Billiam James

Drug companies maximize the sales of new drugs by hyping their benefits while downplaying significant risks. In 2010 the European Medicines Agency began releasing patient-level data from the clinical trials used to approve new medicines in Europe – a development hailed by American, and European researchers and researchers around the world as a major step towards drug safety.

This process has been shut down by a lawsuit taken by two American corporations – AbbVie, makers of Humira, the number one selling medication in the world with projected sales of $10 billion in 2013; and InterMune, whose pulmonary-fibrosis drug Esbriet has recently been approved in Europe at a cost of over $40,000 per year.

Sign the petition here: Let us see Drug Data! Drug hazards are not “trade secrets”!

Read Dr. David Healy’s post here: Letter to Stacy London

Translations:
The posters are being translated into many languages including French, Dutch, Hindi, Kannada, Spanish, Mandarin, Italian, and German as part of RxISK‘s world-wide campaign for open data on pharmaceutical research and drug safety trials.

Humira is a monoclonal antibody – one of the new biological agents that acts on the immune system. Its side effects can be so nasty it has a black box warning on it.

Despite this, it’s on its way to becoming the best-selling drug of all time. You don’t get to be a best-seller on this scale without pushing the marketing envelope way beyond those who are seriously enough ill to warrant taking risks with a dangerous drug. Without running a marketing campaign that is to old-style drug marketing as a HumVie is to one of the smaller European cars.

The company have already been warned by the FDA for promoting Humira for milder conditions and misleading about its safety. The marketing includes many emotive messages – with images suggesting children are repelled by a single patch of psoriasis.

See more at: Stacy London: What not to Take by Dr David Healy

“There are many of us with bad Rheumatoid Arthritis or Crohn’s Disease who would gladly take these risks, especially if the drug produced a real benefit. We might be much less inclined to do for milder conditions. But in all cases the trade-off should be ours.

Ideally we should be helped by our doctors and pharmacists, but doctors and pharmacists who truly know what the problems can be. When AbbVie hide their clinical trial data, they make anyone who was involved in a clinical trial of their drug or a doctor prescribing it or pharmacist dispensing it into a potential accomplice to injury and perhaps homicide because the missing data is used to argue that ‘we’ve done trials and look there is no risk’.”

See full post: Lets do the AbbVie again by Dr. David Healy

“High blood sugars won’t kill rapidly like diabetes does. Very severely raised blood sugars over a prolonged period can raise the risk of heart attacks or strokes just as very high blood pressure or cholesterol levels can in some people. Very severely raised blood sugars can lead to thirst, hunger and infections but very few people with type 2 diabetes experience this. For most people type 2 diabetes is a disease of numbers not of symptoms. For most people there is no good evidence that treating these numbers with the latest diabetes drug improves health.”

See Full Article: Great White Lies by Dr. Dee Mangin

And you thought high blood-sugar was dangerous… Meds for Diabetes Type 2: Reduce your blood-sugar levels and life expectancy. There have been over 83,000 Heart Attack Deaths from Avandia.

For more info see Dr. David Healy’s post: Swimming with Great Whites? If you’ve got “Diabetes” look away now.

My poster for Dr. David Healy’s post “Marilyn’s Curse” about medication, Randomized Controlled Trials (RCTs), and the way medical research uses “randomization” to hide dangerous side effects.

See More: Marilyn’s Curse

My Portrait of Sir Andrew Witty, CEO of Glaxo Smith Kline (GSK), as Frankenstein. for Dr David Healy’s post, Brand Fascism, which tells the story how pharmaceutical marketing seems to be perverting, or limiting, the power of medical science, because it places the interests of corporate investors, before the health of their customers.

“The 100,000 people who work for GSK are just like you, right? I’m sure everybody who reads the BMJ has friends who work for drug companies. They’re normal people… Many of them are doctors”. Sir Andrew Witty

See:

• Brand Fascism
• Andrew Witty: the acceptable face of big pharma?
• Glaxo Smith Kline
• Sir Andrew Witty

Illustration for Dr. David Healy‘s post about the vagaries of diving, fishing and looking for real data in the murky world medicine and pharmaceuticals.

See: April Fool in Harlow: Anecdote Fishing in Harlow

And sure, this is an “April Fool’s” thing, but it’s actually based on some truth… If you want to find out more about the GSK approach to “Open Science” and the “sharing” of research data, you can actually sign up for the GSK Clinical Study data program. Once you’ve signed off off on their legal stuff (caveat emptor), you can request access to their trial data. Currently they have about 220 trials listed… a extremely small fraction of the total trials they’ve done. Your request will be reviewed by independent panel who will decide whether or not you can actually see the data. No promises of course! But why don’t you give it a try… I’ve signed up! ;-)

See: https://clinicalstudydata.gsk.com/

Posters: OpenGSK.pdf, OpenGSK.jpg or OpenGSK.png.

“You And Your Meds: Are They Safe?” was held at the Art Gallery of Ontario on January 15th. It was sold-out public event sponsored by RxISK.org and the Patients’ Association of Canada, which featured presentations by Terence Young, Dr. David Healy and Dr. Sholom Glouberman on prescription drug safety. I was delighted to show six of my “pillustrated” canvases. It was great to meet everyone and share our stories…

You And Your Meds: Are They Safe?
Tuesday, January 15, 2013 from 7:00 PM to 8:30 PM
Jackman Hall at the Art Gallery of Ontario
317 Dundas St W
Toronto, ON M5T 1G4

Terence Young, Canadian MP and author of Death by Prescription
Dr. David Healy, RxISK.org founder and author of Pharmageddon
Dr. Sholom Glouberman, President of the Patients’ Association of Canada and author of My Operation

Photos by Franke James. Thank you!

Revisiting Luke Fildes painting, the Doctor, with a ghost of Matt Miller, who at 13 year was fatally medicated with Zoloft, while the voodoo from a MHRA/FDA continues to confound our doctors.

Read Dr David Healy‘s metaphorical story about the state of modern medicine:
The girl who was not heard when she cried wolf

Samantha’s Story (Excerpts)

My story begins in January 2008, when I was running three times a week and training at kick-boxing. I had changed my diet and everything to get fit, even had my cholesterol checked. I was fit as a person could be. The only thing wrong was the smoking… So I went with my mum to the local stop-smoking clinic where we got to see the person who goes through your options.

Champix: “A Wonder Drug”
I was expecting to be offered Nicotine Replacement Patches but they kept going on about Champix and how it would work well for me. They made it out to be a wonder drug. I said I’d give it a try. I had to go to my own doctor to get the prescription for Champix (Chantix, Varenicline). I started to take the tablets the next day. I thought they were great. I didn’t want a cigarette after a few days and no side effects. By week two I had stopped smoking.

Champix: “I felt like killing myself”
When I got to week 10 of a 12 week course, all of a sudden, I felt like killing myself. This was completely out of character for me. I am scared of dying, always have been, so this was not right. I went straight to my doctor and told her and she told me to stop the Champix…

I stopped immediately. The thoughts went away after a few days. I thought I was fine and was still not smoking.

Champix: “A Small Risk of Seizure”
Then on the 25th March 2008 my partner Anthony woke up to me having a grand mal seizure in my sleep… I was told they thought I had autosomal dominant nocturnal frontal lobe epilepsy – ADNFLE to them… I was put on anti-epileptic drugs. I had side-effects from all of them and I was still having seizures. I just kept being told that it was all about finding the right drug for me.

Then a friend came round to see me and told me that he had just been to the smoking clinic to ask for Champix. He had taken it twice before and stopped smoking both times but had always started again within a month. This time they refused to give it to him as he had a history of a head injury and they said there was a small risk of him having a seizure because of that.

Champix: A Doctor’s Denial
Angrily I got the laptop out and looked to see if the Champix side-effects leaflet had been changed to mention seizures. It had not in the UK but it was in Canada. So I asked my neurologist if Champix could have triggered my epilepsy. Her words: “I am not prepared to put my job on the line by answering that question” were witnessed by my mum. That made me angrier. This is my life – how dare she say that.

My side-effects got worse. I could not eat or function. I told the neurologist I could not live like this for the rest of my life. She shouted at me, saying my choice was side-effects or life-threatening seizures. I ran out crying…

Champix: Finding the Truth
From that day, I have studied epilepsy, drugs, DNA, the brain, RNA and, most important, Champix… I have found links to ADNFLE and Parkinsons and other diseases that might be triggered in some people by Champix… It turns out that changes in cholinergic receptors – in either a4 or b2 subunits – can cause autosomal dominant nocturnal epilepsy. Varenicline is an a4 b2 nicotinic acetylcholine receptor partial agonist – it works by binding to the receptors linked to ADNFLE. The gene changes responsible are the first, and to date only, mutations described in an idiopathic epilepsy.

Read Samantha’s full story on RxISK.org: Smoke & Pfizer get in your eyes

Follow Samantha on Twitter: @varenicline

Related Research Papers:

• Suicidal Behavior and Depression in Smoking Cessation Treatments PLoS, 2011
• Varenicline-induced grand mal seizure, Epileptic Disord 2010
• FDA Warns of Adverse Events Linked to Smoking Cessation Drug and Antiepileptics, The Journal of American Medicine Association, 2008

Dr David Healy writes that “The unsolvable problem medicine faces is that each of us is shipwrecked in the singular.” We are abandoned, floating alone in a health care system that has been trussed in guidelines, and narrow-minded “quality improvement programs”, and an incredibly bureaucratic management pot.

Our only hope is that the basic humanity of people in the system will assert itself. That the doctors, nurses, and support staff will start to look at their “clients”, not as units to be processed, but as individual human beings who need to be listened to, respected and treated with personal care.

Read Dr David Healy’s complete post: The Shipwreck of the Singular

“Uninhibited behaviours” is listed as a possible side effect for Effexor by it’s manufacture, Pfizer. But what is uninhibited behavior? Is it problematic? Well, yes… According to Pfizer, compulsive gambling and sexual misconduct are covered by the term, “uninhibited behaviours”.

A warning… But is it enough? A patient responds:

“How am I supposed to know what an ‘uninhibited behaviour’ was?” he said. “What a cloaking of an evil thing is that? That could be me parachuting or hang gliding or running down the beach with Speedos on! How was I to know it was going to be the type of addictive behaviours that would ruin my life?”

Efexor, first introduced to the American market in 1993, is now well established as one of Australia’s most commonly prescribed anti-depressant medications with more than 1.2 million prescriptions serviced in Australia in the past 12 months. At low and moderate doses, it acts only on the brain’s mood control neurotransmitters, serotonin and norephinephrine. But at high doses of over 300mg a day it also effects a third neurotransmitter called dopamine, which is responsible for reward-driven behaviours and has been associated with risk-taking behaviour and addiction.

It’s this dopamine effect that can cause problems, according to world-renowned psychiatrist, psychopharmacologist and author Dr David Healy. “When Efexor is taken at high dosages it triggers a flood of dopamine and becomes what we call a ‘dopamine agonist’. This can be responsible for the types of dangerous impulsive behaviours.”

Read the full story on RxISK.org: Gambling With Antidepressants

One of the hardest things for people, who suffer from illnesses/disabilities, is getting good information and support. The health care system doesn’t seem to provide it, and so many of us join community support groups where we can share our experiences and support each other. (I go to Epilepsy Toronto and know many who use Fluoroquinolone support groups. The FQ groups are certainly not supported by any Pharmas, but my epilepsy group gets funds from UCB, the people who sell us Keppra and Vimpat.)

The pharmaceutical industry is very aware of this, and lends their financial muscle to support all kinds of community support groups — particularly if group members are potential “customers” for their meds. And this can create a Conflict of Interest, and subvert the group’s mission to serve its members.

This appears to be what has happened to American Foundation for Suicide Prevention. My friend Julie Wood, a suicide survivor, decided to attend a local support group this month, only to find that they were promoting medications as the only way to reduce suicide risk, and trying very hard to ignore the well-documented links between suicide risk and psychiatric meds.

What I find particularly bad about this practice, is that pharmaceutical industry is preying on the weak and sick, offering them hope (a pill?) wrapped in sympathy and support, when in fact they don’t seem to care about whether the medication works or not, or whether it actually helps the patient…

Read Julie’s full story on RxISK.org (Data Based Medicine):
http://wp.rxisk.org/how-pharma-captures-bereaved-mothers/