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RxISK Media Relations officer, David Carmichael tells personal tragic story on prescription drug induced psychosis to radio show host Dr. Lorraine Hurley.

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Answers to these 12 questions could save your life

The medical team behind RxISK.org, today published a checklist to help patients and their health care professionals assess the risks and benefits of prescription medications.  RxISK is the first free, independent website where patients, doctors, and pharmacists can research prescription drugs and easily report a drug side effect.   RxISK provides an individualized causality report for drug side effects enabling the health care team to act sooner.

“If your government allows it, your doctor prescribed it,
and your pharmacist dispensed it, then it must be safe.  Right?“

If your government allows it, your doctor prescribed it, and your pharmacist dispensed it, then it must be safe.  Right?  Not necessarily!  This assumption is wrong.  People die because of this wrong assumption.

Know your Rx RxISK

RxISK Chief Medical Officer Dr. Dee Mangin says “Prescription drug side effects are now a leading cause of death, disability, and illness along with cancer, heart disease and stroke.”  RxISK CEO Dr. David Healy adds “In mental health care, drug side effects are the leading cause of death.”

The RxISK medical team estimates that, each year, 10,000 people die in Canada, 100,000 die in the United States, and 150,000 die in Europe from taking prescription medications as directed.

“Fewer than 5% of “serious” adverse events (those causing hospitalization, disability, or death) are ever reported. The rate of reporting the millions of “medically mild” adverse drug events that occur each year — ones that compromise a person’s  functioning, self-confidence, judgment, and even ability to care – is practically non-existent,” says Dr. Mangin. “Little is known about the effects of drugs on our hair, sex and relationships, extreme acts or thoughts, and our skin and nails, because these effects are not considered medically significant and are not tracked,” she adds.

Dr. David Healy says, “Some of the known or suspected drug side effects are included in the drug manufacturer’s patient information leaflets.  But a review of the over 15.8 million drug side effects reported to the Food and Drug Administration and included in RxISK’s databank, show hundreds more not in the leaflets that are linked to prescription drugs.”

RxISK tools to research and report Rx drug side effects

Dr. Healy says, “Patients about to start taking a drug have a right to an informed choice.  Only then can they weigh the benefits of a prescription drug against potential harms.  For those already on prescription drugs it’s about being on the lookout for links between side effects they are experiencing and their prescription drugs and being aware of potential symptoms on stopping or changing dose.”

Dr. Mangin says, “The checklist together with the RxISK Causality Report and research tools on RxISK.org can help the patient and doctor in their discussion.”

Checklist

1. How does this drug work, how much improvement can I expect, and how soon?
2. If I don’t take this drug now, and instead wait for a while, what will happen?
3. What are the most likely side effects?
4. Are there any rare serious side effects?
5. Are there any permanent problems this drug can cause?
6. If this is a new drug, why can’t I take an older drug?
7. Can I try a lower dose?
8. What date will we review my use/dose of this drug?
9. Are there problems stopping the drug or any special considerations on stopping or changing dose that I should watch for?
10. Are there any potential interactions with food, my other medical conditions, or my current medications?
11. Might this drug affect my weight/sleep/ hair/ skin/ nails/, mood/ sex life and/or relationships, and if so, how?
12. Do I need to stop this drug before I get pregnant?

Both you and your Dr. can use the free drug research function at RxISK.org to help in this process. This provides access to 4.2 million reports on 5.6 million suspected drugs, suspected of causing 15.8 million side effects submitted to the US and RxISK side effects databases. RxISK also includes the FDA drug leaflets and any “black box” warnings, a European Medicines Agency manufacturer’s admitted side effects data set, and the anonymous stories of others’ experiences.

When you visit RxISK.org home page, you can enter the name of the prescription drug you are about to take, or are taking, on the home page, press enter and you are presented with RxISK research view.  Use this view:

• to see what this drug is used for, by clicking on Indications and Usage in the FDA leaflet or clicking Patient Leaflet (Drug Specific).
• to browse a list of the most common side effects reported on this drug, use Tag Cloud in the graphic or table.
• to see how likely a causal link is switch to PRR view.
• to look up a specific side effect that concerns you, use the A-Z Side Effects search function.
• to see which patients report these side effects most often.  Click on Age, Gender,or Weight.
• to see where in the world these reports are coming from. Click on Heat Map.
• to see possible interactions with food, drugs, or conditions. Click on the Interaction Checker.
• to see possible effects on hair, skin, nails, mood, sex & relationships, or withdrawing from a drug. Click on the corresponding Zone.

Help yourself while helping others

RxISK helps you research prescription drugs, but you can do so much more by reporting a drug side effect and adding your anonymized experience to the data on prescription drugs.

About Data Based Medicine Americas Ltd.

RxISK.org is owned and operated by Data Based Medicine Americas Ltd. (DBM). DBM’s founders have international reputations in early drug-side-effect detection and risk mitigation, pharmacovigilance, and patient-centered care. Although drug side effects are known to be a leading cause of death and disability, less than 5% of serious drug side effects are reported. DBM’s mission is to capture this missing data directly from patients through RxISK.org’s free drug side effect reporting tool and use this data to help make medicines safer for all of us.

Media contact

David Carmichael
david.carmichael@RxISK.org
+1 (647) 799-3792

Read more: Daily Mail Online:  What is wrong with randomised trails Part 2

Earlier this week the Daily Mail  published my feature on side-effects and how patients aren’t properly warned about them. Antidepressants, for instance, can cause compulsive heavy drinking but you wouldn’t know it from the drug information leaflet. 

The article is about campaigning psychiatrist Dr David Healy, who believes patients need a more truthful account of the side effects they risk. It describes his new website – Rxisk.org – that makes it easier to report side-effects and provides a forum where you can swap experiences with other pill users.

Information about side effects is often poor because it gets  hidden by the companies running the trials. A campaign by doctors and journals is now well under way to force drug companies to be more transparent.

Turning garbage into gold

But that’s not enough, according to Healy. He believes there are serious problems with the randomised controlled trial (RCT), the so-called gold standard of evidence based medicine, used to test treatments and decide which ones should be licenced.

Rather than distinguishing safe and effective medical treatments from ones that are dangerous and/or useless, the results from RCTs are frequently misleading and wrong. The RCT, he says, is a processor for turning garbage data into drug company gold.

At first sight his critique appears ridiculous. It is a full-frontal challenge to the whole idea of evidence based medicine. You have to have a way of telling if a drug works and is safe and the RCT has been used for years – since the 1960’s in fact – when it was introduced as a response to the thalidomide disaster.

It works by dividing patients randomly into two groups; one lot gets the drug, the other an inert placebo pill. A few months later the results reveal which group benefited more. Two positive RCTs are needed to get a licence to market a drug.

A serious barrier to treating chronic disease

Healy’s case against RCT’s is not based on bare-faced fiddling of results by the drugs companies, although he’s often exposed it. Even if all trials were squeaky clean they would still be a serious barrier to developing really effective ways of tackling the various lifestyle diseases that are threatening to cripple Western health services.

Take the rule that you only need two RCT’s to get a licence. What about if you also have three negative ones where the drug came out as no better than a placebo? At the moment they simply don’t count. This has everything to do with bureaucratic rules and nothing with scientific rigour. Its an arbitrary rule that deprives doctors and patients of valuable information about what the drug does or, just as importantly, doesn’t do.

But there is more fundamental problem.  Properly conducted RCTs are supposed to tell you if a drug is effective. But what does “effective” mean? The poster boy…

Read more: Daily Mail Online:  Why randomised controlled trials don’t tell you what you want to know

April 30, Dr. Healy will be lecturing at Cardiff University Wales about the role of Psychotropic and Other Drugs in Mass Shootings and Homicides. The following week, Dr. Healy will visit Queen’s University in Kingston, Ontario, Canada, to debate the future of psychiatry, and to give a lecture entitled “How Regulating Drugs has Killed the Art of Medicine”.

May 22, Dr. Healy will arrive in San Francisco, for a debate at the American Psychiatric Association Annual meeting on the efficacy of Antidepressants in Major Depressive Disorder.

Next, Dr. Healy will return to the UK to participate in a panel discussion entitled “Are Doctors Bad For US?” on Sunday May 26 at the HowTheLightGetsIn2013 festival at Hay.

In the debates and lectures, Healy will refer to RxISK.org which he sees as a solution to the problems created by Evidence Based Medicine and flawed Random Controlled Trials. RxISK.org, masterminded by Dr. Healy and several close colleagues. RxISK is a project which aims to improve prescription safety through the systematic collection of information about consumer experience. RxISK.org is the first free, independent website where consumers can report their own experience of prescription drug side effects, and receive personalized assessments of the risk that their prescriptions are causing the problems they report.

About Data Based Medicine Americas Ltd.

RxISK.org is owned and operated by Data Based Medicine Americas Ltd. (DBM), based in Toronto, Canada. DBM’s founders have international reputations in early drug-side-effect detection and risk mitigation, pharmacovigilance, and patient-centered care. Although drug side effects are known to be a leading cause of death and disability, less than 5% of serious drug side effects are reported. DBM’s mission is to capture this missing data directly from patients through RxISK.org’s free drug side effect reporting tool and use this data to help make medicines safer for all of us.

Media contact
David Carmichael
david(dot)carmichael(at)RxISK(dot)org
+1 (647) 799-3792

Venues

2013-05-26
Hay-on-Wye
The Institute of Art and Ideas How The Light Gets In 2013, the world’s first philosophy and music festival
Are doctors bad for us? Panel discussion (4-6pm)

2013-05-22
San Fransisco, California
American Psychiatric Association,
San Francisco Convention Center, Moscone South – Esplanade Level – Room 302
Antidepressants in Major Depressive Disorder: The Efficacy Debate
(2-5pm)

2013-05-10
Kingston, Ontario
Johnson Auditorium, Hotel Dieu Hospital
How Regulating Drugs has Killed the Art of Medicine.
(12:15-1pm)

2013-05-10
Kingston, Ontario
Johnson Auditorium, Hotel Dieu Hospital
Psychiatry Debate. The proposition is this: “This House Believes that the speciality of Psychiatry is going to become less important”
(11am-12pm)

2013-04-30
Wales, UK Cardiff University: Stanley Parris Lecture Theatre in Psychology Department
Mass Shootings and Homicide on Psychotropic and Other Drugs
(11am-12pm)

But a few, very few, actually manage to do all of the above…and more.

It is a great honor to be able to interview one such individual who will, for many readers, need no introduction at all. Dr. David Healy is an internationally respected psychiatrist, psychopharmacologist, scientist, and author. A professor of Psychiatry in Wales and former Secretary of the British Association for Psychopharmacology he has written numerous peer-reviewed papers, articles and is the author of 20 books, including his latest entitled Pharmageddon.

David is also one of the founding leaders associated with the www.RxISK.org website, a “free, independent website where patients, doctors, and pharmacists can research prescription drugs and easily report a drug side effect — identifying problems and possible solutions earlier than is currently happening.“ He is, as we say, a 10 talent man.

It is an extraordinary privilege and honor to have David answer a few questions about his work for us here at The Honest Apothecary. He is an advocate for patients, and is very supportive of the role of pharmacists to educate patients about their medications. I do hope you enjoy listening in.

Read the full interview: The Honest Apothecary: Pharmageddon, RxISK.org, and an interview with Dr. David Healy

By JEROME BURNE

PUBLISHED: 23:50 GMT, 22 April 2013 | UPDATED: 06:41 GMT, 23 April 2013

Several years ago, Anne-Marie Cook, a 40-year-old health care assistant from Surrey, was prescribed the antidepressant Seroxat after she’d become anxious and withdrawn following the death of her father.

Within a few months she began to feel better and started going out with friends again. Sensibly, she checked the drug information leaflet to make sure it was all right to have alcohol while on the medication. ‘There is no known interaction between Seroxat and alcohol,’ it read.

But this isn’t the whole story, as Anne-Marie learned to her cost. In rare cases, there is an interaction. She had no idea of it at the time, but with hindsight it explains her changed behaviour.

‘After just a couple of drinks I started to become verbally aggressive and reckless,’ says Anne-Marie (not her real name). ‘Once I started drinking I found it hard to stop. I also found I was becoming confused after drinking alcohol.

‘I got banned from restaurants and bars in my local town and became an embarrassment to my friends. Once I climbed onto my roof. I was not trying to kill myself. I felt as if I was in a dream.’

For over a year her drinking worsened and she was even arrested several times. She lost her job and her home, but couldn’t stop herself. ‘I knew something was wrong; my craving for alcohol was so intense I felt possessed, but couldn’t understand why.’

She searched the internet for clues and, to her astonishment, found she was far from alone. Seroxat is one of a group of antidepressant drugs known as SSRIs, or selective serotonin reuptake inhibitors.

As Anne-Marie explains: ‘There were lots of other people reporting the same desperate craving for alcohol on SSRI medication. Yet no one in the medical profession seemed to be taking notice of it.

‘I had tried telling my GP and doctors I saw in rehab that I thought the drug was the cause, but they accused me of being in denial about my alcoholism.

‘The Patient Information Leaflet (PIL) didn’t mention it because it is a fairly rare side-effect.’

Anne-Marie’s story and how she eventually discovered a link between the drug and her craving, is told on rxisk.org, a new website designed to collect information about uncommon side-effects of drugs, in order to help patients get their concerns taken seriously by their doctor.

Since it was set up last autumn, the website has collected a number of reports about another rare SSRI side-effect — severe hair loss.

It may sound superficial, but it can have devastating consequences, particularly for women.

Unusual adverse reactions such as these will not appear in a drug’s patient leaflet because they have not shown up in a clinical trial. This is because clinical trials don’t study enough people to pick up uncommon effects, says psychiatrist Tim Kendall, a visiting professor at University College London.

‘Drug trials are not a good way of picking up uncommon side-effects because the drugs are tested only on a few thousand people and then prescribed to millions.’ But unreported uncommon side-effects are just part of a bigger problem.

The website also acts as a forum for patients to discuss any problems they are having with drugs, such as hair loss.

RxISK is the brainchild of a leading psychiatrist, Dr David Healy of University of Wales, Bangor. Author of over 100 scientific papers, he is a long-time campaigner for greater transparency about adverse effects of drugs.

‘Drug companies and the drug regulator have never been proactive about uncovering evidence of risks from drugs,’ he says…

Read more: Daily Mail Online: Could your medicine give you a drink problem?

…Yet a rising chorus of researchers is questioning Motherisk’s stance on SSRI use in pregnancy. One of the most vocal is psychiatrist and psychopharmacologist David Healy, director of the North Wales department of psychological medicine at Cardiff University. Healy, who prescribes SSRIs selectively, says there’s no good data suggesting untreated depression is more dangerous to mother and child than SSRIs.

And the damage done by SSRI use, he says, may actually be worse than the numbers suggest. Studies have also linked SSRI use in pregnancy to higher “voluntary terminations,” or abortions, he says, prompted in part by birth defects detected in prenatal scanning. Clinical depression in pregnancy is a serious concern, Healy told Maclean’s. “But effective treatments exist that are less risky for the fetus.” In his 2012 book Pharmageddon, Healy identifies rising SSRI use in pregnancy as the most ominous portend of the grip Big Pharma now exerts over medicine…

Read Maclean’s article There’s a pill for that

View the Global News 16×9 program Drug reactions

Healy first made himself controversial in 1997 when he insisted that antidepressants increased the risk of suicide. Critics accused Healy of driving many patients away who needed help, nearly causing Healy to lose his job.

By 2004 though, British and American drug regulators started issuing warnings on antidepressants, stating that the medicine could cause “suicidal thoughts and behavior in some children and adolescents.”

It is likely Healy’s most recent statement will cause a similar buzz. However, it will not likely be another line added to the warnings on the prescription bottle.

Read the whole story on Collegiate Times