassed their mega-profits, but thousands of patients suffered serious harm. That scenario cannot be tolerated.

AbbVie is the manufacturer of Humira, the number one selling medication in the world with projected sales of $10 billion in 2013; and InterMune, manufactures the pulmonary-fibrosis drug Esbriet that has recently been approved in Europe at a cost of over $40,000 per year.

These two companies have filed a lawsuit against the EMA in an effort to block access to vital safety information about the serious risks the companies know that these drugs pose.

Their motive is simple and self-serving: they are attempting to protect their profits by concealing their products' hazards. 

They are demonstrating that they have no regard for the safety of those who consume their drugs--their only concern is for their profits.

Please sign the petition--drug safety affects all of us.

Link to petition: http://www.change.org/petitions/richard-gonzalez-of-abbvie-and-daniel-welch-of-intermune-drop-your-legal-action-blocking-access-to-ema-clinical-trial-data

The petition calls upon AbbVie and InterMune to drop their European Union lawsuit and release all patient level data on Humira, Esbriet and their other products.

 Copies of the petition have been sent to:

President Barack Obama;

Margaret Hamburg, M.D., Commissioner, Food & Drug Administration;

Secretary General Ban Ki Moon, United Nations;

World Health Organization Director Dr Margaret Chan.

Sign the petition and pass on the request to your colleagues, as I have.

With very little effort, you may help move mountains!

Vera Sharav

cartoon Roger Schillerstrom Drug Discovery and Development 2008

Lost in Translational Science: Anosognosia Due to Pharmacosis

Lost in Translation

via NIMH Director's Blog:

Experimental Medicine
By Thomas Insel on June 12, 2012

an couple excerpts:

"Existing antidepressants and antipsychotics have many proposed molecular targets, but none that have been shown to be necessary or sufficient for their clinical effects. 

Amazingly, after three decades of broad use of these medications, we still don’t know how they work when they are effective.

"As a result, NIMH is shifting from large clinical trials that promise an incremental improvement to a model called “experimental medicine.” In experimental medicine, drugs are used as clinical probes and the immediate goal is not to develop a treatment but to identify or verify a target." here

Psychopharmacology is, and always has been "experimental medicine."  It is not Evidence-Based.  Now, the director of NIMH is stating, "antidepressant effects have variously been proposed to involve changes in serotonin neurotransmission, hippocampal cell birth, and changes in stress hormones, among many other effects. By ruling out some targets and focusing on those involved in the biology of the disorder, we can direct treatment development much more efficiently."

What is Thomas Insel smoking?  A pathophysiological disease process causing depression has not been identified. Belief that depression is caused by an unidentified biological disease, is  not 'evidence' validating a hypothesis. Without identifying a disease and it's pathophysiology; how could anyone hope to identify a treatment target? Let me guess: the target will be identified after a drug's mechanism of action is identified.

This strategy never has worked out very well.

What 1 Boring Old Man had to say about Thomas Insel and this blog post, New Directions: 

He believes what he thinks is the truth.  At Yerkes, he was not reappointed Director after five years – largely because the staff didn’t want him back. He was toodirective. He took the term Director literally and tried to channel the direction there too vigorously. Now he’s doing the same thing at the NIMH. I gather he genuinely believes that the future direction for mental health is in newer, more effective medications. Under his direction, he’s incentivised this goal and micromanaged the direction of research efforts.

The argument he makes in this blog could’ve been made at any point in the history of psychiatry, but he presents it with a messianic sense of urgency and priority. His job at the National Institute of Mental Health is to create an environment that shepherds our best and brightest minds to follow their scientific instincts, not Tom Insel’s. Like his colleagues on the APA’s DSM-5 Task Force, he’s trying to hold on to a paradigm that is in a phase of exhaustion, now bordering on toxic. It’s a time for consolidation, for reflection, for stepping back and contemplating. It’s a time for new directions, and a new Director at the National Institute of Mental Health… here

Thomas Insel must have Pharmacosis: a loss of insight and an inability to access reality.  It is highly contagious, and is spread by disseminating biased, otherwise inaccurate, and/or  completely false 'information' about the illusion of psychiatric diseases; and the effectiveness of psychiatry's prescribed pharmacological treatments  to treat illusory psychiatric diseases...

Dr. David Healy wants to talk to an American woman who contacted GSK about Paxil in 2001

drugs.com

Dr. David Healy a psychiatrist, psychopharmacologist, scientist author, and founder Rxisk, is looking for an American woman who was communicating with GlaxoSmithKline in 2001 asking about the risks of Paxil for fetuses.  The Zip Code on the return address is/was 49426/0989, this would be Hudsonville, Michigan.

via Dr. David Healy's Blog:

American woman

April 19, 2012 

On Thursday, May 31, 2001, a woman whose name is known only to GlaxoSmithKline emailed the company:

I was absolutely distraught

“My name is… I was diagnosed with panic disorder about four-and-a-half years ago. Since that time I’ve been taking Paxil, which is truly a miracle drug. I’ve been panic-free with this drug and have been able to go on with a normal life.

“I was married in October of 2000. My husband and I found out we were pregnant at Christmas time. I was so excited. I love children. The only problem is that I carried the baby to six months gestation and then had to have a termination.

“The doctors diagnosed my son with Truncus arteriosis. They said he would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered (if he was able to make it to that time). To say the least, I was absolutely distraught with this news. I thought this was something that I did, was because I stayed on the Paxil for selfish reasons.

“I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies. My husband and I are ready to try again to get pregnant in the next month or two. I am so nervous. I don’t want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby I want to know upfront. And I will somehow stop taking it for the time being.

“Please contact me as soon as possible. I love everything this drug has done for me. read here