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Your Drug May Be Your Problem PDF Print E-mail
Justice News
Thursday, 04 August 2005 22:00
Your Drug May Be Your Problem
Speaking Tour - May/June 2005
With Angela Bischoff
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.greenspiration.org


I'm a suicide survivor. My soul mate of 17 years, Tooker Gomberg, suicided March, 2004. My life was turned upside down - I lost my best friend and the world lost a warrior - but I've managed to do some research since then, and it's that research that I want to share with you today.

First off, I'm no expert. I'm not a scientist. I'm an activist who's been reading what the experts are saying about the connection between drugs and suicide.

Much of what I'm about to share with you comes from the writings of two experts: Dr. David Healy from England (1), and Dr. Peter Breggin from the US (2), both distinguished physicians of high academic standing and international credibility. Much of what they published in their books comes from years in the courts as medical experts, pouring over company data made available through court injunctions, previously unavailable to the public, such as unreported clinical trial data, internal memos etc.

My brother called last week. His take is that Tooker had a choice to live or to die, and that this choice trumped any possible adverse drug reaction he may have suffered. But I assert that in fact the anti-depressant drug Tooker was taking KILLED him. I realize that's a bold statement, so with an open mind, let's look at the facts around antidepressant drugs and suicide.

First, the personal story - Tooker Gomberg, nationally renowned environmental, peace and justice activist, suicided Mar. 3, 2004 (3). His was a classic textbook case of Adverse Drug Reaction. That is?

- Tooker was in an excellent relationship for 17 years; he had skills and friends; he was kind, humorous, courageous, a fighter, a leader, an environmental and social justice advocate; and he had fame and respect around the world.

- His first depression was in 2001-2 following the FTAA police clamp down and horrific mass poisoning (tear gas etc.) in Quebec City. Tooker was discouraged and exhausted, and his depression hit hard. It lasted nine months. He tried many holistic alternatives to pharmaceutical drugs as well as an SSRI antidepressant drug. Nothing seemed to help, but in time, he climbed out of his despair.

- When his second depression hit a year later after moving to a new city and unemployed, he sought help through counseling and pharmaceutical drugs. He was prescribed Remeron, an antidepressant drug in a class of its own, but sometimes referred to as an SNRI.

- His anxiety and agitation went through the roof - clearly an adverse reaction - however his psychiatrist didn't perceive it as such, and encouraged him to stick with the program, increasing the dosage. After just five weeks on the drug, Tooker's agitation sent him over the railing of the MacDonald Bridge in Halifax.

- He wrote in his suicide note that he was anxious, felt like a zombie, and couldn't think.

- His doctor never once in those five weeks asked him if he had thoughts of self-harm. They even saw each other the day he jumped and aware of his increased agitation, the doctor prescribed a tranquilizer, but still never asked him about thoughts of self harm, nor perceived that the drug might be driving him nuts.

- After Tooker's passing, the doctor did submit an Adverse Drug Reaction Report to Health Canada, but that recognition was too little too late.

- I have since begun an official complaint process through the College of Physicians and Surgeons against the doctor for not doing a suicidal assessment at any time during the five weeks that he saw my husband, for not perceiving the adverse reaction, and for not warning Tooker of the risks associated with the drug.

- I have also formally requested that a judicial "fatality inquiry" be undertaken by the Chief Medical Officer in Nova Scotia, to ascertain if the medical profession adequately prescribes and administers antidepressant drugs.

Some might think that as a grieving widow, I need to lay blame. Let's look at the facts?

Typically one in four patients feels worse when beginning any antidepressant drug and "drops out" or quits use of the drug within the first month (almost half quit within three months). Furthermore, in clinical trials, it is rare to find more than 40% of people continuing to take their antidepressant after four weeks. In other words, SSRIs may not suit up to 60% of those put on them! A 25-40% dropout rate is off the scale for all other drugs. That is to say that while antidepressant drugs may help some people, they are not RELIABLE, not even close.

That might not be such a problem if drug companies were straight up about this, but that wouldn't be good for sales. Check out this GlaxoSmithKline (makers of Paxil) propaganda (show paper copy) (4). Doctors are instructed to "reduce" patient drop out by "managing" the side effects and encouraging patients to stick with the program. Nowhere in this propaganda does it articulate which adverse reactions to take seriously; rather, it encourages doctors to keep patients on the drug and gives them all the arguments to do so.

Perhaps if Tooker's doctor had been better informed about the adverse reaction of agitation, Tooker would be alive today.

Agitation is a very common side effect of antidepressant drugs, primarily during the early stages of treatment or shortly after a change in dosage (up or down). Extreme agitation is known as akathisia, an internal unrest, turmoil, or torture.


In clinical trials for SSRIs (the most commonly prescribed family of antidepressants), the companies code the general problem as "agitation". This reaction has been well recognized and documented since the early '80s. Prozac's own clinical trials, prior to its launch in 1988 and post-launch, recorded rates of agitation and akathisia from between 5 and 25%.

Conservatively speaking then, one in 20 patients becomes agitated on antidepressant drugs - 5% is a significant adverse reaction that doctors need to be informed about and need to warn patients about, but they don't.

Agitation is also a very potent predictor of suicide and violence. The physiological mechanisms by which this happen are relatively well understood. Of the hundreds of cases that have gone through the courts in the US charging drug makers of inducing suicide and violence in patients, only one case has come down in favor of the company; all the rest have either been won by the patient or their advocate, or have been settled out of court.

By extrapolating from clinical trial data and multiplying by numbers of users, Dr. David Healy figures that at least 250,000 people have attempted suicide worldwide because of Prozac alone, and that at least 25,000 have succeeded. Furthermore, he claims that one in 500 users of antidepressant drugs will complete suicide BECAUSE of the drug. That's 100,000 tragic and unnecessary deaths.

Clearly drug companies have a lot to lose if this information becomes public and well understood since there are 40-50 million people world wide on antidepressant drugs, and growing - there was an 80% increase in antidepressant prescriptions in Canada from 1999 - 2004.

Incredibly, there is little evidence that antidepressant drugs actually produce benefits (5). There is plenty of evidence that antidepressants may do some good in the short term, but almost no evidence that things turn out better in the long run, and there are many reasons to believe that we may be making things worse. Remember, they are not reliable. For everyone helped by a drug treatment, there may be another harmed.

And then there's the disturbing and very real issue of dependence on antidepressants. When you try to stop taking these drugs, you can suffer an emotionally distressing withdrawal that includes 'crashing' with depression, fatigue, and feelings of hopelessness, and often involves painful physical symptoms such as flulike syndrome, muscle cramps, and shock-like headaches (6).

The US FDA (Food and Drug Administration, US drug regulatory agency) weighed in on this issue late March, 2004, two weeks after Tooker's death, by issuing warnings to the public about the association between suicide and antidepressant drugs for children and adults (7). Then in Sept. 2004 they demanded that drug companies warn consumers with Black Box labels on all product sales and ads (8). And in June of 2005 they focused on the association of suicidality and antidepressants within the adult population (9). These drastic steps were taken only after FDA public hearings wherein hundreds of families testified that they're loved one suicided after taking an antidepressant drug (10).

Health Canada followed suit and in June of 2004 issued a public advisory stating that makers of antidepressant drugs would be changing their product monographs to warn consumers and physicians of the potential for increased anxiety, agitation and suicidal ideation (11).

In Feb. 2005 an incredible study authored by Dr. Dean Fergusson was published in the British Medical Journal (12). Dr. Fergusson is a scientist with the Ottawa Health Research Institute, and teaches in the Dept. of Medicine at the University of Ottawa. His meta-analysis reviewed data on 90,000 patients from some 700 clinical trials. His team found that patients are TWICE as likely to attempt suicide on antidepressants than on sugar pills.

Similar conclusions were made in 2000 and again in 2001 upon analyzing the clinical trials submitted to the FDA in the early '90s as part of the license applications for 5 antidepressants - here again antidepressants were twice as likely as placebo to be associated with suicide attempts.

Huh? Patients are put on anti depressant drugs to lower suicide risk, not raise it!

A causal relationship between antidepressants and suicide has been established since the early '80s; why did it take till 2004 before regulatory agencies requested of drug companies to warn consumers and physicians? How many people needlessly died in that time, and still are?

And then there's the issue of suicidal assessment. This is the physician's responsibility - both the CPS (Compendium of Prescription Specialties) and DSM IV (Diagnostic and Statistical Manual of Mental Disorders) clearly articulate that physicians must properly access patients that are severely depressed for suicidal ideation, especially when mind-altering drugs are being prescribed and when dosages are increased or decreased.

However, a study published in March of this year (13) claimed that 41% of 1,400 people who committed suicide had contact with a health-care professional in the month prior, and suicidal intent was discussed at only a fifth of those meetings. In other words, doctors are not speaking to their severely distressed patients about thoughts of selfharm.

It is also the physician's responsibility to know what all potential adverse reactions to antidepressant drugs are, and it is her/his legal and moral responsibility to inform patients of all potential side effects and controversies surrounding these drugs (14) - in reality however, doctors are not sufficiently up to date on adverse reactions to drugs.

So, what's to be done?

- I believe physicians' professional bodies need "standard practice" for suicidal assessment.

- I believe physicians need to take seriously their legal and moral responsibility to inform patients of all adverse reaction potential.

- I believe doctors need to be professionally penalized when they put patient's health at risk.

- I believe government needs to fund comprehensive post-marketing drug data collection.

- Reporting adverse reactions to Health Canada's Adverse Drug Reaction Monitoring Program should be mandatory and convenient for all physicians and the public.

- I believe Health Canada needs to enforce their directive to drug companies, pharmacists and physicians to inform patients of all potential adverse reactions - black box labeling for patient awareness would be a good start.

- I believe government needs to fund continuing education of both physicians and the public of the potential risks of antidepressant drugs and of alternatives to a biomedical model of treatment.

- I believe provincial Health Care plans need to broaden their scope to include not just psychiatrists and pharmaceutical drugs for the treatment mental health, but also alternative and complementary medicines and therapies.

- I believe Health Canada needs more stringent regulatory surveillance prior to drugs being approved.

And I believe it's better to light a candle then curse the darkness. With intelligence and integrity, and with the intention of patient safety rather than a profit motive, we can save lives.

We're all making a difference. Thank you for all the work each of you are doing to raise consciousness and to support those in need?

---

In upcoming weeks/months I'll be circulating complementary information on withdrawal from antidepressant drugs, big-pharma marketing and profiteering, alternatives to pharmaceutical drugs to treat depression, and more. Stay tuned?

---

(1) Let Them Eat Prozac, 2003 http://www.healyprozac.com/

(2) The Anti-Depressant Fact Book, 2001 http://www.amazon.com/exec/obidos/tg/detail/-/073820451X/103-8297792-9358227?v=glance

(3) http://www.greenspiration.org

(4) Is patient non-adherence with antidepressants getting you down? Author: Dr. M. Berber, GlaxoSmithKline

(5) For more info, check out these meta-analyses:

Listening for Prozac But Hearing Placebo http://www.journals.apa.org/prevention/volume1/pre0010002a.html and - - Emperor's New Drugs http://www.journals.apa.org/prevention/volume5/pre0050023a.html and - Efficacy of Antidepressants in Adults, July 16, 2005, British Medical Journal http://bmj.bmjjournals.com/cgi/content/full/bmj;331/7509/155

(6) See The Antidepressant Solution, 2005, by Dr. Joseph Glenmullen http://www.prozacbacklash.com/antidepressantSolution.html)

(7) http://www.fda.gov/cder/drug/antidepressants/AntidepressanstPHA.htm

(8) http://www.fda.gov/bbs/topics/news/2004/NEW01116.html

(9) http://www.fda.gov/cder/drug/advisory/SSRI200507.htm

(10) http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4006T1.htm and http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4065T1.htm

(11) http://www.hc-sc.gc.ca/english/protection/warnings/2004/2004_31.htm

(12) http://bmj.bmjjournals.com/cgi/content/full/330/7488/396

(13) March 2005 issue of Psychiatric Services Magazine, by Dr. J. Pierre Loebel

(14) http://www.stacommunications.com/journals/cme/2005/January/PDF/080.pdf


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Last Updated on Thursday, 04 August 2005 22:00
 

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