MHRA Promote Broken System

Yellow Card System Remains a Red Flag

This weekend the British drug regulators, MHRA, are using Twitter to promote their broken Yellow Card ADR reporting system. The Yellow Card is MHRA's initiative whereby prescribers and patients can report adverse drug events regarding prescription drug use.

Here are some recent MHRA tweets:

Medicines you buy are usually for short use, check the leaflet & don’t take them too long. Report side effects to us: https://t.co/ivq8amKHtd pic.twitter.com/W9gO0vN0A1

— MHRAgovuk (@MHRAgovuk) November 24, 2017

Reporting side effects can lead to new warnings for patients. See the positive impact of reporting: https://t.co/FPEv085ih3
Report side effects to us: https://t.co/HjjWaiBmdD pic.twitter.com/Io9jfRudKy

— MHRAgovuk (@MHRAgovuk) November 22, 2017

One would think the MHRA are finally starting to acknowledge that reported adverse drugs reactions can improve patient safety and product warnings. However, the MHRA refuses to follow up on Yellow Card reports. Thus, reporting adverse drug reactions (ADRs) has little to no value in improving public health.

MHRA should follow up Yellow Card reports by contacting doctors and/or consumers to seek relevant info regarding the reported adverse drug event so that MHRA can then determine what role ADRs played in causing harm.

Let's say Mr. Smith loses his wife to suicide. After conducting independent research, Mr. Smith learns the drug his wife was prescribed may have contributed to her demise. He then submits a Yellow Card report to the MHRA.Upon receipt of his report, the MHRA will add the adverse event to a database. MHRA won't bother following up. They won't contact Mr. Smith to ask pertinent questions such as, "Did Mrs. Smith's mood worsen when she was talking the drug?" or "Was Mrs. Smith warned by her prescriber that the product is known to create suicidal thoughts and actions?"  Instead, the MHRA will merely add the adverse event to their database where it will sit for infinity without further investigation.

When consumers alert the MHRA that the adverse event might have possible causation, the MHRA routinely claims, "correlation does not equal causation." I say routinely because the MHRA failed to follow up Yellow Card submissions and can, therefore, continue to claim there's "no correlation."

As a patient advocate, I have, in the past, alerted the MHRA that there were 79 reported cases of suicidal and self-injurious behaviours on the same drug. (Paxil) If Paxil was the product Mrs. Smith was taking at the time of her death, the MHRA would again parrot their "correlation does not equal causation" line. Mrs. Smith's ADR then becomes just another suicide that has very little to do with the drug she was taking.

By promoting the Yellow Card reporting system on Twitter, the MHRA is asking prescribers and consumers to continue sending reports that the MHRA will never follow up. Even if the suicidal and self-injurious behaviours statistic for a particular drug increase, the MHRA will always be able to claim that just because people die of self-inflicted injury whilst taking a prescription drug, it doesn't mean the drug caused the suicide.

This works well for the MHRA but doesn't work to protect consumers. The MHRA responds by repeatedly claiming consumers are dying by suicide because of mental health challenges. They will further stress that patients should continue taking their prescriptions and talk to their doctors if new or worsening symptoms occur.

And so it is: The MHRA's new Twitter campaign promotes consumers as guinea pigs on a dizzying carousel ride. Round and round we go on a cheap carnival ride with faulty rivets and a drunken operator. Similar to the banking industry responsible for the financial demise of countless hardworking citizens, the MHRA knows there's a systemic problem and that it is the public who will pay the price for MHRA's willful indifference to critical drug safety.

Just as the banks sold dodgy mortgages, the MHRA peddle dodgy promises to further the myth that they exist to promote health and safety. In truth, they don't. Their protocol for managing dangerous drugs will always benefit the pharmaceutical companies who pay their wages. The MHRA is fully-funded by the industry who make the products noted in Yellow Card reports. Hence, the MHRA won't follow up Yellow Card reports.

MHRA's new tagline should be "correlation does not equal causation." At least this would help alert unsuspecting consumers that with MHRA at the helm, there is grave danger.

I've been banging the drum about this problem for years. Here's a recent Podcast I did that highlights this.



Bob Fiddaman


MHRA 'Yellow Card' Related

My Meeting With The MHRA - (PDF) September 2, 2008

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I - November 26, 2011

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip" - November 27, 2011

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine - November 28, 2011

MHRA In Buck-Passing Specialist Cahoots - December 07, 2011

MHRA: Follow-Up Rate at a Price - September 29, 2015

MHRA: "We Now Consider This Request Closed" - October 20, 2015

The Mechanics of the MHRA - December 03, 2016

SSRI Deaths in Clinical Trials - May 05, 2017

MHRA Seek Payment For Info on Deadly Drugs - June 05, 2017

MHRA: No Deaths in Pediatric Trials, But What About Adults? - July 17, 2017

Danny Lee-Frost of the MHRA - July 20, 2017

EXCLUSIVE: MHRA Asked Sky News to Remove Antidepressant Reference - July 25, 2017

Guest Post: My Trip Through the Polypharmacy Blender II

The following is a guest post from Rory Tennes. It's a follow-on from a previous guest post he wrote for David Healy on RxISK.

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A couple years ago I wrote my story and posted it on www.RxISK titled: “My Trip Through The Polypharmacy Blender”

Below is a short summary followed by an update on my life as it is now. Many thanks to Bob Fiddaman who kept encouraging me to finish this after several starts, fails, and stalls. It is difficult to write due to having to relive the painful emotions of what I had to survive and live through while telling this account of my life.

In short, I was ill, injured and in constant pain. I went to my doctors for help and they proceeded to drug me into oblivion. I had been in pain for a long time, years in fact and it was getting worse, interfering with my ability to work and function in every area of life. I went to my PCP or family doctor because after all, he knew me well and I could trust him. After a quick and mostly verbal exam, he diagnosed me with fibromyalgia and started prescribing medications. They helped a little but not much so he kept adding and changing medications. Little did I know that he, like the majority of doctors, did not know much about the drugs he was prescribing and what they actually do to a person, physically and emotionally do to a person. He, like most doctors and patients, believe what we have been told about prescription drugs. They are safe, effective and the “side effects” are mild and rare.

Nothing could be further from the truth.  The “side effects” are not mild and they are not rare. Drug companies have done an excellent job of deceiving most of us about the truth of what these chemicals actually do inside a body. I began to have emotional and behavioral problems after a few short months of “treatment” with medications so my doctor sent me to a psychiatrist. That was another huge mistake, one that cannot be exaggerated enough. The shrink added more drugs on top of what I was already taking, completely ignoring the drug interaction warnings and completely neglecting to inform me of what to watch out for. The more he drugged me the worse I became. My emotions, my behavior, my life spiraled out of control and I was at the point of suicide to end the horror of what my life had become.

Five major drug interaction warnings for serotonin syndrome. Seven for seizures and blackouts and he said nothing to me. Neither did any other doctor I was seeing nor any of my pharmacists. No one said a word about it until I specifically asked my family doctor when I went to see him out of desperation and as a last stop before ending my struggle the only way I could think of ending it.

I asked my PCP if he saw a problem with my medications because I was not getting better but getting worse and I was at the end of my rope. When he saw the list he panicked, literally panicked.

“Who prescribed this? You can’t take all of these drugs together. This is lethal! You have to stop. Serotonin syndrome. You have to stop now!” All of my doctors saw my medication list each time I visited them. That is what we are told to do, bring your medication list to every doctor appointment.  He was the first to say anything about my medications and I suspect it is only because I specifically asked him about it.

So I did. I stopped five of the medications cold turkey that day, five that he checked off on the list of more than ten prescriptions. That was the beginning of my recovery. A long and painful recovery that is still in progress.

Three Years Later

The pain was not fibromyalgia, it was autoimmune arthritis. It has a long scary name but basically, it is a form of rheumatoid arthritis that is serum negative for rheumatism. Undifferentiated Spondyloarthropathy or USpA. It is not uncommon, just not well recognized at the time and often misdiagnosed or undiagnosed as in my case. Because it was undiagnosed for 30 plus years it really made a wreck of my spine and shoulders. Three multi-level spinal fusions repaired the worst of the damage but there remains a great deal of structural damage and a good deal of daily pain.

The wreckage left by the disease is much easier to bare than is the wreckage left by the “treatment” by the western medicine model that uses pharmaceuticals and the damage they cause to lives and relationships and reputations.

What Is Left Over?

My marriage did not survive the ordeal and now I am no longer in touch with two of my three children due to the events related to my “treatment”. There is no doubt these events are related, in fact directly caused by my “treatment”. These events, behaviors, are spelled out in black and white in the FDA and in the drug company self-administered test research data and warnings. Spelled out clearly and precisely and then often followed by the phrase, "these side effects are mild and rare". Be advised, that phrase is well crafted to intentionally disarm the natural human self-preservation instinct we all have. The instinct to pay attention, to be alert to a possible danger and to act when we experience the afore-described phenomena. The phrase is very effective. Even effective on the professionals who prescribe and distribute those drugs because most of them do not consider the side effects important enough to mention to the patient. After all, the findings come from those who are educated and in authority so it must be true.

A side note; “Side effect” is a term created by drug manufacturers. Drugs do not have side effects. There is no such thing as a side effect. Drugs have effects. If one has a reaction as a consequence of taking a drug it is an effect of the drug. Calling it a side effect is intended to make you think it is unintentional, inconsequential and therefore not important. It really didn’t happen or really does not matter because that was not the reason you took the medication. The term is an intentional disarming tool created and skillfully used by drug companies.

Another phrase often used by drug companies is, “your doctor has determined the benefits outweigh the risks of using this medicine.” Did your doctor actually say that?  Does your doctor actually know that is true, is it a fact or at least a realistic expectation?

Interestingly the doctors are just as susceptible as we are to the power of suggestion of these phrases. The truth is our doctor often does not know what the risks are. They have not bothered to research the risks, instead relying on what the drug company sales representative verbally told them in the office sales pitch about the drugs.  Sadly, that is as far as most doctors go with research on the tools they use to treat you with.

What Is Left Of My Life Now I Am Alone?

I have a few friends and a few family members who understand and support me. I now have a criminal record as an abuser. Something completely opposite of my true character. That is what the drugs are capable of doing. They can and do change a person to someone they are not.

Take a person who is ill, injured and in pain, put them on mind-altering chemicals that cause serotonin syndrome, akathisia, and disinhibition and see what you get. You get a person stuck in the fight or flight mode. A person who is in survival mindset and who has lost control over how they act regardless of what they know to be right and wrong. Contrary to the belief of many, even professional councilors, it is possible to cause a person to lose the ability to choose how to act 100% of the time and choose how to behave at all times. If you think that is not true try it yourself. It is entirely possible and even very likely that if you alter a persons brain chemistry that person will lose the ability to choose how to behave. They may be able to choose most of the time but not all of the time.

So today I carry around a criminal record as an abuser even though my true identity is nothing like that. My life up until this point had a nearly spotless record save a few traffic tickets, most of which originated in my youth. I was an upstanding, law-abiding citizen, so much so that I had a license to carry a handgun concealed on my person if I chose to do so.

Now during the period of "treatment" in the form of drugging with as many as 12-14 psychoactive pharmaceuticals at a time, all legally prescribed and taken as directed, I was a menace to society. Not so much to society really but more to myself and to the people I loved the most and who bore the brunt of my drug-induced and akathisia driven behavior. Chemically altered, I was not myself and I was helpless to do anything about it.

Seeking Justice

Now having some time to somewhat recover from the drugging and from the emotional turmoil, I wanted to do something to help myself and other individuals and their families, possibly saving them from a similar fate or worse than the one I had to endure. At first, I had anger toward the doctors whose negligence caused my and my families suffering. I went after a way to try to recoup some of the monetary loss caused by their mistakes and at the same time hopefully dissuade the doctors and pharmacists from being so careless in the future. I contacted some 20 law firms, presented my evidence to them and asked if they were interested in representing me in a lawsuit. All of them said I had a strong case, most of them said I had an 80-90% chance of winning. However, they said, because of Tort Reform in Texas limiting the maximum award amount to $250,000, it would not be profitable enough for them to pursue a lawsuit. They said it costs about $100,000 to prosecute a medical negligence case and that there would not be enough money left over to make it worth their while to take the case. It's not that I couldn't win, just that they could make more money on other types of cases.

OK, I thought, I'll go to the Texas Medical Board first and try to obtain a ruling or sanction against the psychiatrist first, then threaten a lawsuit and force him to settle without a trial. Surely that would work in my favor. Wrong again. I filed a complaint and waited for an answer. After two months waiting, I received a letter with a two-sentence denial stating there was not enough evidence to show the 'good doctor' was negligent in his treatment. I was really surprised because I was very careful and methodical in putting together all the evidence. I had my medical records from him and all my doctors including his notes from each appointment, pharmacy records, testimony from my wife who attended most of my appointments, everything I needed to show that he prescribed multiple medications that I should never have been taking simultaneously. Records showing cold stops and starts with multiple psych drugs simultaneously, multiple drug interaction warnings, no instructions about side effects to watch for, reporting from my wife and I about my condition involving anger and aggression. It was all there in black and white.

Stunned, I filed an appeal, went to Austin for the hearing and testified with all of my evidence which was very clear and sufficient to show negligence.

I was stunned again with a ruling that there was not enough "clear evidence" showing negligence. I could not even get validation that anything wrong was done. I could not get the powers that be to acknowledge I had been treated incorrectly. I could get no validation that the doctors and pharmacists had done anything wrong. The evidence was there. It was clear and condemning, even in the doctor's handwritten notes.

You see, the Medical Board is made up of doctors and healthcare providers and they protect their own. They too may one day need the protection of their peers so they are not about to stain the water by punishing one of their own.

Today

So here I sit today. My life completely uprooted, burnt and in ashes from the firestorm of "treatment" I received because I did what I was supposed to do. Go to your doctor and follow his/her instructions. And there is nothing I can do about it. I cannot even get validation that anything was done incorrectly. What irks me even further is that these healthcare professionals were paid well to practice medicine in this way. They were compensated well, praised for their work, respected by the community and their peers while all the while making me out to be the bad guy, the one who was sick. I trusted them and paid them to destroy my life.

The justice system is just as bad. They believe what they are told by professionals in the medicine and healthcare system. Furthermore, they feel compelled to dish out justice when something wrong is done but they suffer from a systemic flaw that does not allow them to find the real culprit. The pressure is on them to do something and they automatically take the easy and most obvious route at dishing out punishment directed at the most obvious offense, even though the offender may not be the one truly at fault. The offender may be a victim as well. But, it is easy, safe and more economical to focus on the most glaring, the most currently popular and trending knee-jerk, emotion-triggering act. Physical abuse. They go home with a win in their pocket and a sense of accomplishment without being questioned by anyone and without ever having to ask the difficult question. Why? What caused this? Who is responsible for this? What contributed to this?

For this, they are compensated and praised by everyone. That praise cements their conviction that they were right, that they did the right thing. Besides, even if they did know or even suspect that the prescriptions were the cause they face a huge uphill battle against wealthy pharmaceutical companies who hire expert lawyers. Lawyers who know how to obfuscate and twist the truth so there is doubt enough to absolve them of guilt. A win would be hard to get and a loss would not look good on a prosecutors record.  That record of wins is how they are graded and compensated so getting at the truth is not their first priority, winning is. That is a systemic flaw preventing true justice being done.

I am left wondering how many times this has happened to unsuspecting people. People who still probably do not know what went wrong. People who are left thinking they are at fault when in fact the fault squarely rests on the healthcare providers and the pharmaceutical companies who peddle this poison and intentionally mislead doctors and the public about what the drugs actually do. It is 10 months since my trip to Austin and the humiliating experience of being blamed again for what was clearly not my fault. I am just now beginning to feel like I can pick myself up and try to salvage a life from this mess. Just now groping to find the will to get up every day and find a positive attitude so I can move forward.  I'm still not sure what I want to do or even what I am capable of accomplishing. I want to continue to try to make a difference, if for no other reason than to possibly help prevent some other persons and families from having to suffer this kind of hell. Just not sure what to do at this point. Somehow I have to find a way to support myself since my wife divorced me and took away the last bit of security I had in this world. After supporting myself I will have to dig up the energy and will to continue trying to make a difference. That is hard to do because I have been having to swallow the bitter pill of defeat each time I made an effort to do something.

Lessons To Be Learned

One invaluable lesson I have learned is to trust no one and no institution until they earn that trust. Not healthcare, not the justice system, not the Medical Boards or any other consumer safety organization and certainly not any business institution such as pharmaceuticals who have a profit margin at stake. If I sound jaded or angry it is because I am. I am with good cause to be angry, not just because of what happened to me but because this continues to happen every day to other good people who often never learn the truth. My Dad was one of those good persons. He died thinking he was sick, but that is another story to tell. A life completely destroyed by negligent treatment by healthcare as it is today.

Lives are being destroyed for the sake of profit and the guilty go unpunished.

Rory Tennes

Malcolm Young (AC/DC)

It is with a heavy heart that I write this.

AC/DC, particularly, Malcolm Young, have been so inspirational for me throughout my life.

I remember being a spotty 14-year-old kid at a local disco. For weeks I listened to Anita Ward, "Ring My Bell", Olivia Newton-John, the Bee Gees, and other disco-type songs that just didn't cut the mustard for me.

I was waiting for something that I could tap my foot to. The DJ then spun a disc. 'Na-na-na-na-na-na-na.' I didn't have to wait to hear the lyrics, the intro was enough. "A Whole Lotta Rosie", off the album, "Let There Be Rock" reeled me in, so much so that I joined a small circle of dandruff-shakers in the middle of the dancefloor.

The rest, as they say, is history.

I went home and listened to the album that, unbeknownst to me, had been purchased by my elder sister.

It was 1978 and AC/DC had been kicking ass for a number of years. Armed with pocket money that I saved I headed toward Birmingham city centre some weeks later and purchased 'Powerage', an AC/DC classic that, to me at least, has never been bettered...by any band.

Nothing but AC/DC for me.

My first live experience was 1979. AC/DC played Stafford Bingley Hall. I was down the front, I even got the thumbs up from Bon. Months later they played the Birmingham Odeon, a gig where they brought on strippers for the song, "The Jack."

I saw them religiously every time they toured and have been lucky enough to appear as an extra in two of their videos (Are You Ready and Rock Or Bust)

Malcolm was the nuts and bolts of AC/DC. I've always said, Malcolm is one of the best guitarists in the world, I've even put his guitar abilities ahead of Angus.

Yeh, in those early days I always watched Angus on stage but later I always turned my attention to Malcolm. Standing at the back, to the left as I looked at them. Occasionally moving forward for harmonies and backing vocals...then returning to his spot for more foot-stomping riffs.

He'd been ill for some time. Dementia had caught up with him along with other illnesses that the band and family kept 'in-house'.

Inevitability doesn't make life any easier and although Malcolm and I never met in person, today's news is still hard to accept. His riffs put a fire in my belly and helped me many times during my darkest hours of battling through Seroxat addiction.

He was the riff master, he always will be.

Rest in peace, you fucking legend!

Bob Fiddaman

Business as Usual Means Bad News for Consumers

As an advocate for drug safety, I sometimes feel as if I'm pissing in the wind. Today is one of those times. (For American readers, the Cambridge Dictionary describes pissing in the wind as "trying to do something when there is no hope of succeeding.")

This week President Trump nominated Alex Azar as the next Secretary of the Department of Health and Human Services (HHS). Azar is former senior vice president of corporate affairs and communication for US pharmaceutical giant Eli Lilly. This US announcement comes on the heels of similar incestuous behavior by the UK government which recently announced Andrew Witty, former head of GlaxoSmithKline, has been selected to head its new pathway, 'Accelerated Access Review' (AAR). Days later, GSK's website highlighted another kick in the teeth for British drug consumers: Patrick Vallance, who is currently GSK's president of research and development, will become the UK government's new Chief Scientific Adviser.

What a sick few weeks for health consumers. Three top executives from Big Pharma land positions that are supposed to better protect health consumers by ensuring scientific information is accurate, and drugs are safe and effective. These three appointments should prompt Britain and US residents to take notice and be on full DEFCON alert. I'm certain families across the globe who have lost loved ones to Prozac and Paxil won't be jumping for joy at this week's announcements, and I imagine their dead relatives are turning in their graves.

Lilly & GSK are two companies that have frequently been sued by consumers who were harmed by their dangerous products. Further, both companies have engaged in abhorrent and illegal tactics to peddle their pills. Some of these unscrupulous behaviors include paying doctors to prescribe, bribing government officials, and fraudulently marketing drugs for unapproved uses. But apparently, this type of leadership is rewarded by governments that prefer corporate collusion to consumer care.

GSK and Lilly have paid billions in fines and lawsuits because their illegal activities caused the suffering and deaths of countless innocent men, women, and children. In 2009, Lilly was fined $1.42 billion to resolve a government investigation regarding off-label promotion of the antipsychotic Zyprexa. Zyprexa had been approved for the treatment of certain psychotic disorders, but Lilly admitted to promoting the drug in elderly populations to treat dementia. The government also alleged that Lilly targeted primary care physicians to promote Zyprexa for unapproved uses and “trained its sales force to disregard the law."

Similarly, in 2012, GSK agreed to pay a fine of $3 billion to resolve civil and criminal liabilities regarding its promotion of drugs and its failure to report safety data. This is the largest healthcare fraud settlement in the United States to date. The company pled guilty to misbranding the drug Paxil for treating depression in patients under 18, even though the drug was not approved for children. GSK also pled guilty to failing to disclose safety information to the FDA about the diabetes drug Avandia. These pharmaceutical companies don't mind paying a couple of billion dollars here and there for criminal violations because shady criminal behavior reaps more sales profits than does subsequent fines. This unethical behavior is just part of pharma's business plan.

Back to Those Incestuous Appointments

Alex Azar has had previous connections to the US government. He was deputy secretary of Health and Human Services under George W. Bush and served as the chief operating officer for two years. In that role, Azar oversaw such agencies as the Food and Drug Administration (FDA), the National Institutes of Health, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services. In May 2007, Azar became senior vice president of corporate affairs and communication for Lilly. This revolving door employment agency is standard US practice. Corporate execs leave the industry for cushy jobs in government, then they leave government for industry and lobbying jobs, etc.

This incestuous fox guarding the hen house is commonplace and will continue to put consumers at great risk. It was US President George W. Bush who named Eli Lilly President and CEO, Sidney Taurel, as a Homeland Security Advisory Council member in 2002. Further, soon after the Homeland Security Act was signed in 2002, New York Times columnist Bob Herbert discovered what had been slipped into the Act at the last minute. On November 25, 2002, he wrote, “Buried in this massive bill, snuck into it in the dark of night by persons unknown…was a provision that incredibly will protect Eli Lilly and a few other big pharmaceutical outfits from lawsuits by parents who believe their children were harmed by thimerosal.” (Thimerosal is a mercury-based preservative that is used in vaccines. It was developed by Lilly in the 1920s and by the 1990s its use was widespread)

In 2003, Bush appointed Taurel to the President’s Export Council. The same year, “60 Minutes II” aired a segment on Lillygate and Prozac. Lilly's patent for Prozac had run out so they began marketing a new drug, Prozac Weekly. According to 60 Minutes II, Lilly sales reps gained access to “confidential” patient information records and mailed out free samples of Prozac Weekly. Regulations, proposed under Bill Clinton and later implemented under George Bush, contained a provision that allowed healthcare providers the right to sell a person’s confidential medical information to marketing firms and drug companies.

Bush was later rewarded for his job placements and overseeing provisions when he left the White House. He went straight to Eli Lilly headquarters where he served as an Eli Lilly Board of Director.

You scratch my back, I'll scratch yours, huh?

Assuming he's confirmed, Azar will oversee 11 agencies including the FDA, Center for Disease Control (CDC), National Institutes of Health (NIH), Administration for Children and Families (ACF) and Centers for Medicare & Medicaid Services (CMS).

When Patrick Vallance of GSK takes over the role of UK Government Chief Scientific Adviser, he will oversee science and technology-related activities and recommend policies to the Prime Minister and  Cabinet. He will also sit as chair of the UK’s Scientific Advisory Group for Emergencies.

Witty's new title is self-explanatory. He will head a new UK government initiative known as 'Accelerated Access Review' (AAR) where his role is to get new drugs and devices on the market quickly.

If you want to know more about how Lilly operates, I highly recommend John Cornwell's book, "The Power to Harm: Mind, Medicine, and Murder on Trial." It's a jaw-dropping insight regarding how far Lilly went to cover up the deadly ADRs caused by their lucrative drug, Prozac. If you want to know how GSK operate, well, there are more than 2,000 posts about GSK's shenanigans on my blog alone.

Unreported Terror & Risk

These appointments are scary and put citizens at greater risk of being harmed by unsafe, ineffective drugs, many of which should never have been approved. In both the UK and the US, we see frequent media reports about terrorist threats and acts, but we almost never hear news about pharma created deaths. When was the last time you heard a news report or read an article highlighting that prescription drugs are the fourth leading cause of death? In America, I chalk this up to the lucrative drug advertisements that essentially pay for TV news production. In the UK we don't have drug ads, but we still have pharma money negatively influencing government policy and political appointments.

Hiring CEO's of criminal corporations to protect citizens is wrong. But these types of crimes pay. If you don't like the status quo, you can petition your respective government and share your disgust. I'm sure they'll be happy to send you a form letter response within 30 days...

So, back to pissing in the wind: It's understandable I'm disgusted by this week's news. It's easy to throw up my hands when hearing such outrageous appointments. But sometimes those who've lost a loved one to pharma help me persevere. As one mom whose child died from pharma products recently said, "To the world, my child was just one person, but to me, she was the world. If my advocacy saves even one child, I have saved someone else's world."

In other news involving incestuous revolving doors, the FDA has now approved a new "digital pill." The pill contains a sensor that digitally tracks whether or not patients have ingested their medication. And what pill has this sensor been embedded into? ~ aripiprazole, (Abilify) a drug used to treat multiple mental mood disorders, including bipolar disorder and schizophrenia.

On top of this, the commissioner of the FDA, Scott Gottlieb, is opposing a natural plant, Kratom, (mitragyna speciosa) that could help people effectively treat an addiction caused by opioids.

More on the aripiprazole and kratom scandals next week.

Bob Fiddaman

Shoddy Journalism Puts Lives At Risk!

TV evangelist, Pat Robertson, has entered the David vs. Goliath arena with his comments regarding Sunday's mass killing by 26-year-old, Devin Patrick Kelley. Kelley, who shot and killed 26 people and left more than 20 wounded at a Southern Baptist Church in Texas, had received mental health "treatment" which undoubtedly involved doctor's prescriptions. Robertson, via Media Matters For America, told viewers, "We understand a lot of these shootings, the people involved, have been taking antidepressant drugs and that may well be the cause of these factors. But something is definitely going on."

Robertson added, "I hope and pray that they don't politicize this thing and start talking about gun control and all that because it won't be necessary, but I do think there's got to be a thorough investigation into the effects of antidepressants on these sorts of events. So many of these mass killings, and almost every one, as I said before, has had some nexus to antidepressants, so we need to see what we're giving people."

Robertson's plea for an investigation prompted an opinion piece on the Newsweek website by self-proclaimed science writer, Kate Sheridan, who states Robertson's assertion is incorrect.

Sheridan, who appears to have no medical background regarding antidepressants, backs her claims touting a study published in 2012 that examined 14 years of data from the Netherlands and supposedly found a significant negative association between violence and antidepressant use.

What Sheridan failed to point out was the limitations of the quoted study, further, the study was based on assumptions and not, as she incorrectly stated, science.

The study's authors summarized:

Detailed information on individuals who committed a form of lethal violence was not available. Future research should attempt to overcome this difficulty by obtaining additional information on autopsy reports from suicide decedents, an approach used in previous studies (Barber et al. 2008). In addition, detailed data per type of antidepressant per age and gender category were only available for the period 2002–2008. By applying average fractions of users per antidepressants, we were able to calculate the total number of users by gender and age group for the period 1996–2001. This approach, however, is based on the assumption that the fraction of users per antidepressants remains fairly stable over time. This assumption might have caused a wrongful estimation of actual use per age and gender category.

In an attempt to further support to her position, Sheridan quotes Antonio E. Puente, president of the American Psychological Association, who claims, "A complex combination of risk factors, including a history of domestic violence, violent misdemeanor crimes and substance use disorders, increases the likelihood of people using a firearm against themselves or others. Calling this shooting a ‘mental health problem’ distracts our nation’s leaders from developing policies and legislation that would focus on preventing gun violence through a scientific, public health approach."

Why she added this quote to her opinion piece slightly baffles me as Puente makes no mention of antidepressants. Puente was actually responding to a tweet by President Trump who labeled the Texas shooting as a "mental health" problem.

What's striking is that the American Psychological Association have, by their own admission, received money from pharmaceutical companies, the manufacturers of the drugs Sheridan seems to defend.

If Sheridan cared one iota about science, she could have reported that more than 27 global drug regulatory warnings on psychiatric drugs cite ADRs to include mania, hostility, violence and--wait for it--even homicidal ideation! (1) Add to this the warnings the FDA are hiding from the public regarding prescription-drug induced homicides (2) and you can understand why even TV evangelists are now voicing concern from their pulpits. If religious organizations are truly concerned with protecting human life, more ministers should be shouting from the mountaintop "We demand a thorough investigation!"

Perhaps Sheridan's blinkered views on antidepressant-induced homicide may be better served if she were to review the hundreds of documents obtained by Andrew Thibault via the Freedom of Information Act. These documents can easily be accessed on the MurderMeds.com website should Sheridan have showed such interest.

The public doesn't yet know whether Texas shooter Devin Patrick Kelley was on or withdrawing from psychiatric medications. In other mass killings, information surrounding prescription drugs as "treatment" has frequently been withheld from the public. What is known, however, is that a high percentage of mass shootings are carried out by health care consumers who are on, or withdrawing from, psychiatrist-prescribed pills. Here are just a few:

 - South Carolina church shooter, Dylann Storm Roof, was on the benzodiazepine anti-anxiety drug Xanax.

- Santa Barbara college shooter, Elliot Rodger, was on Xanax.

- Aurora Colorado theater shooter, James Holmes, was taking the SSRI antidepressant Zoloft.

- Germanwings Airlines co-pilot Andreas Lubitz,  who intentionally crashed his plane and killed 144 passengers, had been on Lorazepam, an anti-anxiety drug, as well as an unnamed antidepressant.

- Geert Michiels was on or withdrawing from Paxil when he purposely drove his coach into a brick wall killing 28 passengers, 22 of whom were children.

The list is endless and will continue to grow as long as shoddy journalism such as Sheridan's continues.

Sheridan is, in essence, telling consumers and healthcare professionals to ignore the 27 global drug regulatory warnings regarding psychiatric drugs. By neglecting to report the 1,531 known cases of drug-induced homicidal ideation, she keeps her readers--and the general public--in the dark. Sheridan's article puts many lives at risk. But her dangerous and intentional ommissions help sell papers, keep pharma advertisers happy and retain her "scientific" sources for future quotes. 

Bob Fiddaman