What Help?

Help! I need somebody

Help! Not just anybody

Help! You know I need someone

Help!

Lennon & McCartney 1965

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Oh, I get by with a little help from my friends

Mmm, I get high with a little help from my friends

Mmm, gonna try with a little help from my friends

Lennon & McCartney 1967

British newspapers were, once again, leading the way today with information regarding the latest brain pellet study that delivers a swift kick in the gonads to drug companies, regulators and prescribers.

The Sun and The Daily Mail ran with headlines, "‘Rare but serious’ risk of suicide for patients on antidepressants, new findings reveal" and "New health alert over antidepressants as study finds a 'rare but serious' risk of suicide for patients on pills."

The Mail's article was penned by Ben Spencer (Medical Correspondent for the Daily Mail), whilst The Sun's piece was written by Gemma Mullin (Digital Health Reporter for The Sun)

Whilst I'm always grateful to the British media for highlighting the suicide risk when taking brain pellets, I still get irked by journalists who take quotes from the Royal College of Psychiatrists on good faith.

Both articles feature a direct quote from Wendy Burn, who is President of the Royal College. Her quote seems to be the trump card played by spokespersons speaking on behalf of the industry but it is rarely questioned. This is where the mainstream media are failing. No pressing questions just an acceptance.

Burn's quote left me thinking that the media have almost come to accept the word of psychiatry as a congregation would of a priest delivering a sermon.

"It is vital that people prescribed antidepressants are monitored closely, made aware of possible side effects and know how to seek help if they experience them.", Burn proclaimed. This after Study leader, Dr Michael Hengartner, of Zurich University in Switzerland, said: "We can be confident that these drugs are producing an excess rate of suicides, beyond the depression itself." He added, "There is no doubt that this must be a response to the pharmacological effect of the drugs themselves."

Burn was never asked by either journalist whom patients should seek help from or, indeed, how, when one is feeling suicidal because of the inducement of akathisia, they can actually think straight, lift up a phone receiver and dial a number for help, on the proviso, of course, that there is such a number to dial. Quite how Burn and other spokespersons from the college get away with such comments leaves me bewildered.

In the past, Burn & Co have recommended that patients speak to their doctors. I find this perverse, don't you?

According to Burn's logic, those who have been prescribed brain pellets that are causing suicidal thoughts should go back to the very same person who prescribed them!

In 1978 more than 900 Americans – members of a San Francisco-based religious group called the Peoples Temple – died after drinking poison at the urging of their leader, the Reverend Jim Jones. Let's imagine for one minute if a spokesperson for a toxicology department had said back in 1978, "If you feel you have taken a substance that has caused you toxicity, we recommend you talk to the Reverend who will be able to help you."

Flippant of me yet you can't deny the facts here.

The media need to ask Wendy Burn exactly what plans are in place to help those suffering at the hands of these mind-altering brain pellets, be it those who are suffering severe withdrawal problems or those who are feeling suicidal because of them.

Wendy Burn is offering false hope to those she and her colleagues prescribe to. What she is saying is 'some people' may have difficulty but, hey, don't worry if you are one of those unfortunate souls who gets the urge to kill yourself "help" is just around the corner. The thing is, Burn and her colleagues have been standing on these street corners for years, first handing out the drugs, secondly, to send people to other corners when they complain of brain pellet withdrawal or feelings of suicidality. Sadly, all the corners are taken by her colleagues who are ready with their prescription pads to hand out yet more brain pellets to help with the suicidal thinking caused by the original prescription they handed out.

Quite why the media cannot see through her 'trump card' is beyond me.

Maybe one day a journalist with good investigative skills will probe the comments from the Royal College. You know, ask for evidence or perhaps the street address of any specialist in the UK who deals with brain pellet withdrawal and suicidality.

As I said at the top of this post, I'm grateful for the British media highlighting the risks of brain pellets but allowing throw away comments without following up those comments is poor journalism.

Wendy Burn blocked me on Twitter some months ago. Last week she had a change of heart and unblocked me. As I don't play to the tune of the piper, I immediately blocked her. I don't wish to correspond with anyone who will only address important issues when they are in a "good mood", least of all a President who, it has to be said, couldn't run a bath.

Maybe one day, the College will apologise to the families of all those who, through no fault of their own, have had to bury loved ones and suffer continuous heartache? I'm not holding my breath.

Michael P. Hengartner and Martin Plöder's study, Newer-Generation Antidepressants and Suicide Risk in Randomized Controlled Trials: A Re-Analysis of the FDA Database, can be read, in full, here.

Bob Fiddaman

Memorial Day Special - An Open Email to Robin Young

Last Thursday, psychologist Kelly Posner Gerstenhaber was given 10 minutes of airtime on WBUR, a National Public Radio station based in Boston.

Gerstenhaber was interviewed by Here & Now's host Robin Young. I say "interviewed," but it was more like a free infomercial for antidepressants.

The 10 minute program which can be listened to here, was a classic example of a one-sided shtick regarding the safety of "antidepressants" such as Prozac, Paxil, Zoloft, etc. Gerstenhaber offered tidbits of information which she claimed to be true. In fact, nothing she said appeared to be true. Neither could she back up her ludicrous claims that prescription drugs cannot cause suicide.

To date, more than 36 comments have been left on the WBUR page and all have gone unanswered by Gerstenhaber and host Robin Young.

One such person who felt compelled to leave a comment was Kristina Gehrki. Kristina has been featured on this blog in the past here and here.

In honor of U.S. veterans and Memorial Day, today she emailed the host. Her open letter, published here in its entirety, includes some interesting analogies. It's powerful. Perhaps Robin Young will have the decency to reply?

Here's the email (Published with the permission of Kristina Gehrki)

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Honoring US Vets, Active Duty Servicemembers & Families through Accurate, Unbias Reporting

Robin Young, Cohost of NPR/WBUR "Here and Now"
890 Commonwealth Avenue, Third Floor
Boston, MA  02215
email: info@wbur.org

Dear Ms. Young,

Today is Memorial Day. Given your father was a United States Marine, I'm sure you are reflecting on his service. As a Marine wife for many years, I share your connection to the Corps and appreciation for veterans, servicemembers, and military families. Here's an old photo of my daughter, Natalie, age three at the Bethesda Naval Hospital.

When reading your bio after last Thursday's NPR radio program I learned we have several other commonalities: We both have journalism backgrounds, been recognized for our efforts on behalf of children, and worked on White House related communications.

However, today I'm contacting you about something we don't have in common--something I hope we never do: I lost my daughter at age 19 to prescription-drug-induced death.

Natalie was suffering from akathisia and Serotonin Toxicity, severe adverse drug reaction (ADRs) caused by SSRIs (Prozac, Zoloft, Paxil, etc.) Dr. Roger Lane, a Pfizer scientist for the company that made the product (Zoloft) that caused my child's demise, has stated "the subjective components of akathisia are distinct and overwhelming." In another peer reviewed medical journal Lane went on to note "It may be less of a question of patients experiencing fluoxetine (Prozac)-induced suicidal ideation, than patients feeling that death is a welcome result."  (SSRI-Induced extrapyramidal side-effects and akathisia: implications for treatment - Roger M. Lane)

Further, Dr. Robert Temple, former director of the FDA's office of medical policy, has said "that analyses of 15 clinical trials, some of which were hidden for years from the public by the drug companies that sponsored them, showed a consistent link with suicidal behavior." (Harris, New York Times, 9/14/04, p. A01)

Yet on your show last week it appears your guest, Kelly Posner Gerstenhaber, withheld this information.  Doctors who don't want to harm their patients would benefit from being better informed.

Natalie's doctor didn't recognize Natalie's symptoms as ADRs. She assumed Natalie was ill with various difficult-to-classify disorders. Natalie unwittingly documented her ADRs despite erroneously being told they were signs of unspecified illness and not ADRs. (You can learn about our avoidable tragedy here & here)). Informed of Natalie's violent death, her doctor screamed, "Oh my God! Oh my God! It doesn't make sense; she wasn't depressed." Natalie's doctor, who didn't communicate the risks related to the product she promoted, said she prescribed Zoloft because Natalie was "too focused on dieting and exercising."

Your program last week never mentioned "akathisia." It featured one guest, Gerstenhaber, with one agenda. Gerstenhaber didn't discuss the adverse side effects and withdrawal problems associated with the "antidepressant" drugs she promoted. Neither of you disclosed Gerstenhaber and her Columbia University project's financial and professional ties to these product manufacturers.

Perhaps this collective failure was simply an oversight? Whatever the reason, it is unethical. It is also poor journalism to cover this critical topic by excluding scientific research, medical experts and consumers whose views and lived experiences are far different from those expressed by a solitary guest. These troubling omissions can cause avoidable suffering and death of our nation's vets, servicemembers, and children.

Suicide is, literally, a life and death topic. More than 22 veterans die by suicide every day, many of whom were prescribed drugs that carry the FDA's Black Box warning stating these products can increase the risk of suicidal thoughts and actions. Like my family, many are never informed of the products' risks vs. benefits and never receive Informed Consent; Therefore, their basic human right to medical freedom of choice is effectively denied.

Your father and all our vets served to protect Americans' right to life, liberty and the pursuit of happiness. Tragically, for some unsuspecting consumers, SSRI drugs rob them of life, liberty and happiness.

Today as we honor our nation's vets, I also remember those who died from terrorist attacks. Some victims of the September 11th World Trade Center attack jumped to their deaths. No decent person would ever state these deaths were "suicides." Rather, these innocent victims jumped to escape a burning building. It is a similar situation when consumers die from self-sustained injury while suffering prescribed akathisia and psychosis. These iatrogenic deaths are not "suicides" in the traditional sense of the term; I use the word "suicide" only because the English language hasn't yet coined a definitive term to describe such death. Prescripticide is likely the most accurate term. And so it is: My teenaged daughter, Natalie, died from prescripticide, as do many veterans.

To hear your guest, Gerstenhaber, claim SSRI drugs have few risks and great benefits conjured up an analogy about peanuts.Years ago I left journalism to pursue a fulfilling profession in education. At the start of every school year, I received district letters alerting me of students with peanut allergies. These serious allergies could result in my students' deaths. When I hear Gerstenhaber dismiss the risk of SSRI drugs and tout all the supposed benefits, I think about peanuts and my students. What would I tell a parent whose allergic child died in my class because I cavalierly chose to bring students a special treat containing peanuts? How would the parent of the dead child react if I replied, "Peanuts are healthy for most children. They are high in protein, easy to swallow, cheap and widely available. Sorry your child died. But remember, for most of my students, these peanuts were a healthy snack."

I've worked with children and teens for decades and recently paid my respects to fallen servicemembers at the Vietnam Veterans Memorial. Many of these casualties were teenagers--the same age as my students--when they died. As I stood at the wall, I pondered how long a wall would be if a similar memorial honored victims of medical error and ADRs. Given that the broken U.S. medical system is the leading cause of death and injury, few visitors would have the stamina to walk such a great distance when paying respects to lost loved ones.

Today some vets who survive akathisia and other ADRs bravely share their experiences. Dave Cope, a Navy veteran, shares his avoidable suffering in an open Letter to Congress. Cope attended the Massachusetts Institute of Technology (MIT) near your WBUR office and, like fellow MIT grad, Dr. Kelly Brogan, would have been an appropriate source for last week's program. Another Boston-area resident and a finalist for the Pulitzer Prize for Public Service, Robert Whitaker, could have also been invited to share his research. Clearly, you need not have ventured far from your office to find reliable sources for more balanced programing.

Since Natalie's death in 2013, I've met many intelligent people whose loved ones also suffered ADRs and died iatrogenic deaths--people with no financial motives nor conflicts of interest. Their loved ones were pharmaceutical executives, lawyers, marketing professionals, doctors, teens, and children. In the interest of public health and responsible journalism, I respectfully request you host a follow-up program in which medical experts and families can share independent research, personal ADR experiences and fatal outcomes.

You can reach me at akathisiamatters@gmail.com should you wish to do so.

Semper Fidelis,
Kristina Kaiser Gehrki

--

"Netherworld," from the film 'Letters from Generation Rx' by Kevin P. Miller.

'Netherworld' is told from the voice of Natalie Gehrki and her mother Kristina.

Back story

Kelly Posner Gerstenhaber - Incredulous!

Guest Post From Kim Witczak - Who is Dan Troy?

Dan Troy ~ GlaxoSmithKline's Senior Vice President & General Counsel and a member of the Corporate Executive Team

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The following is a guest post from patient advocate Kim Witczak. I say patient advocate but Kim is much more than that.

Today's guest post is by Kim Witcack. Our paths first crossed back in 2011. Kim was familiar with my advocacy work as I was of hers. Recently we chewed the cud in Chicago at the Dolin Vs GSK Paxil-induced death trial. Though justice doesn't bring back the dead, we are both keen to see justice. We also are intrigued to see how GSK attempts to defend its product and Paxil labeling.

Kim's husband, Woody, died a Zoloft-induced death in 2004. Woody had no history of depression and was prescribed Zoloft, Pfizer's poison pill, for insomnia (rather ironic considering insomnia is one of many listed side effects of Zoloft!). Five weeks later, Woody was hanging from the rafters of their garage. He left no suicide note. Internal Pfizer documents showed its scientists knew akathisia and suicidality was an adverse drug reaction of Zoloft. Apparently, Pfizer forgot to tell Woody and other trusting consumers.

Kim filed a wrongful death suit against Pfizer and has been advocating for drug safety and transparency ever since.

She is a co-organizer at Selling Sickness, an advocacy group dedicated to creating a new partnership model of professionals and advocates to challenge the selling of sickness.

Kim has also been appointed to the voting position of Consumer Representative on FDA Psychopharmacologic Drugs Advisory Committee. The role of the committee is to review and evaluate data concerning the safety and effectiveness of marketed and investigational human drug products for use in the practice of psychiatry and related fields. The committee also makes recommendations to the Commissioner of Food and Drugs.

Kim has been featured in major news media such as Fortune, Readers Digest, Consumer Reports, Wall Street Journal, New York Times as well as the subject of many local and national television news stories and documentaries. She has testified before the US Senate and FDA regarding  FDA-related consumer safety issues. Her website, WoodyMatters, shares her families adverse drug reaction tragedy so that others might live.

Kim has a vast knowledge of SSRIs and insipid industry/government ties. Her knowledge about Dan Troy exceeds mine, and I invited her to write a guest post. Troy seems to have mastered the art of collusion and uses the revolving door between government regulators and the pharmaceutical industry to turn a personal profit.

As ever, it's left to those who mourn the death of their loved ones to carry the light that will, eventually, lead people to the truth. I salute you, Kim.

--

Kim Witczak

DEJA VU…The Fox Is Still In The Hen House
Kim Witczak

As I watch the federal trial regarding the Paxil-induced death of Stewart Dolin, I can’t help but ponder the role Dan Troy is playing behind the scenes. Troy, Glaxo’s General Counsel, has long protected the pharmaceutical industry concerning FDA issues and government regulations. Now he's the top dog in GlaxoSmithKline's global legal department. Having personally witnessed Troy's negative impact on consumers' rights and civil lawsuits, I see his fingerprints all over Dolin v GSK.

Long before President Bush appointed Troy as Chief Counsel for the FDA, Troy assisted drug companies and drug-company supported trade groups such as the Washington Legal Foundation. Under his unofficial FDA leadership, he helped modify the generic-drug application process, oversaw reform to the Hatch-Waxman Act, and was chief architect and author of the original preemption argument used against private citizens in litigation. Troy's efforts served to protect pharmaceutical companies and erode consumers' rights and protections.

Preemption and Congressman Hinchey

In the early 2000s, the FDA started filing amicus curiae “friend of the court” briefs  intervening on behalf of the pharmaceutical industry. It seemed whenever drug companies faced civil suits regarding their products' harmful side effects--side effects concealed from prescribing physicians and consumers--Troy worked hard to protect drug makers. These FDA briefs argued that because the products were FDA approved, such lawsuits were “preempted” by federal law and should be dismissed. The briefs suggested that, even if drug manufacturer wanted to warn unsuspecting consumers, the FDA wouldn’t let companies update their warning labels if the FDA didn’t agree. Further, these briefs supported the notion that the FDA is the ultimate authority on product safety and effectiveness and related drug labels. Troy's work at the FDA promoted the view that juries and judges should not second-guess decisions made by FDA scientists and experts.

Many civil lawsuits were tossed out by judges across the country who believed the FDA is the final authority on drug labeling. This effort essentially gave drug companies, such as Pfizer, a free pass when their products caused harm and death. In my husband’s case, Witczak v Pfizer, Minnesota Chief Justice James Rosenbaum overturned FDA-supported pre-emption arguments in their entirety stating, “The FDA has no authority to declare, ipse dixit, that a label is false and misleading.” Judge Rosenbaum went on to state, "It is obvious that state failure-to-warn laws do not pressure manufacturers to include false or invalid warnings. Instead, they give drug manufacturers every incentive to warn of real, known risks as soon as they are discovered -- even before any FDA action."

During a December 15, 2003, presentation titled, “The Case for Preemption,” at the annual Drug and Medical Device Litigation conference for in-house counsel and trial attorneys, Troy asked the audience to contact him if they had a case in which the FDA could help. Clearly Troy's "help" was not meant to assist consumers. Fortunately, my talented attorney clandestinely attended Troy's lunchtime presentation long enough to hear Troy declare, “we have to pick our shots so make it sound like a Hollywood pitch."

Of course, considering the FDA is supposed to serve and protect the public, not drug companies, we took Troy's "Hollywood pitch" speech to New York Congressman Maurice Hinchey. Congressman Hinchey then conducted an investigation of Dan Troy.  “For the first time in history,” Hinchey said, “FDA’s Chief Counsel is actively soliciting private industrial company lawyers to bring him cases in which FDA can intervene in support of drug and medical device manufacturers.” Hinchey learned that Pfizer was one of Dan Troy’s previous clients at Wiley, Rein, & Fielding and that in the three years before Troy's appointment as FDA Chief Counsel, Pfizer paid the law firm more than $350K for services provided directly by Troy.

Lo and behold, a few years later Malcolm Wheeler, an attorney for Pfizer, called Troy and requested that the FDA get involved in a Zoloft-induced suicide lawsuit filed against them by a private citizen in California. The FDA, through the Department of Justice which represents the FDA in court, filed a brief in support of Pfizer. Together, they stated the plaintiff’s claims were preempted by federal law. This case was then dismissed on preemption. Case in point: money buys influence and power, which is then used against those who have neither.

By 2004 with much damage done, Troy resigned from the FDA and headed straight to the Sidley Austin law firm where he continued working on lucrative pharmaceutical company litigation. Recognizing Troy's long history as a drug company protector, GlaxoSmithKline hired Troy as its top legal General Counsel in 2008. Andrew Witty, GSK’s then chief executive officer, said of hiring Troy, “Dan’s wealth of experience in the regulatory legislative area will be of enormous benefit to us, and ultimately to patients.”

Hmmm...Troy helps patients? Tell that to my friend Wendy Dolin and thousands of other families whose loved ones have suffered or died from Paxil and other SSRIs. Who needs Hollywood movie pitches when the revolving door between pharmaceutical companies and government regulators provides such real-life drama?

With Troy at the helm, it will be interesting to see what arguments GSK has ready to pull out of its back pocket when appealing a verdict for Dolin. Time will tell. But today one thing is certain: The fox continues to guard the hen house.

Kim Witczak

Antidepressant Induced Suicide - The Mothers and Wives

Watch.

Listen.

Learn.


They have the pharmaceutical industry, medicine regulators and psychiatry to thank for their grief.

There is nothing left for me to say.

Leonie Fennell - Ireland

For Shane
Causation: Cipramil (Celexa, citalopram)

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Stephanie McGill Lynch - Ireland

For Jake

Causation: Prozac (fluoxetine)

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Mathy Downing - USA
For Candace
Causation: Zoloft (sertraline, Lustral)





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Wendy Dolin - USA
For Stewart
Causation: Paxil (paroxetine, Seroxat)

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Kim Witczak - USA

For Woody

Causation: Zoloft (sertraline, Lustral)

Bob Fiddaman

Antidepressant Suicide Link in the News Again

First, three short summaries with links to the original sources.



COMPLETED SUICIDE: Andrew Farrow, 48-year-old, of Festival Close, Devizes, UK.

"A report from his GP stated he had been on anti-depressants for two weeks before he died as ongoing difficulties with his paralysis had made him feel depressed and hopeless.

"On the day of this death he requested a hospital stay again but it was decided that it was not required at that time and for treatment to continue at home. He was told that his request would be discussed at case review meeting later that day.

"He agreed to a medication review and a second visit later the same day.

"It was on this second visit that Mr Farrow’s body was found on the evening of July 7. When police entered his flat vodka bottles and tablet packets were found."

Swindon Advertiser - 15 April 2015

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SUICIDE ATTEMPT: Australian actress, Paula Duncan, 43

"A few days later she began taking antidepressants, and it was during this time Duncan reveals she attempted to take her own life, with daughter Jessica finding her after a suicide attempt."

Daily Mail - 20 April 2015

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COMPLETED SUICIDE: Jeff Klein, 24, USA

"Jeff wondered if antidepressants might ease the anxiety he felt over quitting his job. A local psychiatrist recklessly prescribed one after a single, 45 minute session, and, eight days after taking his first pill, Jeff told us he was having suicidal thoughts. Two months later, after two additional antidepressants had been prescribed, Jeff was gone.

"A bright and vibrant young man with a loving family, a close circle of friends, and a passion for sports and politics fell prey to job-related situational anxiety. He was then put over the edge by his body's catastrophic chemical reaction to the introduction of an antidepressant. The enormity and unnecessary nature of our loss is beyond description."

The Journal News - April 23, 2015

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When I read stories like this my immediate reaction is one of two things.

1. The medication induced the suicide attempt
2. No efficacy was shown in the medication.

I'm trying desperately hard to come up with a third point because the first two would suggest that these drugs shouldn't be on the market!


Perversely, when stories like this appear we get more calls for better mental health care - when in actual fact, it could be argued that it was the 'care' that put the above in situations where they attempted or completed suicide.

There's really nothing more to add.

For balance, I'll leave the last word to Irish psychiatrist, Patricia Casey.

Bob Fiddaman

Antidepressant Aggression, the MHRA Perspective

Last month I wrote a piece entitled, 'Antidepressants: The Power To Harm' which, basically, highlighted the Japanese drug regulator and the Japanese Ministry of Health, Labour and Welfare. [MHLW]

A 2009 review of antidepressants in Japan [1] resulted in MHLW issuing an alert to patients and their families to pay due attention to changes in patient condition during the course of treatment. On May 8, 2009, MHLW required marketing authorization holders [MAHs] to revise precautions in package inserts.

They found that causality between SSRi antidepressants and harmful behavior to others could not be denied in 2 cases of reported adverse reactions associated with fluvoxamine maleate and 2 cases of reported adverse reactions associated with paroxetine hydrochloride hydrate. For the remaining 35 cases of adverse reactions, causality between the drug and adverse reactions was considered unknown.

After reading this review I wrote to the British drug regulator, the MHRA.

Dear Sir/Madam,

I would like to know if the MHRA have any information, be it by study or review, regarding SSRi adverse reactions of aggression including harmful behavior to others (including injury). 

Please state if any alerts to patients and their families have ever been sent out regarding this issue.

Please state if any revision to package inserts have been made regarding this issue.

The MHRA have now answered and, it has to be said, it would appear that patient welfare is far higher on the list in Japan than it is in the UK.

First off, their cover letter to me.

I like the final paragraph...

"The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder."

I'm not going to bother asking the MHRA if I am allowed to republish, what I deem as, important safety information regarding SSRi use and aggression. They've used this threat before with me, see 'The evidence, however, is clear, the Seroxat scandal'. [2]


The MHRA have provided me with 30 pages of information with regard to the question I put to them, much of which is redacted [blacked out]

It would be pointless to post all 30 pages but those wishing to scrutinize can request a copy from me by emailing me.

Some points...

The information sent to me from the MHRA was taken from meetings that occurred between the years 1996 and 2001.

Contrast that to the Japanese information on SSRis and aggression. Their information is more up to date, in fact it is 8 years more up to date than what the MHRA have given me.

The MHRA, or the data they sent me, points to two SSRis causing aggression. Fluoxetine and Paroxetine, namely, Prozac and Seroxat (Paxil)

Remarkably these findings of aggression with Prozac and Seroxat use have been played down by claiming that the reporting rates of aggression increased when stories started appearing in the media. The MHRA do not balance this claim, for instance, (i) the reporting rates may have increased because patients may not have known that the MHRA actually collected such reports and (ii) consumers may have attributed their aggression and suicidal thinking to their illness, opposed to it being a possible adverse reaction to the drug they were taking.

Page 23 of the 30 page document they sent me is quite telling. [Fig 1]

Fig 1

So, when there is a clear sign that aggression is occurring during Prozac and/or Seroxat treatment it has, if you believe the above, nothing to do with the drug/s, it is possibly a "separate event from the underlying illness" or it's "part of a discontinuation syndrome", or maybe the aggression has appeared because of the removal of the therapeutic benefits of the drug.

Once again, the suggestion of media reports on antidepressants and the suicide link are mentioned. It's almost as if they [the committees who reviewed the aggression link in SSRi use] are putting something in place. Rather than look at the blindingly obvious problem they chose to deflect and lay the blame on intense media reporting.

Now, contrast this stance with those of the Japanese.

2009:

The Japanese Ministry of Health, Labour and Welfare issued an alert to patients and their families to pay due attention to changes in patient condition during the course of treatment. On May 8, 2009, MHLW required marketing authorization holders [MAHs] to revise precautions in package inserts.

The above was based on a review where they found an association with SSRis and aggression.

No pussy-footing around, no blaming the media, no blaming a discontinuation syndrome or no blaming the underlying illness causing the aggression. Moreover, the  Japanese Ministry of Health, Labour and Welfare sent an alert out to patients and their families about their findings.

I don't know about you but if one regulator flags a warning about patients becoming aggressive on antidepressants then other regulators around the world should act promptly.

Judging by the material sent to me by the MHRA, they put the SSRi aggression link to bed in 2002 and have done nothing more about it since then.

The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.

Oh really?



Bob Fiddaman


1. 2009 Selective Serotonin Reuptake Inhibitors and Aggression [Japanese Review] [Link]
2. The evidence, however, is clear, the Seroxat scandal. [Link]

Not Recommended

People that know me pretty much know that the words 'not recommended' mean absolutely nothing to me.

When used on drug information leaflets, 'not recommended' serves as a reminder to prescribing physicians that the drug they are about to prescribe to the patient is not recommended for them, be it because they don't have an illness that the drug is indicated to treat or that it could be potentially dangerous.

Last week British tabloid, The Mirror, ran with an article about pensioner Ron Sheppard.

Sheppard had been campaigning for almost 22 years to force changes to the way a steroid [Depo-Medrone] was used on millions of patients. And now, writes The Mirror, "drug company Pfizer has applied to UK drug regulators to change the drug labelling.

"It is likely to be switched from “not recommended” for use in epidurals to “must not be used”."

22 years on and now Pfizer decide that the drug must not be used in epidurals. It would appear that Pfizer know the difference between “not recommended” and “must not be used”, either that or they fear future lawsuits.

“Not recommended” is simply not good enough, particularly when it comes to children being prescribed antidepressants.

Would it be practical for the likes of antidepressant manufacturers to change the patient information leaflets for antidepressants from 'Not recommended for children' to 'Must not be used in children'?

The defence of the pharmaceutical industry has, for many years, been this 'not recommended' nonsense.

"It specifically states that our product is not recommended for use in children", is a line thrown around when pharmaceutical products have been implicated in child/teen suicides. Hidden in their defence, however, are facts that they have promoted the use of antidepressants in children - reps, armed with cash incentives or other lavish gifts have, for decades, persuaded doctors that  "not recommended" are just two words that have to appear on leaflets for legal reasons. A rep from Glaxo would have told doctors that Paxil was safe to use in kids...it was the other SSRi's that were unsafe. A rep from Lundbeck would have told doctors that Celexa was safe to use and that it was other SSRis that were dangerous.

That's how marketing works and it was those two words that allowed pharmaceutical companies to get away with it for decades.

If a rep had visited a doctor and offered him cash incentives to prescribe a drug that said “must not be used”, would the outcome have been the same?

"Not recommended" can be written off as a legal requirement, it can be a discussion starter with a pharma rep and doctor, it can be twisted to convince the doctor that it's okay to prescribe adult drugs to children or drugs with a link to birth defects to pregnant mothers.

It's time to change all of that.

The following “must not be used” in children, adolescents and pregnant mothers.

Citalopram
Fluvoxamine
Escitalopram
Paroxetine
Sertraline
Fluoxetine

They “must not be used” to treat illnesses other than those indicated on the leaflet.

It doesn't take a rocket scientist to figure out why this has never been done.

'Not recommended' has helped the pharmaceutical industry get away with murder and, at the same time, earned them billions of dollars. Money over life.

Just a small example here.

Bob Fiddaman.

Antidepressant Use in Children

Antidepressant use in children.

It's a no-brainer.

Same as it is with adolescents and adults too.

Two videos to watch.






Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Irish Minister To Meet With Antidepressant Experts

Kathleen Lynch, the Irish minister responsible for mental health, has agreed to meet with former state pathologist Declan Gilsenan, Leonie Fennell, the mother of Shane Clancy, who killed a man and took his own life after a short time on Cipramil [Celexa], psychiatrist Prof David Healy, and a former government minister.

Gilsenan had earlier this month spoke about his concerns regarding the amount of suicides he had seen where the victim had recently started taking a course of antidepressant type medication.

Today's Irish Examiner writes:

He [Gilsenan] said in his 30-year experience carrying out postmortems, he had seen "too many suicides" after people had recently started taking the drugs. At Mr Clancy’s inquest, Dr Gilsenan testified there were "toxic" levels of citalopram (brand name Celexa or Cipramil) in Mr Clancy’s blood. 

This move by the Irish minister comes after many patient advocates, including Healy himself, have raised concerns about the antidepressant/suicide link to the British drug regulator, the MHRA. Years of campaigning and meetings with the MHRA have, it appears, fallen on deaf ears and the MHRA continue to give drugs, such as Cipramil, a clean bill of health.

Fennell, who has been threatened in the past by Irish psychiatrist Patricia Casey, hopes the meeting will give Lynch an insight into the lack of warnings provided with these medications.

It will be interesting to see if Kathleen Lynch takes this huge problem by the horns and actually does something about it. A meeting with pharmaceutical executives would be a start as would access to the raw data used in clinical trials to determining whether or not taking these drugs is proving to be more risky than beneficial.

My glass is half-empty on this but I applaud the efforts of Healy, Gilsenan and Fennell for bringing it to the attention of Lynch. It seems Ireland is waking up, my only hope is that Lynch doesn't, like the MHRA, hit the snooze button.




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Psychiatric Drugs In The Media

There's been quite a flurry of activity recently with regard to the mainstream media reporting on psychiatric drugs, particularly in the use of children. We had the UK first with a Channel 4 News Special.

 

Next we had the USA and ABC's flagship current affairs programme, 20/20, reporting on Foster care homes and the use of mind-altering drugs in children, some under the age of 1.

PART ONE

PART TWO

PART THREE

Then TV3's 60 Minutes from New Zealand reporting on the dangers of SSRi medication not only in children...but adults too. [No video but review can be read HERE]

I'd like to say the times are changin'...but there's a bloody long way to go.

Next week Ablechild's co-founders, Patricia Weathers and Sheila Matthews, appear on CNN with their take on the mass drugging of children.

There's a huge spanner been thrown into the works. The people are fighting back...in the name of those your drugs have harmed and killed.

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The Counterfeit Shyness Epidemic

A few UK newspapers ran with stories yesterday regarding future proposals in the DSM.

The updated DSM [The Diagnostic and Statistical Manual of Mental Disorders] is due in 2013 and those wacky white coated men have covered all bases when it comes to targeting children.

Not content with S.A.D. [Social Anxiety Disorder], the wannabe Gods have come up with O.D.D [Oppositional Defiant Disorder]

Let's just take a look at the acronyms used for each of these disorders. Sad and Odd.

According to the wisdom of these nutty professors, your child may have S.A.D. if he/she is quiet in the classroom, you know the kind of kid I'm talking about here, the one who chooses not to raise his/her hand and volunteer an answer. Yup, drug them.

On the other end of the scale we have O.D.D. These are the children, who unlike the S.A.D. individuals, choose to do the opposite. They talk back to 'adults' and may oppose what they are being asked/told to do.

For those in between these two labels, don't fear, you won't feel left out. Early intervention of "mental disorders" means you too can have a label just like your friends. Just tick a series of boxes and your destiny will be planned for you by the white coated soothsayers. Your parents will be informed, "Dear Mr and Mrs Jones, although the mental health screening of your child showed no apparent mental disorder, we feel, by the answers given in the screening survey, that your child has the early signs of psychosis. This may become full blown within the next five years or so. We highly recommend that they be monitored by our team.

Sounds absurd doesn't it? Did deep and you will find that this is already happening.

I foresee future disorders being invented, just so those DSM shills can report back to the pharmaceutical companies with cap in hand, "We did what you asked of us massa, all bases covered massa."

Gone are the days where children can have an imagination, if they are caught daydreaming in class, label them then drug them. If they answer a teacher back, label them and drug them. If they are seen to be mourning the loss of a parent, brother, sister, grandparent or friend, label them and drug them. Yup, another gem from the proposed DSM is "Depressive disorder". If a child mourns the loss of any of the above for longer than 6 months, label them and drug them.

Call me an old cynic if you want but isn't this push to drug children a reflection on decisions made by medicine regulators regarding SSRi's like Seroxat, Cipramil etc?

A while ago, the UK regulator, MHRA, made recommendations that antidepressants like Seroxat should not be given to children. That put a huge dent in the coffers for the pharmaceutical industry. Only way around this would seemingly be to invent a few more disorders. Hey Presto!... and the licence to print money starts all over again.

Don't expect the MHRA to intervene with the latest in the line of new mental disorders. They are spineless and, after all, wholly funded by the pharmaceutical industry. Give it about 10 years and they may send out warning letters to doctors regarding the medication used to treat children who are sad, mourning or just a little bit boisterous. They allow the pharmaceutical industry to make wads of cash before intervening, you see. Everyone, except your child, is a winner.

When the average person reads of the good deeds done by the pharmaceutical industry such as various donations to war-torn countries or vaccines to the poorer countries, it makes us sleep better at night, knowing that big pharma is really looking out for us. That is the image they like to portray, it's a confidence trick, one which they are past masters at.

Delve a little deeper and you may just find a more sinister reason behind the pharmaceutical industries apparent generosity.

As a child growing up I was always out playing games. I fear Hopscotch will now have rules attached. If your child lands on a crack in the pavement then they may just have a mental disorder... because those men in white coats want them to.

More coverage HERE and HERE




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ANTIDEPRESSANT SUICIDE VIDEO

SSRISTORIES.COM has a collection of 4,400+ news stories with the full media article available, mainly criminal in nature, that have appeared in the media (newspapers, TV, scientific journals) or that were part of FDA testimony in either 1991, 2004 or 2006, in which antidepressants are mentioned.

SSRi Stories is a great resource, here's just a small number of SSRi related suicides I have highlighted in this video.

http://ssristories.com/



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